A Phase 3 interventional study of PrEPsteps and Digital pill in HIV Infections and Substance Use Disorders, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Brigham and Women's Hospital · Phase 3, Interventional, and Prevention
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).
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 30 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
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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
Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3.
Device: Digital pill · Drug: Truvada
Smartphone-based adherence intervention based in 1) LifeSteps, 2) Contingent Reinforcement/Corrective Feedback, and 3) Screening Brief Intervention and Referral to Treatment (SBIRT).
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.
Participants receive once daily Truvada as PrEP to prevent HIV.
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.
Time frame: three month study visit
Potential of PrEPsteps to Improve Adherence
Number of digital pill recorded ingestions at week 13 (end of intervention period) recorded as percent adherence
Time frame: 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.
Time frame: three month visit
Accuracy of Digital Pill Compared to Pill Counts and Dried Blood Spot for Adherence
Accuracy of digital pill in measuring PrEP adherence as compared to dried blood spot testing for tenofovir diphosphate
Time frame: one and three month study visits
Participants were recruited from a health clinic in Boston, MA. We also conducted community-based outreach in the greater Boston metropolitan area through flyers and postings. Interested participants contacted the study team and were prescreened for eligibility criteria.
| Milestone | PrEPSteps (Intervention) | Control |
|---|---|---|
| Started | 15 | 15 |
| Completed | 14 | 14 |
| Not completed | 1 | 1 |
Number of participants who were able to complete the trial and record adherence events using the digital pill system in the intervention arm.
| Participants | PrEPsteps | Control |
|---|---|---|
| Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire | 14 | 14 |
Number of digital pill recorded ingestions at week 13 (end of intervention period) recorded as percent adherence
| percentage of pills taken appropriately | PrEPsteps | Control |
|---|---|---|
| Potential of PrEPsteps to Improve Adherence | 86 ± 17.23 | 72 ± 33.14 |
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.
| Participants | PrEPsteps |
|---|---|
| Number of People Who Found the Digital Pill Acceptable to Use Within the Intervention Arm | 14 |
Accuracy of digital pill in measuring PrEP adherence as compared to dried blood spot testing for tenofovir diphosphate
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PrEPsteps | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Control | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | PrEPSteps (Intervention) | Control | Total |
|---|---|---|---|
| Median | 38 (22 to 54) | 37.5 (25 to 59) | 37.5 (22 to 59) |
| Sex: Female, Male(Participants) | PrEPSteps (Intervention) | Control | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 14 | 14 | 28 |
| Ethnicity (NIH/OMB)(Participants) | PrEPSteps (Intervention) | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 5 |
| Not Hispanic or Latino | 12 | 11 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | PrEPSteps (Intervention) | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 12 | 9 | 21 |
| More than one race | 1 | 3 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Number of sexual partners(partners) | PrEPSteps (Intervention) | Control | Total |
|---|---|---|---|
| Median | 14.8 (0 to 30) | 3.36 (0 to 30) | 3.5 (0 to 30) |
| Substance use during sex(events) | PrEPSteps (Intervention) | Control | Total |
|---|---|---|---|
| Median | 3.5 (0 to 65) | 2.5 (0 to 50) | 3 (0 to 65) |
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Brigham and Women's Hospital