Actively Recruiting
Kuwa Free! - Live Free!
Led by University of Alabama at Birmingham · Updated on 2026-04-13
700
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
M
Moi Teaching and Referral Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Kuwa Free! - Live Free!
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex
- HIV-positive status for pharmacokinetic and hybrid trial groups
- Age between 15 and 24 years at enrollment
- Documented viral suppression for HIV (less than 40 copies/mL) within 6 months before enrollment
- On the study oral drug for at least 4 weeks (for pharmacokinetic groups 1-4)
- Initiated and planning to use DMPA or implant contraceptives for at least another 3 or 6 months respectively
- Willing to undergo blood draws every 4 to 12 weeks throughout the study
- Able to consent or assent (with parental consent) in English or Kiswahili
- For qualitative studies, self-identifying as relevant provider, program person, policy-maker, or stakeholder and age 18 or older
You will not qualify if you...
- Currently on ART containing combinations of NNRTIs, PIs, or INSTIs such as efavirenz, atazanavir/ritonavir, lopinavir/ritonavir, raltegravir, or dolutegravir
- Currently pregnant, breastfeeding, or intending pregnancy within the next 12 or 24 weeks for DMPA or implant groups (pharmacokinetic study) or within one year (hybrid trial)
- Had unprotected sex in the last two weeks or currently pregnant by urine test
- Using or planning to use drugs known to interact with hormonal implants or study ART regimen
- Using or planning to use other hormonal contraceptives concurrently
- Obese with BMI of 30 or higher
- Positive for Hepatitis B surface antigen or certain markers indicating active Hepatitis B infection
- Serum alanine aminotransferase (ALT) levels greater than 5 times the upper limit of normal at screening
- Serum creatinine levels greater than 2.5 times the upper limit of normal at screening
AI-Screening
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Trial Site Locations
Total: 1 location
1
Academic Model Providing Access to Healthcare (AMPATH) Moi Teaching And Referral Hospital (MTRH)
Eldoret, Kenya, Kenya
Actively Recruiting
Research Team
R
Rena Patel, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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