Enhancing Wellness Through Affirming Services and Education (EASE)

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:

1. 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?
2. 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.

Study Overview

• Status: Recruiting
• Conditions: HIV; Mental Health Disorder; Substance Use
• Intervention / Treatment: Behavioral: Comprehensive outpatient behavioral health care

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Reif; Phone Number: 17042587111; Email: susan.reif@duke.edu

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • Susan Reif
      • Contact: Susan Reif; Phone Number: 704-258-7111; Email: susan.reif@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. HIV diagnosis or seeking HIV prevention services
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other Names: EASE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Susan Reif, PhD, MSW, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; HIV; PrEP; Substance Use; Comorbidity
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Behavior; Personal Satisfaction; Substance-Related Disorders; Mental Disorders; Psychological Well-Being
• Other Study ID Numbers: Pro00111885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No