MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users (MyTPill)

July 31, 2025 updated by: Edward Boyer, Ohio State University
This study compares several different antiretroviral adherence measures, including digital pills, in HIV+ individuals who are maintained on opioid analgesics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study compares digital pills, electronic pill bottles, self-report, and dried blood spots, in measuring adherence to antiretroviral medications containing emtricitabine and tenofovir.

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

HIV+

Description

Inclusion Criteria:

  • HIV+, Viral load >200copies/mL, on single pill containing TDF/FTC, receiving prescription for opioid analgesics

Exclusion Criteria:

  • Severe renal or hepatic disease
  • Hypersensitivity to silver, magnesium, or zinc following oral use
  • Pregnancy
  • non-English speaking
  • History of Crohn's disease or Ulcerative Colitis
  • History of bowel surgery, gastric bypass, or bowel stricture
  • History of gastrointestinal malignancy or radiation to the abdomen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MyTPill
Participants receive digital pills for three months, have a 2-week washout, then switch to Wisepill.
Device: MyTPill, a digital pill
MyTPill is a digital pill containing an approved medication
Other Names:
  • Wisepill, a digital pillbox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dried blood spots
Time Frame: six months
Measurement of dried blood spots for TDF/FTC concentrations
six months
Adherence per two different electronic adherence measures
Time Frame: Six months
Secondary outcomes are the identification of multi-level factors that are prevalent in the target population most closely linked to ART non-adherence and EAM non-adherence.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pill counts
Time Frame: Six months
Count numbers of antiretroviral pills at followup sessions
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
University of Miami
The Miriam Hospital
Florida International University

Investigators

  • Principal Investigator: Edward W Boyer, MD PhD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

March 12, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (Actual)

June 7, 2019

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

July 31, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021X0070
  • R01DA047236 (U.S. NIH Grant/Contract)
  • K24DA037109 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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