Lead Investigator: Jared Baeten MD,PhD

Other Investigators: Stephen Asiimwe MD, MS, Elioda Tumwesigye MD, MS, David Bangsberg, MD, MPH, Nneka Emenyonu, MPH, Connie Celum, MD, MPH

Specific Objectives:

• To evaluate a medication electronic monitoring system (MEMS) among participants in an HIV-1 prevention clinical trial.
• To examine the validity of MEMS with unannounced home adherence visits.

Design:

Ancillary, observational and interventional study within the clinical trial: “Parallel Comparison of Tenofovir and Emtricitabine/tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition within HIV-1 Discordant Couples.”.

Population:

Participants from the parent clinical trial at the Kabwohe, Kampala, and Tororo, Uganda sites.

Study Size:

All parent clinical trial participants at the Kabwohe, Kampala, and Tororo sites (400-800 couples per site) are eligible for the unannounced pill counts, electronic adherence monitoring, drug levels, and adherence intervention components of this ancillary study. Qualitative interviews about low adherence and drug sharing are conducted at the Kabwohe site – 175 couples estimated to participate in qualitative interviews.