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

HIV Infections Clinical Trial

Official title:

Proyecto SOL: A Risk Reduction Intervention for Hispanic MSM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690976
• Other study ID #: CDC-NCHHSTP-5123
• Status: Completed
• Phase: N/A
• First received: June 3, 2008
• Last updated: March 10, 2010
• Start date: July 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Proyecto SOL
Group intervention
• HCT
Offer of HIV counseling and testing

Locations

Country	Name	City	State
United States	NOVA Southeastern University	Fort Lauderdale	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	DePaul University, Nova Southeastern University, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unprotected sex		three months	No