NCT04810650

SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa

A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,233 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV
• Hypertension
• Alcohol Drinking
• Maternal Child Health
• Cost Effectiveness

Interventions

Type	Name	Description
OTHER	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
OTHER	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
OTHER	Hypertension Linkage	1\) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits
OTHER	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
OTHER	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
OTHER	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
OTHER	Standard of Care	Local country standard of care protocols
OTHER	Hypertension Community	Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications

Timeline

• Start date: 2021-04-15
• Primary completion: 2023-10-16
• Completion: 2023-10-16
• First posted: 2021-03-23
• Last updated: 2025-02-06
• Results posted: 2025-02-06

Locations

2 sites across 2 countries: Kenya, Uganda