HIVEASENCT05700474
Enhancing Wellness Through Affirming Services and Education
A study testing Comprehensive outpatient behavioral health care in people with HIV and Mental Health Disorder, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Mental Health Disorder, Substance Use
- What is being tested?
- Comprehensive outpatient behavioral health care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2023to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1) Inability to consent for services due to reduced mental or physical capacity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Susan Reif
Charlotte, North Carolina, 28207
Susan Reif, 704-258-7111, susan.reif@duke.edu
About this study
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:
- 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?
- 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 .
Read more
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.
Read the detailed description
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.
- Conditions
- HIV, Mental Health Disorder, Substance Use
- Being tested
- Comprehensive outpatient behavioral health care
- Keywords
- HIV, Mental Health, Substance Use, PrEP, Comorbidity
- Medical subject headings
- Mental Disorders, Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive outpatient behavioral health careBehavioural
Also called EASE
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 group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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 Receives: Behavioral: Comprehensive outpatient behavioral health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 6 month follow-up survey
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
Measured: Baseline to 6 month follow-up survey
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
Measured: Baseline to 6 month follow-up survey
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
Measured: Baseline to 6 month follow-up survey
Secondary 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
Measured: Baseline to 6 month follow-up survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start13 Feb 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Reif, PhD, MSW, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700474
- Sponsor's protocol ID
- Pro00111885
- Acronym
- EASE
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Wellness Through Affirming Services and Education
- ClinicalTrials.gov ID
- NCT05700474
- Acronym / sponsor ID
- EASE / Pro00111885
- Conditions
- HIV, Mental Health Disorder, Substance Use
- Keywords
- HIV, Mental Health, Substance Use, PrEP, Comorbidity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Comprehensive outpatient behavioral health careThere 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) Inability to consent for services due to reduced mental or physical capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive outpatient behavioral health careAlso: EASEParticipation 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 | Behavioural | Intervention Arm |
Primary outcome
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
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
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
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
1 secondary outcome
Change in HIV-related stigma as measured by the HIV stigma scale
Time frame: Baseline to 6 month follow-up survey
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Reif, PhD, MSW principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive outpatient behavioral health care in people with HIV and Mental Health Disorder, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Reif (17042587111, susan.reif@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression symptoms measured by the PHQ-9 (time frame: Baseline to 6 month follow-up survey). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.