Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
- Conditions
- HIV InfectionsSubstance Use Disorders
- Interventions
- Registration Number
- NCT03512418
- Lead Sponsor
- Brigham and Women's Hospital
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PrEPsteps Truvada 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. Control Truvada Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3. PrEPsteps PrEPsteps 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. Control Digital pill Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3. PrEPsteps Digital pill 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.
- Primary Outcome Measures
Name Time Method Acceptability of the adherence intervention based on qualitative and quantitive questionnaire three month study visit Acceptability as determined by the mean score of the following questions during study visits (graded on a 1-10 scale): "How satisfied were you with PrEPsteps? How likely are you to recommend PrEPsteps to someone who needs PrEP? How likely are you to recommend PrEPsteps to someone who needs PrEP and uses stimulants?
Feasibility of the adherence intervention qualitative and quantitive questionnaire three month study visit Feasibility of PrEPstesps as determined by the mean number of times intervention was accessed by each study participant during the trial
- Secondary Outcome Measures
Name Time Method Potential of PrEPsteps to improve adherence one/two/three month study visits Comparison of adherence rate in PrEPsteps group versus control
Acceptability of the digital pill three month visit Acceptance of digital pills to monitor PrEP adherence through qualitative interviews
Trial Locations
- Locations (1)
Fenway Health
🇺🇸Boylston, Massachusetts, United States