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

NCT05378399 | Completed Phase 3 DMC FDA Drug FDA Device

• 2 other identifiers: 2021P003683DP2DA056107
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 process will be conducted and study eligibility will be confirmed. Eligible participants will attend three additional visits over the course of the study - the Enrollment Visit (Visit 2), Month 1 Visit (Visit 3), and Month 2 Visit (Visit 4). Participants will take one PrEP digital pill per day, for 60 days total, while using the digital pill system (DPS) and Beiwe, a digital phenotyping app. On nonadherent days, participants will receive brief surveys prompting them to report the reasons for their missed dose, as well as their engagement in substance use and sexual activity. Timeline followback will be conducted at the Month 1 and Month 2 Visits to understand the context of any nonadherence. Qualitative user experience exit interviews and dried blood spots (DBS) will be conducted at the Month 2 Visit.

Conditions

HIV Infections; Substance Use; Adherence, Medication; Adherence, Treatment

Keywords

Pre-Exposure Prophylaxis; Substance Use; Digital Pill System; Adherence; HIV Prevention

Outcome Measures

Primary Outcomes (2)

• PrEP Adherence Patterns

  Percentage adherence to PrEP and adherence patterns over the course of 60 days, as detected by the ID-Cap digital pill system (DPS).

  After Month 2 Visit

• Correlation of PrEP Adherence with Digital Phenotyping Patterns

  Comparison of digital phenotyping data, as detected by Beiwe, on PrEP-adherent versus PrEP-nonadherent days, as detected by the digital pill system (DPS).

  After Month 2 Visit

Secondary Outcomes (2)

• Correlation of PrEP Adherence with DBS Concentrations

  After Month 2 Visit

• Acceptability of DPS and Digital Phenotyping App

  After Month 2 Visit

Study Arms (1)

Digital Pills and Beiwe

EXPERIMENTAL

Participants will take one PrEP digital pill per day, for 60 days total, while using the ID-Cap digital pill system and Beiwe digital phenotyping app.

Drug: Descovy or Truvada; Device: ID-Cap System; Device: Beiwe

Interventions

Descovy or Truvada DRUG

Descovy or Truvada prescribed with digital pills for PrEP

Digital Pills and Beiwe

ID-Cap System DEVICE

Digital pills overencapsulating Descovy or Truvada for PrEP

Also known as: digital pill

Digital Pills and Beiwe

Beiwe DEVICE

Digital phenotyping app

Digital Pills and Beiwe

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender men who have sex with men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Gilead Sciences: collaborator
• The Fenway Institute: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Fenway Health

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders; Medication Adherence; Treatment Adherence and Compliance

Interventions

emtricitabine tenofovir alafenamide; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Peter R Chai, MD MMS

  Brigham and Women's Hopsital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Physician

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: December 20, 2022
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)