Clinical trialNCT05044962RecruitingInterventional

Kuwa Free! - Live Free!

SponsorUniversity of Alabama at BirminghamEnrollment700ContraceptionDrug-drug InteractionHIV Infections

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Edith Apondi
MTRH Adolescent Rafiki Clinic and Pediatric Program at AMPATH
Principal Investigator
clinicaltrials.gov ↗
Edwin Were
Moi Teaching and Referral Hospital
Principal Investigator
clinicaltrials.gov ↗
Rena Patel, MD, MPH, MPhil
University of Alabama at Birmingham
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Kenya

Academic Model Providing Access To Healthcare (ampath) Moi Teaching and Referral Hospital (mtrh)
Eldoret, Kenya, Kenya
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cabotegravir →Etonogestrel →Intramuscular depo-medroxyprogesterone acetateLevonorgestrel →NNRTI, PI, or INSTI-containing 1st or 2nd line ART regimens

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 26 Nov 2021
Primary completion: 31 Mar 2027
Completion: 31 Mar 2027
Last update posted: 13 Apr 2026
Registered enrollment: 700
Registry id: NCT05044962

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.