Eban II: Intervention for HIV Sero-Discordant Couples

NCT01829282 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2016-02-10

No results posted yet for this study

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

Interventions

BEHAVIORAL

Risk Reduction

Sponsors & Collaborators

Principal Investigators

  • Gail E Wyatt, PhD · University of California, Los Angeles

  • John Williams, MD · University of California, Los Angeles

  • Brian Mittman, PhD · VA Office of Research and Development

  • Alison Hamilton, PhD · University of California, Los Angeles

  • Hector Myers, PhD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2017-04-30
Completion
2017-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01829282 on ClinicalTrials.gov