Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)

Conditions
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HIV Infections, Substance Use Disorders

Intervention / Treatment
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* Behavioral: PrEPsteps
* Device: Digital pill
* Drug: Truvada


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrEPsteps<br>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<br>* Smartphone-based adherence intervention based in 1) LifeSteps, 2) Contingent Reinforcement/Corrective Feedback, and 3) Screening Brief Intervention and Referral to Treatment (SBIRT).<br>Device: Digital pill<br>* 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.<br>Drug: Truvada<br>* Participants receive once daily Truvada as PrEP to prevent HIV.<br>|
| Active Comparator: Control<br>Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3. | Device: Digital pill<br>* 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.<br>Drug: Truvada<br>* Participants receive once daily Truvada as PrEP to prevent HIV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the adherence intervention based on qualitative and quantitive questionnaire | 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? | three month study visit | 
| Feasibility of the adherence intervention qualitative and quantitive questionnaire | Feasibility of PrEPstesps as determined by the mean number of times intervention was accessed by each study participant during the trial | three month study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential of PrEPsteps to improve adherence | Comparison of adherence rate in PrEPsteps group versus control | one/two/three month study visits | 
| Acceptability of the digital pill | Acceptance of digital pills to monitor PrEP adherence through qualitative interviews | three month visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Prevention, Pre-exposure Prophylaxis, Digital Pill, Substance Use Disorder