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Completed

NCT Number: NCT03512418

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

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).

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Key information

Conditions

HIV Infections Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance Use Disorders Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Fenway Health

Boylston, Massachusetts, 02215, United States

About this study

PrEPSteps is a novel, smartphone-based behavioral intervention that delivers PrEP adherence messages in response to detected PrEP ingestion via an innovative digital pill. PrEPSteps comprises 1) an adaptation of LifeSteps, an evidence-based medication adherence behavioral intervention, with smartphone-delivered booster sessions, 2) messages of contingent reinforcement and corrective feedback, and 3) stimulant use screening, brief assessment, and referral to treatment. In this K23, the investigators will first refine and inform the specification of PrEPSteps with a series of focus groups. The investigators will next test the feasibility, acceptability and potential for an effect of PrEPSteps to boost PrEP adherence in a pilot randomized controlled trial of men who have sex with men (MSM) with stimulant use. Finally, the investigators will conduct qualitative interviews among participants who used PrEPSteps to understand the participant response to living with the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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).

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.

Truvada

Drug

Participants receive once daily Truvada as PrEP to prevent HIV.

Primary outcomes

  1. Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire

    Time frame: three month study visit

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

Secondary outcomes

  1. Potential of PrEPsteps to Improve Adherence

    Time frame: three month study visit

    Number of digital pill recorded ingestions at week 13 (end of intervention period) recorded as percent adherence

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

    Time frame: three month visit

    Qualitative interviews asking participants if they found the use of the digital pill system acceptable and did not interfere with their daily PrEP use. This outcome was only assessed in the PrEPSteps (intervention arm) only.

Other outcomes

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

    Time frame: one and three month study visits

    Accuracy of digital pill in measuring PrEP adherence as compared to dried blood spot testing for tenofovir diphosphate

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Gilead Sciences
  • National Institute on Drug Abuse (NIDA)
  • The Fenway Institute

Registry information

Acronym: PrEPSteps

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2018
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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