Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-03-10 @ 6:17 PM
Study NCT ID:
NCT03637660
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2018-08-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013587', 'term': 'Syphilis'}], 'ancestors': [{'id': 'D014211', 'term': 'Treponemal Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010401', 'term': 'Penicillin G Benzathine'}], 'ancestors': [{'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ehooks@uabmc.edu', 'phone': '205-932-4204', 'title': 'Edward W. Hook, III', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through Day 31', 'eventGroups': [{'id': 'EG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1', 'otherNumAtRisk': 124, 'deathsNumAtRisk': 124, 'otherNumAffected': 98, 'seriousNumAtRisk': 124, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 109, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 94, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 106, 'numAffected': 106}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Proctocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Substance Induced Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Sided Facial Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Participants With a Serological Response by Month 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.06', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.03', 'pValueComment': 'P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.', 'estimateComment': 'The 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.', 'groupDescription': 'To assess the primary efficacy endpoint, the number and proportion of participants with a serological response by Month 6 and the 95% confidence interval were summarized overall and by treatment. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis for the primary objective was that the difference in proportion of participants with serological responses between the three-dose and one-dose groups was at least 10%', 'statisticalMethod': 'Farrington-Manning', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 180', 'description': 'Serological response to therapy by Month 6 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 6 visit window (i.e., scheduled visits up to and including the Month 6 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated:\n\n* 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 6 visit window compared to baseline, OR\n* RPR-negative at any visit prior to the end of the Month 6 visit window (i.e., seroreversion).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.'}, {'type': 'SECONDARY', 'title': 'Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Gender Identity : Man', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Gender Identity : Woman', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gender Identity : Trans male / trans man', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gender Identity : Trans female / trans woman', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gender Identity : Genderqueer / gender non-conforming', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gender Identity : Multiple', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gender Identity : Non-binary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gender Identity : Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gender Identity : Declined to respond', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Orientation : Heterosexual / straight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Orientation : Homosexual / gay / lesbian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Orientation: Bisexual', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Orientation : Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Orientation : Declined to respond', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Partner: Men', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Partner: Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Partner: Trans male/ trans man', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Partner: Trans female/ trans woman', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Partner: Multiple', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Partner: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Partner: Declined to respond', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sexual intercourse in past 60 days: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sexual intercourse in past 60 days: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sexual intercourse in past 60 days: Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse in past 60 days, Sites of exposure: Oral receptive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse in past 60 days, Sites of exposure: Oral active', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse in past 60 days, Sites of exposure: Rectal receptive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse in past 60 days, Sites of exposure: Rectal insertive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse in past 60 days, Sites of exposure: Genital/vaginal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse in past 60 days, condom or barrier for protection: Always', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse in past 60 days, condom or barrier for protection: Sometimes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse in past 60 days, condom or barrier for protection: Never', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any known exposures to an STD in the past 60 days: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any known exposures to an STD in the past 60 days: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any known exposures to an STD in the past 60 days: Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Diagnosed with gonorrhea in the past 60 days: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diagnosed with gonorrhea in the past 60 days: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Tested for gonorrhea in the past 14 days: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tested for gonorrhea in the past 14 days: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'If tested for