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Behavioral Health Care for Mental Health Disorders and HIV/AIDS (EASE Trial)

N/A

Recruiting

Led By Susan Reif, PhD, MSW

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 month follow-up survey

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the impact of tailored behavioral health treatment on the health outcomes of LGBTQ+ and/or HIV-positive individuals. Participants will get treatment and complete surveys to measure changes.

Who is the study for?

This trial is for adults over 18 living with HIV or identifying as LGBTQ+ who have used alcohol or substances in the last 90 days and reside in Mecklenburg County or nearby. It's not suitable for those unable to consent due to mental or physical limitations.

What is being tested?

The study tests a comprehensive behavioral health care program tailored for LGBTQ+ individuals and/or those living with HIV. It aims to improve mental health, substance use outcomes, and social support through personalized treatment over six months.

What are the potential side effects?

Since this is a behavioral health intervention involving counseling and education rather than medication, typical medical side effects are not expected. However, participants may experience emotional discomfort during therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 month follow-up survey

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 month follow-up survey

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 month follow-up survey for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in alcohol use as measured by alcohol use frequency questions

Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS) (Anxiety subsection)

Change in depression symptoms measured by the PHQ-9

+1 more

Secondary study objectives

Change in HIV-related stigma as measured by the HIV stigma scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention ArmExperimental Treatment1 Intervention

There is one arm of the study and this involves participating in holistic behavioral health treatment for people living with HIV and the LGBTQ+ community for a 6 month period. Specific services include individual and group therapy, case management, peer support, and behavioral health education and awareness

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