Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT00183456
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clatkin@jhsph.edu', 'title': 'Carl Latkin, PhD', 'organization': 'Johns Hopkins Bloomberg School of Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.', 'otherNumAtRisk': 85, 'otherNumAffected': 0, 'seriousNumAtRisk': 85, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.', 'otherNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.', 'otherNumAtRisk': 329, 'otherNumAffected': 0, 'seriousNumAtRisk': 329, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Non-randomized Baseline Index Participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.', 'otherNumAtRisk': 248, 'otherNumAffected': 0, 'seriousNumAtRisk': 248, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '277', 'groupId': 'OG002'}, {'value': '174', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.'}, {'id': 'OG001', 'title': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.'}, {'id': 'OG002', 'title': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.'}, {'id': 'OG003', 'title': 'Non-randomized Baseline Index Participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.63', 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of participants that had 2 or more sex partners in the past 90 days.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '277', 'groupId': 'OG002'}, {'value': '173', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.'}, {'id': 'OG001', 'title': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.'}, {'id': 'OG002', 'title': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.'}, {'id': 'OG003', 'title': 'Non-randomized Baseline Index Participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.68', 'ciLowerLimit': '1.22', 'ciUpperLimit': '5.89', 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '185', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.'}, {'id': 'OG001', 'title': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.'}, {'id': 'OG002', 'title': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.'}, {'id': 'OG003', 'title': 'Non-randomized Baseline Index Participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.84', 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '184', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.'}, {'id': 'OG001', 'title': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.'}, {'id': 'OG002', 'title': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.'}, {'id': 'OG003', 'title': 'Non-randomized Baseline Index Participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.82', 'ciLowerLimit': '1.41', 'ciUpperLimit': '5.64', 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.'}, {'id': 'OG001', 'title': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.'}, {'id': 'OG002', 'title': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.'}, {'id': 'OG003', 'title': 'Non-randomized Baseline Index Participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.68', 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 month', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.'}, {'id': 'OG001', 'title': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.'}, {'id': 'OG002', 'title': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.'}, {'id': 'OG003', 'title': 'Non-randomized Baseline Index Participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.25', 'ciUpperLimit': '0.87', 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.'}, {'id': 'OG001', 'title': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.'}, {'id': 'OG002', 'title': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.'}, {'id': 'OG003', 'title': 'Non-randomized Baseline Index Participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '0.21', 'ciUpperLimit': '0.77', 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.'}, {'id': 'OG001', 'title': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.'}, {'id': 'OG002', 'title': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.'}, {'id': 'OG003', 'title': 'Non-randomized Baseline Index Participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.79', 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.'}, {'id': 'OG001', 'title': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.'}, {'id': 'OG002', 'title': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.'}, {'id': 'OG003', 'title': 'Non-randomized Baseline Index Participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.64', 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '291', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.'}, {'id': 'OG001', 'title': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.'}, {'id': 'OG002', 'title': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.'}, {'id': 'OG003', 'title': 'Non-randomized Baseline Index Participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.41', 'ciLowerLimit': '1.25', 'ciUpperLimit': '4.65', 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.'}, {'id': 'FG001', 'title': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.'}, {'id': 'FG002', 'title': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.'}, {'id': 'FG003', 'title': 'Non-randomized Baseline Index Participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '329'}, {'groupId': 'FG003', 'numSubjects': '248'}]}, {'type': '6 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '278'}, {'groupId': 'FG003', 'numSubjects': '175'}]}, {'type': '12 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '267'}, {'groupId': 'FG003', 'numSubjects': '186'}]}, {'type': '18 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '303'}, {'groupId': 'FG003', 'numSubjects': '207'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'total # of intervention participants that completed any follow-up (6, 12, or 18 month Follow-up)', 'groupId': 'FG000', 'numSubjects': '82'}, {'comment': 'total # of comparison condition participants that completed any follow-up', 'groupId': 'FG001', 'numSubjects': '83'}, {'comment': 'total # of network participants that completed any follow-up', 'groupId': 'FG002', 'numSubjects': '313'}, {'comment': 'total # of non-randomized index participants that completed any follow-up', 'groupId': 'FG003', 'numSubjects': '220'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '28'}]}]}], 'recruitmentDetails': "The sample consisted of women and their social network members. Index participants were recruited through street outreach as well as at health clinics, and other local community agencies. Social network members were recruited by index participants after completion of the index's baseline visit. Recruitment took place from September 2005-July 2007", 'preAssignmentDetails': 'Those index participants that did not recruit a network member or did not show up to be randomized into a study condition were not assigned to a study condition. Network participants completed study interviews but were not assigned to a study condition and did not participate in the intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}, {'value': '248', 'groupId': 'BG003'}, {'value': '746', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.'