Eban II: Intervention for HIV Sero-Discordant Couples

• ClinicalTrials.gov Identifier: NCT01829282
• Recruitment Status: Unknown
• First Posted: April 11, 2013
• Last Update Posted: February 10, 2016
• Sponsor: University of California, Los Angeles
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Gail Wyatt, University of California, Los Angeles

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Sexually Transmitted Diseases; Disease Transmission, Infectious; Safe Sex; HIV	Behavioral: Risk Reduction	Not Applicable

Detailed Description:

The HIV/AIDS epidemic continues to disproportionately affect African Americans. The rate of HIV among African American men is six times the rate for White men and the rate among African American women is almost 15 times the rate for White women. An estimated 56,300 new HIV cases was reported in 2006, of which 49% were among African Americans and 80% were from heterosexual transmission. Sexually transmitted infections (STIs) also disproportionately affect African Americans, further increasing the risk for HIV transmission. Despite the fact that HIV and STIs are primarily transmitted in the context of relationships, few interventions address HIV risk in couples. Furthermore, few evidence-based HIV prevention interventions have been implemented in community-based organizations (CBOs). Thus, there is a substantial need to strengthen the availability and use of relationship oriented prevention interventions in community-based treatment settings.

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.

This study builds upon the multi-site, NIMH-funded "Eban" (a Yoruba term for "fence") trial, which tested this culturally congruent intervention versus a control condition among 535 heterosexual HIV serodiscordant couples in four cities. Couples in the intervention had significantly reduced incidents of unprotected sex and an increased proportion of condom use compared to couples in the control condition. Statistical projections from that study suggest that if Eban participants had not received the intervention, six female and four males would have been infected in one year, and 25 females and 15 males would have become HIV-infected in the next 5 years. Based on these successful outcomes in a controlled trial, it is now appropriate to test the effectiveness of the intervention as delivered in community-based setting. Thus, we propose to conduct a study of implementation - a study of methods to promote the uptake of Eban into community-based organizations (CBOs).

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.

So please note, there are essentially two levels to this study -- first to see how well community agencies can implement or take up and execute the intervention (thus, the interviews with staff) - and the second, to see how effective Eban is in real world setting. We know it was highly effective in a controlled study but now we need to test how well it works in the "real" world(thus, the testing of the intervention with 180 couples). While doing this, we will also be examining the cost-effectiveness of the intervention in the "real" world setting.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Implementing Eban II: An Evidence-Based Intervention for HIV Sero-Discordant Couples
• Study Start Date: July 2012
• Estimated Primary Completion Date: April 2017
• Estimated Study Completion Date: June 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Risk Reduction; 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	Behavioral: Risk Reduction
Active Comparator: Waitlist; 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	Behavioral: Risk Reduction

Outcome Measures

Primary Outcome Measures :

1. Safe Sex [ Time Frame: within 3 months of completion of the intervention ]
   Proportion of unprotected acts of sex.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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
• One partner must be HIV positive and one partner must be HIV negative
• Must be a heterosexual couple (one biological female and one biological man)
• Not currently expecting a child and not planning on having children within the year.

Exclusion Criteria:

• Less than 18 years old
• No partner
• Couple is not heterosexual
• Insufficient relationship length/commitment
• No reported incidents of unprotected intercourse in the past 90 days
• Neither partner is African American/Black
• One/both partners unaware of others HIV status
• Couple is not serodiscordant
• One/both partners reported partner violence
• HIV diagnosis received recently (less than 3 months)
• One/both partners participated in a HIV Risk Reduction study within the past 12 months

Contacts and Locations

Contacts

Contact: Alicia M Eccles, MPH; 310-794-9227; aeccles@mednet.ucla.edu

Locations

United States, California

Tarzana Treatment Centers; Not yet recruiting

Long Beach, California, United States, 90806

AIDS Project Los Angeles; Not yet recruiting

Los Angeles, California, United States, 90005

AIDS Healthcare Foundation; Not yet recruiting

Los Angeles, California, United States, 90015

O.A.S.I.S. Clinic; Not yet recruiting

Los Angeles, California, United States, 90059

HIV Education & Prevention Project of Alameda County; Recruiting

Oakland, California, United States, 94601

Contact: Melissa Struzzo, MPH mstruzzo@casasegura.org

CAL-PEP; Not yet recruiting

Oakland, California, United States, 94608

Allen Temple; Not yet recruiting

Oakland, California, United States, 94612

Women Organized to Respond to Life-Threatening Disease; Not yet recruiting

Oakland, California, United States, 94612

Sponsors and Collaborators

University of California, Los Angeles

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Gail E Wyatt, PhD; University of California, Los Angeles
• Study Director: John Williams, MD; University of California, Los Angeles
• Study Director: Brian Mittman, PhD; VA Office of Research and Development
• Study Director: Alison Hamilton, PhD; University of California, Los Angeles
• Study Director: Hector Myers, PhD; University of California, Los Angeles

More Information

• Responsible Party: Gail Wyatt, Professor, Dept. of Psychiatry & Biobehavioral Sciences, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT01829282
• Other Study ID Numbers: 3294930; R01MH093230-01 ( U.S. NIH Grant/Contract )
• First Posted: April 11, 2013
• Last Update Posted: February 10, 2016
• Last Verified: February 2016

Keywords provided by Gail Wyatt, University of California, Los Angeles:

Implementation; HIV; serodiscordant couples; African American; Cultural congruency

Additional relevant MeSH terms:

Sexually Transmitted Diseases; Communicable Diseases; Infections; Disease Attributes; Pathologic Processes; Genital Diseases; Urogenital Diseases