Enhancing Wellness Through Affirming Services and Education
Part of paid clinical trials in Charlotte, North Carolina.
- Sponsor
- Duke University
- Study ID
- NCT05700474
- Status
- Recruiting
Conditions
- HIV
- Mental Health Disorder
- Substance Use
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Comprehensive outpatient behavioral health care — BEHAVIORALParticipation 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
Study Details
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.
Key Dates
- Start date
- Feb 13, 2023
- Status verified
- Feb 2026
- Primary completion
- Jul 1, 2027
- Completion
- Jul 1, 2027
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Intervention ArmThere 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
Primary Outcome Measure
Change in depression symptoms measured by the PHQ-9 [ Time Frame: Baseline to 6 month follow-up survey ]
Central Contacts
- Susan Reif17042587111
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Susan Reif | Charlotte | North Carolina | 28207 |
Find similar trials in Charlotte, NC
Related Studies
- Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal InjuryRecruiting · Wake Forest University Health Sciences · Winston-Salem, North Carolina
- Human Immunodeficiency Virus (HIV) Food InsecuritiesRecruiting · Wake Forest University Health Sciences · Winston-Salem, North Carolina
- Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV CareRecruiting · Johns Hopkins University · San Diego, California
- Gathering Online for Dialogue and Discussion to Enhance Social SupportRecruiting · RTI International · Durham, North Carolina