PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by
randomization to order with 5 participants per study arm. All participants will sequentially
receive both study products for 28-days with at least a 2-week washout period between
products. Arm 1 will receive the TDF-FTC pod-IVR for Stage 2 followed by the placebo pod-IVR
during Stage 3. Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the TDF-FTC
pod-IVR during Stage 3. During Stages 2 & 3 participants will also complete brief phone
surveys (<3 min), computer-assisted self-interviews (CASIs), and in-depth interviews (IDIs)
regarding perceptibility and acceptability. If willing, participants' male sexual partners
will be invited to complete IDIs as well.
Phase:
Early Phase 1
Details
Lead Sponsor:
Oak Crest Institute of Science
Collaborators:
Johns Hopkins University National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) The Miriam Hospital The University of Texas Medical Branch, Galveston University of California, Los Angeles University of California, San Diego Vanderbilt University