A Trauma-Informed Intervention for Sexual Minority Men Recently Diagnosed With HIV
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Client Satisfaction Questionnaire-8
研究概览
简要总结
The current approach to HIV prevention emphasizes: (1) achieving viral suppression among HIV+ people in order to reduce HIV transmissibility, particularly for disproportionately affected groups such as Black sexual minority men (BSMM), by increasing retention in HIV care, and (2) addressing comorbidities and complications, which include mental health concerns such as trauma symptomology and severe acute stress reactivity. Despite the disproportionate impact of both HIV and traumatic stress on BSMM and the adverse effects of stress on engagement in HIV care, BSMM remain grossly underserved with respect to mental health. To address these gaps, the proposed study will develop an intervention that will: (1) provide a brief, resilience-oriented, trauma-informed intervention that combines online sessions and highly tailored text-messaging to reduce participant burden and motivate clients between sessions, (2) provide preliminary treatment for HIV+ BSMM's unaddressed mental health needs, and (3) be embedded early in the HIV continuum of care immediately after diagnosis to facilitate linkage to and retention in HIV care.
详细描述
Compared to the general population in the United States, people living with HIV (PLWH) show high rates of trauma- and stress-related disorders and severe acute stress reactivity to events that are, diagnostically, not considered traumatic. Trauma is highly correlated with depression, a robust predictor of antiretroviral treatment (ART) non-adherence. Additionally, reporting a high number of recent stressful events is associated with ART non-adherence. Despite Black sexual minority men (BSMM), particularly those under age 40, being disproportionately affect by HIV and trauma and less likely to be linked to HIV care after diagnosis, BSMM remain grossly underserved with respect to mental health. Further, although interventions exist that address trauma for PWLH, few HIV-related interventions emphasize the traumatic stress cycle and acute stress reactivity immediately following an HIV diagnosis. To address the need for early mental health intervention immediately after HIV diagnosis, in general, as well as the under-addressed mental-health needs of HIV+ BSMM (+BSMM), in particular, the investigators will develop and pilot-test a resilience-focused, trauma-informed intervention called, Resilience- Based Intervention for Stress Reduction and HIV-Related Efficacy (RISE). RISE will be based on approaches and techniques of Cognitive-Behavior Therapy (CBT) and the framework of Resilience Theory. It will address trauma- and stress-related symptomology and acute stress reactivity within three months of an HIV diagnosis to facilitate linkage to HIV care. The brief RISE will include six online sessions, a booster session, and text messaging. Innovative commercial marketing techniques will be used to develop highly targeted messages to supplement the CBT- and resilience-based approach of RISE. First, Aim 1 will involve formative research to assess +BSSM's needs, preferences, and perceptions regarding mental health and engagement in HIV care via in-depth interviews with +BSMM and service providers. Next, Aim 2 will include development of the RISE intervention manual and digital health infrastructure. Tailored text messages and health-promotion materials will be developed via in-depth interview-derived quantitative surveys with 50 +BSMM. The Aim will also include an iterative process of intervention development, including focus groups with +BSMM and service providers, respectively, and intervention theatre tests with 6 +BSMM. Finally, Aim 3 will consist of a randomized, controlled pilot trial for feasibility (e.g., recruitment and enrollment rates, fidelity), acceptability (i.e., feedback interview, satisfaction questionnaire), and preliminary efficacy (i.e., increased HIV care engagement, including attending an HIV care appointment, antiretroviral treatment ART initiation, and ART adherence primary outcome; reduced trauma symptoms, including intrusive experiences, avoidance, and hyperarousal secondary outcome) with 40 +BSMM diagnosed within the past three months. Participants will be assessed at baseline, post-intervention, and 6- and 9-month follow-ups post-baseline. The investigators will develop and maintain a community advisory board for consultation throughout the study.
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
- 否
入选标准
- •Diagnosed with HIV within the past 3 months
- •Self-identification as Black or African American
- •Aged 18-39 years
- •Elevated traumatic stress as indicated by scores above clinical cutoffs on either of the following subscales of the Impact of Event Scale--Revised: Intrusion (score of 5 or greater) and Avoidance (score of 7 or greater)
- •Owning a phone with short-message service or messaging
- •Access to a device with a screen, a web browser, and adequate internet speed for videoconferencing (e.g., smartphone, computer).
排除标准
- •Demonstrating cognitive impairment or acute psychosis
- •Reporting unvailability to participate in the Baseline Assessment, the RISE intervention, and 3-, 6, and 9-Month Follow-Up Assessments
结局指标
主要结局
Client Satisfaction Questionnaire-8
时间窗: Throughout study completion: 3-, 6- and 9-Month Follow-Up Post-Baseline
Acceptability, specifically participant satisfaction. Values: Range from 8 to 32. Scoring: Higher scores indicate greater percentage of HIV medication dosages taken over the past 30 days.
次要结局
- Question (Yes/No; Attended HIV care appointment in past 3 months): "Have [the participant] attended an HIV care appointment with a HIV care, primary care, or similarly care provider in the past 3 months?"(Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline)
- Question (Yes/No; Initiated antiretroviral treatment): "Have [the participant] begun taking medication prescribed to treat HIV?"(Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline)
- Question (Yes/No; Have future appointment scheduled): "Do [the participant] have a future HIV care appointment scheduled?"(Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up)
- Visual Analog Scale(Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline)
- Berlin Social Support Scale(Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline)
- Impact of Event Scale - Revised(Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline)
- Center for Epidemiologic Studies - Depression Scale(Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline)
- Beck Depression Inventory-II(Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline)
- Coping Self-Efficacy Scale(Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline)
- Illness Intrusiveness Ratings Scale(Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline)
- HIV Treatment Adherence Self-Efficacy Scale(Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline)
- Demographics(Baseline)
- Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)(Baseline)
- (Frequency of) Events (i.e., Barriers) in Care Screening Questionnaire(Baseline)
- Group-Based Medical Mistrust Scale(Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline)
- Internalized AIDS-Related Stigma Scale(Throughout study completion: Baseline and 3-, 6-, and 9-Month Follow-Up Post-Baseline)
- Cultural Assessment of Risk for Suicide (CARS) Minority Stress Subscale(Throughout study completion: Baseline and 3-, 6-, and 9-Month Follow-Up Post-Baseline)
- Everyday Discrimination Scale(Baseline)