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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH093230-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risk Reduction | Experimental | The Risk Reduction group will receive the Eban II Intervention upon enrollment. This group will do the following:
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| Waitlist | Active Comparator | The Waitlist group will receive the same intervention after waiting for the Risk Reduction group to complete the entire intervention.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk Reduction | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Safe Sex | Proportion of unprotected acts of sex. | within 3 months of completion of the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alicia M Eccles, MPH | Contact | 310-794-9227 | aeccles@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gail E Wyatt, PhD | University of California, Los Angeles | Principal Investigator |
| John Williams, MD | University of California, Los Angeles | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tarzana Treatment Centers | Not yet recruiting | Long Beach | California | 90806 | United States | |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D021841 | Safe Sex |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D061366 | Numbers Needed To Treat |
| ID | Term |
|---|---|
| D018401 | Sample Size |
| D012107 | Research Design |
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| 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 |
| AIDS Project Los Angeles |
| Not yet recruiting |
| Los Angeles |
| California |
| 90005 |
| United States |
| AIDS Healthcare Foundation | Not yet recruiting | Los Angeles | California | 90015 | United States |
| O.A.S.I.S. Clinic | Not yet recruiting | Los Angeles | California | 90059 | United States |
| HIV Education & Prevention Project of Alameda County | Recruiting | Oakland | California | 94601 | United States |
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| CAL-PEP | Not yet recruiting | Oakland | California | 94608 | United States |
| Allen Temple | Not yet recruiting | Oakland | California | 94612 | United States |
| Women Organized to Respond to Life-Threatening Disease | Not yet recruiting | Oakland | California | 94612 | United States |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012725 | Sexual Behavior |
| D001519 | Behavior |