gonorrhea in past 14 days, Test results: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If tested for gonorrhea in past 14 days, Test results: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Diagnosed with chlamydia in the past 60 days: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diagnosed with chlamydia in the past 60 days: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Tested for chlamydia in the past 14 days: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tested for chlamydia in the past 14 days: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'If tested for chlamydia in the past 14 days, Test results: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If tested for chlamydia in the past 14 days, Test results: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Diagnosed with any other STI in the past 60 days: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diagnosed with any other STI in the past 60 days: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Gender identity, sexual orientation, sexual partner, sex history in last 60 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.'}, {'type': 'SECONDARY', 'title': 'Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Days since last had sexual intercourse in the past 60 days (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.3', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '12.1', 'groupId': 'OG001'}]}]}, {'title': 'Days since last had sexual intercourse in the past 60 days (HIV-uninfected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.8', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'Days since last diagnosed with gonorrhea in the past 60 days (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'only one participant reported as diagnosed with gonorrhea, SD could not be calculated', 'groupId': 'OG000'}, {'value': '24.7', 'spread': '26.4', 'groupId': 'OG001'}]}]}, {'title': 'Days since last diagnosed with gonorrhea in the past 60 days (HIV-uninfected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '13.0', 'spread': 'NA', 'comment': 'only one participant reported as diagnosed with gonorrhea, SD could not be calculated', 'groupId': 'OG001'}]}]}, {'title': 'Days since last diagnosed with chlamydia in the past 60 days (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '21.6', 'groupId': 'OG001'}]}]}, {'title': 'Days since last diagnosed with chlamydia in the past 60 days (HIV-uninfected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.0', 'spread': 'NA', 'comment': 'only one participant reported as diagnosed with chlamydia, SD could not be calculated', 'groupId': 'OG001'}]}]}, {'title': 'Days since last diagnosed with any other STI in the past 60 days (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Days since last diagnosed with any other STI in the past 60 days (HIV-uninfected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Sex history in last 60 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.\n\nParticipants with unknown HIV status not included. Participants contributing to this outcome measure include those who answered yes to either having intercourse in the past 60 days or reported being diagnosed with at least one STI in the past 60 days.'}, {'type': 'SECONDARY', 'title': 'Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Total number of partners in the past 60 days (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Total number of partners in the past 60 days (HIV-uninfected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '9.7', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners (HIV-uninfected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Number of regular partners (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Number of regular partners (HIV-uninfected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Number of occasional partners (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Number of occasional partners (HIV-uninfected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Number of male partners (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Number of male partners (HIV-uninfected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '9.9', 'groupId': 'OG001'}]}]}, {'title': 'Number of female partners (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Number of female partners (HIV-uninfected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Sex history in last 60 days', 'unitOfMeasure': 'count of partners', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.\n\nParticipants with unknown HIV status not included. Participants contributing to this outcome measure include those who answered yes to either having intercourse in the past 60 days or reported being diagnosed with at least one STI in the past 60 days.'}, {'type': 'SECONDARY', 'title': 'Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Highest level of education completed: Did not complete high school', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Highest level of education completed: Completed high school', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Highest level of education completed: Completed junior college', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Highest level of education completed: Completed Completed college (undergraduate degree)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Completed graduate degree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Stage of syphilis: Early latent syphilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Stage of syphilis: Primary syphilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stage of syphilis: Secondary syphilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Prior syphilis history: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Highest level of education completed, stage of syphilis, prior syphilis history', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.'}, {'type': 'SECONDARY', 'title': 'Continuous Descriptive Statistics of Socio-epidemiologic Characterictics at Baseline Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'HIV-infected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.5', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '36.5', 'spread': '9.7', 'groupId': 'OG001'}]}]}, {'title': 'HIV-uninfected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.4', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '30.1', 'spread': '10.