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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2025-04-30

Brief Summary

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

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Detailed Description

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

Conditions

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HIV-positive Individuals

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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MyTPill

Participants receive digital pills for three months, have a 2-week washout, then switch to Wisepill.

MyTPill, a digital pill

Intervention Type DEVICE

MyTPill is a digital pill containing an approved medication

Interventions

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MyTPill, a digital pill

MyTPill is a digital pill containing an approved medication

Intervention Type DEVICE

Other Intervention Names

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Wisepill, a digital pillbox

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No