SEARCH SAPPHIRE Phase B

June 29, 2023 updated by: University of California, San Francisco

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

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 (Estimated)

160000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Kisumu, Kenya
        • Recruiting
        • SEARCH Office / GPRT
        • Contact:
          • James Ayeiko, MBChB, PhD
          • Phone Number: +254-720-925262
        • Principal Investigator:
          • Elizabeth Bukusi, MBChB, PhD
      • Kampala, Uganda
        • Recruiting
        • Infectious Diseases Research Collaboration
        • Principal Investigator:
          • Moses Kamya, MBChB, PhD
        • Contact:
          • Jane Kabami, MPH
          • Phone Number: +256-706-315810

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
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-enhancement to improve precision of interventions.
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 system, leveraging existing mobile outreaches in the community.
Structured approach to provide patient-centered biomedical options for prevention. Tailored services for youth, pregnant women, and persons without viral suppression, mobile populations, with heavy alcohol use, or severe hypertension.
Both community-enhanced reach and person-centered delivery will be strengthened through the strategic collection and use of data. Analysis will be conducted to enhance the effectiveness of ongoing outreach activities by identifying high yield venues and locations and local regions and persons who would benefit form more frequent or intensive outreach or services due to, eg, elevated risk of HIV infection, unsuppressed viral load, and uncontrolled HTN.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of persons with new HIV infections
Time Frame: 2.5 years
HIV incidences per 100 person-year
2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 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)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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