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Years of formal education', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.\n\nParticipants with unknown HIV status not included.'}, {'type': 'SECONDARY', 'title': 'Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Sex: Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sex: Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ethnicity: Not Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Ethnicity: Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ethnicity: Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Race: American Indian or Alaskan Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Race: Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Race: Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Race: Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Race: White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Race: Multi-Racial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Race: Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'HIV-uninfected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Sex, Ethnicity, Race', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.'}, {'type': 'SECONDARY', 'title': 'Continuous Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'HIV-infected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.5', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '36.5', 'spread': '9.7', 'groupId': 'OG001'}]}]}, {'title': 'HIV-uninfected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.4', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '30.1', 'spread': '10.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Age', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.\n\nParticipants with unknown HIV status not included.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Receive All Assigned Doses Within the Assigned Visit Windows', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was calculated based on 2-sided Pearson Chi-Square test. Difference in proportion was reported with the Wilson 95% CI', 'groupDescription': 'The number and proportion of participants who were compliant to the treatment, receiving all assigned doses within the assigned visit windows. The null hypothesis was no difference between two treatment groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The alternative hypothesis was that the two treatment groups were unequal.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Month 12', 'description': 'Compliance with study product will be defined as the participant received all assigned doses within the assigned visit windows. A participant is not adherent to study product if they miss at least one dose or receive at least one dose out of the visit window.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Report Jarisch-Herxheimer Reaction Manifestations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 2', 'description': 'Approximately 24 hours after Visit 1, participants were contacted and evaluated for symptoms of a JHR, which included fever, chills, myalgia, weakness, flushing, worsening of skin rash, tachycardia, heart palpitations, arthralgia, nausea, headache, and dizziness, including time of onset and time of resolution of each symptom reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serological Response by Month 6 Among Participants With or Without HIV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'HIV-infected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'HIV-uninfected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.05', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.07', 'pValueComment': 'P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) in HIV-infected participants by Farrington-Manning method with a 10% margin.', 'groupDescription': 'The number and proportion of participants with serological response by month 6 among participants with HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.', 'statisticalMethod': 'Farrington-Manning', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.'}, {'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.06', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.09', 'pValueComment': 'P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.', 'groupDescription': 'The number and proportion of participants with serological response by month 6 among participants without HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.', 'statisticalMethod': 'Farrington-Manning', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 180', 'description': 'Serological response to therapy by Month 6 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 6 visit window (i.e., scheduled visits up to and including the Month 6 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated:\n\n* 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 6 visit window compared to baseline, OR\n* RPR-negative at any visit prior to the end of the Month 6 visit window (i.e., seroreversion).\n\nSerological response to therapy by Month 6 was examined among participants with and without HIV infection,', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.\n\nParticipants with unknown HIV status not included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serological Response (Defined as Either a 4-fold or Greater Decline in Rapid Plasma Regain (RPR) Titer Compared to Baseline or Being Rapid Plasma Regain -Negative [Seroreversion]) by Month 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.05', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.04', 'pValueComment': 'P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.', 'estimateComment': 'The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.', 'groupDescription': 'The number and proportion of participants with a serological response by Month 12 and the 95% confidence interval (CI) were summarized overall and by treatment. