Supporting Treatment Adherence for Resilience and Thriving
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Unsuppressed HIV Viral Load
研究概览
简要总结
This Phase II randomized controlled trial is testing the efficacy of a cell phone application called START for helping men who use stimulants like methamphetamine to get the most out of their HIV treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Assigned male at birth;
- •Identifies as male;
- •Age 18 or older;
- •Reads and speaks English;
- •Continental US residency;
- •Reports ever having had anal sex with a man;
- •Self-reported HIV diagnosis for 3 or more months and currently taking anti-retroviral therapy (ART)
- •Reports a detectable viral load during past year OR no viral load test in the past 10+ months OR reports < 90% adherence to ART;
- •Screens positive for a moderate or severe stimulant use disorder in the past 3 months with an abbreviated version of the National Institute on Drug Abuse (NIDA)-modified Alcohol, Smoking and Substance. Involvement Screening Test (ASSIST);
- •Has an iPhone or Android smartphone;
- •Is willing to participate in an mHealth intervention
排除标准
- •HIV-negative or never tested for HIV;
- •HIV-positive men without a current ART prescription;
- •Does not return a viable DBS specimen at baseline for viral load testing
- •Not a sexual minority man
研究组 & 干预措施
START mHealth Intervention
Participants randomized to receive the START mHealth intervention will have access to the mHealth application for 6 months following randomization.
干预措施: START mHealth Intervention (Behavioral)
Website referrals
Participants in this condition will receive no intervention and will have access to a website with resources related to substance use disorder treatment and HIV treatment.
结局指标
主要结局
Unsuppressed HIV Viral Load
时间窗: 6 Months
Proportion of participants with a viral load \> 300 copies/mL from dried blood spot samples
次要结局
- Unsuppressed Viral Load(12 Months)
- Self-Reported Stimulant Use Severity(12 Months)
- Self-Reported Anti-Retroviral Therapy (ART) Adherence(12 Months)
- Positive Affect(12 Months)
研究者
Adam Carrico, PhD
Professor and Chair
Florida International University