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

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ClinicalTrials.gov Identifier: NCT03512418
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : May 13, 2022
Sponsor:
Collaborators:
Brigham and Women's Hospital
Gilead Sciences
Information provided by (Responsible Party):
Peter Chai, Fenway Community Health

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).

Condition or disease Intervention/treatment Phase
HIV Infections Substance Use Disorders Behavioral: PrEPsteps Device: Digital pill Drug: Truvada Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Truvada

Arm Intervention/treatment
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.
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.

Active Comparator: Control
Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3.
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.




Primary Outcome Measures :
  1. 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?

  2. 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


Secondary Outcome Measures :
  1. Potential of PrEPsteps to improve adherence [ Time Frame: one/two/three month study visits ]
    Comparison of adherence rate in PrEPsteps group versus control

  2. Acceptability of the digital pill [ Time Frame: three month visit ]
    Acceptance of digital pills to monitor PrEP adherence through qualitative interviews


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   cisgender men who have sex with men (MSM)
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512418


Contacts
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Contact: Peter R Chai, MD, MMS 617-732-5640 pchai@bwh.harvard.edu
Contact: Georgia Goodman, BS 857-301-8820 ggoodman@fenwayhealth.org

Locations
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United States, Massachusetts
Fenway Health Recruiting
Boylston, Massachusetts, United States, 02215
Contact: Peter R Chai, MD, MMS    617-732-5640    pchai@bwh.harvard.edu   
Contact: Georgia Goodman, BS    857-301-8820    ggoodman@fenwayhealth.org   
Sponsors and Collaborators
Fenway Community Health
Brigham and Women's Hospital
Gilead Sciences
Investigators
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Principal Investigator: Peter R Chai, MD, MMS Brigham and Women's Hospital
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Responsible Party: Peter Chai, Adjunct Faculty, Fenway Community Health
ClinicalTrials.gov Identifier: NCT03512418    
Other Study ID Numbers: 1162312
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Peter Chai, Fenway Community Health:
HIV Prevention
Pre-exposure Prophylaxis
Digital Pill
Substance Use Disorder
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents