Clinical trial NCT04810650: SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
Official title: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Hypertension
Alcohol Drinking
Maternal Child Health
Cost Effectiveness
Keywords: PrEP
PEP
HIV Treatment and Prevention
Community Health
Mobile Populations
Youth and Adolescents
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Infectious Diseases Research Collaboration, Uganda
name: Makerere University
name: Kenya Medical Research Institute
name: University of California, Berkeley
name: University College, London
name: University of Pennsylvania
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: National Institute of Mental Health (NIMH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-03-23
Enrollment: 2233
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: INDIVIDUAL LEVEL INCLUSION CRITERIA FOR COMPONENT INTERVENTIONS

PrEP/PEP at Outpatient Clinics

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

INDIVIDUAL LEVEL EXCLUSION CRITERIA FOR COMPONENT INTERVENTIONS

PrEP/PEP at Outpatient 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 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

Primary outcomes:
measure: Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP
timeFrame: 48 weeks
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
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
measure: Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml
timeFrame: 48 weeks
measure: Percentage of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml
timeFrame: 24 weeks
measure: Number of Participants Who Linked to Hypertension Care
timeFrame: 30 days
measure: Percentage of Participants With Hypertension Control <140/90 mmHg
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: GPRT / SEARCH Office
city: Mbarara
country: Uganda
facility: IDRC Southwest Uganda
Study officials:
affiliation: University of California, San Francisco
name: Diane Havlir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: Moses Kamya, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Berkeley
name: Maya Petersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.