NCT05768763

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81,952

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable hiv

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

March 28, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

March 3, 2023

Last Update Submit

April 8, 2026

Conditions

HIV

Keywords

PrEPHIV TreatmentHIV PreventionCommunity HealthYouth and AdolescentsHypertension

Outcome Measures

Primary Outcomes (1)

  • HIV incidence

    HIV incidence per 100 person-year

    24 months

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Precision Community Health

EXPERIMENTAL

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 activitiesBehavioral: Person-centered care deliveryOther: Data system enhancement to improve reach and person-centered delivery

Control

ACTIVE COMPARATOR

Standard of Care

Behavioral: Standard of Care

Interventions

Person-centered care deliveryBEHAVIORAL

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.

Precision Community Health
Standard of CareBEHAVIORAL

Standard of Care in Uganda and Kenya

Control
Community-enhanced reach activitiesBEHAVIORAL

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.

Precision Community Health
Data system enhancement to improve reach and person-centered deliveryOTHER

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.

Precision Community Health

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 15 years
  • Living in SEARCH study communities
  • Provided informed consent

You may not qualify if:

  • \<15 years of age
  • Living outside SEARCH study communities
  • Unable to provide consent or parental co-consent as per country guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SEARCH Office / GPRT

Kisumu, Kenya

Location

Infectious Diseases Research Collaboration

Kampala, Uganda

Location

MeSH Terms

Conditions

Hypertension

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Diane Havlir, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Moses Kamya, MBChB, PhD

    Makerere University; Infectious Diseases Research Collaboration

    PRINCIPAL INVESTIGATOR

  • Maya Petersen, PhD

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 14, 2023

Study Start

March 28, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)UG(1)