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.
Phase:
N/A
Details
Lead Sponsor:
University of Washington
Collaborators:
Indiana University Moi Teaching and Referral Hospital National Institute of Allergy and Infectious Diseases (NIAID) University of Nebraska