Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03842436
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : April 28, 2020
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
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
Actual Primary Completion Date : April 22, 2020
Actual Study Completion Date : April 22, 2020

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. MSM (cisgender male)
  2. Self-reported use of non-alcohol substances of abuse in past 6 months
  3. Currently taking PrEP
  4. Has qualifying laboratory tests (Cr, hepatitis B immunization, STI testing and syphilis)
  5. Age 18 or older

Exclusion Criteria:

  1. Does not speak English
  2. HIV positive
  3. Identifies as transgender
  4. Estimated creatinine clearance <60ml/min
  5. Active hepatitis B treatment
  6. Does not own a smartphone
  7. Taking proton pump inhibitors
  8. History of Crohn's disease or ulcerative colitis
  9. History of bowel surgery, gastric bypass, bowel stricture
  10. History of GI malignancy or radiation to abdomen
  11. Unable/unwilling to ingest digital pill

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 identifier (NCT number): NCT03842436

Layout table for location information
United States, Massachusetts
Fenway Health
Boylston, Massachusetts, United States, 02215
Sponsors and Collaborators
Peter Chai
Gilead Sciences
Layout table for additonal information
Responsible Party: Peter Chai, Affiliated Faculty, Fenway Community Health Identifier: NCT03842436    
Other Study ID Numbers: 1087733
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Peter Chai, Fenway Community Health:
Substance Use Disorder
Digital Pills
Medication Adherence
Additional relevant MeSH terms:
Layout table for MeSH terms
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