NCT00218699

Brief Summary

This study will evaluate the effectiveness of a single specialized pre-test counseling session in reducing HIV infection risk behavior in men who are not HIV infected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Aug 2002

Typical duration for not_applicable hiv-infections

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

August 1, 2002

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

August 5, 2013

Status Verified

August 1, 2013

Enrollment Period

3.1 years

First QC Date

September 16, 2005

Last Update Submit

August 2, 2013

Conditions

HIV Infections

Keywords

HIVMSM Men Who Have Sex with MenMen Who Have Sex With MenCognitive-BehavioralHIV Counseling and TestingHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Reduction in HIV infection risk behavior; measured at Months 6 and 12

    6 and 12 months

Interventions

Cognitive-Behavioral InterventionBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • History of two or more HIV antibody tests prior to study entry
  • History of at least one episode of unprotected anal intercourse (receptive or insertive) within 12 months prior to study entry

You may not qualify if:

  • History of injection drug use within 12 months of study enrollment
  • Insufficient proficiency in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF AIDS Health Project

San Francisco, California, 94102, 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

  • James W. Dilley, MD

    UCSF AIDS Health Project

    PRINCIPAL INVESTIGATOR

  • William J. Woods, PhD

    UCSF Center for AIDS Prevention Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

August 1, 2002

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

August 5, 2013

Record last verified: 2013-08

Locations

US(1)