SEARCH SAPPHIRE Phase B

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.

Conditions

• HIV

Interventions

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.

BEHAVIORAL

Standard of Care

Standard of Care in Uganda and Kenya

Sponsors & Collaborators

• Infectious Diseases Research Collaboration, Uganda

  collaborator OTHER

• Makerere University

  collaborator OTHER

• Kenya Medical Research Institute

  collaborator OTHER

• University of California, Berkeley

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University College, London

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Diane Havlir, MD · University of California, San Francisco

• Moses Kamya, MBChB, PhD · Makerere University; Infectious Diseases Research Collaboration

• Maya Petersen, PhD · University of California, Berkeley

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-03-28

Primary Completion

2026-03-31

Completion

2026-03-31

Countries

• Kenya
• Uganda

Study Locations