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.', 'statisticalMethod': 'Farrington-Manning', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through month 12', 'description': 'Serological response to therapy by Month 12 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 12 visit window (i.e., scheduled visits up to and including the Month 12 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 12 visit window) were evaluated:\n\n* 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 12 visit window compared to baseline, OR\n* RPR-negative at any visit prior to the end of the Month 12 visit window (i.e., seroreversion).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serological Response by Month 12 Among Subjects With or Without HIV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'HIV-infected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'HIV-uninfected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.06', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.05', 'pValueComment': 'P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) in HIV-infected participants by Farrington-Manning method with a 10% margin.', 'estimateComment': 'The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) among HIV-infected participants by Farrington-Manning method with a 10% margin.', 'groupDescription': 'The number and proportion of participants with a serological response by month 12 among participants with HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.', 'statisticalMethod': 'Farrington-Manning', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.'}, {'pValue': '0.064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.03', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.11', 'pValueComment': 'P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.', 'estimateComment': 'The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.', 'groupDescription': 'The number and proportion of participants with a serological response by month 12 amont participants without HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.', 'statisticalMethod': 'Farrington-Manning', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through month 12', 'description': 'Serological response to therapy by Month 12 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 12 visit window (i.e., scheduled visits up to and including the Month 12 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated:\n\n* 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 12 visit window compared to baseline, OR\n* RPR-negative at any visit prior to the end of the Month 12visit window (i.e., seroreversion).\n\nSerological response to therapy by Month 12 was examined among participants with and without HIV infection,', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.'}, {'type': 'SECONDARY', 'title': 'Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Sexual intercourse since last visit: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sexual intercourse since last visit: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, sites of exposure: Oral receptive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, sites of exposure: Oral active', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, condom or barrier for protection: Always', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, condom or barrier for protection: Never', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any known exposures to syphilis since last visit: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Any known exposures to syphilis since last visit: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any known exposures to syphilis since last visit: Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any known exposures to another STD since last visit: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected'}, {'title': 'Non HIV-infected'}, {'title': 'Unknown HIV status'}]}, {'title': 'Any known exposures to another STD since last visit: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any known exposures to another STD since last visit: Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected'}, {'title': 'Non HIV-infected'}, {'title': 'Unknown HIV status'}]}, {'title': 'Since last visit, treated or require retreatment for syphilis apart from study treatment: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through week 1', 'description': 'Sex history since last visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.'}, {'type': 'SECONDARY', 'title': 'Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Sexual intercourse since last visit: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sexual intercourse since last visit: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, sites of exposure: Oral receptive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, sites of exposure: Oral active', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '3If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, condom or barrier for protection: Always', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'If yes to sexual intercourse since last visit, condom or barrier 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'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Any known exposures to syphilis since last visit: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any known exposures to syphilis since last visit: Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Any known exposures to another STD since last visit: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any known exposures to another STD since last visit: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any known exposures to another STD since last visit: Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Since last visit, treated or require retreatment for syphilis apart from study treatment: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Non HIV-infected', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unknown HIV status', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Since last visit, if treated for syphilis how was retreatment need determined: Known re-exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected'}, {'title': 'Non HIV-infected'}, {'title': 'Unknown HIV status'}]}, {'title': 'Since last visit, if treated for syphilis how was retreatment need determined: Return worsening sx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected'}, {'title': 'Non HIV-infected'}, {'title': 'Unknown HIV status'}]}, {'title': 'Since last visit, if treated for syphilis how was retreatment need determined: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'HIV-infected'}, {'title': 'Non HIV-infected'}, {'title': 'Unknown HIV status'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through month 12', 'description': 'Sex history since last visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.'