Status:
COMPLETED
Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV/AIDS
Substance Use Disorders
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief 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 r...
Detailed Description
Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). Participants will complete a quantitative assessment on their history fo substance use, sexual risk and PrEP ad...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03842436
Start Date
October 1 2018
End Date
April 22 2020
Last Update
December 22 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fenway Health
Boylston, Massachusetts, United States, 02215