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OpenTrials
Completed

NCT Number: NCT03978793

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

This study compares several different antiretroviral adherence measures, including digital pills, in HIV+ individuals who are maintained on opioid analgesics.

Completed

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Key information

Conditions

HIV-positive Individuals

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MyTPill, a digital pill

Device

MyTPill is a digital pill containing an approved medication

Other names: Wisepill, a digital pillbox

Primary outcomes

  1. Dried blood spots

    Time frame: six months

    Measurement of dried blood spots for TDF/FTC concentrations

  2. 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.

Secondary outcomes

  1. Pill counts

    Time frame: Six months

    Count numbers of antiretroviral pills at followup sessions

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

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

Registry information

Acronym: MyTPill

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2019
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.