NCT05768763

SEARCH SAPPHIRE Phase B

SEARCH Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa Phase B

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81,952 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the effects of optimized dynamic prevention and treatment packages delivered in a precision community health model on HIV incidence, as well as other health outcomes, in a community randomized trial design.

Detailed description

In the "evaluation" Phase B, the SEARCH SAPPHIRE study will evaluate the effects of Dynamic Prevention and Dynamic Treatment intervention packages based on data from Phase A (NCT04810650) and new advances from outside the study delivered in a precision community health model, on HIV incidence and other health outcomes, in a pair-matched community randomized design. The Phase B precision community health intervention will consist of a three part intervention: 1) Community-enhanced reach activities 2) Person-centered care delivery; and, 3) Data-enhancement to improve precision of interventions. The study hypothesis for the Phase B population level study is: A Precision Community Health Model leveraging existing facility-based outreach and community health workers, enabled by dynamic choice prevention/treatment multi-disease approaches and interactive data systems -will reduce HIV infections, deaths and improve health. Structured stakeholder consultations are formally incorporated in the study design and leverage regular and ongoing collaborations the study team has with the HIV, non-communicable disease and general health leads in Kenya and Uganda Ministries of Health and PEPFAR implementing partners at the national and the regional level.

Conditions

• HIV

Interventions

Type	Name	Description
BEHAVIORAL	Community-enhanced reach activities	We will conduct a series of community engagement activities designed to reach persons at risk for HIV, undiagnosed with HIV or diagnosed, or hypertension, and fallen out of care, working closely with community health workers, integrated in the community health system.
BEHAVIORAL	Person-centered care delivery	Structured approach to provide patient-centered biomedical options for HIV prevention (dynamic choice prevention). Tailored services for HIV treatment support using structured life stage evaluation and assessment plan (LEAP) for youth, pregnant women, and persons with or at risk of HIV viral non-suppression, that includes counselling for heavy alcohol users. Structured approach to offer telehealth for severe hypertension follow up.
OTHER	Data system enhancement to improve reach and person-centered delivery	Both community-enhanced reach and person-centered delivery will be strengthened through a customized in-country Ministry of Health-compatible community health worker smartphone app and two-way data system linking community health workers and clinical records.
BEHAVIORAL	Standard of Care	Standard of Care in Uganda and Kenya

Timeline

• Start date: 2023-03-28
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2023-03-14
• Last updated: 2026-04-13

Locations

2 sites across 2 countries: Kenya, Uganda