Status:
RECRUITING
SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Gilead Sciences
The Fenway Institute
Conditions:
HIV Infections
Substance Use
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This is a single-arm, observational study of HIV-negative MSM with substance use disorder. Those who meet pre-screening criteria will attend a Screening Visit (Visit 1), where the informed consent pro...
Detailed Description
This study will develop a dataset of annotated smartphone usage in the context of PrEP adherence and nonadherence. In order to understand smartphone context, the investigators will utilize a digital p...
Eligibility Criteria
Inclusion
- Age 18 or older
- Cisgender male
- Has sex with men
- HIV negative
- On PrEP or initiating PrEP (including switching from 2-1-1 or "on-demand" PrEP dosing to once-daily dosing)
- Moderate risk score on ASSIST substance use screener (11-26 for alcohol, 4-26 for all other substances) or higher
- Qualifying laboratory testing for PrEP: Cr clearance in past 3 months, HBV vaccination, liver function tests
- Owns a smartphone with Android or iOS
Exclusion
- Does not speak English
- History of Crohn's disease or ulcerative colitis
- History of gastric bypass or bowel stricture
- History of GI malignancy or radiation to abdomen
- Allergy to gelatin, silver, or zinc (components of digital pill)
- Allergy to PrEP
- Not willing to operate DPS or Beiwe app
Key Trial Info
Start Date :
December 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05378399
Start Date
December 20 2022
End Date
March 31 2026
Last Update
April 16 2025
Active Locations (1)
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1
Fenway Health
Boston, Massachusetts, United States, 02215