Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 1:29 AM
Study NCT ID:
NCT04810650
Status:
COMPLETED
Last Update Posted:
2025-02-06
First Post:
2021-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'douglas.black@ucsf.edu', 'phone': '4158063016', 'title': 'Douglas Black', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Between 30 days and 48 weeks depending on the primary outcome measure.', 'description': 'Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed in both intervention and control arms.', 'eventGroups': [{'id': 'EG000', 'title': 'PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention', 'description': "PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 197, 'otherNumAffected': 0, 'seriousNumAtRisk': 197, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'PREP/PEP at Outpatient Clinics Control', 'description': 'Standard of Care: Local country standard of care protocols', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 206, 'otherNumAffected': 0, 'seriousNumAtRisk': 206, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention', 'description': "PrEP/PEP at Antenatal Clinics: Intervention delivered at Antenatal Clinics: Counseling and education on choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 203, 'otherNumAffected': 0, 'seriousNumAtRisk': 203, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG003', 'title': 'PREP/PEP at Antenatal Clinics Control', 'description': 'Standard of Care: Local country standard of care protocols', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 197, 'otherNumAffected': 0, 'seriousNumAtRisk': 197, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'PREP/PEP at Community Households Dynamic Prevention Intervention', 'description': "PrEP/PEP at Community Households: Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 212, 'otherNumAffected': 0, 'seriousNumAtRisk': 212, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'PREP/PEP at Community Households Control', 'description': 'Standard of Care: Local country standard of care protocols', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 217, 'otherNumAffected': 0, 'seriousNumAtRisk': 217, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Mobility Dynamic Treatment Intervention', 'description': 'Mobility Dynamic Treatment Intervention: 1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a "travel pack" with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'deathsNumAffected': 2, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Mobility Control', 'description': 'Standard of Care: Local country standard of care protocols', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'Healthy Living for Heavy Alcohol Users Intervention', 'description': 'Health Living Intervention for Heavy Alcohol Users: 1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 197, 'otherNumAffected': 0, 'seriousNumAtRisk': 197, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG009', 'title': 'Heavy Alcohol Users Control', 'description': 'Standard of Care: Local country standard of care protocols', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 203, 'otherNumAffected': 0, 'seriousNumAtRisk': 203, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'Hypertension Linkage Intervention', 'description': 'Hypertension Linkage: 1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG011', 'title': 'Hypertension Linkage Control', 'description': 'Standard of Care: Local country standard of care protocols', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Hypertension Community Intervention', 'description': 'Hypertension Community: Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 98, 'otherNumAffected': 0, 'seriousNumAtRisk': 98, 'deathsNumAffected': 2, 'seriousNumAffected': 5}, {'id': 'EG013', 'title': 'Hypertension Community Control', 'description': 'Standard of Care: Local country standard of care protocols', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Death of premature infant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency caesarian section', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incarcerated inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Miscarriage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intimate partner violence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pre-term delivery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetes Type 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine fibroids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death due to unknown illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydatidiform mole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lumbar spondylosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incomplete abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cryptococcal meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Homicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urine retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Right inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention', 'description': "PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services"}, {'id': 'OG001', 'title': 'PREP/PEP at Outpatient Clinics Control', 'description': 'Standard of Care: Local country standard of care protocols'}], 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000', 'lowerLimit': '42.3', 'upperLimit': '52.7'}, {'value': '18.3', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '22.