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

Completed · Phase 4

Conditions studied: HIV/AIDS, Substance Use Disorders, Adherence, Medication

In brief

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.

Key facts

Study ID: NCT03842436
Run by: Brigham and Women's Hospital
People needed: 16
Starts: 2018-10-01
Expected to finish: 2020-04-22
Last updated by the study team: 2022-12-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

MSM (cisgender male)
Self-reported use of non-alcohol substances of abuse in past 6 months
Currently taking PrEP
Has qualifying laboratory tests (Cr, hepatitis B immunization, STI testing and syphilis)
Age 18 or older

You may not qualify if…

Does not speak English
HIV positive
Identifies as transgender
Estimated creatinine clearance <60ml/min
Active hepatitis B treatment
Does not own a smartphone
Taking proton pump inhibitors
History of Crohn's disease or ulcerative colitis
History of bowel surgery, gastric bypass, bowel stricture
History of GI malignancy or radiation to abdomen
Unable/unwilling to ingest digital pill

Where it is running

Fenway Health — Boylston, Massachusetts, United States

Full record on ClinicalTrials.gov

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