A Network Intervention for Reducing Sexual Risk for HIV With African American Men Who Have Sex With Men (AA MSM) - Full Text View

Sponsor:	Centers for Disease Control and Prevention
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00691041

Purpose

The purpose of the study is to examine the efficacy of a network-oriented "outreach intervention" to reduce HIV and sexually transmitted infection (STI) related risk behaviors among African American men who have sex with men (AA MSM)and their social network. The hypothesis is to determine whether the new intervention is more efficacious at reducing high risk sexual behaviors than the standard normal of care provided to the public (a single session of individual HIV counseling and testing.

Condition	Intervention
HIV Infections	Behavioral: Unity in Diversity

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment
Official Title:	A Network Intervention for Reducing Sexual Risk for HIV With African American Men Who Have Sex With Men (AA MSM)

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

To increase participants knowledge of HIV/STI risks to assist with decreasing high risk sex/drug behaviors [ Time Frame: 3 months after completing intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To increase participants' level of knowledge and skills concerning HIV/STI prevention and diffusing the information to their social network) [ Time Frame: 3 months after completing the intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	725
Study Start Date:	August 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental HIV/STI counseling and testing and a 7 session intervention to increase participants' level of knowledge and skills concerning HIV prevention (to decrease HIV acquisition or transmission) and to diffuse the information to their social network	Behavioral: Unity in Diversity HIV/STI counseling and testing and a 7 session intervention to increase participants' level of knowledge and skills concerning HIV prevention (to decrease HIV acquisition or transmission) and to diffuse the information to their social network
2: No Intervention HIV/STI counseling and testing and a single 15 minute session of resources available in the community

Detailed Description:

The intervention increases participants' personal level of knowledge and skills concerning HIV prevention and inspires participants to diffuse the information to their social network.

Eligibility

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

Criteria

Inclusion Criteria:

Identify as a black / African American male
Report sex with at least 2 people in past 3 months/ 1 being male
Willingness to take HIV test or provide documentation if HIV+
Willingness to identify and recruit friend/relative to study

Exclusion Criteria:

Under age 18
Identify as female or transgender
Not identify as Black / African American

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691041

Locations

United States, Maryland
Lighthouse
Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Carl Latkin, PhD

Johns Hopkins University -Bloomberg School of Public Health

More Information

No publications provided

Responsible Party:	Johns Hopkins University Bloomberg School of Public Health ( Carl Latkin / PhD )
Study ID Numbers:	CDC-NCHHSTP-5221
Study First Received:	June 3, 2008
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00691041 History of Changes
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by Centers for Disease Control and Prevention:

HIV Prevention
Men who have sex with men
African American
Unprotected sex
HIV Seronegativity

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010