Enhancing Wellness Through Affirming Services and Education
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in depression symptoms measured by the PHQ-9
研究概览
简要总结
The goal of this treatment study is to learn about the mental health, substance use and physical health outcomes associated with participating in the EASE holistic behavioral health and wellness program for individuals seeking HIV prevention and/or living with HIV. The main questions it aims to answer are:
- Do important health outcomes, including substance use, mental health and social support related outcomes of individuals who participated in the holistic behavioral health and wellness program change after study participation?
- Does a tailored approach to meet the specific needs of different subpopulations including 1) older (40+) PLWH with or at risk for additional health comorbidities and 2) PLWH and/or young adults (18-40) seeking HIV prevention to improve health outcomes including improvement in health and health behaviors .
Participants will be asked to:
- participate in 6 months of behavioral health treatment tailored to their needs, which may include individual counseling, group counseling, case management, peer support, and related education.
- Complete surveys at the time of study entry and 6 months later to measure changes in health outcomes over time.
详细描述
Enhancing Wellness through Affirming Services and Education (EASE) is a comprehensive behavioral health program aimed at improving health outcomes for individuals living with HIV and individuals seeking HIV prevention services in Charlotte NC. Over the course of the proposed five-year program, 200 clients will receive an array of services to address substance use and mental health as well as underlying conditions including trauma, minority stress, comorbidities, stigma, and life instability (i.e. unstable housing, lack of access to medical care, employment barriers, and isolation).
EASE is a collaboration led by the Center for Health Policy and Inequalities Research with county and community partners including Mecklenburg County Community Support Services, RAIN, and individual therapists. Service offered will include evidence-based individual and group therapy, case management, peer programming, psychoeducation, and comorbidity management education. Building on previously successful programming, EASE will serve two client populations with tailored programs to meet their distinct needs. One track will serve an older population (over 40) with current drug use and living with or at higher risk of HIV to address substance use along with mental health and medical co-morbidities. A focus on overall wellness addressing stress management, nutrition, and chronic illness management will dovetail with substance use and mental health treatment to engage clients in whole body/mind wellness. The second track will serve individuals seeking prevention services, primarily adults under 40 to meet their specific mental and physical health needs addressing substance use, mental health, intersectional stress, gender-affirming health care, life skills development and sexual health . This track aims to address the behavioral health of this population by supporting overall wellbeing. Programmatic outcomes will be assessed through two secure online surveys completed by participants at baseline and six months after baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •HIV diagnosis or seeking HIV prevention services
- •Any alcohol or illicit substance use in the last 90 days
- •18 or older
- •Residing in Mecklenburg County or surrounding areas.
排除标准
- •1) Inability to consent for services due to reduced mental or physical capacity
研究组 & 干预措施
Intervention Arm
There is one arm of the study and this involves participating in holistic behavioral health treatment for people living with HIV and individuals seeking HIV prevention services for a 6 month period. Specific services include individual and group therapy, case management, peer support, and behavioral health education and awareness
干预措施: Comprehensive outpatient behavioral health care (Behavioral)
结局指标
主要结局
Change in depression symptoms measured by the PHQ-9
时间窗: Baseline to 6 month follow-up survey
PHQ-9 is a nine item depression scale with scores ranging from 0 to 27. A higher score indicates greater depressive symptoms
Change in illicit substance use as measured by illicit substance use frequency questions
时间窗: Baseline to 6 month follow-up survey
The participant survey will include questions regarding any use of illicit drugs and 30 day use of illicit drugs
Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS) (Anxiety subsection)
时间窗: Baseline to 6 month follow-up survey
HADS anxiety subscale is a seven item anxiety scale with scores ranging from 0 to 21. A higher score indicates greater anxiety
Change in alcohol use as measured by alcohol use frequency questions
时间窗: Baseline to 6 month follow-up survey
The participant survey will include questions regarding any use of alcohol use in last 30 days and days of use in the last 30 days
次要结局
- Change in HIV-related stigma as measured by the HIV stigma scale(Baseline to 6 month follow-up survey)