Enhancing Wellness Through Affirming Services and Education

HIV Clinical Trial

— EASE  

Official title:

Enhancing Wellness Through Affirming Services and Education

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700474
• Other study ID #: Pro00111885
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: July 1, 2027

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Susan Reif
• Phone: 17042587111
• Email: susan.reif[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Mental Disorders
• Mental Health Disorder
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Comprehensive outpatient behavioral health care
Participation will include clinical assessment and outpatient behavioral health services, case management, individual and group counseling, peer support, case management, and education regarding behavioral health and medical care

Locations

Country	Name	City	State
United States	Susan Reif	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression symptoms measured by the PHQ-9	PHQ-9 is a nine item depression scale with scores ranging from 0 to 27. A higher score indicates greater depressive symptoms	Baseline to 6 month follow-up survey
Primary	Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS) (Anxiety subsection)	HADS anxiety subscale is a seven item anxiety scale with scores ranging from 0 to 21. A higher score indicates greater anxiety	Baseline to 6 month follow-up survey
Primary	Change in alcohol use as measured by alcohol use frequency questions	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	Baseline to 6 month follow-up survey
Primary	Change in illicit substance use as measured by illicit substance use frequency questions	The participant survey will include questions regarding any use of illicit drugs and 30 day use of illicit drugs	Baseline to 6 month follow-up survey
Secondary	Change in HIV-related stigma as measured by the HIV stigma scale	The negative self-image subscale of HIV stigma scale has 13 items with likert response scores ranging from 13 to 52; higher scores indicate greater negative self image	Baseline to 6 month follow-up survey