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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on February 27, 2015

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