HeadStART: Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV
NCT06126913 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2720
Last updated 2025-01-09
Summary
This is a cluster randomized controlled trial at 12 health centers in refugee settlements in Uganda aiming to evaluate effectiveness of expansion of community antiretroviral therapy (ART) delivery to people newly diagnosed with HIV in achieving HIV viral suppression.
Conditions
- HIV Infections
- Hiv
Interventions
- OTHER
-
Community Antiretroviral Therapy
Newly diagnosed individuals (diagnosed in the prior 6 months) at intervention sites will be offered community ART delivery on a rolling basis during the enrollment window, initiating individuals into groups as close to their date of diagnosis as possible. Newly enrolled individuals will join existing community ART delivery groups, or when a new group is needed based on group size or geographic location, a new group will be formed.
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH - lead OTHER
Principal Investigators
-
Kelli N. O'Laughlin, MD, MPH · University of Washington
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-15
- Primary Completion
- 2028-01-31
- Completion
- 2028-01-31
Countries
- Uganda
Study Locations
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