SEARCH SAPPHIRE Phase B

Not Applicable

Recruiting

• Conditions: HIV
• Interventions: Behavioral: Community-enhanced reach activities; Behavioral: Standard of Care; Behavioral: Person-centered care delivery; Other: Data system enhancement to improve reach and person-centered delivery

• Registration Number: NCT05768763
• Lead Sponsor: University of California, San Francisco

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 Timeline

• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-14
• Study Start: 2023-03-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80000

Inclusion Criteria

1. Age >= 15 years
2. Living in SEARCH study communities
3. Provided informed consent

Exclusion Criteria

1. <15 years of age
2. Living outside SEARCH study communities
3. Unable to provide consent or parental co-consent as per country guidelines

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Precision Community Health	Community-enhanced reach activities	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
Precision Community Health	Person-centered care delivery	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
Precision Community Health	Data system enhancement to improve reach and person-centered delivery	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
Control	Standard of Care	Standard of Care

Primary Outcome Measures

Name	Time	Method
HIV incidence	24 months	HIV incidence per 100 person-year

Secondary Outcome Measures

Name	Time	Method
Population-Level Viremia	24 months	Proportion of adults with plasma RNA levels \> 1000 c/mL
Prevention Coverage	assessed between 18-24 month follow up	Proportion of HIV-negative follow-up months during which PrEP/PEP was used
Population Level Viral Suppression among PWH	assessed between 18-24 month follow up	Proportion of HIV+ adults with plasma RNA level \<400 cps/mL
Mortality risk	assessed between 18-24 month follow up	Mortality risk of all community members aged ≥ 15 years at baseline
Hypertension Control	assessed between 18-24 month follow up	HTN control (BP \<140/90 mmHG) of community members aged ≥ 40 years with blood pressure \>160/100 mmHG
Severe Hypertension	assessed between 18-24 month follow up	Severe HTN (BP \>160/100 mmHG)
Persons presenting with late HIV disease	assessed between 18-24 month follow up	Proportion of PWH adults with CD4 T-cell count \< 200
Late Pediatric HIV Diagnosis	assessed between 18-24 month follow up	Proportion of children of HIV+/unknown status mothers diagnosed with HIV
Heavy Alcohol Use	assessed between 18-24 month follow up	AUDIT-C score ≥3 for women, ≥4 for men
HPV Immunization Coverage	assessed between 18-24 month follow up	Proportion of adolescent girls who have received ≥1 HPV vaccine

Trial Locations

Locations (2)

Infectious Diseases Research Collaboration; 🇺🇬 Kampala, Uganda

SEARCH Office / GPRT; 🇰🇪 Kisumu, Kenya