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| ID | Type | Description | Link |
|---|---|---|---|
| U10MH078819 | U.S. NIH Grant/Contract | View source | |
| DAHBR 9A-ASGT |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| University of California, Los Angeles | OTHER |
| Emory University | OTHER |
| Columbia University |
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This study will evaluate the effectiveness of a risk-reduction program in preventing the transmission of HIV and sexually transmitted diseases among African-American heterosexual couples, with one partner having been previously diagnosed with an HIV infection.
The transmission of sexually transmitted diseases (STDs), including HIV, is a major public health concern, especially among minority groups in the United States. Although STDs are prevalent across all racial and ethnic groups in the United States, the rate of STD infection is disproportionately higher for African Americans than for white Americans. African Americans have higher rates of HIV, chlamydia, gonorrhea, syphilis, and herpes than white Americans. An important part of the prevention process is early education on HIV to reduce sexual-risk behavior and to promote safe sexual practices. Interventions are needed in a variety of settings to extensively address African Americans' risk of STDs, including HIV. Although most HIV/STD risk-reduction interventions are conducted at the individual level, a couple-based approach may be more effective and consistent with cultural values. This study will compare the effectiveness of the Eban HIV/STD Risk Reduction Intervention with the Eban Health Promotion Intervention in reducing the risk of STDs among African-American HIV-serodiscordant heterosexual couples.
Participation in this study will last 12 months. All participants will first undergo baseline assessments that will consist of questionnaires and biospecimen collection for STD testing. Participants will then be assigned randomly to one of two treatment groups: the Eban HIV/STD Risk Reduction Intervention group or the Eban Health Promotion Intervention group. Both groups will participate in weekly 2-hour sessions over 8 weeks. The sessions will include couple and group sessions led by trained male and female co-facilitators. The Eban HIV/STD Risk Reduction Intervention sessions will focus on the couple and will teach the couple about communication skills. The approach will draw upon social cognitive theory, an ecological framework, and HIV/STD risk-reduction research with inner-city African-American populations. The Eban Health Promotion Intervention sessions will focus on the individual and will provide factual information on health, screening, exercise, diet management, and medication adherence. Follow-up visits for all participants will occur at Months 3, 6, and 12 and will include repeat baseline assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive Eban HIV/STD Risk Reduction Intervention. |
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| 2 | Active Comparator | Participants will receive Eban Health Promotion Intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eban HIV/STD Risk Reduction Intervention | Behavioral | The eight-session Eban HIV/STD Risk Reduction Intervention is embedded in a cultural context and is gender tailored in its prevention messages and activities. Sessions will focus on the couple and will teach the couple about communication skills. The approach will draw upon social cognitive theory, an ecological framework, and HIV/STD risk-reduction research with inner-city African-American populations. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported proportion of condom-protected sexual intercourse | Measured at Month 12 | |
| Occurrence of STDs (chlamydia, gonorrhea, and trichomonas) | Measured at Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Unprotected sex occurrence | Measured at Month 12 | |
| Number of sexual partners | Measured at Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Jemmott, PhD | University of Pennsylvania | Principal Investigator |
| Nabila el-Bassel, DSW | Columbia University | Principal Investigator |
| Gail Wyatt, PhD | University of California, Los Angeles | Principal Investigator |
| Gina Wingood, ScD | Emory University | Principal Investigator |
| J. Richard Landis, PhD | University of Pennsylvania/Data Coordinating Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90024 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24950708 | Derived | Hamilton AB, Mittman BS, Williams JK, Liu HH, Eccles AM, Hutchinson CS, Wyatt GE. Community-based implementation and effectiveness in a randomized trial of a risk reduction intervention for HIV-serodiscordant couples: study protocol. Implement Sci. 2014 Jun 20;9:79. doi: 10.1186/1748-5908-9-79. | |
| 21518939 | Derived | El-Bassel N, Jemmott JB 3rd, Landis JR, Pequegnat W, Wingood GM, Wyatt GE, Bellamy SL; National Institute of Mental Health Multisite HIV/STD Prevention Trial for African-American Couples Group. Intervention to influence behaviors linked to risk of chronic diseases: a multisite randomized controlled trial with African-American HIV-serodiscordant heterosexual couples. Arch Intern Med. 2011 Apr 25;171(8):728-36. doi: 10.1001/archinternmed.2011.136. |
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| OTHER |
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| Eban Health Promotion Intervention | Behavioral | The eight-session Eban Health Promotion Intervention is guided by a social cognitive approach that engages health promotion skills. Sessions will focus on the individual and will provide factual information on health, screening, exercise, diet management, and medication adherence. |
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| Atlanta |
| Georgia |
| 30322 |
| United States |
| Columbia University | New York | New York | 10027 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| 20625011 | Derived | El-Bassel N, Jemmott JB, Landis JR, Pequegnat W, Wingood GM, Wyatt GE, Bellamy SL; NIMH Multisite HIV/STD Prevention Trial for African American Couples Group. National Institute of Mental Health Multisite Eban HIV/STD Prevention Intervention for African American HIV Serodiscordant Couples: a cluster randomized trial. Arch Intern Med. 2010 Sep 27;170(17):1594-601. doi: 10.1001/archinternmed.2010.261. Epub 2010 Jul 12. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D012749 | Sexually Transmitted Diseases |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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