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Enhancing Wellness Through Affirming Services and Education (EASE)

Primary Purpose

HIV, Mental Health Disorder, Substance Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive outpatient behavioral health care
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV focused on measuring HIV, Mental Health, Substance Use, PrEP, Comorbidity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: HIV diagnosis or self-identified LGBTQ+ Any alcohol or illicit substance use in the last 90 days 18 or older Residing in Mecklenburg County or surrounding areas. Exclusion Criteria: 1) Inability to consent for services due to reduced mental or physical capacity

Sites / Locations

  • Susan ReifRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
January 17, 2023
Last Updated
February 13, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05700474
Brief Title
Enhancing Wellness Through Affirming Services and Education
Acronym
EASE
Official Title
Enhancing Wellness Through Affirming Services and Education
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
July 1, 2027 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Mental Health Disorder, Substance Use
Keywords
HIV, Mental Health, Substance Use, PrEP, Comorbidity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive outpatient behavioral health care
Other Intervention Name(s)
EASE
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in depression symptoms measured by the PHQ-9
Description
PHQ-9 is a nine item depression scale with scores ranging from 0 to 27. A higher score indicates greater depressive symptoms
Time Frame
Baseline to 6 month follow-up survey
Title
Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS) (Anxiety subsection)
Description
HADS anxiety subscale is a seven item anxiety scale with scores ranging from 0 to 21. A higher score indicates greater anxiety
Time Frame
Baseline to 6 month follow-up survey
Title
Change in alcohol use as measured by alcohol use frequency questions
Description
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
Time Frame
Baseline to 6 month follow-up survey
Title
Change in illicit substance use as measured by illicit substance use frequency questions
Description
The participant survey will include questions regarding any use of illicit drugs and 30 day use of illicit drugs
Time Frame
Baseline to 6 month follow-up survey
Secondary Outcome Measure Information:
Title
Change in HIV-related stigma as measured by the HIV stigma scale
Description
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
Time Frame
Baseline to 6 month follow-up survey

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV diagnosis or self-identified LGBTQ+ Any alcohol or illicit substance use in the last 90 days 18 or older Residing in Mecklenburg County or surrounding areas. Exclusion Criteria: 1) Inability to consent for services due to reduced mental or physical capacity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Reif
Phone
17042587111
Email
susan.reif@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Reif, PhD, MSW
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Susan Reif
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Reif
Phone
704-258-7111
Email
susan.reif@duke.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhancing Wellness Through Affirming Services and Education

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