}, {'type': 'SECONDARY', 'title': 'Continuous Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Total number of partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Total number of partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (Non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through week 1', 'description': 'Sex history since last visit', 'unitOfMeasure': 'count of partners', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.\n\nParticipants with unknown HIV status not included.'}, {'type': 'SECONDARY', 'title': 'Continuous Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Total number of partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Total number of partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (Non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through week 2', 'description': 'Sex history since last visit', 'unitOfMeasure': 'count of partners', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.\n\nParticipants with unknown HIV status not included.'}, {'type': 'SECONDARY', 'title': 'Continuous Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Total number of partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Total number of partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (Non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through month 1', 'description': 'Sex history since last visit', 'unitOfMeasure': 'count of partners', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.\n\nParticipants with unknown HIV status not included.'}, {'type': 'SECONDARY', 'title': 'Continuous Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Total number of partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Total number of partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '9.2', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (Non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through month 3', 'description': 'Sex history since last visit', 'unitOfMeasure': 'count of partners', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.\n\nParticipants with unknown HIV status not included.'}, {'type': 'SECONDARY', 'title': 'Continuous Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Total number of partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Total number of partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (Non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through month 6', 'description': 'Sex history since last visit', 'unitOfMeasure': 'count of partners', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.\n\nParticipants with unknown HIV status not included.'}, {'type': 'SECONDARY', 'title': 'Continuous Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Total number of partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Total number of partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (Non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through month 9', 'description': 'Sex history since last visit', 'unitOfMeasure': 'count of partners', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.\n\nParticipants with unknown HIV status not included.'}, {'type': 'SECONDARY', 'title': 'Continuous Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'OG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}], 'classes': [{'title': 'Total number of partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'Total number of partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Number of new partners since last visit (non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Number of continuing partners since last visit (Non HIV-infected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through month 12', 'description': 'Sex history since last visit', 'unitOfMeasure': 'count of partners', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.\n\nParticipants with unknown HIV status not included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 million units (MU) of Benzathine penicillin G (BPG) intramuscularly on Day 1\n\nBenzathine Penicillin: BPG will be administered as a deep intramuscular injection in the upper, outer quadrant of the buttock.'}, {'id': 'FG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 million units (MU) of Benzathine penicillin G (BPG) intramuscularly weekly for three successive weeks\n\nBenzathine Penicillin: BPG will be administered as a deep intramuscular injection in the upper, outer quadrant of the buttock.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '43'}]}]}], 'recruitmentDetails': 'Participants were aged 18 years or older with untreated early syphilis recruited from the communities at large around the ten clinical sites. Participants were enrolled between 31OCT2018 and 03MAR2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'One Dose BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly on Day 1'}, {'id': 'BG001', 'title': 'Three Doses BPG 2.4 MU', 'description': '2.4 MU of BPG intramuscularly weekly for three successive weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '34.4', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '35.0', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Highest Level of Education Completed', 'classes': [{'categories': [{'title': 'Did Not Complete High School', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Completed High School', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': 'Completed Junior College', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Completed College (Undergraduate Degree)', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Completed Graduate Degree', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stage of Syphilis', 'classes': [{'categories': [{'title': 'Early Latent Syphilis', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Primary Syphilis', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Secondary Syphilis', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': "Missing 'Stage of Syphilis'", 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Syphilis Staging:\n\nEarly latent - current reactive serologic tests for syphilis (STS) and a documented non-reactive STS, or documented sexual exposure to an individual known to have syphilis diagnosed within the last 12 months.