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

Ohio State University31 enrolled

Overview

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

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

Conditions

HIV-positive Individuals

Interventions

MyTPill, a digital pillDEVICE

MyTPill is a digital pill containing an approved medication

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Dried blood spots

Measurement of dried blood spots for TDF/FTC concentrations

Time frame: 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.

Time frame: Six months

Secondary Outcomes

Pill counts

Count numbers of antiretroviral pills at followup sessions

Time frame: Six months

Data from ClinicalTrials.gov

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