Phase 4
N=16
Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
HIV/AIDS · Substance Use Disorders · Adherence, Medication
Bottom Line
View on ClinicalTrials.gov: NCT03842436 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Feasibility of Digital Pills to Measure PrEP Adherence — 411; 368; 320 Expected ingestions per pill counts
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Digital pill (Device); Truvada (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Digital Pills to Measure PrEP Adherence |
411; 368; 320 | — |
| SECONDARY Digital Pill Performance - Number of Recorded Ingestions |
922; 177 | — |
| SECONDARY Digital Pill Performance - System Accuracy |
92 | — |
| SECONDARY Digital Pill Performance - Manually Reported Ingestions |
158; 19 | — |
| SECONDARY Digital Pill Performance - Successful Operation of System |
922; 19 | — |
| SECONDARY Dried Blood Spot Correlation With Digital Pill Adherence |
0.58; 0.85; 0.75 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03842436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.