Enhancing Wellness Through Affirming Services and Education
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
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
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline to 6 month follow-up survey2
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
Time frame
Baseline to 6 month follow-up survey3
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
Time frame
Baseline to 6 month follow-up survey4
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
Time frame
Baseline to 6 month follow-up surveySecondary outcomes
1
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
Time frame
Baseline to 6 month follow-up surveySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov