Proyecto SOL: A Risk Reduction Intervention for Hispanic Men Who Have Sex With Men (MSM)
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ClinicalTrials.gov Identifier: NCT00690976 |
Recruitment Status
:
Completed
First Posted
: June 5, 2008
Last Update Posted
: March 11, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Behavioral: Proyecto SOL Behavioral: HCT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 220 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Proyecto SOL: A Risk Reduction Intervention for Hispanic MSM |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
---|---|
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
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Behavioral: HCT
Offer of HIV counseling and testing
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- Unprotected sex [ Time Frame: three months ]

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Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
Sexes Eligible for Study: | 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:
- have previously participated in any Phase of this study;
- self-identify as transgender;
- not being a resident of South Florida.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690976
United States, Florida | |
NOVA Southeastern University | |
Fort Lauderdale, Florida, United States, 33328-2018 |
Principal Investigator: | Isa Fernandez, PhD | Nova Southeastern University |
Responsible Party: | Isa fernandez, Prinicpal Investigator, Nova Southeastern University |
ClinicalTrials.gov Identifier: | NCT00690976 History of Changes |
Other Study ID Numbers: |
CDC-NCHHSTP-5123 |
First Posted: | June 5, 2008 Key Record Dates |
Last Update Posted: | March 11, 2010 |
Last Verified: | March 2010 |
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 |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |