SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
NCT ID: NCT04810650
Last Updated: 2025-02-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2233 participants
INTERVENTIONAL
2021-04-15
2023-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention
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
PREP/PEP at Outpatient Clinics Control
Standard of Care
Local country standard of care protocols
PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention
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
PREP/PEP at Antenatal Clinics Control
Standard of Care
Local country standard of care protocols
PREP/PEP at Community Households Dynamic Prevention Intervention
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
PREP/PEP at Community Households Control
Standard of Care
Local country standard of care protocols
Mobility Dynamic Treatment Intervention
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
Mobility Control
Standard of Care
Local country standard of care protocols
Healthy Living for Heavy Alcohol Users Intervention
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
Heavy Alcohol Users Control
Standard of Care
Local country standard of care protocols
Hypertension Linkage Intervention
Hypertension Linkage
1\) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits
Hypertension Linkage Control
Standard of Care
Local country standard of care protocols
Hypertension Community Intervention
Hypertension Community
Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications
Hypertension Community Control
Standard of Care
Local country standard of care protocols
Interventions
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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
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
Hypertension Linkage
1\) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits
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
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
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
Standard of Care
Local country standard of care protocols
Hypertension Community
Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications
Eligibility Criteria
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Inclusion Criteria
1. Age ≥15 years
2. HIV-negative
3. Current or anticipated risk for HIV-infection
PrEP/PEP at Antenatal Clinics
1. Age ≥15 years
2. HIV-negative
3. Current or anticipated risk for HIV-infection
PrEP/PEP at Community Households
1. Age \> 15 years
2. HIV-negative
3. Current or anticipated risk for HIV-infection
Mobility Dynamic Treatment Intervention
1. Age ≥15 years
2. HIV-positive
3. 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
4. Travel outside the community ≥2 times in past 12 months
5. Enrolled or new to care in a study clinic
Healthy Living Intervention for Heavy Alcohol Users
1. Age ≥18 years
2. HIV-positive
3. 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
4. Heavy alcohol use per AUDIT-C tool (scores of ≥4 for men, and ≥3 for women)
5. Enrolled or new to care in a study clinic
Hypertension Linkage Intervention
1. Age ≥25 years
2. Blood pressure ≥140/90 mmHg on three repeated measurements during community-based hypertension screening
3. Resident (by self-report) within catchment area of referral health center
Community Hypertension Intervention
1. Age \>=40
2. Blood pressure ≥160/100 on average of 2nd and 3rd measurements at initial screening
3. Sustained blood pressure elevation to ≥140/90 at initial clinic enrollment visit
Exclusion Criteria
1. \<15 years of age
2. Unable to provide consent or parental co-consent as per country guidelines
3. Participation in another Phase A RCT intervention component
PrEP/PEP at Antenatal Clinics
1. \<15 years of age
2. unable to provide consent or parental co-consent as per country guidelines
3. Participation in another Phase A RCT intervention component
PrEP/PEP at Community Households
1. \<15 years of age
2. unable to provide consent or parental co-consent as per country guidelines
3. Participation in another Phase A RCT intervention component
Mobility Dynamic Treatment intervention
1. \<15 years of age
2. Participation in another Phase A RCT intervention component
Healthy Living Intervention for Heavy Alcohol Users
1. \<18 years of age
2. Participation in another Phase A RCT intervention component
3. No access to mobile phone
Hypertension Linkage Intervention
1. \<25 years of age
2. Plan to out-migrate from the catchment area of referral health center within 30 days of screening visit
3. Already engaged in hypertensive care (by self-report)
4. Blood pressure measure of ≥180/110 mmHg during screening symptoms of hypertensive emergency
Community Hypertension Intervention
1. Pregnancy
2. Co-morbidities that preclude home monitoring
15 Years
ALL
Yes
Sponsors
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Infectious Diseases Research Collaboration, Uganda
OTHER
Makerere University
OTHER
Kenya Medical Research Institute
OTHER
University of California, Berkeley
OTHER
University College, London
OTHER
University of Pennsylvania
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
National Institute of Mental Health (NIMH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Diane Havlir, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Moses Kamya, MBChB, PhD
Role: PRINCIPAL_INVESTIGATOR
Makerere University
Maya Petersen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Berkeley
Locations
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GPRT / SEARCH Office
Kisumu, , Kenya
IDRC Southwest Uganda
Mbarara, , Uganda
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Other Identifiers
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SEARCH SAPPHIRE Phase A
Identifier Type: -
Identifier Source: org_study_id
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