Clinical trial NCT03512418: Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
Official title: Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Substance Use Disorders
Keywords: HIV Prevention
Pre-exposure Prophylaxis
Digital Pill
Substance Use Disorder
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
name: The Fenway Institute
First posted: 2018-04-30
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized controlled trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Acceptability of the adherence intervention based on qualitative and quantitive questionnaire
timeFrame: three month study visit
measure: Feasibility of the adherence intervention qualitative and quantitive questionnaire
timeFrame: three month study visit
Secondary outcomes:
measure: Potential of PrEPsteps to improve adherence
timeFrame: one/two/three month study visits
measure: Acceptability of the digital pill
timeFrame: three month visit
Other outcomes:
measure: Accuracy of digital pill compared to pill counts and dried blood spot for adherence
timeFrame: one and three month study visits
Locations:
city: Boylston
country: United States
facility: Fenway Health
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Peter R Chai, MD, MMS
role: PRINCIPAL_INVESTIGATOR
References: