search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proyecto SOL
HCT
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Eligibility Criteria

18 Years - 49 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • NOVA Southeastern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1.Group Intervention

2. HCT

Arm Description

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.

Offer of HIV counseling and testing

Outcomes

Primary Outcome Measures

Unprotected sex

Secondary Outcome Measures

Full Information

First Posted
June 3, 2008
Last Updated
March 10, 2010
Sponsor
Centers for Disease Control and Prevention
Collaborators
Nova Southeastern University, University of Miami, DePaul University
search

1. Study Identification

Unique Protocol Identification Number
NCT00690976
Brief Title
Proyecto SOL: A Risk Reduction Intervention for Hispanic Men Who Have Sex With Men (MSM)
Official Title
Proyecto SOL: A Risk Reduction Intervention for Hispanic MSM
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Nova Southeastern University, University of Miami, DePaul University

4. Oversight

Data Monitoring Committee
No

5. 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.

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1.Group Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
2. HCT
Arm Type
Active Comparator
Arm Description
Offer of HIV counseling and testing
Intervention Type
Behavioral
Intervention Name(s)
Proyecto SOL
Intervention Description
Group intervention
Intervention Type
Behavioral
Intervention Name(s)
HCT
Intervention Description
Offer of HIV counseling and testing
Primary Outcome Measure Information:
Title
Unprotected sex
Time Frame
three 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isa Fernandez, PhD
Organizational Affiliation
Nova Southeastern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NOVA Southeastern University
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33328-2018
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs