Effectiveness of a Risk Reduction Program in Preventing the Transmission of HIV and Sexually Transmitted Diseases in African-American Couples

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
Emory University
Columbia University
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00644163
First received: March 24, 2008
Last updated: January 23, 2014
Last verified: February 2009
  Purpose

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.


Condition Intervention
HIV Infections
Sexually Transmitted Disease
Behavioral: Eban HIV/STD Risk Reduction Intervention
Behavioral: Eban Health Promotion Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: NIMH Multisite HIV/STD Prevention Trial for African American Couples

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Self-reported proportion of condom-protected sexual intercourse [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Occurrence of STDs (chlamydia, gonorrhea, and trichomonas) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Unprotected sex occurrence [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Number of sexual partners [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Enrollment: 1070
Study Start Date: November 2003
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Each partner agrees that the relationship has lasted at least 6 months before study entry
  • Each partner intends to remain together for at least 12 months after study entry (e.g., state independently that he/she is confident or very confident that they will remain together)
  • At least one partner of the couple reports having unprotected intercourse at least once in the 90 days before study entry
  • Neither partner has plans to relocate beyond a reasonable distance from the study site
  • At least one partner is African American
  • At least one partner agrees that he/she is not planning pregnancy within the next 18 months after study entry
  • Each partner is aware of his/her partner's HIV serostatus
  • Only one partner is HIV seropositive and has known his or her status for at least 3 months before study entry

Exclusion Criteria:

  • One or both partners do not have an address where they can receive mail
  • One or both partners have significant psychiatric, physical, or neurological impairment that would limit their effective participation as confirmed on a Mini Mental State Examination and/or Quick Test
  • History of severe physical or sexual abuse in the 1 year before study entry in the current relationship (e.g., significant enough to require medical, psychological, and/or legal intervention)
  • One or both partners are unwilling or unable to commit to participate in the study through to completion
  • Both partners have previously participated in an HIV sexual risk-reduction intervention for couples in the 12 months before study entry
  • One or both partners are not fluent in English as determined by the informed consent process
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644163

Locations
United States, California
UCLA
Los Angeles, California, United States, 90024
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, New York
Columbia University
New York, New York, United States, 10027
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
University of California, Los Angeles
Emory University
Columbia University
Investigators
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
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00644163     History of Changes
Other Study ID Numbers: U10 MH078819, U10MH078819, DAHBR 9A-ASGT
Study First Received: March 24, 2008
Last Updated: January 23, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
HIV
STI
Risk Reduction
Couples
African American
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 16, 2014