SEARCH SAPPHIRE Phase B

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 81952
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • SEARCH Office / GPRT
• Uganda
  • Kampala, Uganda
    • Infectious Diseases Research Collaboration

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Standard of Care	Behavioral: Standard of Care; Standard of Care in Uganda and Kenya
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV incidence	HIV incidence per 100 person-year	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Mental Health (NIMH); University of California, Berkeley; National Heart, Lung, and Blood Institute (NHLBI); University College, London; Makerere University; Kenya Medical Research Institute; Infectious Diseases Research Collaboration, Uganda
• Investigators: Principal Investigator: Moses Kamya, MBChB, PhD, Makerere University; Infectious Diseases Research Collaboration; Principal Investigator: Diane Havlir, MD, University of California, San Francisco; Principal Investigator: Maya Petersen, PhD, University of California, Berkeley

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Actual): March 31, 2026
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; PrEP; HIV Prevention; Community Health; Youth and Adolescents; HIV Treatment
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: SEARCH SAPPHIRE Phase B; U01AI150510 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No