Actively Recruiting

Phase Not Applicable
All Genders
NCT06126913

HeadStART: Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV

Led by University of Washington · Updated on 2025-01-09

2720

Participants Needed

1

Research Sites

211 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

HeadStART: Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Evidence of signed informed consent indicating understanding of the study
  • Willingness and ability to comply with study visits, treatment plans, lab tests, and procedures
  • Adults 18 years or older, or mature minors (14-17 years with drug/alcohol dependency or STI) or emancipated minors (under 18 who are pregnant, married, have a child, or self-sufficient)
  • Tested HIV positive within the past 6 months and not already known to be HIV positive
  • Able to communicate in Kiswahili, Runyankore, Kinyarwanda, Somali, or English
  • For data abstraction only: adults 18 years or older, mature minors, or emancipated minors
  • For data abstraction only: tested HIV positive in the past 6 months and not previously known to be HIV positive
Not Eligible

You will not qualify if you...

  • Pregnant and breastfeeding women
  • Clients deemed by clinicians unfit for community-based care due to medical needs
  • Concurrent enrollment in another biomedical clinical trial

AI-Screening

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Trial Site Locations

Total: 1 location

1

Infectious Diseases Institute, Makerere University

Kampala, Uganda

Actively Recruiting

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Research Team

L

Layla Anderson

CONTACT

K

Kelli O'Laughlin, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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