SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder

Launched by BRIGHAM AND WOMEN'S HOSPITAL · May 12, 2022

Keywords

ClinConnect Summary

The SmartSteps trial is studying a new way to help men who have sex with men (MSM) and have substance use disorders stick to their daily medication called PrEP, which helps prevent HIV infection. This study is for adult men who are HIV-negative and are either already using PrEP or starting it for the first time. To participate, individuals need to be at least 18 years old, have a smartphone, and meet certain health criteria related to their substance use.

Participants will be part of the study for about two months, where they will take one digital PrEP pill every day. They'll use a special app to track their medication and answer questions about any days they miss their dose. The study aims to understand the reasons behind missed doses and gather feedback on the experience of using the digital tools. This is an important step in finding better ways to support people in taking their HIV prevention medication consistently.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 or older
• • 2. Cisgender male
• • 3. Has sex with men
• • 4. HIV negative
• • 5. On PrEP or initiating PrEP (including switching from 2-1-1 or "on-demand" PrEP dosing to once-daily dosing)
• • 6. Moderate risk score on ASSIST substance use screener (11-26 for alcohol, 4-26 for all other substances) or higher
• • 7. Qualifying laboratory testing for PrEP: Cr clearance in past 3 months, HBV vaccination, liver function tests
• • 8. Owns a smartphone with Android or iOS
• Exclusion Criteria:
• • 1. Does not speak English
• • 2. History of Crohn's disease or ulcerative colitis
• • 3. History of gastric bypass or bowel stricture
• • 4. History of GI malignancy or radiation to abdomen
• • 5. Allergy to gelatin, silver, or zinc (components of digital pill)
• • 6. Allergy to PrEP
• • 7. Not willing to operate DPS or Beiwe app