HeadStART: Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV
Recruiting · NCT06126913 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Washington
View the official record on ClinicalTrials.gov →Interventions studied
Community Antiretroviral Therapy
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Infectious Diseases Institute, Makerere University - Kampala, Uganda