A Crossover Study Evaluating 3 Non-medicated Silicone IVRs

NACompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

January 20, 2022

Primary Completion Date

December 31, 2022

Study Completion Date

January 31, 2023

Conditions
HivPregnancy Related
Interventions
DEVICE

Impact of ring size on adherence

The study design is a randomized, open-label, parallel group 3-way crossover study comparing adherence, preference and overall acceptability of 3 different-sized placebo IVRs (IVRs A, B and C) in 24 US couples. At enrollment, each couple will be randomly assigned to 1 of 6 sequences of IVR use: A-B-C, A-C-B, B-A-C, B-C-A, C-A-B or C-B-A. Each couple will use each of the 3 IVRs (IVRs A, B and C) for 30 days per IVR, 90 days total.

Trial Locations (2)

10461

Albert Einstein College of Medicine,, New York

30322

Emory University, Atlanta

All Listed Sponsors
collaborator

Albert Einstein College of Medicine

OTHER

collaborator

Emory University

OTHER

lead

Population Council

OTHER