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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

Tracking Information
First Submitted Date  ICMJE February 13, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date March 1, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03842436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
Official Title  ICMJE Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Single group pilot demonstration project
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV/AIDS
  • Substance Use Disorders
  • Adherence, Medication
Intervention  ICMJE
  • Device: Digital pill
    Digital pills over encapsulating Truvada
    Other Name: eTectRx ID Cap
  • Drug: Truvada
    Truvada prescribed with digital pills for PrEP
Study Arms  ICMJE Experimental: Digital Pills
Digital Pills containing Truvada ingested once daily as PrEP
Interventions:
  • Device: Digital pill
  • Drug: Truvada
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 10, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peter R Chai, MD, MMS 857-313-6722 pchai@fenwayhealth.org
Contact: Georgia Goodman 857-313-6722 ggoodman@fenwayhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03842436
Other Study ID Numbers  ICMJE 1087733
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: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Peter Chai, Fenway Community Health
Study Sponsor  ICMJE Peter Chai
Collaborators  ICMJE Gilead Sciences
Investigators  ICMJE Not Provided
PRS Account Fenway Community Health
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP