Kuwa Free! - Live Free!

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.

Conditions

• HIV Infections
• Contraception
• Drug-drug Interaction

Interventions

DRUG

Cabotegravir/ 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

DRUG

Etonogestrel (ETG) implant

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

DRUG

Intramuscular depo-medroxyprogesterone acetate (IM DMPA)

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

DRUG

Levonorgestrel

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

DRUG

NNRTI, 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

Sponsors & Collaborators

• Moi Teaching and Referral Hospital

  collaborator OTHER

• Indiana University

  collaborator OTHER

• University of Nebraska

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Rena Patel, MD, MPH, MPhil · University of Alabama at Birmingham

• Edwin Were · Moi Teaching and Referral Hospital

• Edith Apondi · MTRH Adolescent Rafiki Clinic and Pediatric Program at AMPATH

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

24 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-26

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• Kenya

Study Locations