HIV-positive Individuals
Conditions
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.
Interventions
DEVICEMyTPill, a digital pill
MyTPill is a digital pill containing an approved medication
Sponsors
University of Miami
The Miriam Hospital
Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
Florida International University
Ohio State University
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pill counts | Six months | Count numbers of antiretroviral pills at followup sessions |
Countries
United States
Outcome results
None listed