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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 : Completed
First Posted : February 15, 2019
Results First Posted : November 1, 2021
Last Update Posted : December 22, 2022
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Peter R Chai, Fenway Community Health

Study Description
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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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 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

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of Digital Pills to Measure PrEP Adherence [ Time Frame: Months 1, 2, and 3 ]
    Participants' engagement with the digital pill system (DPS) was measured over the 90-day study period. The percentages for the total expected ingestions recorded by DPS each month were compared.


Secondary Outcome Measures :
  1. Digital Pill Performance - Number of Recorded Ingestions [ Time Frame: Months 1, 2, and 3 ]
    The total number recorded ingestions recorded by the digital pill system (DPS) - which included both the number of Reader-detected and manually-reported ingestions - was collected. The Reader-detected ingestions count was used to reflect the number of times the DPS was operated correctly. Successful DPS operation was defined as ingestion of a digital pill, proper use of the wearable Reader, and confirmation of the ingestion on both the Reader and the app. Cumulative data collected at months 1, 2, and 3 are reported in the data table below.

  2. Digital Pill Performance - System Accuracy [ Time Frame: Months 1, 2, and 3 ]
    Accuracy of the digital pill system (DPS) in measuring PrEP adherence. To analyze the performance of the DPS, the ground truth of PrEP ingestion events was defined as the pill counts obtained each month (i.e., the number of unused pills returned, subtracted from the number of pills previously dispensed). The number of DPS-recorded ingestions - which included the number of both Reader-detected and manually-reported ingestions - was compared with the aggregate pill count at each monthly timepoint; this was defined as the overall performance metric for the DPS. Cumulative data collected at months 1, 2, and 3 are reported in the data table below.

  3. Digital Pill Performance - Manually Reported Ingestions [ Time Frame: Months 1, 2, and 3 ]
    The total number of manually reported ingestions was collected. The percentages for instances of manually reported ingestions were calculated. The two instances for manually recording ingestions included, a lack of engagement with the Reader or failure to use the Reader properly, and when reported ingestion was not detected by the Reader despite supporting use metrics indicating proper Reader use. Cumulative data collected at months 1, 2, and 3 are reported in the data table below.

  4. Digital Pill Performance - Successful Operation of System [ Time Frame: Months 1, 2, and 3 ]
    The total number of instances in which ingestions were successfully detected by the Reader (i.e., the radio frequency emitter was activated, and the ingestion was recorded by the DPS) was collected. The total number of instances in which manually reported ingestions were not detected by the Reader, despite supporting use metrics (e.g., accelerometer data) indicating proper Reader use was also collected. These counts were combined and interpreted as the number of times that the DPS was operated correctly. Cumulative data collected at months 1, 2, and 3 are reported in the data table below.

  5. Dried Blood Spot Correlation With Digital Pill Adherence [ Time Frame: Months 1 and 3 ]
    We dichotomized TFV-DP levels using a cutoff of ≥700 fmol/punch to indicate at least four doses of PrEP ingested per week. Using TFV-DP in DBS <700 vs ≥700 fmol/punch as a dichotomous variable, and considering the granular continuous adherence data from the digital pill, we then calculated a point biserial correlation between TFV-DP in DBS and digital pill adherence. Additionally, drug concentrations of tenofovir diphosphate as measured in dried blood spot collection at months one and three were compared to DPS-recorded PrEP adherence.


Other Outcome Measures:
  1. Number of Participants That Completed Qualitative Interview to Evaluate Acceptability of Digital Pills [ Time Frame: Month 3 ]
    Acceptability was assessed via individual, semi-structured, qualitative exit interviews conducted at the end of the 90-day study period. The qualitative interview guide was grounded in the Technology Acceptance Model. Questions explored participants' experiences using the digital pill system (DPS), including facilitators and barriers to use, engagement with the technology, and willingness to use the DPS long-term.


Eligibility Criteria
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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:

  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
Contacts and Locations
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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


Locations
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United States, Massachusetts
Fenway Health
Boylston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Peter R Chai, Fenway Community Health:
Study Protocol  [PDF] November 5, 2019
Statistical Analysis Plan  [PDF] September 3, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Peter R Chai, Emergency Medicine Physician, Fenway Community Health
ClinicalTrials.gov Identifier: NCT03842436    
Other Study ID Numbers: 2019P000793
First Posted: February 15, 2019    Key Record Dates
Results First Posted: November 1, 2021
Last Update Posted: December 22, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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