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

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

Study Overview

• Status: Recruiting
• Conditions: HIV-positive Individuals
• Intervention / Treatment: Device: MyTPill, a digital pill

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 (Estimated): 80

Contacts and Locations

• Study Contact: Name: Edward W Boyer, MD PhD; Phone Number: 6142938305; Email: edward.boyer@osumc.edu
• Study Contact Backup: Name: Adam Carrico, PhD; Phone Number: 305-348-7789; Email: acarrico@fiu.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Kathryn McCollister, PhD; Phone Number: 305-243-3479; Email: kmccolli@med.miami.edu
      • Contact: Michael Viamonte, MPH; Phone Number: 305-586-4651; Email: icarus@miami.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

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	Measurement of dried blood spots for TDF/FTC concentrations	six months
Adherence per two different electronic adherence measures	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	Count numbers of antiretroviral pills at followup sessions	Six months

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: National Institute on Drug Abuse (NIDA); Massachusetts General Hospital; University of Miami; The Miriam Hospital
• Investigators: Principal Investigator: Edward W Boyer, MD PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

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): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Urogenital Diseases; Genital Diseases; HIV Seropositivity
• Other Study ID Numbers: 2021X0070; R01DA047236 (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