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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
  Purpose

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.


Condition Intervention
HIV Infections
 Behavioral: Proyecto SOL
Behavioral: HCT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Proyecto SOL: A Risk Reduction Intervention for Hispanic MSM

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Unprotected sex [ Time Frame: three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: July 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Behavioral: Proyecto SOL
Group intervention
Active Comparator: 2. HCT
Offer of HIV counseling and testing
 Behavioral: HCT
Offer of HIV counseling and testing

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690976

Locations
United States, Florida
NOVA Southeastern University
Fort Lauderdale, Florida, United States, 33328-2018
Sponsors and Collaborators
Centers for Disease Control and Prevention
Nova Southeastern University
University of Miami
DePaul University
Investigators
Principal Investigator: Isa Fernandez, PhD Nova Southeastern University
  More Information

No publications provided

Responsible Party: Isa fernandez, Prinicpal Investigator, Nova Southeastern University
ClinicalTrials.gov Identifier: NCT00690976     History of Changes
Other Study ID Numbers: CDC-NCHHSTP-5123
Study First Received: June 3, 2008
Last Updated: March 10, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Centers for Disease Control and Prevention:
HIV Seronegativity
HIV risk behavior
Unprotected sex
men who have sex with men
 gay
Latino
Unsafe Sex

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013