Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-02-24 @ 7:26 AM
Study NCT ID:
NCT04772469
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2021-02-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018761', 'term': 'Multiple Endocrine Neoplasia Type 1'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012897', 'term': 'Slow 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'}, {'id': 'D009377', 'term': 'Multiple Endocrine Neoplasia'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Carol.Camlin@ucsf.edu', 'phone': '5109679558', 'title': 'Dr. Carol Camlin', 'organization': 'University of California San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected among each participant over a period of 6 months, from baseline to follow up.', 'description': 'Same definition', 'eventGroups': [{'id': 'EG000', 'title': 'Promoter Training, Multiple Self-test Kits, and Incentives', 'description': 'Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.\n\nProvision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.\n\nSmall monetary incentives: Use of small incentive voucher (\\~$5) to encourage linkage to confirmatory testing.\n\nUse of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.', 'otherNumAtRisk': 374, 'deathsNumAtRisk': 374, 'otherNumAffected': 1, 'seriousNumAtRisk': 374, 'deathsNumAffected': 14, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Short Training and Referral for Testing', 'description': 'Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.', 'otherNumAtRisk': 359, 'deathsNumAtRisk': 359, 'otherNumAffected': 0, 'seriousNumAtRisk': 359, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'notes': '13 deaths and 1 fracture. All were unrelated to participation in study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Self-reported HIV Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Promoter Training, Multiple Self-test Kits, and Incentives', 'description': 'Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.\n\nProvision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.\n\nSmall monetary incentives: Use of small incentive voucher (\\~$5) to encourage linkage to confirmatory testing.\n\nUse of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.'}, {'id': 'OG001', 'title': 'Short Training and Referral for Testing', 'description': 'Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'groupId': 'OG000', 'lowerLimit': '59.5', 'upperLimit': '71.7'}, {'value': '31.3', 'groupId': 'OG001', 'lowerLimit': '25.4', 'upperLimit': '37.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 months', 'description': 'Percentage of participants who self-report HIV testing (yes/no) within the past 3 months, measured at 3-month follow-up.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We used cluster adjusted means'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Linked to a Study-affiliated Clinic Within 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Promoter Training, Multiple Self-test Kits, and Incentives', 'description': 'Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.\n\nProvision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.\n\nSmall monetary incentives: Use of small incentive voucher (\\~$5) to encourage linkage to confirmatory testing.\n\nUse of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.'}, {'id': 'OG001', 'title': 'Short Training and Referral for Testing', 'description': 'Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'groupId': 'OG000', 'lowerLimit': '61.2', 'upperLimit': '73.5'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '20.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 months', 'description': 'The percentage of participants who attended a study-affiliated clinic for HIV treatment or care within 3 months of the intervention baseline', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Linkage to PrEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Promoter Training, Multiple HIV Self-test Kit Distribution, and Incentive Distribution', 'description': 'Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.\n\nProvision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.\n\nSmall monetary incentives: Use of small incentive voucher (\\~$5) to encourage linkage to confirmatory testing.\n\nUse of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.'}, {'id': 'OG001', 'title': 'Control: Promoter Training and Referral for Testing', 'description': 'Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': '25.8'}, {'value': '19.6', 'groupId': 'OG001', 'lowerLimit': '9.24', 'upperLimit': '30.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 months', 'description': 'Percentage of PrEP-eligible HIV-negative participants who initiate PrEP prescription (yes/no), 3-months following confirmatory testing and eligibility screening (combined)', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We used cluster adjusted means, thus the value does not yield a whole number of participants.'}, {'type': 'SECONDARY', 'title': 'Adherence to PrEP (% With Detectable Tenofovir in the Urine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Promoter Training, Multiple HIV Self-test Kit Distribution, and Incentive Distribution', 'description': 'Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.\n\nProvision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.\n\nSmall monetary incentives: Use of small incentive voucher (\\~$5) to encourage linkage to confirmatory testing.\n\nUse of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.'}, {'id': 'OG001', 'title': 'Control: Promoter Training and Referral for Testing', 'description': 'Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'PrEP: Percentage of PrEP-taking HIV-negative participants who are adherent to PrEP (TFV levels of \\>= 1500 ng/mL) at 6 months following PrEP initiation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adherence to ART', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Promoter Training, Multiple HIV Self-test Kit Distribution, and Incentive Distribution', 'description': 'Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.\n\nProvision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.\n\nSmall monetary incentives: Use of small incentive voucher (\\~$5) to encourage linkage to confirmatory testing.\n\nUse of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.'}, {'id': 'OG001', 'title': 'Control: Promoter Training and Referral for Testing', 'description': 'Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000', 'lowerLimit': '25.2', 'upperLimit': '46.3'}, {'value': '40.2', 'groupId': 'OG001', 'lowerLimit': '27.0', 'upperLimit': '53.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'ART: Percentage of HIV-positive participants who attain viral suppression (HIV RNA \\<400 c/mL), 6 months following ART initiation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Promoter Training, Multiple Self-test Kits, and Incentives', 'description': 'Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.\n\nProvision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.\n\nSmall monetary incentives: Use of small incentive voucher (\\~$5) to encourage linkage to confirmatory testing.\n\nUse of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.'}, {'id': 'FG001', 'title': 'Short Training and Referral for Testing', 'description': 'Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number of participants allocated to the intervention.', 'groupId': 'FG000', 'numUnits': '77', 'numSubjects': '453'}, {'comment': 'Number of participants allocated to the control arm.', 'groupId': 'FG001', 'numUnits': '79', 'numSubjects': '481'}]}, {'type': 'Individuals', 'achievements': [{'comment': 'These are number of participants who completed baseline in the intervention arm.', 'groupId': 'FG000', 'numUnits': '76', 'numSubjects': '374'}, {'comment': 'These are participants in the control arm for baseline.', 'groupId': 'FG001', 'numUnits': '79', 'numSubjects': '359'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Number of participants who completed 3-month follow-up.', 'groupId': 'FG000', 'numUnits': '74', 'numSubjects': '353'}, {'comment': 'Number of participants who completed 3-month follow-up.', 'groupId': 'FG001', 'numUnits': '76', 'numSubjects': '313'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '100'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '168'}]}]}], 'typeUnitsAnalyzed': 'social network clusters', 'preAssignmentDetails': 'Between June 2021 and March 2022, we enumerated 1,509 fishermen in three beach communities. Among these fishermen, 934 were mapped to social networks and comprised the intent-to-treat sample. Of these, 733 men were reached and completed a baseline survey.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'BG000'}, {'value': '359', 'groupId': 'BG001'}, {'value': '733', 'groupId': 'BG002'}]}, {'units': 'Social network clusters', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention: Promoter Training, Multiple HIV Self-test Kit Distribution, and Incentive Distribution', 'description': 'Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.\n\nProvision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.\n\nSmall monetary incentives: Use of small incentive voucher (\\~$5) to encourage linkage to confirmatory testing.\n\nUse of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.'}, {'id': 'BG001', 'title': 'Control: Promoter Training and Referral for Testing', 'description': 'Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.'}, {'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': '366', 'groupId': 'BG000'}, {'value': '352', 'groupId': 'BG001'}, {'value': '718', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'groupId': 'BG000', 'lowerLimit': '28.9', 'upperLimit': '41.2'}, {'value': '37.2', 'groupId': 'BG001', 'lowerLimit': '31.9', 'upperLimit': '43.4'}, {'value': '35.5', 'groupId': 'BG002', 'lowerLimit': '30.1', 'upperLimit': '42.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '374', 'groupId': 'BG000'}, {'value': '359', 'groupId': 'BG001'}, {'value': '733', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '374', 'groupId': 'BG000'}, {'value': '359', 'groupId': 'BG001'}, {'value': '733', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Kenya', 'categories': [{'measurements': [{'value': '374', 'groupId': 'BG000'}, {'value': '359', 'groupId': 'BG001'}, {'value': '733', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Social network clusters', 'populationDescription': 'A total of 733 participants in 155 social network clusters.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-29', 'size': 797623, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-10T16:58', 'hasProtocol': True}, {'date': '2021-07-21', 'size': 424703, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-13T17:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The study design is a cluster randomized controlled trial where the unit of randomization will be a clusters of men's close social network in study communities."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 934}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2021-02-23', 'resultsFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-24', 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported HIV Testing', 'timeFrame': 'Up to 3 months', 'description': 'Percentage of participants who self-report HIV testing (yes/no) within the past 3 months, measured at 3-month follow-up.'}, {'measure': 'Percentage of Participants Who Linked to a Study-affiliated Clinic Within 3 Months', 'timeFrame': 'Up to 3 months', 'description': 'The percentage of participants who attended a study-affiliated clinic for HIV treatment or care within 3 months of the intervention baseline'}], 'secondaryOutcomes': [{'measure': 'Linkage to PrEP', 'timeFrame': 'Up to 3 months', 'description': 'Percentage of PrEP-eligible HIV-negative participants who initiate PrEP prescription (yes/no), 3-months following confirmatory testing and eligibility screening (combined)'}, {'measure': 'Adherence to PrEP (% With Detectable Tenofovir in the Urine)', 'timeFrame': 'Up to 6 months', 'description': 'PrEP: Percentage of PrEP-taking HIV-negative participants who are adherent to PrEP (TFV levels of \\>= 1500 ng/mL) at 6 months following PrEP initiation.'}, {'measure': 'Adherence to ART', 'timeFrame': 'Up to 6 months', 'description': 'ART: Percentage of HIV-positive participants who attain viral suppression (HIV RNA \\<400 c/mL), 6 months following ART initiation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV/AIDS', 'Social Networks', 'Behavioral Economics', 'Incentives', 'PrEP', 'HIV Self-Testing', 'Fishermen', 'Sub Saharan Africa', 'Men', 'HIV Prevention'], 'conditions': ['Human Immunodeficiency Virus', 'Acquired Immunodeficiency Syndrome', 'HIV Infections', 'Sexually Transmitted Diseases, Viral', 'Retroviridae Infections', 'Virus Diseases', 'Virus-HIV', 'RNA Virus Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'UNAIDS. 90-90-90: An ambitious treatment target to help end the AIDS epidemic. 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The study includes a longitudinal qualitative and mixed methods (quantitative and qualitative assessments) to identify the pathways of intervention action, and understand how the social network-based approach with support for linkage affects testing and ART and PrEP uptake and retention in men.", 'detailedDescription': 'In Aim 1, following the study pilot, community selection, and preparation the investigators will conduct a census/BMU registry verification in study communities to identify the population of men eligible for the study. The study will screen, recruit and enroll eligible men who give their informed consent to participate, then measure their close social networks identify network-central, highly-connected men ("promoters") and randomize their close social network (a cluster) to 1:1 intervention and control groups. Investigators will then conduct a baseline survey to collect socio demographic and baseline sexual behavior data among men in the close social networks. Following this baseline data collection, all promoters will be provided a training. Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration. Promoters in the control group will receive basic HIV education and training about the study, and will be given vouchers that can be exchanged for HIV tests (standard or free HIVST kits) at nearby health facilities. Using follow-up survey data, investigators will test the hypothesis that a higher rate of HIV testing will be observed after 3 months among men in networks that receive the intervention compared to control.\n\nIn Aim 2, investigators will test whether network-central promoters can enhance linkage to ART and PrEP after HIV testing among men in their close social networks. Promoters in the Aim 1 intervention group will be asked to distribute information and transport vouchers for ART or PrEP when distributing HIV self-tests to men in their close social networks. Investigators will use clinic data to test the primary hypothesis that the intervention will result in higher rates of linkage to ART or PrEP (confirmatory testing and ART referral for positives, and PrEP screening for negatives). Investigators also will test the hypothesis that higher ART and PrEP uptake will be observed within 3 months (+ about one month) in the intervention group.\n\nIn Aim 3, investigators will measure 6 month VL and 6 month tenofovir levels using viral load testing and a novel point of care PrEP adherence assay (an antibody-based assay permitting measurement of tenofovir levels in urine) in study sites, and test the hypothesis that higher rates of virologic suppression will be observed in HIV-infected men, and PrEP adherence in un-infected men, in the intervention group. Viral load measurements will be conducted by drawing additional venous blood during routine blood draws scheduled for MOH viral load monitoring (as well as additional draws during scheduled appointments for those occurring outside of the annual VL testing standard of care window). PrEP adherence will be measured utilizing the study urine assay at 6 months. HIV treatment adherence will measured through adherence assessment during 3 and 6 routine clinic visits.\n\nAcross all aims, investigators will assess the pathways of intervention action using qualitative and mixed methods. Investigators will identify the mechanisms of action, and barriers and facilitators of the social network and incentives intervention implementation, using qualitative and mixed methods quantitative and qualitative assessments embedded in Aims 1, 2 and 3. The data collection approach will include in-depth interviews with participants in both groups, key informant interviews with network-central promoters, and focus group discussions with study participants stratified by HIV status and study group. Data will be collected at baseline and three follow-up periods corresponding to the timing of quantitative outcome measurements in Aims 1 through 3.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (18 years or older)\n* Male\n* Working as a fisherman or fishing-related occupation\n* Willing and able to provide informed consent for participation\n* Not participating in another research study related to HIV testing, treatment and/or prevention\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Female\n* Included in another intervention study on HIV/AIDS\n* Inadequate cognitive and/or hearing capacity to complete planned study procedures, at the discretion of the study team'}, 'identificationModule': {'nctId': 'NCT04772469', 'briefTitle': 'Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men', 'orgStudyIdInfo': {'id': '19-28205'}, 'secondaryIdInfos': [{'id': '1R01MH120176', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH120176', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Promoter training, multiple self-test kits, and incentives', 'description': 'Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.', 'interventionNames': ['Behavioral: Provision of multiple self-tests', 'Other: Small monetary incentives', 'Behavioral: Use of SMS/text reminders to motivate adherence to ART or PrEP']}, {'type': 'NO_INTERVENTION', 'label': 'Short training and referral for testing', 'description': 'Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.'}], 'interventions': [{'name': 'Provision of multiple self-tests', 'type': 'BEHAVIORAL', 'description': 'Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.', 'armGroupLabels': ['Promoter training, multiple self-test kits, and incentives']}, {'name': 'Small monetary incentives', 'type': 'OTHER', 'description': 'Use of small incentive voucher (\\~$5) to encourage linkage to confirmatory testing.', 'armGroupLabels': ['Promoter training, multiple self-test kits, and incentives']}, {'name': 'Use of SMS/text reminders to motivate adherence to ART or PrEP', 'type': 'BEHAVIORAL', 'description': 'Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.', 'armGroupLabels': ['Promoter training, multiple self-test kits, and incentives']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Siaya', 'country': 'Kenya', 'facility': 'Impact Research Development Organization', 'geoPoint': {'lat': 0.0607, 'lon': 34.28806}}], 'overallOfficials': [{'name': 'Carol S Camlin, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Harsha Thirumurthy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'Impact Research & Development Organization', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}