Kuwa Free! - Live Free!

Sponsor
University of Alabama at Birmingham
Study ID
NCT05044962
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 24 Years
Healthy Volunteers
Accepted

Interventions

  • Cabotegravir/ Rilpivirine — DRUG
    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
  • Etonogestrel (ETG) implant — DRUG
    Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm
  • Intramuscular depo-medroxyprogesterone acetate (IM DMPA) — DRUG
    DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide
  • Levonorgestrel — DRUG
    Contraceptive estrogen implants are thin rods inserted under the skin of a woman's arm
  • NNRTI, PI, or INSTI-containing 1st or 2nd line ART regimens — DRUG
    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

Study Details

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 Dates

First listed
Sep 16, 2021
Start date
Nov 26, 2021
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aim 1a (PK study group 1)
    Initiating injectable cabotegravir/rilpivirine (LA ART) and DMPA
  • Experimental: Aim 1a (PK study group 2)
    Initiating injectable cabotegravir/rilpivirine (LA ART) and and etonogestrel implant
  • Experimental: Aim 1a (PK study group 3)
    Initiating injectable cabotegravir/rilpivirine (LA ART) and levonorgestrel implant.
  • Active Comparator: Aim 1a (PK study group 4)
    Receiving injectable cabotegravir/ rilpivirine (LA ART) and not using any hormonal contraceptive method (e.g. copper IUD)
  • Active Comparator: Aim 1a (PK study group 5)
    AGYW without HIV and not exposed to antiretrovirals (e.g., for PrEP) initiating DMPA
  • Experimental: Aim 2a (Hybrid trial intervention group)
    AGYW with viral suppression on their current ART regimen to switch to cabotegravir/ rilpivirine.
  • Active Comparator: Aim 2a (Hybrid trial comparator group)
    AGYW with viral suppression to continue their oral ART regimen.

Primary Outcome Measure

Hormone concentrations with cabotegravir/rilpivirine use (Aim 1a) [ Time Frame: 12 or 24 weeks after DMPA or implant initiation, respectively ]

Central Contacts

Find similar trials

Nationwide
HIV trialsInfectious disease trials

Related Studies