Kuwa Free! - Live Free!

ConditionsHIV Infections Contraception Drug-drug Interaction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age15-24

SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

Qualifiers

Female sex,

HIV-positive (for PK groups #1-4) or HIV-uninfected (for PK group #5 only),

Age 15-24 years at the time of enrollment,

Documented or confirmed viral suppression for HIV (defined as <40 copies/mL) within 6 months prior to study enrollment,

Disqualifiers

Already be on ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir

Currently pregnant or intends to become pregnant or breastfeeding within the next 12 or 24 weeks for DMPA or implant groups, respectively,

Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,

Use or anticipated use of drugs for the duration of the study period known to interact with hormonal implants or the study ART regimen,

Trial design

Treatments tested in this trial

Cabotegravir/ Rilpivirine
Etonogestrel (ETG) implant
Intramuscular depo-medroxyprogesterone acetate (IM DMPA)
Levonorgestrel
NNRTI, PI, or INSTI-containing 1st or 2nd line ART regimens

Treatment groups

700 Participants

are divided into 7 treatment groups

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

Moi Teaching and Referral Hospital

Collaborator

Indiana University

Collaborator

University of Nebraska

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov