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

Recruiting

• Conditions: HIV-positive Individuals
• Interventions: Device: MyTPill, a digital pill

• Registration Number: NCT03978793
• Lead Sponsor: Ohio State University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-07
• Study Start: 2021-02-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MyTPill	MyTPill, a digital pill	Participants receive digital pills for three months, have a 2-week washout, then switch to Wisepill.

Primary Outcome Measures

Name	Time	Method
Dried blood spots	six months	Measurement of dried blood spots for TDF/FTC concentrations
Adherence per two different electronic adherence measures	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 Outcome Measures

Name	Time	Method
Pill counts	Six months	Count numbers of antiretroviral pills at followup sessions

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States