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Clinical Trials/NCT00877695
NCT00877695
Completed
N/A

Young Hispanic Men "Entre Culturas": Navigating Culture, Identity and HIV Risk

Nova Southeastern University1 site in 1 country200 target enrollmentAugust 2010
ConditionsHIV Infections

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Nova Southeastern University
Enrollment
200
Locations
1
Primary Endpoint
The main outcome measure for the Stage 1b trial will be reduction in at least one of the two main outcome variables - number of unprotected anal sex acts and number of sex partners (both in the last 3 months).
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this study is to develop and pilot test a culturally and developmentally tailored Motivational Enhancement Intervention (MEI) to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM).

Detailed Description

Stage 1, divided into Stage 1a and Stage 1b, focuses on development, refinement, and pilot testing of interventions. The formative research leading to and including intervention development is completed in Stage 1a. A pilot study to provide acceptability/feasibility data and obtain effect size estimates of the intervention's strength in changing a desired outcome is conducted in Stage 1b. If Stage 1b results are "promising," the intervention moves to full scale efficacy testing in Stage 2 using the classic experimental design of a randomized control trial (RCT). The intervention is ready for Stage 3 effectiveness testing only after its efficacy has been demonstrated in at least two Stage 2 trials.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
June 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • To be eligible, participants must:
  • self-identify as Hispanic/Latino;
  • be 18 - 29 years of age;
  • live in South Florida;
  • have had at least 1 episode of unprotected anal sex with a man in the last 6 months;
  • have had at least 2 male sex partners in the last 6 months;
  • be HIV negative or not known to be HIV positive; and
  • have not previously participated in this study.

Exclusion Criteria

  • living with HIV infection

Outcomes

Primary Outcomes

The main outcome measure for the Stage 1b trial will be reduction in at least one of the two main outcome variables - number of unprotected anal sex acts and number of sex partners (both in the last 3 months).

Time Frame: 16 months

Secondary Outcomes

  • acceptability and feasibility of the intervention(16 months)

Study Sites (1)

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