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

NCT ID: NCT00690976

Last Updated: 2010-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Proyecto SOL

Intervention Type BEHAVIORAL

Group intervention

2. HCT

Offer of HIV counseling and testing

Group Type ACTIVE_COMPARATOR

HCT

Intervention Type BEHAVIORAL

Offer of HIV counseling and testing

Interventions

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Proyecto SOL

Group intervention

Intervention Type BEHAVIORAL

HCT

Offer of HIV counseling and testing

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nova Southeastern University

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role collaborator

DePaul University

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Responsible Party

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Nova Southeastern University

Principal Investigators

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Isa Fernandez, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

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NOVA Southeastern University

Fort Lauderdale, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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CDC-NCHHSTP-5123

Identifier Type: -

Identifier Source: org_study_id

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