Eban II: Intervention for HIV Sero-Discordant Couples

NCT01829282 | Unknown DMC

• 2 other identifiers: 3294930R01MH093230-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 8

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. 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. 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. 3.To determine the cost-effectiveness of implementation of Eban, based on implementation costs and potential cost savings.

Conditions

Sexually Transmitted Diseases; Disease Transmission, Infectious; Safe Sex; HIV

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safe Sex

  Proportion of unprotected acts of sex.

  within 3 months of completion of the intervention

Study Arms (2)

Risk Reduction

EXPERIMENTAL

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

Waitlist

ACTIVE COMPARATOR

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

Interventions

Risk Reduction BEHAVIORAL

Risk Reduction; Waitlist

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (8)

Tarzana Treatment Centers

Long Beach, California, 90806, United States

NOT YET RECRUITING

AIDS Project Los Angeles

Los Angeles, California, 90005, United States

NOT YET RECRUITING

AIDS Healthcare Foundation

Los Angeles, California, 90015, United States

NOT YET RECRUITING

O.A.S.I.S. Clinic

Los Angeles, California, 90059, United States

NOT YET RECRUITING

HIV Education & Prevention Project of Alameda County

Oakland, California, 94601, United States

RECRUITING

CAL-PEP

Oakland, California, 94608, United States

NOT YET RECRUITING

Allen Temple

Oakland, California, 94612, United States

NOT YET RECRUITING

Women Organized to Respond to Life-Threatening Disease

Oakland, California, 94612, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Sexually Transmitted Diseases; Communicable Diseases; Safe Sex

Interventions

Numbers Needed To Treat

Condition Hierarchy (Ancestors)

Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Sample Size; Research Design; Methods; Investigative Techniques

Study Officials

• Gail E Wyatt, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Central Study Contacts

Alicia M Eccles, MPH

CONTACT

310-794-9227; aeccles@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dept. of Psychiatry & Biobehavioral Sciences

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 11, 2013
• Study Start: July 1, 2012
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

US (8)