Recruiting

Wellness Enhancement

Sponsor:

Duke University

Code:

NCT05700474

Conditions

HIV

Mental Health Disorder

Substance Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Comprehensive outpatient behavioral health care

Study Details

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 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.

Conditions

HIV

Mental Health Disorder

Substance Use

Study ID

NCT05700474

Start date

Feb 13, 2023

Status verified date

Feb, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

Interventions

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

Primary outcome measure

  • Change in depression symptoms measured by the PHQ-9 [ Time Frame: Baseline to 6 month follow-up survey ]
  • Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS) (Anxiety subsection) [ Time Frame: Baseline to 6 month follow-up survey ]
  • Change in alcohol use as measured by alcohol use frequency questions [ Time Frame: Baseline to 6 month follow-up survey ]
  • Change in illicit substance use as measured by illicit substance use frequency questions [ Time Frame: Baseline to 6 month follow-up survey ]

Central Contacts and Locations

Central contacts

Susan Reif

17042587111susan.reif@duke.edu

Locations

Susan Reif

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Susan Reif

704-258-7111susan.reif@duke.edu

More Information

Sponsor

Duke University

Last update posted

Apr 9, 2026

Last verified

Feb, 2026

Keywords

  • HIV
  • Mental Health
  • Substance Use
  • PrEP
  • Comorbidity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-17. This information was provided to ClinicalTrials.gov by Duke University on 2026-04-09.