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

Primary Purpose

HIV Infections, Sexually Transmitted Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eban HIV/STD Risk Reduction Intervention
Eban Health Promotion Intervention
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, STI, Risk Reduction, Couples, African American, HIV Seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA
  • Emory University
  • Columbia University
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive Eban HIV/STD Risk Reduction Intervention.

Participants will receive Eban Health Promotion Intervention.

Outcomes

Primary Outcome Measures

Self-reported proportion of condom-protected sexual intercourse
Occurrence of STDs (chlamydia, gonorrhea, and trichomonas)

Secondary Outcome Measures

Unprotected sex occurrence
Number of sexual partners

Full Information

First Posted
March 24, 2008
Last Updated
January 23, 2014
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH), University of California, Los Angeles, Emory University, Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT00644163
Brief Title
Effectiveness of a Risk Reduction Program in Preventing the Transmission of HIV and Sexually Transmitted Diseases in African-American Couples
Official Title
NIMH Multisite HIV/STD Prevention Trial for African American Couples
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH), University of California, Los Angeles, Emory University, Columbia University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Disease
Keywords
HIV, STI, Risk Reduction, Couples, African American, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
1070 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive Eban HIV/STD Risk Reduction Intervention.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive Eban Health Promotion Intervention.
Intervention Type
Behavioral
Intervention Name(s)
Eban HIV/STD Risk Reduction Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Eban Health Promotion Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported proportion of condom-protected sexual intercourse
Time Frame
Measured at Month 12
Title
Occurrence of STDs (chlamydia, gonorrhea, and trichomonas)
Time Frame
Measured at Month 12
Secondary Outcome Measure Information:
Title
Unprotected sex occurrence
Time Frame
Measured at Month 12
Title
Number of sexual partners
Time Frame
Measured at Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Jemmott, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nabila el-Bassel, DSW
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gail Wyatt, PhD
Organizational Affiliation
University of California Los Angeles (UCLA)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gina Wingood, ScD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Richard Landis, PhD
Organizational Affiliation
University of Pennsylvania/Data Coordinating Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24950708
Citation
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.
Results Reference
derived
PubMed Identifier
21518939
Citation
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.
Results Reference
derived
PubMed Identifier
20625011
Citation
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.
Results Reference
derived

Learn more about this trial

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

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