Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility of Recruitment
研究概览
简要总结
This pilot randomized clinical trial will randomize 60 participants 1:1 to either enhanced usual care or to adapted CETA, a counseling intervention for HIV care engagement plus depression, anxiety, PTSD, and/or substance use.
详细描述
Patient participants in this study will be randomized 1:1 to either enhanced usual care or the adapted CETA intervention. Enhanced usual care will include provision of feedback about psychiatric diagnoses to the HIV provider and the clinic's behavioral health team for follow-up according to the clinic's standard care. Participants randomized to the adapted CETA arm will initiate CETA with the trained counselor. The number of CETA sessions will depend on the patient's presentation but will range from 7-13 weekly in-person 1-hour sessions.Before randomization, enrolled participants will complete a baseline assessment including sociodemographic information; self-reported health; standardized assessments of depressive, anxiety, and post-traumatic stress symptoms and substance use; and key related structural and psychosocial factors including housing stability,intimate partner violence (IPV), other violence in the home, coping, social support, and experiences of stigma related to mental health.
Participants in the Enhanced Contact arm will complete a follow-up research assessment at 3 months post baseline.Participants in the adapted CETA arm will complete this assessment after the final CETA session,also expected to be at approximately 3 months post-baseline. All participants will complete a final research assessment at 9 months post-baseline (approximately 6 months post-treatment exit for those in the adapted CETA arm). These follow-up assessments will assess the same domains as the baseline assessment.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years.
- •Patient receiving HIV care at UAB 1917 Clinic.
- •Elevated symptoms of depression, anxiety, post-traumatic stress, or substance use disorder: At least one of the following:
- •Patient Health Questionnaire-9 score >= 10;
- •Generalized Anxiety Disorder 7-Item Scale score >= 10;
- •Post-Traumatic Stress Symptoms Checklist for DSM-5 score >= 33;
- •ASSIST score >=11 for alcohol or >=4 for any other substance
- •At risk for suboptimal HIV care engagement: At least one of the following:
- •Engaged in HIV care for the first time within the past 6 months;
- •Have an HIV RNA viral load >1,000 copies/mL within the past 6 months;
- •Antiretroviral regimen was changed due to treatment failure within the past 6 months;
- •No-showed to an HIV primary care appointment within the past year.
- •Willing to provide written informed consent.
排除标准
- •Non-English speaking
- •Unable to attend counseling sessions
- •Unwilling to provide informed consent
结局指标
主要结局
Feasibility of Recruitment
时间窗: Duration of recruitment phase (9 months)
We defined feasibility as the total number of patients approached in order to accrue the final study sample size of n=60.
Client Acceptability
时间窗: At treatment exit (approximately 9 months post-baseline)
Client acceptability will be assessed via the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item questionnaire, with a minimum value of 8 and a maximum score of 32. A higher score indicates greater client acceptability.
Fidelity
时间窗: At the end of CETA completion or withdrawal, across all CETA participants
Counselor fidelity to CETA will be rated by the trainer based on the trainer's supervisory experience working with CETA counselors. After all CETA patients complete the study, the trainer will rate up to 5 cross-cutting aspects of CETA delivery and 13 CETA components targeting specific symptoms for fidelity. The trainer will rate the degree of confidence on a scale of 0 ("Not at all") to 4 ("Completely") that the counselor was routinely delivering each cross-cutting aspect or component of CETA with fidelity, for those aspects and components that the trainer had experience supervising the counselor in. The fidelity rating will be calculated separately for the 2 CETA counselors and reported as the mean score across the number of CETA aspects and components rated by the trainer. Higher scores indicate greater fidelity to CETA.
次要结局
- Number of Participants Suppressed HIV RNA Viral Load(4 months post-baseline)
- Number of Participants With Suppressed HIV RNA Viral Load(9 months post-baseline)
- HIV Appointment Attendance(From baseline to 12 months post-baseline)
- Depressive Symptoms(4 months post-baseline)
- Anxiety Symptoms(4 months post-baseline)
- Post-traumatic Stress Symptoms(4 months post-baseline)
- Substance Use Symptoms(4 months post-baseline)
- HIV Kept Visit Attendance(From baseline to 12 months post-baseline)
研究者
Michael J Mugavero, MD
Professor
University of Alabama at Birmingham