Substance Use & PrEP Research Study
Researchers at the Fenway Institute are conducting a study in adult men who have sex with men, are currently taking or considering PrEP and use substances other than nicotine, to learn more about PrEP use and how substance use may affect it.
If you have any questions or concerns, please contact us at 617.927.6266 or smartsteps@fenwayhealth.org.
Fast Facts
Taking or considering PrEP
Adult men who have sex with men
Use substances other than nicotine
Compensation
Provided
Conducted in
Boston, MA
Study Background
Researchers at The Fenway Institute are conducting a study in adult men who have sex with men, are currently taking or considering PrEP, and use substances other than nicotine to develop new ways to track PrEP use and prevent missed doses.
Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV, but its protection depends on taking every dose as prescribed. Missed doses can leave people vulnerable, and current methods of tracking adherence often fail to capture why or when those lapses occur. This study uses a digital pill system and a smartphone app to measure real-time PrEP use and identify patterns that might signal a missed dose before it happens. We are especially interested in understanding how factors such as daily routines and substance use influence PrEP adherence among adult men who have sex with men. By combining digital health technology with participant feedback, we aim to develop practical tools and strategies that support consistent PrEP use and strengthen HIV-prevention efforts.
Eventually, the findings of this study may help create innovative ways to support adherence and reduce HIV risk worldwide.
Study Background
Researchers at The Fenway Institute are conducting a study in adult men who have sex with men, are currently taking or considering PrEP, and use substances other than nicotine to develop new ways to track PrEP use and prevent missed doses.
Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV, but its protection depends on taking every dose as prescribed. Missed doses can leave people vulnerable, and current methods of tracking adherence often fail to capture why or when those lapses occur. This study uses a digital pill system and a smartphone app to measure real-time PrEP use and identify patterns that might signal a missed dose before it happens. We are especially interested in understanding how factors such as daily routines and substance use influence PrEP adherence among adult men who have sex with men. By combining digital health technology with participant feedback, we aim to develop practical tools and strategies that support consistent PrEP use and strengthen HIV-prevention efforts.
Eventually, the findings of this study may help create innovative ways to support adherence and reduce HIV risk worldwide.
Additional Information
In this research study, we are trying to understand the factors that affect how consistently people take pre-exposure prophylaxis (PrEP), a daily medication that prevents HIV. We aim to learn how daily routines, substance use, and other life experiences influence PrEP adherence in adult men who have sex with men. To do this, we are using a digital pill system and a smartphone app that collect real-time information about PrEP use and surrounding behaviors. This approach allows us to see when doses are missed and what might be happening at those times, so we can identify ways to help people stay on track with their PrEP regimen.
You may be eligible for this study if you meet the following criteria.
Inclusion Criteria:
Adult men who have sex with men
Currently taking or interested in starting PrEP
Use substances other than nicotine (e.g., cannabis, alcohol, cocaine)
HIV negative
Own an Android or iOS smartphone
Speak English
Ages 18+
Not allergic to gelatin, silver, or zinc
Exclusion Criteria:
Do not speak English
History of Crohn’s disease, ulcerative colitis, or serious gastrointestinal conditions (e.g., gastric bypass, bowel stricture, GI malignancy, abdominal radiation)
Allergies to gelatin, silver, zinc (components of the digital pill), or PrEP
The study lasts 2 months. Once enrolled, participation involves:
In the lab / in person:
4 study visits: Screening Visit, Enrollment Visit, Month 1 Visit, and Month 2 Visit
Visits include assessments, discussions about missed PrEP doses, a pill count, a blood draw, and a qualitative exit interview
Training on the digital pill system and the smartphone app
From home:
Daily use of the digital pill version of PrEP
Use of a smartphone app that collects information about PrEP adherence, Wi-Fi usage, battery power, and brief surveys after any missed doses
Surveys take just a few minutes and ask about reasons for missed doses, substance use, and sexual activity
As a participant, you may receive up to $150.
There is no cost for you to participate in our research study.