HIV InfectionsPhase 3PrEPStepsNCT03512418
Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
A Phase 3 study testing PrEPsteps, Digital pill and Truvada in people with HIV Infections and Substance Use Disorders, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. 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 Disorders
- What is being tested?
- PrEPsteps, Digital pill and Truvada
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2019to 10 Apr 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
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.
- Conditions
- HIV Infections, Substance Use Disorders
- Being tested
- PrEPsteps, Digital pill, Truvada
- Keywords
- HIV Prevention, Pre-exposure Prophylaxis, Digital Pill, Substance Use Disorder
- Medical subject headings
- HIV Infections, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPstepsBehavioural
Smartphone-based adherence intervention based in 1) LifeSteps, 2) Contingent Reinforcement/Corrective Feedback, and 3) Screening Brief Intervention and Referral to Treatment (SBIRT).
Digital pillDevice
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.
TruvadaDrug
Participants receive once daily Truvada as PrEP to prevent HIV.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Digital pill; Drug: Truvada |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three month study visit
Secondary outcomes (2)
Potential of PrEPsteps to Improve Adherence
Number of digital pill recorded ingestions at week 13 (end of intervention period) recorded as percent adherence
Measured: three month study visit
Number of People Who Found the Digital Pill Acceptable to Use Within the Intervention Arm
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.
Measured: three month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start20 Jun 2019
- Primary completion10 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 30 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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512418
- Sponsor's protocol ID
- 2019P000792
- Other IDs
- K23DA044874
- Acronym
- PrEPSteps
- Status last verified
- Sep 2025
- First submitted
- 21 Mar 2018
- Last updated
- 17 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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 Jul;30(7):2242-2255. doi: 10.1007/s10461-026-05049-x. Epub 2026 Feb 2.
PubMed 41627697
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
- ClinicalTrials.gov ID
- NCT03512418
- Acronym / sponsor ID
- PrEPSteps / 2019P000792
- Conditions
- HIV Infections, Substance Use Disorders
- Keywords
- HIV Prevention, Pre-exposure Prophylaxis, Digital Pill, Substance Use Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 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 Jun 2019 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Posted 17 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| PrEPsteps | Experimental | Behavioral: PrEPsteps, Device: Digital pill, Drug: TruvadaParticipants 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. |
| Control | Active comparator | Device: Digital pill, Drug: TruvadaParticipants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3. |
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)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| PrEPstepsSmartphone-based adherence intervention based in 1) LifeSteps, 2) Contingent Reinforcement/Corrective Feedback, and 3) Screening Brief Intervention and Referral to Treatment (SBIRT). | Behavioural | PrEPsteps |
| Digital pillThe 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. | Device | Control, PrEPsteps |
| TruvadaParticipants receive once daily Truvada as PrEP to prevent HIV. | Drug | Control, PrEPsteps |
Primary outcome
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.
2 secondary outcomes
Potential of PrEPsteps to Improve Adherence
Time frame: three month study visit
Number of People Who Found the Digital Pill Acceptable to Use Within the Intervention Arm
Time frame: three month visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41627697Chai 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 Jul;30(7):2242-2255. doi: 10.1007/s10461-026-05049-x. Epub 2026 Feb 2.
- Individual participant dataSharing planned: Undecided
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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 Hospital
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 PrEPsteps, Digital pill and Truvada in people with HIV Infections and Substance Use Disorders, 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 8 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 17 Sep 2025. 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?
Yes. Results are posted in the registry (first posted 17 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire (time frame: three month study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512418, which also lists 1 linked publication.
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 17 Sep 2025.