Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use

• Status: Completed
• Trial end date: 2020-04-22
• Target enrollment: 0
• Participant gender: Male

Summary

This study deploys a novel digital pill with Emtricitabine/Tenofovir (TDF/FTC) among MSM with substance use to monitor PrEP adherence. The investigators will enroll N=15 HIV uninfected MSM with self reported substance use who are on PrEP or initiating PrEP to use digital pills over encapsulating TDF/FTC for 3 months. The investigators will assess the feasibility of using digital pills in this study population as well as understand the acceptability of digital pills for adherence measurement using semi-structured individual interviews. Additionally, the investigators will measure adherence over time, as well as episodes of suboptimal PrEP adherence.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fenway Community Health; Peter Chai
• Collaborator: Gilead Sciences
• Treatments: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Criteria

Inclusion Criteria:

1. MSM (cisgender male)

2. Self-reported use of non-alcohol substances of abuse in past 6 months

3. Currently taking PrEP

4. Has qualifying laboratory tests (Cr, hepatitis B immunization, STI testing and syphilis)

5. Age 18 or older

Exclusion Criteria:

1. Does not speak English

2. HIV positive

3. Identifies as transgender

4. Estimated creatinine clearance <60ml/min

5. Active hepatitis B treatment

6. Does not own a smartphone

7. Taking proton pump inhibitors

8. History of Crohn's disease or ulcerative colitis

9. History of bowel surgery, gastric bypass, bowel stricture

10. History of GI malignancy or radiation to abdomen

11. Unable/unwilling to ingest digital pill