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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00690976
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : March 11, 2010
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
HIV Infections Behavioral: Proyecto SOL Behavioral: HCT

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Proyecto SOL: A Risk Reduction Intervention for Hispanic MSM
Study Start Date : July 2008
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Unprotected sex [ Time Frame: three months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690976

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
Principal Investigator: Isa Fernandez, PhD Nova Southeastern University
More Information

Responsible Party: Isa fernandez, Prinicpal Investigator, Nova Southeastern University
ClinicalTrials.gov Identifier: NCT00690976     History of Changes
Other Study ID Numbers: CDC-NCHHSTP-5123
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: March 11, 2010
Last Verified: March 2010

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

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