Development of a Trauma Informed Intervention to Support Adaptive Engagement in Care Among MSM Living With HIV: Project THRIVE+
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- ACTG Adherence Interview
研究概览
简要总结
This purpose of this project is to specify and provide an initial test of a 10 session, individual-based cognitive therapy intervention to address symptoms of PTSD and poor engagement in HIV care among men who have sex with men (MSM) with trauma histories
详细描述
The proposed intervention will incorporate the most current approaches to mediating trauma responses and stressors related to experiences of HIV stigma and homonegativity with cognitive-processing therapy, an empirically validated, cognitive-behavioral intervention for reducing negative consequences of traumatic stress. This intervention intends to improve uptake of HIV care in the prevention, engagement, and care cascade while also addressing the mental health needs of HIV-positive persons in a program of research that leads to outcomes in the short-term. If found to be efficacious, this intervention can also be scalable across clinical settings.
The study will be implemented at The Fenway Institute at Fenway Health (TFI) and at Ryerson University, Toronto, Canada and Drs. O'Cleirigh and Hart will assume the responsibility of coordinating the study across sites.
Randomization will be to the 10 session intervention or to two medication adherence/engagement in care sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomization is known to the study investigator, study clinician, project coordinator, and participant. The outcomes assessor is privy to randomization information.
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
- •HIV-infected
- •is a man who has sex with men
- •has a history of trauma and is experiencing trauma-related distress (as operationalized by a score of >/= 20 on the Davidson Trauma Scale)
- •is sub-optimally engaged in HIV care (as operationalized by missing 1 or more HIV care appointments in the past 12 months, having a detectable viral load at most recent testing, or having poor adherence - </=80% - to HIV medications)
排除标准
- •has a significant mental health diagnosis that requires immediate treatment (e.g., acute major depression; panic disorder; any psychotic disorder)
- •unable to complete the informed consent process (e.g., substantial cognitive impairment, inadequate English language skills).
结局指标
主要结局
ACTG Adherence Interview
时间窗: up to 4 times over 9 months
HIV medication adherence is collected at all major time points (baseline, 3 month follow-up, 6 month follow-up, and 9 month follow-up) via self-report, using the AIDS Clinical Trials Group Adherence Interview. Participants are asked to give the number of doses they take of each of their HIV medications per day, and to note how many doses were missed at 4 time time points (yesterday, day before yesterday, 3 days ago, in the past 2 weeks).
次要结局
- Viral Load(baseline and 9 months)
- Davidson Trauma Scale(1 week)
研究者
Conall O'Cleirigh
Director of Behavioral Medicine Program, Department of Psychiatry
Massachusetts General Hospital