\n\nPrimary - presence of an ulcerative lesion at a potential site of inoculation or by darkfield, acceptable polymerase chain reaction, or direct fluorescence antibody-T. pallidum positive ulcers.\n\nSecondary - classical palmar/plantar rash, condylomata lata, mucous patches, etc. or by darkfield, acceptable PCR, or DFA-TP positive lesions.', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Syphilis History', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Years of Formal Education', 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '14.0', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '14.0', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-22', 'size': 765341, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-23T13:33', 'hasProtocol': True}, {'date': '2022-12-22', 'size': 2608743, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-23T13:34', 'hasProtocol': False}, {'date': '2019-05-02', 'size': 533564, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-06-13T13:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09-19', 'completionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2018-08-16', 'resultsFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-07', 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants With a Serological Response by Month 6.', 'timeFrame': 'Day 1 to Day 180', 'description': 'Serological response to therapy by Month 6 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 6 visit window (i.e., scheduled visits up to and including the Month 6 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated:\n\n* 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 6 visit window compared to baseline, OR\n* RPR-negative at any visit prior to the end of the Month 6 visit window (i.e., seroreversion).'}], 'secondaryOutcomes': [{'measure': 'Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire', 'timeFrame': 'Day 1', 'description': 'Gender identity, sexual orientation, sexual partner, sex history in last 60 days'}, {'measure': 'Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire', 'timeFrame': 'Day 1', 'description': 'Sex history in last 60 days'}, {'measure': 'Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire', 'timeFrame': 'Day 1', 'description': 'Highest level of education completed, stage of syphilis, prior syphilis history'}, {'measure': 'Continuous Descriptive Statistics of Socio-epidemiologic Characterictics at Baseline Collected Via a Study-specific Questionnaire', 'timeFrame': 'Day 1', 'description': 'Years of formal education'}, {'measure': 'Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire', 'timeFrame': 'Day 1', 'description': 'Sex, Ethnicity, Race'}, {'measure': 'Continuous Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire', 'timeFrame': 'Day 1', 'description': 'Age'}, {'measure': 'The Number of Participants Who Receive All Assigned Doses Within the Assigned Visit Windows', 'timeFrame': 'Through Month 12', 'description': 'Compliance with study product will be defined as the participant received all assigned doses within the assigned visit windows. A participant is not adherent to study product if they miss at least one dose or receive at least one dose out of the visit window.'}, {'measure': 'The Number of Participants Who Report Jarisch-Herxheimer Reaction Manifestations', 'timeFrame': 'Day 1 through Day 2', 'description': 'Approximately 24 hours after Visit 1, participants were contacted and evaluated for symptoms of a JHR, which included fever, chills, myalgia, weakness, flushing, worsening of skin rash, tachycardia, heart palpitations, arthralgia, nausea, headache, and dizziness, including time of onset and time of resolution of each symptom reported.'}, {'measure': 'Number of Participants With Serological Response by Month 6 Among Participants With or Without HIV Infection', 'timeFrame': 'Day 1 to Day 180', 'description': 'Serological response to therapy by Month 6 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 6 visit window (i.e., scheduled visits up to and including the Month 6 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated:\n\n* 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 6 visit window compared to baseline, OR\n* RPR-negative at any visit prior to the end of the Month 6 visit window (i.e., seroreversion).\n\nSerological response to therapy by Month 6 was examined among participants with and without HIV infection,'}, {'measure': 'Number of Participants With Serological Response (Defined as Either a 4-fold or Greater Decline in Rapid Plasma Regain (RPR) Titer Compared to Baseline or Being Rapid Plasma Regain -Negative [Seroreversion]) by Month 12.', 'timeFrame': 'Through month 12', 'description': 'Serological response to therapy by Month 12 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 12 visit window (i.e., scheduled visits up to and including the Month 12 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 12 visit window) were evaluated:\n\n* 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 12 visit window compared to baseline, OR\n* RPR-negative at any visit prior to the end of the Month 12 visit window (i.e., seroreversion).'}, {'measure': 'Number of Participants With Serological Response by Month 12 Among Subjects With or Without HIV Infection', 'timeFrame': 'Through month 12', 'description': 'Serological response to therapy by Month 12 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 12 visit window (i.e., scheduled visits up to and including the Month 12 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated:\n\n* 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 12 visit window compared to baseline, OR\n* RPR-negative at any visit prior to the end of the Month 12visit window (i.e., seroreversion).