HIV InfectionsPhase 3SmartStepsNCT05378399
SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder
A Phase 3 study testing Descovy or Truvada, ID-Cap System and Beiwe in people with HIV Infections and Substance Use, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections, Substance Use, Adherence, Medication
- What is being tested?
- Descovy or Truvada, ID-Cap System and Beiwe
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2022to 31 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- Descovy or Truvada, ID-Cap System, Beiwe
- Keywords
- Pre-Exposure Prophylaxis, Substance Use, Digital Pill System, Adherence, HIV Prevention
- Medical subject headings
- HIV Infections, Substance-Related Disorders, Medication Adherence, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descovy or TruvadaDrug
Descovy or Truvada prescribed with digital pills for PrEP
ID-Cap SystemDevice
Also called digital pill
Digital pills overencapsulating Descovy or Truvada for PrEP
BeiweDevice
Digital phenotyping app
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Descovy or Truvada; Device: ID-Cap System; Device: Beiwe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: After Month 2 Visit
Secondary outcomes (2)
Correlation of PrEP Adherence with DBS Concentrations
Correlation of PrEP adherence patterns, as detected by the digital pill system (DPS), with tenofovir diphosphate concentrations in dried blood spots (DBS).
Measured: After Month 2 Visit
Acceptability of DPS and Digital Phenotyping App
User acceptance of and willingness to interact with the digital pill system (DPS) and Beiwe digital phenotyping app, as assessed via qualitative exit interviews.
Measured: After Month 2 Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start20 Dec 2022
- Primary completion27 Feb 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, The Fenway Institute, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Peter R Chai MD, Brigham and Women's Hospital
- Investigators
- Peter R Chai, MD MMS, Principal investigator, Brigham and Women's Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378399
- Sponsor's protocol ID
- 2021P003683
- Other IDs
- DP2DA056107
- Acronym
- SmartSteps
- Status last verified
- Jul 2026
- First submitted
- 12 May 2022
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmartSteps: A Context-Aware, Pre-Exposure Prophylaxis Adherence Intervention for Individuals With Substance Use Disorder
- ClinicalTrials.gov ID
- NCT05378399
- Acronym / sponsor ID
- SmartSteps / 2021P003683
- Keywords
- Pre-Exposure Prophylaxis, Substance Use, Digital Pill System, Adherence, HIV Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Gilead Sciences, The Fenway Institute, National Institute on Drug Abuse (NIDA)
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Pills and Beiwe | Experimental | Drug: Descovy or Truvada, Device: ID-Cap System, Device: BeiweParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Descovy or TruvadaDescovy or Truvada prescribed with digital pills for PrEP | Drug | Digital Pills and Beiwe |
| ID-Cap SystemAlso: digital pillDigital pills overencapsulating Descovy or Truvada for PrEP | Device | Digital Pills and Beiwe |
| BeiweDigital phenotyping app | Device | Digital Pills and Beiwe |
Primary outcome
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).
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).
2 secondary outcomes
Correlation of PrEP Adherence with DBS Concentrations
Time frame: After Month 2 Visit
Acceptability of DPS and Digital Phenotyping App
Time frame: After Month 2 Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter R Chai, MD MMS principal investigator
Brigham and Women's Hopsital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Descovy or Truvada, ID-Cap System and Beiwe in people with HIV Infections and Substance Use, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Adherence Patterns (time frame: After Month 2 Visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.