Status:
RECRUITING
HeadStART: Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
HIV Infections
Hiv
Eligibility:
All Genders
Phase:
NA
Brief 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 ...
Detailed Description
Community antiretroviral therapy (ART) delivery is a differentiated care model that fosters social support and reduces time and transportation barriers yielding improved engagement in HIV care. In Uga...
Eligibility Criteria
Inclusion
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Adult ≥18 years of age or mature minors or emancipated minor. Mature minors are defined as individuals 14-17 years of age who have drug or alcohol dependency or a sexually transmitted infection. Emancipated minors are defined as individuals below the age of majority (18 years) who are pregnant, married, have a child, or are self-sufficient.
- Tested HIV positive in the past 6 months and not already known to be HIV positive.
- Able to communicate in one of the following 5 study languages: Kiswahili, Runyankore, Kinyarwanda, Somali, or English.
- Inclusion criteria for data abstraction only:
- Adult ≥18 years of age or mature minors or emancipated minor.
- Tested HIV positive in the past 6 months and not already known to be HIV positive.
Exclusion
- Pregnant and breastfeeding women.
- Clients deemed by the clinician(s) unfit for community-based care secondary to medical need.
- Concurrently enrolled in another biomedical clinical trial.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2028
Estimated Enrollment :
2720 Patients enrolled
Trial Details
Trial ID
NCT06126913
Start Date
January 15 2024
End Date
January 31 2028
Last Update
January 9 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Infectious Diseases Institute, Makerere University
Kampala, Uganda