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

• ClinicalTrials.gov Identifier: NCT03512418
• Recruitment Status: Active, not recruiting
• First Posted: April 30, 2018
• Last Update Posted: March 15, 2024
• Sponsor: Brigham and Women's Hospital
• Collaborators: Gilead Sciences; The Fenway Institute
• Information provided by (Responsible Party): Peter R Chai MD, Brigham and Women's Hospital

Tracking Information

• First Submitted Date: March 21, 2018
• First Posted Date: April 30, 2018
• Last Update Posted Date: March 15, 2024
• Actual Study Start Date: June 20, 2019
• Estimated Primary Completion Date: May 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 19, 2018)

• Acceptability of the adherence intervention based on qualitative and quantitive questionnaire [ Time Frame: 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 [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 19, 2018)

• Potential of PrEPsteps to improve adherence [ Time Frame: one/two/three month study visits ]
  Comparison of adherence rate in PrEPsteps group versus control
• Acceptability of the digital pill [ Time Frame: three month visit ]
  Acceptance of digital pills to monitor PrEP adherence through qualitative interviews

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: April 19, 2018)

Accuracy of digital pill compared to pill counts and dried blood spot for adherence [ Time Frame: one and three month study visits ]

Accuracy of digital pill in measuring PrEP adherence as compared to dried blood spot testing for tenofovir diphosphate

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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)
• 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.
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Pilot randomized controlled trial

Masking: None (Open Label)
Primary Purpose: Prevention

Condition

• HIV Infections
• Substance Use Disorders

Intervention

• Behavioral: PrEPsteps
  Smartphone-based adherence intervention based in 1) LifeSteps, 2) Contingent Reinforcement/Corrective Feedback, and 3) Screening Brief Intervention and Referral to Treatment (SBIRT).
• Device: Digital pill
  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.
• Drug: Truvada
  Participants receive once daily Truvada as PrEP to prevent HIV.

Study Arms

• Experimental: 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.
  Interventions:

  • Behavioral: PrEPsteps
  • Device: Digital pill
  • Drug: Truvada
• Active Comparator: Control
  Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3.
  Interventions:

  • Device: Digital pill
  • Drug: Truvada

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 13, 2024): 36
• Original Estimated Enrollment (submitted: April 19, 2018): 60
• Estimated Study Completion Date: May 31, 2024
• Estimated Primary Completion Date: May 31, 2024 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: cisgender men who have sex with men (MSM)

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03512418
• Other Study ID Numbers: 2019P000792
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Peter R Chai MD, Brigham and Women's Hospital
• Original Responsible Party: Fenway Community Health
• Current Study Sponsor: Brigham and Women's Hospital
• Original Study Sponsor: Fenway Community Health

Collaborators

• Gilead Sciences
• The Fenway Institute

Investigators

• Principal Investigator: Peter R Chai, MD, MMS; Brigham and Women's Hospital

• PRS Account: Brigham and Women's Hospital
• Verification Date: March 2024