drugset
drugset / Trial / NCT03255915

PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)

NCT03255915 ↗

Phase 0 Unknown 15 enrolled Oak Crest Institute of Science Johns Hopkins University · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabNational Institutes of Health (NIH) · collabThe Miriam Hospital · collabThe University of Texas Medical Branch, Galveston · collabUniversity of California, Los Angeles · collabUniversity of California, San Diego · collabVanderbilt University · collab
RandomizedCrossoverTriple-blindPrevention

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.

Timeline

Start
2018-09-20
Primary completion
2020-09-30
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenofovir disoproxil fumarate Small molecule 1 mg Other
Subject emtricitabine Other / unclassified 2 mg Other

Indications

No indication recorded.