Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- TFV-DP concentrations
研究概览
简要总结
The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age: 18 years or older
- •Male sex at birth or trans man (current gender identity is male) assigned female sex at birth
- •Self-reports as a person who has sex with men
- •PrEP naïve or is currently prescribed PrEP and reports uncertainty about future adherence
- •Medical providers at each site will determine that the participant is indicated for PrEP per Centers for Disease Control (CDC) guidelines
- •Screens in for currently having one or more of the following psychosocial syndemic problems: depression; heavy alcohol use; problematic substance use or polydrug use; history of trauma or abuse; and/or current interpersonal violence
- •Owns a cell phone that has texting and internet / data capacity
排除标准
- •Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview
- •Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of enrollment (these patients will be referred immediately for treatment, but may join the study when this is resolved)
- •Laboratory or clinical findings that would preclude PrEP initiation (e.g. decreased creatinine clearance)
研究组 & 干预措施
Standard of Care
Participants in this group will not receive an intervention outside the standard of care.
Life-Steps for PreP
Participants in this group will receive standard of care treatment plus daily text message reminders. A subset of participants who demonstrate continued adherence challenges will also receive 4-6 weekly sessions of the Lifesteps for PrEP intervention.
干预措施: Lifesteps for PrEP (Behavioral)
Life-Steps for PreP
Participants in this group will receive standard of care treatment plus daily text message reminders. A subset of participants who demonstrate continued adherence challenges will also receive 4-6 weekly sessions of the Lifesteps for PrEP intervention.
干预措施: Daily text message reminders (Behavioral)
结局指标
主要结局
TFV-DP concentrations
时间窗: 3, 6, 9, 12, 15, and 18 months
Medication adherence as reported by Tenofovir diphosphate (TFV-DP) concentrations measured using dried blood spot (DBS) testing.
Wilson Medication Adherence self-report
时间窗: up to 18 months
Medication adherence as reported by the Wilson Medication Adherence self-report. The questionnaire has a total score ranging from 0-40, with a higher score indicating greater adherence.
Participants With TFV-DP Concentrations Consistent With Adherence (≥4 Doses/Week)
时间窗: 3, 6, 9, 12, 15, and 18 months
Medication adherence as reported by Tenofovir diphosphate (TFV-DP) concentrations measured using dried blood spot (DBS) testing. Measured by the concentration of PrEP medication in dried blood spots (DBS), displaying levels consistent with adherence (4+ pills per week). Outcomes reported categorically as "adherent" vs. "not adherent." Count of participants measures participants with TFV-DP concentrations consistent with adherence (4+ pill per week).
Wilson Medication Adherence Self-Report
时间窗: 3, 6, 9, 12, 15, and 18 months
Medication adherence as reported by the Wilson Medication Adherence self-report. The questionnaire has a score ranging from 0-1, with a higher score indicating greater adherence.
次要结局
- Retention in PrEP care(3, 6, 9, 12, 15, and 18 months)
- Retention in PrEP Care(3, 6, 9, 12, 15, and 18 months)
研究者
Steven Safren
Professor
University of Miami