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Proyecto SOL: A Risk Reduction Intervention for Hispanic Men Who Have Sex With Men (MSM)

This study has been completed.
Sponsor:
Collaborators:
Nova Southeastern University
University of Miami
DePaul University
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00690976
First received: June 3, 2008
Last updated: March 10, 2010
Last verified: March 2010
History of Changes

June 3, 2008
March 10, 2010
July 2008
March 2010   (final data collection date for primary outcome measure)
Unprotected sex [ Time Frame: three months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00690976 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Proyecto SOL: A Risk Reduction Intervention for Hispanic Men Who Have Sex With Men (MSM)
Proyecto SOL: A Risk Reduction Intervention for Hispanic MSM

The purpose of this project is to determine the acceptability, feasibility, and the preliminary efficacy of an HIV prevention behavioral intervention (Proyecto SOL) to reduce behaviors associated with HIV acquisition among Hispanic men who have sex with men (HMSM). The primary goal of the intervention is to motivate and assist participants in forming and carrying out a "Safer Options for Life" plan, thereby reducing their risk of HIV acquisition or transmission.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Behavioral: Proyecto SOL
    Group intervention
  • Behavioral: HCT
    Offer of HIV counseling and testing
  • Experimental: 1.Group Intervention
    A group-based intervention consisting of 4 sessions lasting approximately 90 minutes each. Using a variety of pedagogical and interactive approaches, facilitators will introduce new concepts and skills.
    Intervention: Behavioral: Proyecto SOL
  • Active Comparator: 2. HCT
    Offer of HIV counseling and testing
    Intervention: Behavioral: HCT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • self-identify as Hispanic or Latino;
  • be between 18 and 49 years of age;
  • be a resident of South Florida (Miami-Dade, Broward or Palm Beach counties) and not planning to move out of the area for the next 9 months;
  • self-identify as male;
  • have had at least one episode of unprotected anal sex with a man in the preceding 3 months;
  • have had 2 or more male sex partners in the preceding 3 months;
  • be HIV negative or of unknown serostatus;
  • speak English and/or Spanish;
  • provide informed consent.

Exclusion Criteria:

  • have previously participated in any Phase of this study;
  • self-identify as transgender;
  • not being a resident of South Florida.
Male
18 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00690976
CDC-NCHHSTP-5123
No
Isa fernandez, Prinicpal Investigator, Nova Southeastern University
Centers for Disease Control and Prevention
  • Nova Southeastern University
  • University of Miami
  • DePaul University
Principal Investigator: Isa Fernandez, PhD Nova Southeastern University
Centers for Disease Control and Prevention
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP