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Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use (DigiPrEP)

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ClinicalTrials.gov Identifier: NCT03842436
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Peter Chai, Fenway Community Health

Brief Summary:
This study deploys a novel digital pill with Emtricitabine/Tenofovir (TDF/FTC) among MSM with substance use to monitor PrEP adherence. The investigators will enroll N=15 HIV uninfected MSM with self reported substance use who are on PrEP or initiating PrEP to use digital pills over encapsulating TDF/FTC for 3 months. The investigators will assess the feasibility of using digital pills in this study population as well as understand the acceptability of digital pills for adherence measurement using semi-structured individual interviews. Additionally, the investigators will measure adherence over time, as well as episodes of suboptimal PrEP adherence.

Condition or disease Intervention/treatment Phase
HIV/AIDS Substance Use Disorders Adherence, Medication Device: Digital pill Drug: Truvada Phase 4

Detailed Description:
Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). Participants will complete a quantitative assessment on their history fo substance use, sexual risk and PrEP adherence, and be trained to use the digital pill for 90 days and instructed to take PrEP daily during the course of the study. Participants will return each month for a study visit to assess their use of the technology. At study visit 1 and 3, we will obtain dried blood spots (DBS) to measure drug levels and to confirm adherence detected by the digital pill. The investigators will also obtain drugs of abuse screens from DBS. At the final study visit (3 months), participants will undergo a semi-structured qualitative interview to understand the user response to digital pills.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group pilot demonstration project
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 10, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Truvada

Arm Intervention/treatment
Experimental: Digital Pills
Digital Pills containing Truvada ingested once daily as PrEP
Device: Digital pill
Digital pills over encapsulating Truvada
Other Name: eTectRx ID Cap

Drug: Truvada
Truvada prescribed with digital pills for PrEP




Primary Outcome Measures :
  1. Acceptability of digital pills to measure PrEP adherence [ Time Frame: 3 month study visit ]
    Acceptance of digital pills to monitor PrEP adherence through qualitative interviews


Secondary Outcome Measures :
  1. Accuracy of digital pills in measure adherence [ Time Frame: 1 month and 3 month study visit ]
    Accuracy of digital pill in measuring PrEP adherence as compared to dried blood spot testing for tenofovir diphosphate

  2. Feasibility of digital pills to measure PrEP adherence [ Time Frame: 3 month study visit ]
    Number of times the digital pill is used (detected ingestion events) over the course of the study



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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • man who has sex with men (MSM)
  • self-reported substance use in the past 6 months
  • on Truvada for PrEP or initiating PrEP

Exclusion Criteria:

  • HIV positive
  • Transgender individuals
  • History of GI neoplasm
  • unable/unwilling to ingest digital pills
  • Allergy to components of Truvada
  • History of bowel surgery, bowel structure, or gastric bypass
  • History of Crohn's Disease or Ulcerative Colitis

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): NCT03842436


Contacts
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Contact: Peter R Chai, MD, MMS 857-313-6722 pchai@fenwayhealth.org
Contact: Georgia Goodman 857-313-6722 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: Samantha Marquez, LCSW    617-927-6465    smarquez@fenwayhealth.org   
Sponsors and Collaborators
Peter Chai
Gilead Sciences

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Responsible Party: Peter Chai, Affiliated Faculty, Fenway Community Health
ClinicalTrials.gov Identifier: NCT03842436     History of Changes
Other Study ID Numbers: 1087733
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
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: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Peter Chai, Fenway Community Health:
PrEP
Substance Use Disorder
Digital Pills
Medication Adherence

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
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents