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

NCT00644163 | Completed DMC

• 2 other identifiers: U10MH078819DAHBR 9A-ASGT
• Study Type: interventional
• Target: 1,070
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV Infections; Sexually Transmitted Disease

Keywords

HIV; STI; Risk Reduction; Couples; African American; HIV Seronegativity

Outcome Measures

Primary Outcomes (2)

• Self-reported proportion of condom-protected sexual intercourse

  Measured at Month 12

• Occurrence of STDs (chlamydia, gonorrhea, and trichomonas)

  Measured at Month 12

Secondary Outcomes (2)

• Unprotected sex occurrence

  Measured at Month 12

• Number of sexual partners

  Measured at Month 12

Study Arms (2)

1

EXPERIMENTAL

Participants will receive Eban HIV/STD Risk Reduction Intervention.

Behavioral: Eban HIV/STD Risk Reduction Intervention

2

ACTIVE COMPARATOR

Participants will receive Eban Health Promotion Intervention.

Behavioral: Eban Health Promotion Intervention

Interventions

Eban HIV/STD Risk Reduction Intervention BEHAVIORAL

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.

1

Eban Health Promotion Intervention BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator
• University of California, Los Angeles: collaborator
• Emory University: collaborator
• Columbia University: collaborator

Study Sites (4)

UCLA

Los Angeles, California, 90024, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Columbia University

New York, New York, 10027, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• 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.

  PMID: 24950708 DERIVED

• 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.

  PMID: 21518939 DERIVED

• 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.

  PMID: 20625011 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• John Jemmott, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Nabila el-Bassel, DSW

  Columbia University

  PRINCIPAL INVESTIGATOR

• Gail Wyatt, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Gina Wingood, ScD

  Emory University

  PRINCIPAL INVESTIGATOR

• J. Richard Landis, PhD

  University of Pennsylvania/Data Coordinating Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 26, 2008
• Study Start: November 1, 2003
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: January 27, 2014

Record last verified: 2009-02

Locations

US (4)