PrEPSteps: A Pilot Randomized Controlled Trial to Assess the Feasibility and Acceptability of a Digital Pill-Based PrEP Adherence Intervention in Men Who Have Sex with Men with Substance Use Disorder.
| Title: | PrEPSteps: A Pilot Randomized Controlled Trial to Assess the Feasibility and Acceptability of a Digital Pill-Based PrEP Adherence Intervention in Men Who Have Sex with Men with Substance Use Disorder. |
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| Authors: | Chai PR; Department of Emergency Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02411, USA. pchai@bwh.harvard.edu.; Koch Institute for Integrated Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, USA. pchai@bwh.harvard.edu.; Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, MA, USA. pchai@bwh.harvard.edu.; The Fenway Institute, Fenway Health, Boston, MA, USA. pchai@bwh.harvard.edu.; Lee JS; Department of Emergency Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02411, USA.; The Fenway Institute, Fenway Health, Boston, MA, USA.; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.; Goodman GR; Department of Emergency Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02411, USA.; The Fenway Institute, Fenway Health, Boston, MA, USA.; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.; Albrechta H; Mid-Atlantic Permanente Research Institute, Mid-Atlantic Permanente Medical Group, Washington, DC, USA.; Hokayem J; The Fenway Institute, Fenway Health, Boston, MA, USA.; Loo L; The Fenway Institute, Fenway Health, Boston, MA, USA.; Mohamed Y; The Fenway Institute, Fenway Health, Boston, MA, USA.; Glynn TR; Department of Emergency Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02411, USA.; The Fenway Institute, Fenway Health, Boston, MA, USA.; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.; Rosen RK; The Miriam Hospital, Brown University Health, Brown University, Providence, RI, USA.; Mayer KH; The Fenway Institute, Fenway Health, Boston, MA, USA.; Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.; Boyer EW; Department of Emergency Medicine, Ohio State University, Columbus, OH, USA.; Alpert P; eTectRx Inc., Gainesville, FL, USA.; Buffkin E; eTectRx Inc., Gainesville, FL, USA.; Carnes C; eTectRx Inc., Gainesville, FL, USA.; O'Cleirigh C; The Fenway Institute, Fenway Health, Boston, MA, USA.; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA. |
| Source: | AIDS and behavior [AIDS Behav] 2026 Feb 02. Date of Electronic Publication: 2026 Feb 02. |
| Publication Model: | Ahead of Print |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Springer Science + Business Media Country of Publication: United States NLM ID: 9712133 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-3254 (Electronic) Linking ISSN: 10907165 NLM ISO Abbreviation: AIDS Behav Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2005- : New York, NY : Springer Science + Business Media; Original Publication: New York, NY : Plenum Press, 1997- |
| Abstract: | One of the key pillars of Ending the HIV Epidemic is ensuring adherence to oral HIV pre-exposure prophylaxis (PrEP). Men who have sex with men (MSM) who also have substance use disorders experience multiple challenges to maintaining PrEP adherence. We developed a digital pill system (DPS) linked to a personalized adherence intervention, PrEPSteps, to address barriers to PrEP adherence, and tested the feasibility and acceptability of this system, as well as its potential for an effect on PrEP adherence. We enrolled MSM with moderate to severe substance use disorder who were on oral PrEP in a two-arm pilot randomized controlled trial. Both arms received the DPS co-encapsulated with oral PrEP. Participants in the intervention arm also received "PrEPSteps" - a personalized cognitive-behavioral adherence intervention. Primary outcomes were feasibility and acceptability of DPS + PrEPSteps. To explore potential intervention effects, adherence changes from baseline to 3-month follow-up were compared across arms. At 6-month follow-up, adherence was assessed via self-report. Thirty-six participants were enrolled, 32, completed the run-in period, 28 were randomized, and 27 completed the 3-month intervention period. Of those, 26 completed six-month follow-up. Operation of the DPS and PrEPSteps was feasible, with consistent data recording throughout the 3-month intervention period. Qualitative interviews in the intervention arm at 3 months demonstrated PrEPSteps was acceptable. Intervention arm participants had 14% higher PrEP adherence (b = 13.67, 95%CI [.77-26.57], p = .039) at 3 month follow up. This effect persisted at six months, suggesting that PrEPSteps has the potential to improve PrEP adherence and help individuals sustain adherence benefits over time.Trial registration: www.ClinicalTrials.gov identifier: NCT03512418.; (© 2026. The Author(s).) |
| Competing Interests: | Declarations. Conflict of interest: PRC is funded by K23DA044874 and DP2DA056107. KM and CO are funded by P30AI060354. TRG’s is funded by NIDA K23DA060719. TDF/FTC as PrEP was provided for this study by Gilead Sciences (ISR-17-1018). PA, CC and EB are employees of eTectRx. |
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| Grant Information: | DP2DA056107 United States DA NIDA NIH HHS; K23 DA060719 United States DA NIDA NIH HHS; K23 DA044874 United States DA NIDA NIH HHS; DP2 DA056107 United States DA NIDA NIH HHS; K24 DA062568 United States DA NIDA NIH HHS; K23DA044874 United States DA NIDA NIH HHS; K23DA060719 United States DA NIDA NIH HHS; P30 AI060354 United States AI NIAID NIH HHS |
| Contributed Indexing: | Keywords: Adherence intervention; Digital pill system; HIV prevention; Ingestible sensor; PrEP |
| Molecular Sequence: | ClinicalTrials.gov NCT03512418 |
| Entry Date(s): | Date Created: 20260202 Latest Revision: 20260328 |
| Update Code: | 20260328 |
| PubMed Central ID: | PMC12974493 |
| DOI: | 10.1007/s10461-026-05049-x |
| PMID: | 41627697 |
| Database: | MEDLINE |
Journal Article