\n\nSerological response to therapy by Month 12 was examined among participants with and without HIV infection,'}, {'measure': 'Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through week 1', 'description': 'Sex history since last visit.'}, {'measure': 'Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through week 2', 'description': 'Sex history since last visit.'}, {'measure': 'Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through month 1', 'description': 'Sex history since last visit.'}, {'measure': 'Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through month 3', 'description': 'Sex history since last visit.'}, {'measure': 'Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through month 6', 'description': 'Sex history since last visit.'}, {'measure': 'Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through month 9', 'description': 'Sex history since last visit.'}, {'measure': 'Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through month 12', 'description': 'Sex history since last visit.'}, {'measure': 'Continuous Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through week 1', 'description': 'Sex history since last visit'}, {'measure': 'Continuous Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through week 2', 'description': 'Sex history since last visit'}, {'measure': 'Continuous Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through month 1', 'description': 'Sex history since last visit'}, {'measure': 'Continuous Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through month 3', 'description': 'Sex history since last visit'}, {'measure': 'Continuous Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through month 6', 'description': 'Sex history since last visit'}, {'measure': 'Continuous Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through month 9', 'description': 'Sex history since last visit'}, {'measure': 'Continuous Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire', 'timeFrame': 'Through month 12', 'description': 'Sex history since last visit'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Benzathine penicillin G', 'Early Syphillis', 'HIV', 'Phase 4'], 'conditions': ['Syphilis']}, 'referencesModule': {'references': [{'pmid': '40902161', 'type': 'DERIVED', 'citation': 'Hook EW 3rd, Dionne JA, Workowski K, McNeil CJ, Taylor SN, Batteiger TA, Dombrowski JC, Mayer KH, Sena AC, Hamill MM, Wiesenfeld HC, Zhu C, Perlowski C, Mejia-Galvis JE, Newman LM. One Dose versus Three Doses of Benzathine Penicillin G in Early Syphilis. N Engl J Med. 2025 Sep 4;393(9):869-878. doi: 10.1056/NEJMoa2401802.'}, {'pmid': '39946129', 'type': 'DERIVED', 'citation': 'Dionne JA, Zhu C, Mejia-Galvis J, Workowski K, Batteiger TA, Dombrowski JC, Mayer KH, McNeil CJ, Sena AC, Taylor S, Wiesenfeld HC, Hamill MM, Perlowski C, Hook EW 3rd. Jarisch-Herxheimer Reaction After Benzathine Penicillin G Treatment in Adults With Early Syphilis: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459490. doi: 10.1001/jamanetworkopen.2024.59490.'}, {'pmid': '38124508', 'type': 'DERIVED', 'citation': 'Dionne JA, Giacani L, Tamhane A, Workowski K, Lieberman NAP, Greninger AL, Perlowski C, Newman L, Hook EW 3rd. Prevalence and Predictors of Oral Treponema pallidum Detection by Quantitative Polymerase Chain Reaction in Early Syphilis. J Infect Dis. 2024 Jun 14;229(6):1628-1636. doi: 10.1093/infdis/jiad582.'}, {'pmid': '35067599', 'type': 'DERIVED', 'citation': 'Dionne-Odom J, Workowski K, Perlowski C, Taylor SN, Mayer KH, McNeil CJ, Hamill MM, Dombrowski JC, Batteiger TA, Sena AC, Wiesenfeld HC, Newman L, Hook EW 3rd. Coinfection With Chlamydial and Gonorrheal Infection Among US Adults With Early Syphilis. Sex Transm Dis. 2022 Aug 1;49(8):e87-e89. doi: 10.1097/OLQ.0000000000001605. Epub 2022 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 4, randomized, open-label, multicenter trial to evaluate the efficacy of a single injected dose of Benzathine Penicillin G (BPG) 2.4 MU (Arm 1) compared to three successive weekly injected doses of BPG 2.4 MU (Arm 2) for treatment of early syphilis in human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects. The study will enroll 560 adults (to achieve 420 evaluable subjects) aged 18 years or older with untreated early syphilis (primary, secondary, or early latent). It will be conducted at 9 sites in the US and last for 48 months with patient participation duration of 12 months. The primary objective is to compare the serological response to therapy in subjects with early (primary, secondary, or early latent) syphilis treated with Benzathine Penicillin G (BPG) 2.4 million units (MU) once or weekly for three successive weeks.', 'detailedDescription': 'This is a phase 4, randomized, open-label, multicenter trial to evaluate the efficacy of a single injected dose of Benzathine Penicillin G (BPG) 2.4 MU (Arm 1) compared to three successive weekly injected doses of BPG 2.4 MU (Arm 2) for treatment of early syphilis in human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects. The study will enroll 560 adults (to achieve 420 evaluable subjects) aged 18 years or older with untreated early syphilis (primary, secondary, or early latent). It will be conducted at 9 sites in the US and last for 48 months with patient participation duration of 12 months. The primary objective is to compare the serological response to therapy in subjects with early (primary, secondary, or early latent) syphilis treated with Benzathine Penicillin G (BPG) 2.4 million units (MU) once or weekly for three successive weeks. The secondary objectives are: 1) to determine if the difference in response to therapy between treatment arms by Month 6 differs among subjects with or without HIV infection; 2) to determine the impact of multiple BPG injected doses on subject compliance with study product and adherence to the corresponding scheduled visits; 3) to determine the incidence and manifestations of the Jarisch-Herxheimer reaction among subjects treated for early syphilis with BPG; 4) to collect prospective data up to Month 12 on the serological response to therapy in subjects treated for early syphilis with either BPG regimen; 5) to compare epidemiological characteristics of early syphilis among subjects with or without HIV infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is aged 18 years or older.