Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
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Details and patient eligibility
About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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 design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Georgia Goodman, BS; Peter R Chai, MD, MMS
Data sourced from clinicaltrials.gov
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