Clinical trial NCT05700474: Enhancing Wellness Through Affirming Services and Education
Official title: Enhancing Wellness Through Affirming Services and Education
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Mental Health Disorder
Substance Use
Keywords: HIV
Mental Health
Substance Use
PrEP
Comorbidity
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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 identifying as LGBTQ+ and/or living with HIV. The main questions it aims to answer are:

1. Do important health outcomes, including substance use, mental health and social support related outcomes of individuals living with HIV and/or identifying as LGBTQ who participated in the holistic behavioral health and wellness program change after study participation?
2. Does a tailored approach to meet the specific needs of different subpopulations including 1) older (40+) PLWH and/or LGBTQ individuals with or at risk for additional health comorbidities and 2) PLWH and/or LGBTQ young adults (18-40) 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.

Detailed description: 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 in the LGBT community 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 minority LGBTQ+ adults, 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 . The LGBTQ+ community, particularly minority communities, has experienced more isolation and worse outcomes during the COVID pandemic; 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.

Eligibility criteria: Inclusion Criteria:

1. HIV diagnosis or self-identified LGBTQ+
2. Any alcohol or illicit substance use in the last 90 days
3. 18 or older
4. Residing in Mecklenburg County or surrounding areas.

Exclusion Criteria:

1) Inability to consent for services due to reduced mental or physical capacity

Primary outcomes:
measure: Change in depression symptoms measured by the PHQ-9
timeFrame: Baseline to 6 month follow-up survey
measure: Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS) (Anxiety subsection)
timeFrame: Baseline to 6 month follow-up survey
measure: Change in alcohol use as measured by alcohol use frequency questions
timeFrame: Baseline to 6 month follow-up survey
measure: Change in illicit substance use as measured by illicit substance use frequency questions
timeFrame: Baseline to 6 month follow-up survey
Secondary outcomes:
measure: Change in HIV-related stigma as measured by the HIV stigma scale
timeFrame: Baseline to 6 month follow-up survey
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Susan Reif
state: North Carolina
Study officials:
affiliation: Duke University
name: Susan Reif, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References: