Enhancing Wellness Through Affirming Services and Education

NCT ID: NCT05700474

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-13

Study Completion Date

2027-07-01

Brief Summary

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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

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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.

Conditions

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HIV Mental Health Disorder Substance Use

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention Arm

There is one arm of the study and this involves participating in holistic behavioral health treatment for people living with HIV and the LGBTQ+ community for a 6 month period. Specific services include individual and group therapy, case management, peer support, and behavioral health education and awareness

Group Type EXPERIMENTAL

Comprehensive outpatient behavioral health care

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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EASE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Reif, PhD, MSW

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Susan Reif

Charlotte, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Susan Reif

Role: CONTACT

17042587111

Facility Contacts

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Susan Reif

Role: primary

704-258-7111

Other Identifiers

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Pro00111885

Identifier Type: -

Identifier Source: org_study_id

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