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 weeks', 'description': 'Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at outpatient clinics vs. PrEP/PEP standard of care at outpatient clinics (not applicable to other arms). Primary definition of coverage will rely on self report.', 'unitOfMeasure': 'Percentage of months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the Week 48 visit.'}, {'type': 'PRIMARY', 'title': 'Prevention Coverage Defined as Percentage of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention', 'description': "PrEP/PEP at Antenatal Clinics: Intervention delivered at Antenatal Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services"}, {'id': 'OG001', 'title': 'PREP/PEP at Antenatal Clinics Control', 'description': 'Standard of Care: Local country standard of care protocols'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '74'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '34'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 weeks', 'description': 'Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at antenatal clinics vs. PrEP/PEP standard of care at antenatal clinics (not applicable to other arms). Primary definition of coverage will rely on self report.', 'unitOfMeasure': 'Percentage of months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prevention Coverage Defined as Proportion of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PREP/PEP at Community Households Dynamic Prevention Intervention', 'description': "PrEP/PEP at Community Households: Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services"}, {'id': 'OG001', 'title': 'PREP/PEP at Community Households Control', 'description': 'Standard of Care: Local country standard of care protocols'}], 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000', 'lowerLimit': '23.5', 'upperLimit': '32.4'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 weeks', 'description': 'Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at community households vs. PrEP/PEP standard of care at community households (not applicable to other arms). Primary definition of coverage will rely on self report.', 'unitOfMeasure': 'Percentage of months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobility Dynamic Treatment Intervention', 'description': 'Mobility Dynamic Treatment Intervention: 1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a "travel pack" with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel'}, {'id': 'OG001', 'title': 'Mobility Control', 'description': 'Standard of Care: Local country standard of care protocols'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 weeks', 'description': 'Primary outcome for comparison of Mobility Dynamic Treatment intervention vs. standard of care control (not applicable to other arms). Data collected from medical records.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Living for Heavy Alcohol Users Intervention', 'description': 'Health Living Intervention for Heavy Alcohol Users: 1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls'}, {'id': 'OG001', 'title': 'Heavy Alcohol Users Control', 'description': 'Standard of Care: Local country standard of care protocols'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '89'}, {'value': '82', 'groupId': 'OG001', 'lowerLimit': '77', 'upperLimit': '87'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Primary outcome for comparison of Healthy Living Intervention for Heavy Alcohol Users vs. standard of care control (not applicable to other arms). Data collected from medical records.', 'unitOfMeasure': 'Percentage of participants with VL <400', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Linked to Hypertension Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertension Linkage Intervention', 'description': 'Hypertension Linkage: 1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits'}, {'id': 'OG001', 'title': 'Hypertension Linkage Control', 'description': 'Standard of Care: Local country standard of care protocols'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Primary outcome for comparison of Hypertension linkage intervention vs. hypertension linkage control (not applicable for other arms). Linkage to hypertension care at the local government clinic within 30 days of screening positive for high blood pressure during community screening. The primary definition will rely on clinical records.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Hypertension Control <140/90 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertension Community Intervention', 'description': 'Hypertension Community: Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications'}, {'id': 'OG001', 'title': 'Hypertension Community Control', 'description': 'Standard of Care: Local country standard of care protocols'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '85'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '60'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Primary outcome for hypertension community treatment intervention vs. hypertension community treatment control (not applicable for other arms). Blood pressure will be measured three times using standardized procedures in all trial participants at the 24-week study visit. Hypertension is considered controlled if the average of the 2nd and 3rd measures \\<140 mmHg systolic and \\<90 mmHg diastolic.', 'unitOfMeasure': 'Percentage of persons with HTN control', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 24-week follow-up visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention', 'description': "PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services"}, {'id': 'FG001', 'title': 'PREP/PEP at Outpatient Clinics Control', 'description': 'Standard of Care: Local country standard of care protocols'}, {'id': 'FG002', 'title': 'PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention', 'description': "PrEP/PEP at Antenatal Clinics: Intervention delivered at Antenatal Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services"}, {'id': 'FG003', 'title': 'PREP/PEP at Antenatal Clinics Control', 'description': 'Standard of Care: Local country standard of care protocols'}, {'id': 'FG004', 'title': 'PREP/PEP at Community Households Dynamic Prevention Intervention', 'description': "PrEP/PEP at Community Households: Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services"}, {'id': 'FG005', 'title': 'PREP/PEP at Community Households Control', 'description': 'Standard of Care: 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'populationDescription': "1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error."}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-26', 'size': 2591339, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-06T14:58', 'hasProtocol': True}, {'date': '2021-12-21', 'size': 862381, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-06T14:39', 'hasProtocol': False}, {'date': '2022-08-10', 'size': 214201, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-06T14:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2021-03-18', 'resultsFirstSubmitDate': '2024-11-07', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-04', 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP', 'timeFrame': '48 weeks', 'description': 'Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at outpatient clinics vs. PrEP/PEP standard of care at outpatient clinics (not applicable to other arms). Primary definition of coverage will rely on self report.'}, {'measure': 'Prevention Coverage Defined as Percentage of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP', 'timeFrame': '48 weeks', 'description': 'Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at antenatal clinics vs. PrEP/PEP standard of care at antenatal clinics (not applicable to other arms). Primary definition of coverage will rely on self report.'}, {'measure': 'Prevention Coverage Defined as Proportion of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP', 'timeFrame': '48 weeks', 'description': 'Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at community households vs. PrEP/PEP standard of care at community households (not applicable to other arms). Primary definition of coverage will rely on self report.'}, {'measure': 'Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml', 'timeFrame': '48 weeks', 'description': 'Primary outcome for comparison of Mobility Dynamic Treatment intervention vs. standard of care control (not applicable to other arms). Data collected from medical records.'}, {'measure': 'Percentage of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml', 'timeFrame': '24 weeks', 'description': 'Primary outcome for comparison of Healthy Living Intervention for Heavy Alcohol Users vs. standard of care control (not applicable to other arms). Data collected from medical records.'}, {'measure': 'Number of Participants Who Linked to Hypertension Care', 'timeFrame': '30 days', 'description': 'Primary outcome for comparison of Hypertension linkage intervention vs. hypertension linkage control (not applicable for other arms). Linkage to hypertension care at the local government clinic within 30 days of screening positive for high blood pressure during community screening. The primary definition will rely on clinical records.'}, {'measure': 'Percentage of Participants With Hypertension Control <140/90 mmHg', 'timeFrame': '24 weeks', 'description': 'Primary outcome for hypertension community treatment intervention vs. hypertension community treatment control (not applicable for other arms). Blood pressure will be measured three times using standardized procedures in all trial participants at the 24-week study visit. Hypertension is considered controlled if the average of the 2nd and 3rd measures \\<140 mmHg systolic and \\<90 mmHg diastolic.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PrEP', 'PEP', 'HIV Treatment and Prevention', 'Community Health', 'Mobile Populations', 'Youth and Adolescents'], 'conditions': ['HIV', 'Hypertension', 'Alcohol Drinking', 'Maternal Child Health', 'Cost Effectiveness']}, 'referencesModule': {'references': [{'pmid': '37861683', 'type': 'RESULT', 'citation': 'Koss CA, Ayieko J, Kabami J, Balzer LB, Kakande E, Sunday H, Nyabuti M, Wafula E, Shade SB, Biira E, Opel F, Atuhaire HN, Okochi H, Ogachi S, Gandhi M, Bacon MC, Bukusi EA, Chamie G, Petersen ML, Kamya MR, Havlir DV; SEARCH study team. Dynamic choice HIV prevention intervention at outpatient departments in rural Kenya and Uganda. AIDS. 2024 Mar 1;38(3):339-349. doi: 10.1097/QAD.0000000000003763. Epub 2023 Oct 19.'}, {'pmid': '38489493', 'type': 'RESULT', 'citation': 'Kabami J, Koss CA, Sunday H, Biira E, Nyabuti M, Balzer LB, Gupta S, Chamie G, Ayieko J, Kakande E, Bacon MC, Havlir D, Kamya MR, Petersen M; SEARCH Study Team. Randomized Trial of Dynamic Choice HIV Prevention at Antenatal and Postnatal Care Clinics in Rural Uganda and Kenya. J Acquir Immune Defic Syndr. 2024 Apr 15;95(5):447-455. doi: 10.1097/QAI.0000000000003383. Epub 2024 Mar 11.'}, {'pmid': '38054535', 'type': 'RESULT', 'citation': 'Kakande ER, Ayieko J, Sunday H, Biira E, Nyabuti M, Agengo G, Kabami J, Aoko C, Atuhaire HN, Sang N, Owaranganise A, Litunya J, Mugoma EW, Chamie G, Peng J, Schrom J, Bacon MC, Kamya MR, Havlir DV, Petersen ML, Balzer LB; SEARCH Study Team. A community-based dynamic choice model for HIV prevention improves PrEP and PEP coverage in rural Uganda and Kenya: a cluster randomized trial. J Int AIDS Soc. 2023 Dec;26(12):e26195. doi: 10.1002/jia2.26195.'}, {'pmid': '38054932', 'type': 'RESULT', 'citation': 'Ayieko J, Balzer LB, Inviolata C, Kakande E, Opel F, Wafula EM, Kabami J, Owaraganise A, Mwangwa F, Nakato H, Bukusi EA, Camlin CS, Charlebois ED, Bacon MC, Petersen ML, Kamya MR, Havlir DV, Chamie G; SEARCH Study Team. Randomized Trial of a "Dynamic Choice" Patient-Centered Care Intervention for Mobile Persons With HIV in East Africa. J Acquir Immune Defic Syndr. 2024 Jan 1;95(1):74-81. doi: 10.1097/QAI.0000000000003311. Epub 2023 Dec 1.'}, {'pmid': '38054564', 'type': 'RESULT', 'citation': 'Puryear SB, Mwangwa F, Opel F, Chamie G, Balzer LB, Kabami J, Ayieko J, Owaraganise A, Kakande E, Agengo G, Bukusi E, Kabageni S, Omoding D, Bacon M, Schrom J, Woolf-King S, Petersen ML, Havlir DV, Kamya M, Hahn JA. Effect of a brief alcohol counselling intervention on HIV viral suppression and alcohol use among persons with HIV and unhealthy alcohol use in Uganda and Kenya: a randomized controlled trial. J Int AIDS Soc. 2023 Dec;26(12):e26187. doi: 10.1002/jia2.26187.'}, {'pmid': '36342940', 'type': 'RESULT', 'citation': 'Hickey MD, Owaraganise A, Sang N, Opel FJ, Mugoma EW, Ayieko J, Kabami J, Chamie G, Kakande E, Petersen ML, Balzer LB, Kamya MR, Havlir DV. Effect of a one-time financial incentive on linkage to chronic hypertension care in Kenya and Uganda: A randomized controlled trial. PLoS One. 2022 Nov 7;17(11):e0277312. doi: 10.1371/journal.pone.0277312. eCollection 2022.'}, {'pmid': '37408473', 'type': 'DERIVED', 'citation': 'Kabami J, Kakande E, Chamie G, Balzer LB, Petersen ML, Camlin CS, Nyabuti M, Koss CA, Bukusi EA, Kamya MR, Havlir DV, Ayieko J. Uptake of a patient-centred dynamic choice model for HIV prevention in rural Kenya and Uganda: SEARCH SAPPHIRE study. J Int AIDS Soc. 2023 Jul;26 Suppl 1(Suppl 1):e26121. doi: 10.1002/jia2.26121.'}], 'seeAlsoLinks': [{'url': 'https://www.searchendaids.com/', 'label': 'SEARCH'}]}, 'descriptionModule': {'briefSummary': 'The randomized trials in this record will assess effectiveness, fidelity and cost of prevention and treatment interventions for HIV and hypertension with the objective of informing a population-based study of multi-sectored, multi-disease interventions for HIV.', 'detailedDescription': 'The study will conduct randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions. The study will conduct two randomization trials to evaluate dynamic treatment interventions tailored to the needs of heavy alcohol users and mobile populations. The study will conduct three randomized trials to evaluate dynamic choice prevention interventions delivered in the context of antenatal clinics, the outpatient department, and in the community delivered by village health teams. The trial will conduct a randomized trial to evaluate a linkage intervention for patients with hypertension and a randomized trial to evaluate a clinic vs. community based intervention for hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'INDIVIDUAL LEVEL INCLUSION CRITERIA FOR COMPONENT INTERVENTIONS\n\nPrEP/PEP at Outpatient Clinics\n\n1. Age ≥15 years\n2. HIV-negative\n3. Current or anticipated risk for HIV-infection\n\nPrEP/PEP at Antenatal Clinics\n\n1. Age ≥15 years\n2. HIV-negative\n3. Current or anticipated risk for HIV-infection\n\nPrEP/PEP at Community Households\n\n1. Age \\> 15 years\n2. HIV-negative\n3. Current or anticipated risk for HIV-infection\n\nMobility Dynamic Treatment Intervention\n\n1. Age ≥15 years\n2. HIV-positive\n3. HIV RNA non-suppression (\\>400 c/mL in the prior 12 months) or missed 2 visits in past 12 months or missed 2 visits in past 12 months or no VL measured in past 12 months\n4. Travel outside the community ≥2 times in past 12 months\n5. Enrolled or new to care in a study clinic\n\nHealthy Living Intervention for Heavy Alcohol Users\n\n1. Age ≥18 years\n2. HIV-positive\n3. HIV RNA non-suppression (\\>400 c/mL in the prior 12 months) or missed clinic visits (\\>2 weeks or \\<=90 days from last scheduled clinic visit) within past 6 months, or out of care without return to care (\\>90 days from last scheduled clinic visit) within past 6 months\n4. Heavy alcohol use per AUDIT-C tool (scores of ≥4 for men, and ≥3 for women)\n5. Enrolled or new to care in a study clinic\n\nHypertension Linkage Intervention\n\n1. Age ≥25 years\n2. Blood pressure ≥140/90 mmHg on three repeated measurements during community-based hypertension screening\n3. Resident (by self-report) within catchment area of referral health center\n\nCommunity Hypertension Intervention\n\n1. Age \\>=40\n2. Blood pressure ≥160/100 on average of 2nd and 3rd measurements at initial screening\n3. Sustained blood pressure elevation to ≥140/90 at initial clinic enrollment visit\n\nINDIVIDUAL LEVEL EXCLUSION CRITERIA FOR COMPONENT INTERVENTIONS\n\nPrEP/PEP at Outpatient Clinics\n\n1. \\<15 years of age\n2. Unable to provide consent or parental co-consent as per country guidelines\n3. Participation in another Phase A RCT intervention component\n\nPrEP/PEP at Antenatal Clinics\n\n1. \\<15 years of age\n2. unable to provide consent or parental co-consent as per country guidelines\n3. Participation in another Phase A RCT intervention component\n\nPrEP/PEP at Community Households\n\n1. \\<15 years of age\n2. unable to provide consent or parental co-consent as per country guidelines\n3. Participation in another Phase A RCT intervention component\n\nMobility Dynamic Treatment intervention\n\n1. \\<15 years of age\n2. Participation in another Phase A RCT intervention component\n\nHealthy Living Intervention for Heavy Alcohol Users\n\n1. \\<18 years of age\n2. Participation in another Phase A RCT intervention component\n3. No access to mobile phone\n\nHypertension Linkage Intervention\n\n1. \\<25 years of age\n2. Plan to out-migrate from the catchment area of referral health center within 30 days of screening visit\n3. Already engaged in hypertensive care (by self-report)\n4. Blood pressure measure of ≥180/110 mmHg during screening symptoms of hypertensive emergency\n\nCommunity Hypertension Intervention\n\n1. Pregnancy\n2. Co-morbidities that preclude home monitoring'}, 'identificationModule': {'nctId': 'NCT04810650', 'acronym': 'SAPPHIRE PhA', 'briefTitle': 'SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa', 'orgStudyIdInfo': {'id': 'SEARCH SAPPHIRE Phase A'}, 'secondaryIdInfos': [{'id': 'U01AI150510', 'link': 'https://reporter.nih.gov/quickSearch/U01AI150510', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention', 'interventionNames': ['Other: PrEP/PEP at Outpatient Clinics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PREP/PEP at Outpatient Clinics Control', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention', 'interventionNames': ['Other: PrEP/PEP at Antenatal Clinics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PREP/PEP at Antenatal Clinics Control', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'PREP/PEP at Community Households Dynamic Prevention Intervention', 'interventionNames': ['Other: PrEP/PEP at Community Households']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PREP/PEP at Community Households Control', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Mobility Dynamic Treatment Intervention', 'interventionNames': ['Other: Mobility Dynamic Treatment Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mobility Control', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Living for Heavy Alcohol Users Intervention', 'interventionNames': ['Other: Health Living Intervention for Heavy Alcohol Users']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heavy Alcohol Users Control', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Hypertension Linkage Intervention', 'interventionNames': ['Other: Hypertension Linkage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypertension Linkage Control', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Hypertension Community Intervention', 'interventionNames': ['Other: Hypertension Community']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypertension Community Control', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'Mobility Dynamic Treatment Intervention', 'type': 'OTHER', 'description': '1\\) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a "travel pack" with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel', 'armGroupLabels': ['Mobility Dynamic Treatment Intervention']}, {'name': 'Health Living Intervention for Heavy Alcohol Users', 'type': 'OTHER', 'description': '1\\) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls', 'armGroupLabels': ['Healthy Living for Heavy Alcohol Users Intervention']}, {'name': 'Hypertension Linkage', 'type': 'OTHER', 'description': '1\\) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits', 'armGroupLabels': ['Hypertension Linkage Intervention']}, {'name': 'PrEP/PEP at Outpatient Clinics', 'type': 'OTHER', 'description': "Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services", 'armGroupLabels': ['PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention']}, {'name': 'PrEP/PEP at Antenatal Clinics', 'type': 'OTHER', 'description': "Intervention delivered at Antenatal Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services", 'armGroupLabels': ['PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention']}, {'name': 'PrEP/PEP at Community Households', 'type': 'OTHER', 'description': "Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services", 'armGroupLabels': ['PREP/PEP at Community Households Dynamic Prevention Intervention']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Local country standard of care protocols', 'armGroupLabels': ['Heavy Alcohol Users Control', 'Hypertension Community Control', 'Hypertension Linkage Control', 'Mobility Control', 'PREP/PEP at Antenatal Clinics Control', 'PREP/PEP at Community Households Control', 'PREP/PEP at Outpatient Clinics Control']}, {'name': 'Hypertension Community', 'type': 'OTHER', 'description': 'Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications', 'armGroupLabels': ['Hypertension Community Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisumu', 'country': 'Kenya', 'facility': 'GPRT / SEARCH Office', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Mbarara', 'country': 'Uganda', 'facility': 'IDRC Southwest Uganda', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}], 'overallOfficials': [{'name': 'Diane Havlir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Moses Kamya, MBChB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Makerere University'}, {'name': 'Maya Petersen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Berkeley'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Infectious Diseases Research Collaboration, Uganda', 'class': 'OTHER'}, {'name': 'Makerere University', 'class': 'OTHER'}, {'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}, {'name': 'University of California, Berkeley', 'class': 'OTHER'}, {'name': 'University College, London', 'class': 'OTHER'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}