No Excuses/Sin Buscar Excusas Intervention to Reduce Lati... | NCT00690690

Studies
No Excuses/Sin Buscar Excusas Intervention to Reduce Latino Men's HIV Risks

NCT00690690

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Mar 9, 2010Estimated

Enrollment

370Actual

Phase

Phase 2Phase 3

Conditions

HIV Infections

Interventions

Video (group-delivered video-based intervention)
HCT

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Jun 3, 2008

First Submission Date that Met QC Criteria

Jun 4, 2008

First Posted Date

Jun 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2010

Last Update Posted Date

Mar 9, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Centers for Disease Control and PreventionFED

Collaborators

Name	Class
Education Development Center, Inc.	INDUSTRY
Callen-Lorde Community Health Center	OTHER
Hispanic AIDS Forum, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

370Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
video	Experimental		Behavioral: Video (group-delivered video-based intervention)
HCT	Active Comparator	Offer of HIV counseling and testing	Behavioral: HCT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Video (group-delivered video-based intervention)	Behavioral	group-delivered video-based intervention	video

Measure	Description	Time Frame
Sexual risk behavior		past 3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lydia O'Donnell, PhD	Education Development Center, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Education Development Center, Inc.		New York	New York	10014	United States

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D047568	Unsafe Sex
D006716	Homosexuality

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014743	Videotape Recording

Ancestor Terms

ID	Term
D013637	Tape Recording
D001296	Audiovisual Aids
D018961	Educational Technology
D013672	Technology

Browse Leaves

Not provided

Browse Branches

Not provided