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

Brigham and Women's Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

PrEPstepsBEHAVIORAL

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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