NCT00690690

Brief Summary

The overall goal of this study is to develop and evaluate a brief, video-based, group-level intervention designed to reduce sexual risk taking among culturally diverse English- and Spanish-speaking Latino 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
370

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2 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

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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
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

March 9, 2010

Status Verified

March 1, 2010

Enrollment Period

1.4 years

First QC Date

June 3, 2008

Last Update Submit

March 8, 2010

Conditions

Keywords

HIV SeronegativityHIV risk behaviorUnprotected sexmen who have sex with mengayLatinounsafe sexhigh risk sex

Outcome Measures

Primary Outcomes (1)

  • Sexual risk behavior

    past 3 months

Study Arms (2)

video

EXPERIMENTAL
Behavioral: Video (group-delivered video-based intervention)

HCT

ACTIVE COMPARATOR

Offer of HIV counseling and testing

Behavioral: HCT

Interventions

group-delivered video-based intervention

video
HCTBEHAVIORAL

Offer of HIV counseling and testing

HCT

Eligibility Criteria

Age18 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be between the ages of 18 - 49
  • Self-identify as Latino or Hispanic
  • Speak English and/or Spanish
  • Reside in NYC and not plan to move in the next 3 months
  • Have had 2 or more sex partners in the last 3 months
  • Have had at least 1 male sex partner in the last 3 months
  • Have engaged in unprotected anal intercourse with at least one male partner in the last 3 months
  • Be HIV negative or not know their status

You may not qualify if:

  • Participated in a program (research or non-research) during the past 6 months where they have received HIV prevention education (e.g. an in-person or online group session, workshop, support group).
  • Report being HIV-positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Education Development Center, Inc.

New York, New York, 10014, United States

Location

MeSH Terms

Conditions

HIV InfectionsUnsafe SexHomosexuality

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Lydia O'Donnell, PhD

    Education Development Center, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 5, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

March 9, 2010

Record last verified: 2010-03

Locations