NCT03978793已完成不适用
MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Dried blood spots
研究概览
简要总结
This study compares several different antiretroviral adherence measures, including digital pills, in HIV+ individuals who are maintained on opioid analgesics.
详细描述
This study compares digital pills, electronic pill bottles, self-report, and dried blood spots, in measuring adherence to antiretroviral medications containing emtricitabine and tenofovir.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV+, Viral load >200copies/mL, on single pill containing TDF/FTC, receiving prescription for opioid analgesics
排除标准
- •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.
结局指标
主要结局
Dried blood spots
时间窗: six months
Measurement of dried blood spots for TDF/FTC concentrations
Adherence per two different electronic adherence measures
时间窗: 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.
次要结局
- Pill counts(Six months)
研究者
Edward Boyer
Professor
Ohio State University
研究点 (1)
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