Effectiveness of a Risk Reduction Program in Preventing the Transmission of HIV and Sexually Transmitted Diseases in African-American Couples
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00644163|
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : January 27, 2014
|Condition or disease||Intervention/treatment|
|HIV Infections Sexually Transmitted Disease||Behavioral: Eban HIV/STD Risk Reduction Intervention Behavioral: Eban Health Promotion Intervention|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1070 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||NIMH Multisite HIV/STD Prevention Trial for African American Couples|
|Study Start Date :||November 2003|
|Primary Completion Date :||June 2007|
|Study Completion Date :||June 2007|
Participants will receive Eban HIV/STD Risk Reduction Intervention.
Behavioral: Eban HIV/STD Risk Reduction Intervention
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.
Active Comparator: 2
Participants will receive Eban Health Promotion Intervention.
Behavioral: Eban Health Promotion Intervention
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.
- Self-reported proportion of condom-protected sexual intercourse [ Time Frame: Measured at Month 12 ]
- Occurrence of STDs (chlamydia, gonorrhea, and trichomonas) [ Time Frame: Measured at Month 12 ]
- Unprotected sex occurrence [ Time Frame: Measured at Month 12 ]
- Number of sexual partners [ Time Frame: Measured at Month 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644163
|United States, California|
|Los Angeles, California, United States, 90024|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, New York|
|New York, New York, United States, 10027|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||John Jemmott, PhD||University of Pennsylvania|
|Principal Investigator:||Nabila el-Bassel, DSW||Columbia University|
|Principal Investigator:||Gail Wyatt, PhD||University of California Los Angeles (UCLA)|
|Principal Investigator:||Gina Wingood, ScD||Emory University|
|Principal Investigator:||J. Richard Landis, PhD||University of Pennsylvania/Data Coordinating Center|