RecruitingNot ApplicableNCT05044962

Kuwa Free! - Live Free!

Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives

Sponsor

University of Alabama at Birmingham

Enrollment

700 participants

Start Date

Nov 26, 2021

Study Type

INTERVENTIONAL

Conditions

HIV Infections Contraception Drug-drug Interaction

Summary

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

Sex: FEMALEMin Age: 15 YearsMax Age: 24 Years

Plain Language Summary

Simplified for easier understanding

This trial — called "Kuwa Free! (Live Free!)" — is studying how different HIV medications and contraceptive methods interact in young women (ages 15–24) with HIV in sub-Saharan Africa, specifically how drug levels in the blood change with these combinations. **You may be eligible if...** - You are female between 15 and 24 years old - You are HIV-positive with a suppressed viral load (below 40 copies/mL in the past 6 months) - You have been on the study antiretroviral drug for at least 4 weeks - You are currently using or plan to use an injectable contraceptive (DMPA) or implant - You are willing to have regular blood draws during the study - You can consent (or assent with parental consent) in English or Kiswahili **You may NOT be eligible if...** - You are already on antiretroviral drug combinations that have known harmful interactions with the study contraceptives - You are unable to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCabotegravir/ Rilpivirine

For initial injection participants will be given CABENUVA 600-mg/900-mg Kit: (single-dose vial of 600 mg/3 mL (200 mg/mL) cabotegravir , single-dose vial of 900 mg/3 mL (300 mg/mL) rilpivirin). For subsequent injections participants will be given CABENUVA 400-mg/600-mg Kit: (single-dose vial of 400 mg/2 mL (200 mg/mL) cabotegravir, single-dose vial of 600 mg/2 mL (300 mg/mL) rilpivirine) CABENUVA® is owned by or licensed to the ViiV Healthcare group of companies, GlaxoSmithKline Research Triangle Park, NC 27709

DRUGEtonogestrel (ETG) implant

Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm

DRUGIntramuscular depo-medroxyprogesterone acetate (IM DMPA)

DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide

DRUGLevonorgestrel

Contraceptive estrogen implants are thin rods inserted under the skin of a woman's arm

DRUGNNRTI, PI, or INSTI-containing 1st or 2nd line ART regimens

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