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NCT Number: NCT05700474

Enhancing Wellness Through Affirming Services and Education

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.

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Key information

Conditions

HIV Behavior Chemically-Induced Disorders Mental Disorders Mental Health Disorder Personal Satisfaction Psychological Well-Being Substance Use Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Susan Reif

Charlotte, North Carolina, 28207, United States

Location status: Recruiting

Location contact

Susan Reif

CONTACT

[email protected]

704-258-7111

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV diagnosis or seeking HIV prevention services
  • Any alcohol or illicit substance use in the last 90 days
  • 18 or older
  • Residing in Mecklenburg County or surrounding areas.

Exclusion criteria

  • Inability to consent for services due to reduced mental or physical capacity

Treatment and study plan

Comprehensive outpatient behavioral health care

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

Other names: EASE

Primary outcomes

  1. Change in depression symptoms measured by the PHQ-9

    Time frame: Baseline to 6 month follow-up survey

    PHQ-9 is a nine item depression scale with scores ranging from 0 to 27. A higher score indicates greater depressive symptoms

  2. Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS) (Anxiety subsection)

    Time frame: Baseline to 6 month follow-up survey

    HADS anxiety subscale is a seven item anxiety scale with scores ranging from 0 to 21. A higher score indicates greater anxiety

  3. Change in alcohol use as measured by alcohol use frequency questions

    Time frame: Baseline to 6 month follow-up survey

    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

  4. Change in illicit substance use as measured by illicit substance use frequency questions

    Time frame: Baseline to 6 month follow-up survey

    The participant survey will include questions regarding any use of illicit drugs and 30 day use of illicit drugs

Secondary outcomes

  1. Change in HIV-related stigma as measured by the HIV stigma scale

    Time frame: Baseline to 6 month follow-up survey

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Susan Reif

CONTACT

[email protected]

17042587111

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: EASE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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