Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives
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.
• Female sex,
• HIV-positive (for PK groups #1-4) or HIV-uninfected (for PK group #5 only),
• Age 15-24 years at the time of enrollment,
• Documented or confirmed viral suppression for HIV (defined as \<40 copies/mL) within 6 months prior to study enrollment,
• Have been on the study oral drug for at least 4 weeks for the PK groups #1-4,
• Have initiated and intends to use DMPA or implant for at least another three or 6 months, respectively,
• Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period
• Able to consent or assent (with parental consent) for study participation in English or Kiswahili
• Participating in PK study for study participants,
• Self-identifying as provider, program person, policy-maker, or stakeholder relevant to the study topics, and age 18 years of age or older,
• Able to consent for study participation in English or Kiswahili
• Female sex,
• HIV-positive,
• Age 15-24 years at the time of enrollment,
• Documented or confirmed viral suppression for HIV (defined as \<40 copies/mL) within 6 months prior to study enrollment,
• Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period,
• Able to consent or assent (with parental consent) for study participation in English or Kiswahili
• Participating in hybrid trial study for study participants,
• Self-identifying as provider, program person, policy-maker, or stakeholder relevant to the study topics, and age 18 years of age or older,
• Able to consent for study participation in English or Kiswahili