Substance Use Research Study
Taking PrEP (pre-exposure prophylaxis) or interested in starting PrEP for HIV prevention? Ready to find a SMARTer solution for not forgetting your PrEP? Join the SmartSteps Study!
Fast Facts
Ages 18+
Men Who Have Sex With Other Men
Currently Uses Substances
Compensation Provided
Conducted in Boston, MA
Study Background
Fenway Health is seeking men who have sex with other men to use a digital pill version of PrEP daily, for 2 months, which will help us develop an algorithm to better predict when people might miss their dose of PrEP before it happens.
In this study, we are developing an algorithm that uses a digital pill system, along with an app that collects data from your smartphone, to better predict non-adherence to PrEP (pre-exposure prophylaxis taken for HIV prevention) before it happens. We are enrolling HIV-negative men who have sex with other men (MSM) who use substances in this study.
Your participation would consist of using a digital pill version of PrEP daily for 2 months. You would also use a mobile app that will collect data from your smartphone, including Wi-Fi usage and battery power. At the end of the study, we would ask you to complete an exit interview where you would comment on your experience using the digital pill and the app. The study involves 4 study visits. If you attend all 4 study visits, you will receive a total of $150 via a reloadable debit card called a ClinCard.
If you meet preliminary eligibility criteria, the next step would be to schedule an in-person visit at Fenway Health, where we will describe the study in detail and answer your questions. You will also learn about the digital pill system and have a chance to try it. At that visit, we will determine whether or not you are fully eligible to participate in the study.
Study Background
Fenway health is seeking men who have sex with men to use a digital pill version of PrEP daily, for 2 months, which will help us develop an algorithm to better predict when people might miss their dose of PrEP before it happens.
In this study, we are developing an algorithm that uses a digital pill system, along with an app that collects data from your smartphone, to better predict nonadherence to PrEP – or pre-exposure prophylaxis taken for HIV prevention – before it happens. We are enrolling 40 HIV-negative men who have sex with men (MSM) who use substances in this study.
Your participation would consist of using a digital pill version of PrEP daily for 2 months. You would also use a mobile app that will collect data from your smartphone, including Wi-Fi usage and battery power. At the end of the study, we would ask you to complete an exit interview where you would comment on your experience using the digital pill and the app. The study involves 4 study visits. If you attend all 4 study visits, you will receive total of $150 via a reloadable debit card called a ClinCard.
If you meet preliminary eligibility criteria, the next step would be to schedule an in-person visit at Fenway Health, where we will describe the study in detail and answer your questions. You will also learn about the digital pill system and have a chance to try it. At that visit, we will determine whether or not you are fully eligible to participate in the study.
Additional Information
The purpose of this research study is to develop an algorithm to better predict when people might miss their dose of PrEP (pre-exposure prophylaxis for HIV prevention) before the missed dose happens.
You may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- Ages 18+
- Men engaging in sexual relations with other men
- Currently using substances (e.g., cannabis, alcohol, cocaine, methamphetamine)
- HIV negative
- Interested in starting or currently taking PrEP
- Not allergic to silver, zinc, or gelatin
- Own a smartphone
- Speak English
Once enrolled, this study involves a total of 4 visits:
- Screening Visit
- Involves the informed consent process, substance use screener, rapid HIV test, and confirmation of all qualifying PrEP laboratory work (which may include review of medical records and/or a blood draw)
- Enrollment Visit
- Involves a baseline quantitative assessment, training on digital pill system (DPS) technology and a digital phenotyping mobile app, and dispensing of 30 PrEP digital pills
- Month 1 Visit
- Involves a pill count of any unused PrEP, a timeline follow-back discussion to contextualize any missed doses, technology refresher/troubleshooting as needed, and dispensing of an additional 30 PrEP digital pills
- Month 2 Visit
- Involves a pill count of any unused PrEP, a timeline follow-back discussion, a blood draw, and a qualitative exit interview to explore participant experiences in the study
Participants will be compensated up to $150 via ClinCards (a reloadable debit card system) for their time.
- Screening Visit ($30)
- Enrollment Visit ($30)
- Month 1 Visit ($40)
- Month 2 Visit ($50)
There is no cost for you to participate in our research study.
