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CompletedNCT00690976Updated Mar 11, 2010

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

An interventional study of Proyecto SOL and HCT in HIV Infections, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in United States. Open to male participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-11.

Sponsored by Centers for Disease Control and Prevention · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • HIV Seronegativity
  • HIV risk behavior
  • Unprotected sex
  • men who have sex with men
  • gay
  • Latino
  • Unsafe Sex
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 220 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

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Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
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

Exclusion Criteria:

  • have previously participated in any Phase of this study;
  • self-identify as transgender;
  • not being a resident of South Florida.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • 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

  • Active comparator
    2. HCT

    Offer of HIV counseling and testing

    Behavioral: HCT

Interventions

  • BehavioralProyecto SOL

    Group intervention

  • BehavioralHCT

    Offer of HIV counseling and testing

06

What researchers measure

Primary outcomes

  1. Unprotected sex

    Time frame: three months

07

Study locations

1 site
  • NOVA Southeastern University
    Fort Lauderdale, Florida 33328-2018, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00690976
Lead sponsor
Centers for Disease Control and Prevention
Collaborators
Nova Southeastern University, University of Miami, DePaul University
First posted
Jun 5, 2008
Start date
Jul 2008
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Mar 11, 2010

Study contacts

Isa Fernandez, PhD
principal investigator · Nova Southeastern University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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