No Excuses/Sin Buscar Excusas Intervention to Reduce Latino Men's HIV Risks
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Video (group-delivered video-based intervention)
HCT
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, HIV risk behavior, Unprotected sex, men who have sex with men, gay, Latino, unsafe sex, high risk sex
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
Sites / Locations
- Education Development Center, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
video
HCT
Arm Description
Offer of HIV counseling and testing
Outcomes
Primary Outcome Measures
Sexual risk behavior
Secondary Outcome Measures
Full Information
NCT ID
NCT00690690
First Posted
June 3, 2008
Last Updated
March 8, 2010
Sponsor
Centers for Disease Control and Prevention
Collaborators
Education Development Center, Inc., Callen-Lorde Community Health Center, Hispanic AIDS Forum, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00690690
Brief Title
No Excuses/Sin Buscar Excusas Intervention to Reduce Latino Men's HIV Risks
Official Title
No Excuses/Sin Buscar Excusas Intervention to Reduce Latino Men's HIV Risks
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Education Development Center, Inc., Callen-Lorde Community Health Center, Hispanic AIDS Forum, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Seronegativity, HIV risk behavior, Unprotected sex, men who have sex with men, gay, Latino, unsafe sex, high risk sex
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
370 (Actual)
8. Arms, Groups, and Interventions
Arm Title
video
Arm Type
Experimental
Arm Title
HCT
Arm Type
Active Comparator
Arm Description
Offer of HIV counseling and testing
Intervention Type
Behavioral
Intervention Name(s)
Video (group-delivered video-based intervention)
Intervention Description
group-delivered video-based intervention
Intervention Type
Behavioral
Intervention Name(s)
HCT
Intervention Description
Offer of HIV counseling and testing
Primary Outcome Measure Information:
Title
Sexual risk behavior
Time Frame
past 3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia O'Donnell, PhD
Organizational Affiliation
Education Development Center, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Education Development Center, Inc.
City
New York City
State/Province
New York
ZIP/Postal Code
10014
Country
United States
12. IPD Sharing Statement
Learn more about this trial
No Excuses/Sin Buscar Excusas Intervention to Reduce Latino Men's HIV Risks
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