Evaluating community delivery of HIV treatment for newly diagnosed individuals
Achieving HIV Viral Suppression in Refugee Settlements in Uganda With Head StART: A Cluster Randomized Trial Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV
This study is testing if providing HIV treatment in community settings can help newly diagnosed individuals in Uganda stick to their care and achieve better health outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2720 (estimated) |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Kampala) |
| Trial ID | NCT06126913 on ClinicalTrials.gov |
What this trial studies
This trial is a cluster randomized controlled trial conducted at 12 health centers in refugee settlements in Uganda. It aims to assess the effectiveness of expanding community antiretroviral therapy (ART) delivery to individuals newly diagnosed with HIV, focusing on improving engagement in care and achieving viral suppression. The study leverages a differentiated care model that enhances social support and reduces barriers to accessing treatment. Participants will be monitored for their adherence to treatment and overall health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults and mature minors who have tested positive for HIV within the last six months and are not already in care.
Not a fit: Patients who are already stable on ART or have been diagnosed with HIV for more than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve access to HIV treatment and support for newly diagnosed individuals in refugee settings.
How similar studies have performed: Other studies have shown success with community-based ART delivery models, indicating potential for positive outcomes in similar approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. 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. 4. Tested HIV positive in the past 6 months and not already known to be HIV positive. 5. Able to communicate in one of the following 5 study languages: Kiswahili, Runyankore, Kinyarwanda, Somali, or English. Inclusion criteria for data abstraction only: 1. Adult ≥18 years of age or mature minors or emancipated minor. 2. Tested HIV positive in the past 6 months and not already known to be HIV positive. Exclusion Criteria: 1. Pregnant and breastfeeding women. 2. Clients deemed by the clinician(s) unfit for community-based care secondary to medical need. 3. Concurrently enrolled in another biomedical clinical trial.
Where this trial is running
Kampala
- Infectious Diseases Institute, Makerere University — Kampala, Uganda (Recruiting)
Study contacts
- Principal investigator: Kelli N. O'Laughlin, MD, MPH — University of Washington
- Study coordinator: Layla Anderson
- Email: anderla@uw.edu
- Phone: 206-744-5594
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.