Recruiting

Eban II

Sponsor:

UCLA

Code:

NCT01829282

Conditions

Sexually Transmitted Diseases

Disease Transmission, Infectious

Safe Sex

HIV

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Risk Reduction

Study Details

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.

Conditions

Sexually Transmitted Diseases

Disease Transmission, Infectious

Safe Sex

HIV

Study ID

NCT01829282

Start date

Jul, 2012

Status verified date

Feb, 2016

Completion date

Jun, 2017

Anticipated

Primary completion date

Apr, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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

Interventions

Risk Reduction

Primary outcome measure

  • Safe Sex [ Time Frame: within 3 months of completion of the intervention ]

Central Contacts and Locations

Central contacts

Alicia M Eccles, MPH

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

Locations

HIV Education & Prevention Project of Alameda County

Recruiting

Oakland, California, United States, 94601

Contacts

Melissa Struzzo, MPH

mstruzzo@casasegura.org

More Information

Sponsor

University of California, Los Angeles

Last update posted

Feb 10, 2016

Last verified

Feb, 2016

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2016-02-10.