NCT00691496

Brief Summary

The purpose of this project is to test the efficacy of an HIV prevention behavioral intervention to reduce sexual risk among African-American men who have sex with men (MSM).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
326

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started May 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

Study Start

First participant enrolled

May 1, 2008

Completed
1 month until next milestone

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
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

1.4 years

First QC Date

June 3, 2008

Last Update Submit

June 12, 2012

Conditions

HIV Infections

Keywords

HIV PreventionAfrican-Americangaybisexualintervention trialHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • The primary goal of the intervention is to reduce HIV transmission or acquisition by reducing the frequency of unprotected anal intercourse among African-American MSM.

    3 months after completing intervention

Secondary Outcomes (1)

  • Encourage participants to engage in discussions to reduce sexual risk within their social network and with sexual partners.

    3 months after completing the intervention

Study Arms (2)

1

EXPERIMENTAL

Receives HIV testing and counseling and 5 week intervention

Behavioral: Behavioral intervention to reduce sexual risk among African-American men who have sex with men

2

NO INTERVENTION

Receives only HIV Testing and Counseling

Interventions

Behavioral intervention to reduce sexual risk among African-American men who have sex with menBEHAVIORAL

5 week intervention to increase skill level of participants with talking to their social networks and sexual partners about reducing high risk sexual behaviors while preparing a healthy meal

1

Eligibility Criteria

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

You may not qualify if:

  • Participated in pilot
  • Identify as transgender
  • Plan to move before end of study
  • Refuse HIV testing at baseline or identified as a newly diagnosed HIV through testing at the baseline
  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Blood Center

New York, New York, 10003, United States

Location

Related Publications (3)

  • Koblin BA, Bonner S, Powell B, Metralexis P, Egan JE, Patterson J, Xu G, Hoover DR, Goodman K, Chin J, Tieu HV, Spikes P. A randomized trial of a behavioral intervention for black MSM: the DiSH study. AIDS. 2012 Feb 20;26(4):483-8. doi: 10.1097/QAD.0b013e32834f9833.

    PMID: 22156967RESULT

  • Tieu HV, Spikes P, Patterson J, Bonner S, Egan JE, Goodman K, Stewart K, Frye V, Xu G, Hoover DR, Koblin BA. Sociodemographic and risk behavior characteristics associated with unprotected sex with women among black men who have sex with men and women in New York City. AIDS Care. 2012;24(9):1111-9. doi: 10.1080/09540121.2012.672723. Epub 2012 Apr 25.

    PMID: 22533637RESULT

  • Tieu HV, Xu G, Bonner S, Spikes P, Egan JE, Goodman K, Stewart K, Koblin BA. Sexual partner characteristics, serodiscordant/serostatus unknown unprotected anal intercourse and disclosure among human immunodeficiency virus-infected and uninfected black men who have sex with men in New York City. Sex Transm Dis. 2011 Jun;38(6):548-54. doi: 10.1097/OLQ.0b013e318203e2d7.

    PMID: 21217419RESULT

MeSH Terms

Conditions

HIV InfectionsHomosexualityBisexuality

Interventions

Menogaril

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NogalamycinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Beryl Koblin, PhD

    New York Blood Center

    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

May 1, 2008

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

US(1)