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

HIV-positive Individuals Clinical Trial

— MyTPill  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03978793
• Other study ID #: 2021X0070
• Secondary ID: R01DA047236
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: Ohio State University
• Contact: Edward W Boyer, MD PhD
• Phone: 6142938305
• Email: edward.boyer[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Seropositivity
• HIV-positive Individuals

Intervention

Device:
• MyTPill, a digital pill
MyTPill is a digital pill containing an approved medication

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (5)

Lead Sponsor	Collaborator
Ohio State University	Massachusetts General Hospital, National Institute on Drug Abuse (NIDA), The Miriam Hospital, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dried blood spots	Measurement of dried blood spots for TDF/FTC concentrations	six months
Primary	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	Pill counts	Count numbers of antiretroviral pills at followup sessions	Six months