NCT00691561

Brief Summary

The purpose of this study to conduct a small randomized control trial to compare the relative effectiveness of a single-session of HIV testing and counseling risk reduction intervention (HCT-only) to an enhanced intervention that includes the standard HCT intervention plus a theory-based and culturally-tailored group-level intervention designed to reduce or eliminate HIV and STI risk behaviors (HCT-plus) among African-American men who have sex with men (AA-MSM).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Jun 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 days 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
1.7 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

March 11, 2010

Status Verified

March 1, 2010

Enrollment Period

1.7 years

First QC Date

June 3, 2008

Last Update Submit

March 10, 2010

Conditions

Keywords

HIV PreventionAfrican AmericanBlackgayMen who have sex menHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • The HCT-plus intervention will result in a greater proportion of men who abstain from anal and vaginal intercourse.

    3 months after completing intervention

Secondary Outcomes (1)

  • The HCT-plus intervention will result in a smaller proportion of men who had an act of anal or vaginal intercourse without the use of a condom.

    3 months after completing the intervention

Study Arms (2)

1

EXPERIMENTAL

Participants receive HIV counseling and testing and 8 intervention sessions to assist them with reducing unsafe sexual behaviors.

Behavioral: Project ABLE

2

NO INTERVENTION

Participants receive HIV counseling and testing only.

Interventions

Project ABLEBEHAVIORAL

Participants will receive HIV counseling and testing. Those selected for the intervention arm will attend small groups consisting of 10 men who meet once a week for 8 consecutive weeks. The weekly two hour discussion sessions will address HIV risk behavior within a framework of contextual influences that may moderate men's risk reduction motivation and behavior. The factors include identity, stigma, connections to community, and situation factors.

1

Eligibility Criteria

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

You may qualify if:

  • reside in Milwaukee county;
  • are at least 18 years of age;
  • self-identify as male;
  • self-identify as Black or African-American;
  • can provide informed consent;
  • report unprotected anal sex with a man in the past 3 months;
  • report at least two sexual partners with whom they have had unprotected anal or vaginal sex in the past 3 months;
  • are willing to be tested for HIV using rapid oral fluid procedures or willing to provide evidence of HIV seropositivity

You may not qualify if:

  • Under 18 years of age,
  • involvement in a HIV prevention study currently or in the past 6 months,
  • Participation in the pilot phase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diverse and Resilient

Milwaukee, Wisconsin, 53202, United States

Location

MeSH Terms

Conditions

HIV InfectionsHomosexuality

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

  • David Seal, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 5, 2008

Study Start

June 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 11, 2010

Record last verified: 2010-03

Locations