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临床试验/NCT01829282
NCT01829282Unknown不适用

Implementing Eban II: An Evidence-Based Intervention for HIV Sero-Discordant Couples

University of California, Los Angeles16 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
16
主要终点
Safe Sex

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Safe Sex

时间窗: within 3 months of completion of the intervention

Proportion of unprotected acts of sex.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gail Wyatt

Professor, Dept. of Psychiatry & Biobehavioral Sciences

University of California, Los Angeles

研究点 (16)

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