NCT00691041

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

1.6 years

First QC Date

June 3, 2008

Last Update Submit

June 12, 2012

Conditions

Keywords

HIV PreventionMen who have sex with menAfrican AmericanUnprotected sexHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • To increase participants knowledge of HIV/STI risks to assist with decreasing high risk sex/drug behaviors

    3 months after completing intervention

Secondary Outcomes (1)

  • To increase participants' level of knowledge and skills concerning HIV/STI prevention and diffusing the information to their social network)

    3 months after completing the intervention

Study Arms (2)

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

2

NO INTERVENTION

HIV/STI counseling and testing and a single 15 minute session of resources available in the community

Interventions

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

1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lighthouse

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

  • Tobin KE, German D, Spikes P, Patterson J, Latkin C. A comparison of the social and sexual networks of crack-using and non-crack using African American men who have sex with men. J Urban Health. 2011 Dec;88(6):1052-62. doi: 10.1007/s11524-011-9611-4.

  • Latkin C, Yang C, Tobin K, Penniman T, Patterson J, Spikes P. Differences in the social networks of African American men who have sex with men only and those who have sex with men and women. Am J Public Health. 2011 Oct;101(10):e18-23. doi: 10.2105/AJPH.2011.300281. Epub 2011 Aug 18.

  • Latkin C, Yang C, Tobin K, Roebuck G, Spikes P, Patterson J. Social network predictors of disclosure of MSM behavior and HIV-positive serostatus among African American MSM in Baltimore, Maryland. AIDS Behav. 2012 Apr;16(3):535-42. doi: 10.1007/s10461-011-0014-z.

MeSH Terms

Conditions

HIV InfectionsHomosexualityUnsafe Sex

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexualitySexual BehaviorBehavior

Study Officials

  • Carl Latkin, PhD

    Johns Hopkins University -Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 5, 2008

Study Start

August 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations