NCT00690976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 11, 2010

Status Verified

March 1, 2010

Enrollment Period

1.7 years

First QC Date

June 3, 2008

Last Update Submit

March 10, 2010

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV risk behaviorUnprotected sexmen who have sex with mengayLatinoUnsafe Sex

Outcome Measures

Primary Outcomes (1)

  • Unprotected sex

    three months

Study Arms (2)

1.Group Intervention

EXPERIMENTAL

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

2. HCT

ACTIVE COMPARATOR

Offer of HIV counseling and testing

Behavioral: HCT

Interventions

Proyecto SOLBEHAVIORAL

Group intervention

1.Group Intervention
HCTBEHAVIORAL

Offer of HIV counseling and testing

2. HCT

Eligibility Criteria

Age18 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NOVA Southeastern University

Fort Lauderdale, Florida, 33328-2018, United States

Location

MeSH Terms

Conditions

HIV InfectionsUnsafe SexHomosexuality

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexual BehaviorBehaviorSexuality

Study Officials

  • Isa Fernandez, PhD

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 5, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 11, 2010

Record last verified: 2010-03

Locations

US(1)