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

NCT ID: NCT03842436

Last Updated: 2022-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-04-22

Brief Summary

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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

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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.

Conditions

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HIV/AIDS Substance Use Disorders Adherence, Medication

Keywords

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PrEP Substance Use Disorder Digital Pills Medication Adherence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group pilot demonstration project
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Digital Pills

Digital Pills containing Truvada ingested once daily as PrEP

Group Type EXPERIMENTAL

Digital pill

Intervention Type DEVICE

Digital pills over encapsulating Truvada

Truvada

Intervention Type DRUG

Truvada prescribed with digital pills for PrEP

Interventions

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Digital pill

Digital pills over encapsulating Truvada

Intervention Type DEVICE

Truvada

Truvada prescribed with digital pills for PrEP

Intervention Type DRUG

Other Intervention Names

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eTectRx ID Cap

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peter R Chai

Emergency Medicine Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fenway Health

Boylston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35089449 (View on PubMed)

Chai 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.

Reference Type DERIVED
PMID: 34753871 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019P000793

Identifier Type: -

Identifier Source: org_study_id