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

HIV Infections Clinical Trial

Official title:

NIMH Multisite HIV/STD Prevention Trial for African American Couples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644163
• Other study ID #: U10MH078819
• Secondary ID: U10MH078819DAHBR
• Status: Completed
• Phase: N/A
• First received: March 24, 2008
• Last updated: January 23, 2014
• Start date: November 2003
• Est. completion date: June 2007

Study information

• Verified date: February 2009
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1070
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Sexually Transmitted Disease
• Sexually Transmitted Diseases

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.
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	UCLA	Los Angeles	California
United States	Columbia University	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Pennsylvania	Columbia University, Emory University, National Institute of Mental Health (NIMH), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported proportion of condom-protected sexual intercourse		Measured at Month 12	No
Primary	Occurrence of STDs (chlamydia, gonorrhea, and trichomonas)		Measured at Month 12	No
Secondary	Unprotected sex occurrence		Measured at Month 12	No
Secondary	Number of sexual partners		Measured at Month 12	No