Eban II: Intervention for HIV Sero-Discordant Couples

Recruiting at 7 trial locations

Overseen by Gail E Wyatt, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, Los Angeles

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study focuses on the implementation of an evidence-based HIV risk reduction intervention for HIV-serodiscordant, heterosexual African American couples ("Eban II") in two geographic areas (Northern and Southern California - roughly, Alameda and Los Angeles Counties) that have a high prevalence of HIV infection and risk conditions among African Americans. The Specific Aims are as follows: 1. To evaluate implementation of Eban for HIV serodiscordant African American couples in 10 CBOs in California. To do this, we will document the implementation process and identify barriers and facilitators to Eban's adoption and use by the CBOs. We will interview 200 staff at CBOs to obtain this information. 2. To evaluate the effect of Eban on behavioral and biological outcomes among 180 couples, specifically incidents of protected sex, proportion of condom use, and incident sexually transmitted infections. Eban will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and 3-month follow-up (i.e., at these 10 CBOs, Eban will be conducted and offered to couples and evaluated for effectiveness - that is, how well it works in the real world.) 3. To determine the cost-effectiveness of implementation of Eban, based on implementation costs and potential cost savings.

Research Team

Alison Hamilton, PhD

Principal Investigator

University of California, Los Angeles

John Williams, MD

Principal Investigator

University of California, Los Angeles

Hector Myers, PhD

Principal Investigator

University of California, Los Angeles

Gail E Wyatt, PhD

Principal Investigator

University of California, Los Angeles

Brian Mittman, PhD

Principal Investigator

VA Office of Research and Development

Eligibility Criteria

Inclusion Criteria

Must be in a relationship with study partner for at least 3 months

Both partners must be 18 years or older

At least one partner must identify as African American/Black

Treatment Details

Interventions

• Risk Reduction (Behavioral Intervention)

Participant Groups

Group I: Risk Reduction Experimental Treatment 1 Intervention

The Risk Reduction group will receive the Eban II Intervention upon enrollment. This group will do the following: * Provide HIV and STI test results * First Interview * Attend 8 sessions - 1 session per week * Second interview occurs immediately following the 8th session with HIV and STI tests * Third interview occurs 3 months after the 8th session with HIV and STI tests

Group II: Waitlist Active Control 1 Intervention

The Waitlist group will receive the same intervention after waiting for the Risk Reduction group to complete the entire intervention. * Provide HIV and STI test results * First Interview * No sessions for 8 weeks * Second interview and proof of HIV and STI status occurs after the 8 weeks from when you were enrolled * Third interview occurs 3 months after the 8th session with HIV and STI tests The Waitlist Group will then be invited to participate in the Risk Reduction group activities. * Attend 8 sessions - 1 session per week * Fourth interview occurs immediately after the 8th session with HIV and STI tests * Fifth interview occurs 3 months after the 8th session with HIV and STI tests

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD