drugset / Trial / NCT03842436
Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
NaSingle-groupOpen-labelPrevention
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.
Timeline
- Start
- 2018-10-01
- Primary completion
- 2020-04-22
- Completion
- 2020-04-22
Publications
- Chai PR, Goodman GR, Bronzi O, Gonzales G, Baez A, Bustamante MJ, Najarro J, Mohamed Y, Sullivan MC, Mayer KH, Boyer EW, O'Cleirigh C, Rosen RK. Real-World User Experiences with a Digital Pill System to Measure PrEP Adherence: Perspectives from MSM with Substance Use. AIDS Behav. 2022 Jul;26(7):2459-2468. doi: 10.1007/s10461-022-03594-9. Epub 2022 Jan 28.
- Chai PR, Mohamed Y, Bustamante MJ, Goodman GR, Najarro J, Castillo-Mancilla J, Baez A, Bronzi O, Sullivan MC, Pereira LM, Baumgartner SL, Carnes TC, Mayer KH, Rosen RK, Boyer EW, O'Cleirigh C. DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances. J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):e5-e15. doi: 10.1097/QAI.0000000000002854.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenofovir | Small molecule | — | Oral |