Kuwa Free! - Live Free!
Recruiting now · Not applicable
Conditions studied: HIV Infections, Contraception, Drug-drug Interaction
In brief
The study investigators are conducting foundational pharmacokinetic (PK) and qualitative studies, among 15-24 years old (inclusive) adolescent girls and young women living with HIV (AGYWLHIV) already on oral antiretroviral therapy (ART) and virally suppressed, leading up to a hybrid type I effectiveness-implementation trial randomizing individual AGYWLHIV to receive long-acting (LA) injectable cabotegravir/rilpivirine vs. standard of care within one of Kenya's largest HIV treatment programs. The PK and qualitative studies will investigate potential issues arising from co-delivery and guide delivery of the effectiveness-implementation trial. The PK and qualitative studies will largely be conducted with a sentinel cohort of AGYWLHIV. Learning from this early LA ART use, the investigators will refine the procedures in the LA ART hybrid trial.
Key facts
- Study ID
- NCT05044962
- Run by
- University of Alabama at Birmingham
- People needed
- 700
- Starts
- 2021-11-26
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2026-04-13
Who can join
Age: 15 and older, up to 24. Sex: female. Healthy volunteers: accepted.
Where it is running
- Academic Model Providing Access to Healthcare (AMPATH) Moi Teaching And Referral Hospital (MTRH) — Eldoret, Kenya, Kenya (enrolling)
Full record on ClinicalTrials.gov
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