Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
DigiPrEP
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 13, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2020
CompletedResults Posted
Study results publicly available
November 1, 2021
CompletedDecember 22, 2022
December 1, 2022
1.6 years
February 13, 2019
September 3, 2021
December 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of Digital Pills to Measure PrEP Adherence
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.
Months 1, 2, and 3
Secondary Outcomes (5)
Digital Pill Performance - Number of Recorded Ingestions
Months 1, 2, and 3
Digital Pill Performance - System Accuracy
Months 1, 2, and 3
Digital Pill Performance - Manually Reported Ingestions
Months 1, 2, and 3
Digital Pill Performance - Successful Operation of System
Months 1, 2, and 3
Dried Blood Spot Correlation With Digital Pill Adherence
Months 1 and 3
Other Outcomes (1)
Number of Participants That Completed Qualitative Interview to Evaluate Acceptability of Digital Pills
Month 3
Study Arms (1)
Digital Pills
EXPERIMENTALDigital Pills containing Truvada ingested once daily as PrEP
Interventions
Digital pills over encapsulating Truvada
Eligibility Criteria
You may qualify if:
- MSM (cisgender male)
- Self-reported use of non-alcohol substances of abuse in past 6 months
- Currently taking PrEP
- Has qualifying laboratory tests (Cr, hepatitis B immunization, STI testing and syphilis)
- Age 18 or older
You may not qualify if:
- Does not speak English
- HIV positive
- Identifies as transgender
- Estimated creatinine clearance \<60ml/min
- Active hepatitis B treatment
- Does not own a smartphone
- Taking proton pump inhibitors
- History of Crohn's disease or ulcerative colitis
- History of bowel surgery, gastric bypass, bowel stricture
- History of GI malignancy or radiation to abdomen
- Unable/unwilling to ingest digital pill
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Gilead Sciencescollaborator
Study Sites (1)
Fenway Health
Boylston, Massachusetts, 02215, United States
Related Publications (2)
Chai PR, Goodman GR, Bronzi O, Gonzales G, Baez A, Bustamante MJ, Najarro J, Mohamed Y, Sullivan MC, Mayer KH, Boyer EW, O'Cleirigh C, Rosen RK. Real-World User Experiences with a Digital Pill System to Measure PrEP Adherence: Perspectives from MSM with Substance Use. AIDS Behav. 2022 Jul;26(7):2459-2468. doi: 10.1007/s10461-022-03594-9. Epub 2022 Jan 28.
PMID: 35089449DERIVEDChai PR, Mohamed Y, Bustamante MJ, Goodman GR, Najarro J, Castillo-Mancilla J, Baez A, Bronzi O, Sullivan MC, Pereira LM, Baumgartner SL, Carnes TC, Mayer KH, Rosen RK, Boyer EW, O'Cleirigh C. DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances. J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):e5-e15. doi: 10.1097/QAI.0000000000002854.
PMID: 34753871DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
(1) Most participants were White and well-educated, limiting generalizability. (2) Opportunities for technical DPS improvements arose during the study, which required some participants to temporarily manually record doses. (3) The assay utilized for TFV-DP has not been cross-validated and may result in errors in assayed concentration of TFV-DP. (4) Reliance on pill counts may have decreased the measured accuracy of the DPS among participants who did not return unused pills each month.
Results Point of Contact
- Title
- Peter R. Chai, MD, MMS
- Organization
- Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Emergency Medicine Physician
Study Record Dates
First Submitted
February 13, 2019
First Posted
February 15, 2019
Study Start
October 1, 2018
Primary Completion
April 22, 2020
Study Completion
April 22, 2020
Last Updated
December 22, 2022
Results First Posted
November 1, 2021
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share