Study of Long-acting Injectable HIV Treatment and Contraceptives for Girls and Young Women Aged 15 to 24 with HIV in Kenya

What this Trial Is About

Researchers are studying adolescent girls and young women aged 15 to 24 years living with HIV who are already on oral antiretroviral therapy ART and have viral suppression. The research includes foundational pharmacokinetic PK and qualitative studies to understand the effects and delivery challenges of long-acting LA injectable cabotegravirrilpivirine compared to standard oral ART, conducted within a large HIV treatment program in Kenya. This study aims to inform a future hybrid effectiveness-implementation trial by evaluating drug interactions and health system readiness. The study involves several components a PK study with five groups to assess drug interactions between LA ART and injectable or implantable contraceptives a qualitative study with participants and stakeholders exploring preferences and system preparedness for co-delivery of LA ART and contraceptives and a 48-week open-label trial randomizing participants to switch to injectable cabotegravirrilpivirine or continue oral ART. Participants also receive contraceptives such as injectable DMPA or hormone implants based on group assignment. Participants are monitored through regular blood sampling every 4 to 12 weeks to measure hormone levels and viral suppression over 48 weeks. Researchers assess adherence and persistence to ART and contraceptive use, as well as implementation outcomes like acceptability and feasibility. Data collected will guide future studies and wider implementation of LA ART and contraceptive co-delivery to improve treatment adherence and reproductive health among young women living with HIV.

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