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

July 20, 2026 updated by: Peter R Chai MD, Brigham and Women's Hospital

SmartSteps: A Context-Aware, Pre-Exposure Prophylaxis Adherence Intervention for Individuals With Substance Use Disorder

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 pill system (DPS) to measure real-time PrEP ingestion events. Eligibility will be confirmed during the Screening Visit (Visit 1). During the Enrollment Visit (Visit 2), participants will complete a baseline quantitative assessment (e.g., sociodemographics, sexual history, attitudes about technology), receive training on the operation of the DPS and Beiwe, and will ingest their first digital pill dose under observation by study staff. Participants will be instructed to take one PrEP pill once daily while using the DPS and Beiwe app for 60 days. Participants will return for a study visit at the end of month one (Visit 3) for a refill of digital pills. Following a 24-hour period which no PrEP ingestion is detected by the DPS, participants will receive a brief online substance use and sexual risk survey, which will inform specific contexts of nonadherence. At the Month 1 Visit (Visit 3) and Month 2 Visit (Visit 4), timeline followback discussions will be conducted to better understand the context of any PrEP nonadherence events detected by the DPS, and phenotypic data collected by the Beiwe app, during the prior 30 days. At the Month 2 (Visit 4), the investigators will administer a blood draw for dried blood spot (DBS) testing to measure participants' PrEP adherence and compare it against adherence detected by the DPS. To gain insight into user experiences operating the DPS and Beiwe app as part of the study, the investigators will conduct the semi-structured qualitative exit interviews with participants at Month 2 (Visit 4).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Fenway Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Digital Pills and Beiwe
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
Descovy or Truvada prescribed with digital pills for PrEP
Device: ID-Cap System
Digital pills overencapsulating Descovy or Truvada for PrEP
Other Names:
  • digital pill
Device: Beiwe
Digital phenotyping app

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PrEP Adherence Patterns
Time Frame: After Month 2 Visit
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
Time Frame: After Month 2 Visit
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation of PrEP Adherence with DBS Concentrations
Time Frame: After Month 2 Visit
Correlation of PrEP adherence patterns, as detected by the digital pill system (DPS), with tenofovir diphosphate concentrations in dried blood spots (DBS).
After Month 2 Visit
Acceptability of DPS and Digital Phenotyping App
Time Frame: After Month 2 Visit
User acceptance of and willingness to interact with the digital pill system (DPS) and Beiwe digital phenotyping app, as assessed via qualitative exit interviews.
After Month 2 Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Gilead Sciences
The Fenway Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter R Chai, MD MMS, Brigham and Women's Hopsital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021P003683
  • DP2DA056107 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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