\n2. Subject has provided informed consent.\n3. Subject has untreated primary\\*, secondary\\*\\*, or early latent\\*\\*\\* syphilis.\n\n \\*Primary syphilis is characterized by the presence of an ulcerative lesion at a potential site of inoculation (while classically solitary, shallow, painless and with an indurated, clean base, primary lesions may be multiple, may vary considerably in appearance, and/or may not be painless) or by darkfield, acceptable polymerase chain reaction (PCR), or direct fluorescence antibody-T. pallidum (DFA-TP) positive ulcers.\n\n \\*\\*Secondary syphilis is characterized by classical palmar/plantar rash, condylomata lata, mucous patches, etc. or by darkfield, acceptable PCR, or DFA-TP positive lesions.\n\n \\*\\*\\*Early latent syphilis is characterized by current reactive serologic tests for syphilis (STS) and a documented non-reactive STS, or documented sexual exposure to an individual known to have primary, secondary, or early latent syphilis diagnosed within the last 12 months.\n4. Subject either has a newly reactive non-treponemal test (such as an RPR test) or a history of syphilis and a current increase in RPR titer of two or more dilutions (i.e., four-fold).\n5. If subject is of childbearing potential, subject has a negative urine or serum pregnancy test.\n6. Subject is willing to have an human immunodeficiency virus (HIV) test, participate in HIV counseling, and return to clinic for follow-up.\n7. In the opinion of the investigator, subject is able and willing to comply with study procedures, including receipt of three Benzathine Penicillin G (BPG) injected doses if randomized to Arm 2.\n8. If female, subject must be of non-childbearing potential\\* or must be using an acceptable method of birth control\\*\\* to avoid becoming pregnant.\n\n * Non-childbearing potential is defined as being post-menopausal for at least 1 year, status after bilateral tubal ligation, or status after bilateral oophorectomy, or status after hysterectomy.\n\n * Subject must agree to avoid becoming pregnant by using one of the following acceptable methods of birth control for the entire duration of participation in the trial:\n\n * Intrauterine contraceptive device; OR\n * Oral contraceptives; OR\n * Hormonal injections; OR\n * Hormonal implants; OR\n * Contraceptive patches; OR\n * Monogamous relationship with vasectomized partner; OR\n * Exclusively same-sex relationships; OR\n * Use of condoms by the male partner; OR\n * Abstinence\n\nExclusion Criteria:\n\n1. Subject previously enrolled in this trial.\n2. Subject has latent syphilis of unknown duration, late latent syphilis, or evidence of neurosyphilis, including ocular syphilis.\\*\n\n \\*e.g., eye pain/redness, recent ocular change, and/or changes in visual acuity\n3. Subject has a known or suspected allergy or hypersensitivity to penicillin or other beta-lactam antibiotics.\n4. Subject has a known or suspected sexually transmitted infection (STI) other than syphilis requiring treatment with a drug active against T. pallidum.\n5. Subject has used antibiotics\\* active against T. pallidum in the preceding 30 days.\n\n \\*Note: the use of antimicrobials known to NOT be effective against T. pallidum (e.g., quinolones, sulfonamides, trimethoprim, metronidazole, spectinomycin) will be allowed.\n6. Subject has suspected or known ongoing drug use that might interfere with study participation and follow-up treatment.\n7. Subject is breastfeeding.\n8. Subject has used an investigational drug in the past 30 days that might interfere with safety or efficacy assessment.\n\n \\*If the subject has used any investigational drugs in the past 30 days, contact the Principal Investigator, Division of Microbiology and Infectious Diseases (DMID) Clinical Project Manager, DMID Medical Officer, and FHI 360 to confirm eligibility.\n9. Subject has any other condition that, in the opinion of the investigator, would interfere with participation in the study.'}, 'identificationModule': {'nctId': 'NCT03637660', 'briefTitle': 'Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase 4 Comparative Trial of Benzathine Penicillin G 2.4 Million Units Administered as a Single Dose Versus Three Successive Weekly Doses for Treatment of Early Syphilis in Subjects With or Without HIV Infection', 'orgStudyIdInfo': {'id': '17-0101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '2.4 million units (MU) of Benzathine penicillin G (BPG) intramuscularly on Day 1, n=280', 'interventionNames': ['Drug: Benzathine Penicillin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '2.4 million units (MU) of Benzathine penicillin G (BPG) intramuscularly weekly for three successive weeks, n=280', 'interventionNames': ['Drug: Benzathine Penicillin']}], 'interventions': [{'name': 'Benzathine Penicillin', 'type': 'DRUG', 'description': 'BPG will be administered as a deep intramuscular injection in the upper, outer quadrant of the buttock.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham School of Medicine - Infectious Disease', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital Midtown - Emory Clinic Infectious Diseases', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine - Infectious Diseases', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bayview Medical Center - Infectious Diseases', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Fenway Health - The Fenway Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27701-3720', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina School of Medicine - Center for Infectious Diseases', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health - Infectious Diseases', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Magee Women's Hospital of UPMC - Reproductive Infectious Disease Research", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98104-2433', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington - Harborview Medical Center - Center for AIDS and STD', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}