Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 3:36 PM
Study NCT ID:
NCT00076804
Status:
TERMINATED
Last Update Posted:
2015-03-27
First Post:
2004-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D023801', 'term': 'Directly Observed Therapy'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'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': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rchaiss@jhmi.edu', 'phone': '4109551755', 'title': 'Richard E. Chaisson', 'organization': 'Johns Hopkins University Center for TB Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Intervention was stopped at 12 months, transition phase did not ensure that participants developed a set of adherence strategies to replace DOT-ART. Low incidence of AIDS-defining illness and death limit our ability to make final conclusions'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Peer Supporter', 'description': 'Use of a patient nominated peer supporter who sill observe the morning dose of ARVs', 'otherNumAtRisk': 137, 'otherNumAffected': 71, 'seriousNumAtRisk': 137, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Self Administration', 'description': 'Self administration of ARVs', 'otherNumAtRisk': 137, 'otherNumAffected': 89, 'seriousNumAtRisk': 137, 'seriousNumAffected': 29}], 'otherEvents': [{'term': 'AIDS-Defining Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 35, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DAIDS Grade III Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New Diagnosis/Worsening Medical Condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 39, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 52, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DAIDS Grade IV AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer Supporter', 'description': 'Use of a patient nominated peer supporter who sill observe the morning dose of ARVs'}, {'id': 'OG001', 'title': 'Self Administration', 'description': 'Self administration of ARVs'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Logistic regression analysis \\& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence', 'groupDescription': "Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'one degree of freedom', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'at 12 and 24 months of treatment', 'description': 'Proportion of Patients with HIV RNA Levels of \\<400 at 12 Months - Intention-to-treat', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer Supporter', 'description': 'Use of a patient nominated peer supporter who sill observe the morning dose of ARVs'}, {'id': 'OG001', 'title': 'Self Administration', 'description': 'Self administration of ARVs'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Logistic regression analysis \\& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence', 'groupDescription': "Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'one degree of freedom', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Proportion of Patients with HIV RNA Levels of \\<400 Copies/mL at 24 Months \\[Intention-to-treat (ITT)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer Supporter', 'description': 'Use of a patient nominated peer supporter who sill observe the morning dose of ARVs'}, {'id': 'OG001', 'title': 'Self Administration', 'description': 'Self administration of ARVs'}], 'classes': [{'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000', 'lowerLimit': '108', 'upperLimit': '276'}, {'value': '160', 'groupId': 'OG001', 'lowerLimit': '78', 'upperLimit': '236'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Logistic regression analysis \\& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence', 'groupDescription': "Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer Supporter', 'description': 'Use of a patient nominated peer supporter who sill observe the morning dose of ARVs'}, {'id': 'OG001', 'title': 'Self Administration', 'description': 'Self administration of ARVs'}], 'classes': [{'categories': [{'measurements': [{'value': '281', 'groupId': 'OG000', 'lowerLimit': '144', 'upperLimit': '403'}, {'value': '262', 'groupId': 'OG001', 'lowerLimit': '149', 'upperLimit': '363'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Logistic regression analysis \\& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence', 'groupDescription': "Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '24 months', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peer Supporter', 'description': 'Use of a patient nominated peer supporter who sill observe the morning dose of ARVs'}, {'id': 'FG001', 'title': 'Self Administration', 'description': 'Self administration of ARVs'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '111 completed week 48, 77 completed week 96.', 'groupId': 'FG000', 'numSubjects': '77'}, {'comment': '102 completed week 48, 68 completed week 96', 'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '69'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Early study Closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}]}]}], 'recruitmentDetails': 'The study site was a public sector ART clinic at the GF Jooste Hospital, a secondary level facility in Cape Town, Western Cape province of South Africa, serving several peri-urban townships. Enrollment began February 13, 2005, and ended on July 7, 2007, with the last follow-up occurring on July 25, 2008.