Optimizing PrEP Adherence in Sexual Minority Men Who Use Stimulants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 2
- 主要终点
- Percentage of Participants Engaging HIV Acquisition Risk
研究概览
简要总结
This multi-site randomized controlled trial enrolling sexual minority men who use stimulants and are currently taking pre-exposure prophylaxis (PrEP). This randomized controlled trial will test the efficacy of a PrEP Affect Regulation Treatment Innovation (PARTI) condition comprised of a 5-session positive affect intervention delivered during smartphone-based Contingency Management (CM) for directly observed PrEP doses (PARTI+CM) compared to an attention-control condition delivered during CM. The primary outcome is HIV acquisition risk measured using a combination of tenofovir-diphosphate levels in dried blood spots that are indicative of sub-optimal adherence to PrEP and recent condomless anal sex.
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
- Single (Outcomes Assessor)
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
- •Assigned male at birth
- •Identifies as male
- •Age 18 or older
- •Reads and speaks English
- •Reports condomless anal sex (CAS) with men in the past 6 months
- •self-reported HIV negative
- •Active prescription for daily oral PrEP for at least 2 months and reports any non-adherence in the past month OR initiated daily oral PrEP in the past 2 months, regardless of self-reported adherence
- •Has an iPhone or Android smartphone
- •Screens positive for a moderate or severe stimulant use disorder with an abbreviated version of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST; total score of 4 or more) OR reports using stimulants at least weekly in the past 3 months.
- •Lives in California or Florida with no plans to move out of state in the next 6 months
排除标准
- •Unable or unwilling to provide informed consent
- •Unwilling to upload upload 3 video recordings of directly observed PrEP doses using a smartphone application
- •Identifies as transfeminine (e.g., transgender woman)
- •Unable or Unwilling to provide dried blood spot (DBS) specimen at baseline
- •Switched from daily oral PrEP with disoproxil fumarate (TDF) to daily oral PrEP with tenofovir alafenamide (TAF) in the past 5 months
研究组 & 干预措施
PARTI and CM (Contingency Management)
The PARTI intervention will be delivered in five individual sessions during a 12-week contingency management protocol for PrEP adherence
干预措施: PARTI (Behavioral)
PARTI and CM (Contingency Management)
The PARTI intervention will be delivered in five individual sessions during a 12-week contingency management protocol for PrEP adherence
干预措施: Contingency Management for PrEP Adherence (Behavioral)
Attention-Control and CM (Contingency Management)
The attention-control condition will consist of five individual sessions where participants complete self-report measures and neutral writing exercises during a 12-week contingency management protocol for PrEP adherence
干预措施: Attention-Control (Behavioral)
Attention-Control and CM (Contingency Management)
The attention-control condition will consist of five individual sessions where participants complete self-report measures and neutral writing exercises during a 12-week contingency management protocol for PrEP adherence
干预措施: Contingency Management for PrEP Adherence (Behavioral)
结局指标
主要结局
Percentage of Participants Engaging HIV Acquisition Risk
时间窗: Up to 12 months
Percentage of participants engaging in HIV acquisition risk (i.e., defined as tenofovir - diphosphate levels from dried blood spots that are indicative of less than four oral PrEP doses per week AND any self-reported recent condomless anal sex)
次要结局
- PrEP Persistence(Up to 12 months)
- Self-Reported Stimulant Use Severity(Up to 12 months)
- Positive Affect(Up to 12 months)
- Retention in PrEP Care(Up to 12 months)
研究者
Adam Carrico, PhD
Professor and Chair
Florida International University