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.
Timeline
- Start
- 2021-11-26
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabotegravir | Small molecule | 400 mg | — |
| Subject | Etonogestrel | Unknown | — | Subcutaneous |
| Subject | Levonorgestrel | Small molecule | — | Subcutaneous |
| Subject | Rilpivirine | Small molecule | 600 mg | — |
| Subject | medroxyprogesterone acetate | Other / unclassified | 150 mg | Intramuscular |
| Comparator | Atazanavir | Other / unclassified | — | — |
| Comparator | Dolutegravir | Other / unclassified | — | — |
| Comparator | Efavirenz | Other / unclassified | — | — |
| Comparator | Lopinavir | Other / unclassified | — | — |
| Comparator | Raltegravir | Other / unclassified | — | — |
| Comparator | Ritonavir | Other / unclassified | — | — |