Status:
COMPLETED
Effectiveness of a Risk Reduction Program in Preventing the Transmission of HIV and Sexually Transmitted Diseases in African-American Couples
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
University of California, Los Angeles
Conditions:
HIV Infections
Sexually Transmitted Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 par...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
1070 Patients enrolled
Trial Details
Trial ID
NCT00644163
Start Date
November 1 2003
End Date
June 1 2007
Last Update
January 27 2014
Active Locations (4)
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1
UCLA
Los Angeles, California, United States, 90024
2
Emory University
Atlanta, Georgia, United States, 30322
3
Columbia University
New York, New York, United States, 10027
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104