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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

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 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

Primary Outcome Measure

Change in depression symptoms measured by the PHQ-9 [ Time Frame: Baseline to 6 month follow-up survey ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Susan ReifCharlotteNorth Carolina28207
Susan Reif
704-258-7111

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