}, {'id': 'BG001', 'title': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.'}, {'id': 'BG002', 'title': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.'}, {'id': 'BG003', 'title': 'Non-randomized Baseline Index Participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}, {'value': '247', 'groupId': 'BG003'}, {'value': '739', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'spread': '7', 'groupId': 'BG000'}, {'value': '43.3', 'spread': '7', 'groupId': 'BG001'}, {'value': '42.9', 'spread': '10', 'groupId': 'BG002'}, {'value': '40.6', 'spread': '8', 'groupId': 'BG003'}, {'value': '42', 'spread': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '248', 'groupId': 'BG003'}, {'value': '567', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '179', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}, {'value': '248', 'groupId': 'BG003'}, {'value': '746', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 746}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-24', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2012-09-14', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-14', 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)', 'timeFrame': '6 months', 'description': 'Number of participants that had 2 or more sex partners in the past 90 days.'}, {'measure': 'Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)', 'timeFrame': '12 months'}, {'measure': 'Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)', 'timeFrame': '18 month'}, {'measure': 'Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)', 'timeFrame': '18 months'}, {'measure': 'Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)', 'timeFrame': '18 months'}, {'measure': 'Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)', 'timeFrame': '18 months'}, {'measure': 'Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)', 'timeFrame': '6 months'}, {'measure': 'HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)', 'timeFrame': '12 months'}, {'measure': 'HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)', 'timeFrame': '18 months'}]}, 'conditionsModule': {'keywords': ['Sex Education', 'Peer Group', 'Social Identity Theory', 'HIV Seronegativity', 'Intervention', 'women', 'Social Networks', 'Peer Education'], 'conditions': ['HIV Infections', 'Sexually Transmitted Diseases']}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of a peer outreach intervention in preventing HIV infection in adults at high risk for contracting HIV and other sexually transmitted diseases (STDs).', 'detailedDescription': "The persistence of HIV and STD epidemics indicates that more effective, sustainable preventive interventions are needed, particularly for low-income, inner-city populations. This study will determine the effectiveness of a theoretically based peer outreach program in preventing HIV and STD transmission among adults in the Baltimore, Maryland area.\n\nParticipants will be randomly assigned to receive either a network-oriented peer program emphasizing one's social identity and the goals of protecting one's family and community or group cognitive behavioral therapy (CBT). The peer program will also train participants to provide HIV/STD education to their peers. Participants will be assessed at study entry and during several subsequent follow-up visits. At these study visits, participants will complete questionnaires about their sexual health knowledge and sexual behaviors. Participants and members of their peer network will have follow-up visits at Months 6, 12, and 18."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for CBT or Peer Intervention Participants:\n\n1. Female\n2. Age 18-55\n3. Did not inject drugs in the past 6 months\n4. Self-reported sex with at least 1 male partner in the past 6 months\n5. Had at least 1 of the following sexual risk factors:\n\n 1. More than 2 sex partners in the past 6 months\n 2. STI diagnosis in the past 6 months\n 3. Had a high risk sex partner in the past 90 days (i.e. a sex partner that injected drugs, smoked crack, was HIV+, or MSM)\n\nInclusion Criteria for Peer Network Participants:\n\n1. 18 years old or older\n2. One of the following:\n\n 1. Injected drugs\n 2. Sex partner of index\n 3. Social network member that the index felt comfortable talking to about HIV/STIs\n\nExclusion Criteria for All Participants:\n\n* Currently enrolled in another HIV prevention intervention'}, 'identificationModule': {'nctId': 'NCT00183456', 'briefTitle': 'A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Network HIV Prevention Intervention for Drug Users', 'orgStudyIdInfo': {'id': 'R01MH066810', 'link': 'https://reporter.nih.gov/quickSearch/R01MH066810', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH066810', 'link': 'https://reporter.nih.gov/quickSearch/R01MH066810', 'type': 'NIH'}, {'id': 'DAHBR 9A-ASI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Condition: CHAT', 'description': 'Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.', 'interventionNames': ['Behavioral: Peer-oriented intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison Condition: Standard of Care', 'description': 'The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.', 'interventionNames': ['Behavioral: Group cognitive behavioral therapy (CBT)']}, {'type': 'NO_INTERVENTION', 'label': 'Network Participants', 'description': 'Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.'}, {'type': 'NO_INTERVENTION', 'label': 'Non-randomized Baseline index participants', 'description': 'This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.'}], 'interventions': [{'name': 'Peer-oriented intervention', 'type': 'BEHAVIORAL', 'description': 'The peer-oriented intervention program emphasized social identity and the goals of protecting family and community. The peer program also trained participants to provide HIV/STD education to their peers.', 'armGroupLabels': ['Intervention Condition: CHAT']}, {'name': 'Group cognitive behavioral therapy (CBT)', 'type': 'BEHAVIORAL', 'description': 'Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.', 'armGroupLabels': ['Comparison Condition: Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Lighthouse', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Carl A. Latkin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}