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Peer Supporter', 'description': 'Use of a patient nominated peer supporter who sill observe the morning dose of ARVs'}, {'id': 'BG001', 'title': 'Self Administration', 'description': 'Self administration of ARVs'}, {'id': 'BG002', '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': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '36.7', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '36.2', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Africa', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}}, 'statusModule': {'whyStopped': 'DSMB stopped trial for futility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-09', 'studyFirstSubmitDate': '2004-02-03', 'resultsFirstSubmitDate': '2010-06-01', 'studyFirstSubmitQcDate': '2004-02-05', 'lastUpdatePostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-01', 'studyFirstPostDateStruct': {'date': '2004-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment', 'timeFrame': 'at 12 and 24 months of treatment', 'description': 'Proportion of Patients with HIV RNA Levels of \\<400 at 12 Months - Intention-to-treat'}, {'measure': 'Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment', 'timeFrame': '24 months', 'description': 'Proportion of Patients with HIV RNA Levels of \\<400 Copies/mL at 24 Months \\[Intention-to-treat (ITT)'}, {'measure': 'Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm', 'timeFrame': '12 months'}, {'measure': 'Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Directly Observed Therapy', 'DOT'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '20453627', 'type': 'RESULT', 'citation': 'Nachega JB, Chaisson RE, Goliath R, Efron A, Chaudhary MA, Ram M, Morroni C, Schoeman H, Knowlton AR, Maartens G. Randomized controlled trial of trained patient-nominated treatment supporters providing partial directly observed antiretroviral therapy. AIDS. 2010 Jun 1;24(9):1273-80. doi: 10.1097/QAD.0b013e328339e20e.'}]}, 'descriptionModule': {'briefSummary': 'Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These drug regimens must be closely followed in order to be successful. Having a support person watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her regimen. This study will see if patient-chosen treatment supporters help patients take HIV medicines correctly and improve their health.\n\nStudy hypothesis: The mean change in CD4 count at 12 and 24 months will be significantly higher in the directly observed therapy-highly active antiretroviral therapy (DOT-HAART) arm as compared to the self-administered arm.', 'detailedDescription': 'South Africa has one of the worst and fastest growing HIV epidemics in the world. Highly active antiretroviral therapy (HAART) has been shown both at the individual and public health levels to reduce morbidity, mortality, and vertical and possibly horizontal HIV transmission. However, expenses, feasibility, long-term adherence, and effective delivery of HAART remain formidable barriers, particularly in developing nations. Recently, international initiatives have provided hope for widespread use of HAART at affordable cost in sub-Saharan Africa. Simplified, once-daily HAART regimens with directly observed therapy (DOT) may help to achieve high levels of treatment adherence, a key component for long-term viral suppression and treatment success. Peer advocates have been used to improve adherence with medical therapies in a variety of settings. This study will evaluate the effectiveness and feasibility of DOT using patient-nominated peer supervisors to improve adherence to HAART in HIV infected adults in South Africa.\n\nParticipants will be randomly assigned to either Peer-DOT-HAART or self-administration of a once-daily combination of the Western Cape Province ART program medications for 24 months. Study measures will include CD4 cell count and HIV viral load, adherence questionnaires, genotypic HAART resistance testing, and incidence of new or recurrent opportunistic infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infected\n* Viral load greater than 1000 copies/ml\n* CD4 count of 200 cells/mm3 or less, or World Health Organization Stage 4 disease\n* Living in the area of the study site\n* Had a known address for more than 3 months\n* Willing to nominate a treatment supervisor (a close family member, sexual partner, friend, or community volunteer) to observe daily ingestion of tablets\n* Willing to disclose HIV status to a treatment supervisor and ready to commit to long-term antiretroviral therapy\n* Acceptable methods of contraception\n\nExclusion Criteria:\n\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT00076804', 'briefTitle': 'Helping HIV Infected Patients in South Africa Adhere to Drug Regimens', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'DOT-HAART for HIV-Infected South African Adults', 'orgStudyIdInfo': {'id': '1R01AI055359-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01AI055359-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R01AI055359-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01AI055359-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Use of a patient nominated peer supporter who will observe the morning dose of ARVs', 'interventionNames': ['Behavioral: Directly Observed Therapy']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Self administration of ARVs'}], 'interventions': [{'name': 'Directly Observed Therapy', 'type': 'BEHAVIORAL', 'description': 'Use of a patient nominated peer supporter who will observe the morning dose of ARVs', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7925', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'University of Cape Town', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'Richard E Chaisson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cape Town', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Center for TB Research', 'investigatorFullName': 'Dr. Richard Chaisson', 'investigatorAffiliation': 'Johns Hopkins University'}}}}