Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
研究概览
简要总结
Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for individuals with HIV with various psychological comorbidities, which the investigators call "syndemics". Syndemics are co-occurring psychosocial problems that interact with each other and with health behavior such as HIV sexual transmission risk behavior and adherence to self care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV+ individuals
- •Uncontrolled virus (plasma HIV RNA concentrations that reach detectable limits) or being diagnosed with a sexually transmitted infection (STI) (gonorrhea, chlamydia, syphilis, trichomoniasis (female only)) currently or within the past 3 months.
排除标准
- •Unable or unwilling to provide informed consent
- •Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania) that would interfere with study participation
- •Opinion of the PI that the participant would be at risk for harm to himself or others as a result of study participation,
- •Under the age of 18 or over the age of 65,
- •Current CBT for a psychiatric disorder, or a course of CBT in the past year.
研究组 & 干预措施
Cognitive Behavioral Therapy
Integrating CBT for any substance use or mental health problems with CBT for adherence/self-care
干预措施: Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
时间窗: 8 month assessment
Attaining viral suppression
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
时间窗: 4 months assessment
Attaining viral suppression
次要结局
- Adherence to antiretroviral therapy via real time monitoring(Changes over time from baseline to 8 month follow-up)
研究者
Steven Safren
Professor
University of Miami