Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)

NCT03512418 | Completed Phase 3 Results DMC FDA Drug FDA Device

• 2 other identifiers: 2019P000792K23DA044874
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real-time PrEP adherence and nonadherence detected through the use of a digital pill. The PrEPSteps intervention will be developed and refined through a series of focus groups. Participants will be screened at the Screening Visit, and, if eligible, will then begin using the digital pill system at Study Visit 1 for 2 weeks. At Study Visit 2, participants will undergo randomization to using either PrEPSteps + the digital pill, or the digital pill alone to measure PrEP adherence, for 90 days. Participants will then complete 3 monthly study visits (Study Visits 3-5) where the investigators will assess digital pill adherence, conduct manual pill counts, obtain dried blood spots to confirm adherence, provide substance use disorder counseling, and obtain urine drug screens. At Study Visit 5, the investigators will conduct a semi-structured qualitative interview with participants in the PrEPsteps arm, which will be grounded in the Technology Acceptance Model, in order to understand the user response to PrEPSteps and the digital pill. All participants will complete the final follow-up assessment 3 months after Study Visit 5 (Study Visit 6).

Conditions

HIV Infections; Substance Use Disorders

Keywords

HIV Prevention; Pre-exposure Prophylaxis; Digital Pill; Substance Use Disorder

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire

  Number of participants who were able to complete the trial and record adherence events using the digital pill system in the intervention arm.

  three month study visit

Secondary Outcomes (2)

• Potential of PrEPsteps to Improve Adherence

  three month study visit

• Number of People Who Found the Digital Pill Acceptable to Use Within the Intervention Arm

  three month visit

Other Outcomes (1)

• Accuracy of Digital Pill Compared to Pill Counts and Dried Blood Spot for Adherence

  one and three month study visits

Study Arms (2)

PrEPsteps

EXPERIMENTAL

Participants receive the digital pills with Truvada, plus the PrEPsteps intervention that is programmed at the randomization study visit (Study Visit 2). Participants will use PrEPsteps and the digital pill to measure Truvada adherence for months 1-3.

Behavioral: PrEPsteps; Device: Digital pill; Drug: Truvada

Control

ACTIVE COMPARATOR

Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3.

Device: Digital pill; Drug: Truvada

Interventions

PrEPsteps BEHAVIORAL

Smartphone-based adherence intervention based in 1) LifeSteps, 2) Contingent Reinforcement/Corrective Feedback, and 3) Screening Brief Intervention and Referral to Treatment (SBIRT).

PrEPsteps

Digital pill DEVICE

The digital pill comprises a standard gelatin capsule with an integrated radiofrequency emitter that overencapsulates the desired medication (Truvada). When participants ingest the digital pill, the chloride ion gradient in the stomach activates the radiofrequency emitter which transmits direct evidence of medication ingestion to a wearable reader which relays this data to the participant's smartphone and cloud server.

Control; PrEPsteps

Truvada DRUG

Participants receive once daily Truvada as PrEP to prevent HIV.

Control; PrEPsteps

Eligibility Criteria

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

You may qualify if:

• Cisgender MSM
• Moderate to severe non-alcohol substance use disorder
• Self-reported missed PrEP doses (\> or equal to 2 doses in 1 week over past 3 months)
• HIV negative
• On PrEP or initiating PrEP
• Has qualifying laboratory testing: Cr clearance, HBV, liver function tests
• Owns a smartphone with Android or iOS
• Age 18 or older

You may not qualify if:

• Non-English speaker
• HIV positive
• History of Crohn's disease or ulcerative colitis
• History of gastric bypass, bowel stricture
• History of GI malignancy or radiation to abdomen
• Unable/unwilling to ingest a digital pill
• Allergy to gelatin, silver or zinc (components of the digital pill)
• Does not qualify for PrEP (abnormal liver function, or Cr Clearance \<60)

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

Boylston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Chai PR, Lee JS, Goodman GR, Albrechta H, Hokayem J, Loo L, Mohamed Y, Glynn TR, Rosen RK, Mayer KH, Boyer EW, Alpert P, Buffkin E, Carnes C, O'Cleirigh C. PrEPSteps: A Pilot Randomized Controlled Trial to Assess the Feasibility and Acceptability of a Digital Pill-Based PrEP Adherence Intervention in Men Who Have Sex with Men with Substance Use Disorder. AIDS Behav. 2026 Feb 2. doi: 10.1007/s10461-026-05049-x. Online ahead of print.

  PMID: 41627697 DERIVED

MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders

Interventions

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

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

Limitations and Caveats

Our study had several limitations. First, it was conducted at a single federally qualified community health center with expertise in HIV treatment and prevention, which may differ from settings with less familiarity in prescribing PrEP or infrastructure to support PrEPSteps deployment. Second, our study population was predominantly white; other demographic groups at higher HIV risk, such as Black and Latinx individuals with potential medical mistrust, might have different perspectives.

Results Point of Contact

• Title: Peter Chai
• Organization: Brigham and Women's Hospital

pchai@bwh.harvard.edu

617-732-5640

Study Officials

• Peter R Chai, MD, MMS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: Pilot randomized controlled trial

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 30, 2018
• Study Start: June 20, 2019
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2024
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-09

Locations

US (1)