NCT06126913 HeadStART: Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV
| NCT ID | NCT06126913 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,720 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,720 participants in total. It began in 2024-01-15 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 people newly diagnosed with HIV in achieving HIV viral suppression.
Eligibility 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.
Contact & Investigator
Kelli N. O'Laughlin, MD, MPH
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT06126913 clinical trial?
This trial is open to participants of all sexes, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06126913 currently recruiting?
Yes, NCT06126913 is actively recruiting participants. Contact the research team at anderla@uw.edu for enrollment information.
Where is the NCT06126913 trial being conducted?
This trial is being conducted at Kampala, Uganda.
Who is sponsoring the NCT06126913 clinical trial?
NCT06126913 is sponsored by University of Washington. The principal investigator is Kelli N. O'Laughlin, MD, MPH at University of Washington. The trial plans to enroll 2,720 participants.
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