Development and clinical assessment of new objective adherence markers for four microbicide delivery systems used in HIV prevention studies.

ABSTRACT:

Background

Adherence is critical for successful topical, vaginally delivered anti-retroviral (ARV)-based HIV pre-exposure prophylaxis (PrEP). Quantitating systemic or tissue ARV levels through LC-MS/MS is currently viewed as the most reliable measure of adherence. However, for placebo-controlled trials, this is a high cost analysis that measures adherence only in the drug treatment group. A desirable marker of adherence is one that is measured in both placebo and drug treatment groups using a simple on-site clinical laboratory test, which allows necessary interventions for supporting participant adherence. Our objective was to develop adherence markers for four vaginal placebo products currently used as microbicide delivery systems: gel, film, insert, and intravaginal ring. Excipie

SUBMITTER: Jacot TA 

PROVIDER: S-EPMC6219998 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature