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

Mass General Brigham

Status and phase: Completed; Phase 4

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

Treatments: Device: Digital pill; Drug: Truvada

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03842436

2019P000793

Details and patient eligibility

About

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.

Full 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 adherence, and be trained to use the digital pill for 90 days and instructed to take PrEP daily during the course of the study. Participants will return each month for a study visit to assess their use of the technology. At study visit 1 and 3, we will obtain dried blood spots (DBS) to measure drug levels and to confirm adherence detected by the digital pill. The investigators will also obtain drugs of abuse screens from DBS. At the final study visit (3 months), participants will undergo a semi-structured qualitative interview to understand the user response to digital pills.

Enrollment: 16 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Digital Pills

Experimental group

Description:

Digital Pills containing Truvada ingested once daily as PrEP

Treatment:

Drug: Truvada

Device: Digital pill