SEARCH Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa Phase B
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 81,952
- Locations
- 4
- Primary Endpoint
- HIV incidence
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age >= 15 years
- •Living in SEARCH study communities
- •Provided informed consent
Exclusion Criteria
- •<15 years of age
- •Living outside SEARCH study communities
- •Unable to provide consent or parental co-consent as per country guidelines
Arms & Interventions
Precision Community Health
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 system enhancement to improve reach and person-centered delivery
Intervention: Community-enhanced reach activities (Behavioral)
Precision Community Health
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 system enhancement to improve reach and person-centered delivery
Intervention: Person-centered care delivery (Behavioral)
Precision Community Health
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 system enhancement to improve reach and person-centered delivery
Intervention: Data system enhancement to improve reach and person-centered delivery (Other)
Control
Standard of Care
Intervention: Standard of Care (Behavioral)
Outcomes
Primary Outcomes
HIV incidence
Time Frame: 24 months
HIV incidence per 100 person-year
Secondary Outcomes
- Population-Level Viremia(24 months)
- Prevention Coverage(assessed between 18-24 month follow up)
- Population Level Viral Suppression among PWH(assessed between 18-24 month follow up)
- Mortality risk(assessed between 18-24 month follow up)
- Hypertension Control(assessed between 18-24 month follow up)
- Severe Hypertension(assessed between 18-24 month follow up)
- Persons presenting with late HIV disease(assessed between 18-24 month follow up)
- Late Pediatric HIV Diagnosis(assessed between 18-24 month follow up)
- Heavy Alcohol Use(assessed between 18-24 month follow up)
- HPV Immunization Coverage(assessed between 18-24 month follow up)