Motiv82Change: an HIV Prevention Study for Young Latino Men

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT00877695
• Lead Sponsor: Nova Southeastern University

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.

Study Timeline

• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-07
• Study First Posted: 2009-04-08
• Study Start: 2010-08
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-03-01
• Last Update Posted: 2013-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

To be eligible, participants must:

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

Exclusion Criteria

1. living with HIV infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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).	16 months

Secondary Outcome Measures

Name	Time	Method
acceptability and feasibility of the intervention	16 months

Trial Locations

Locations (1)

Nova Southeastern University (Miami Office); 🇺🇸 Miami, Florida, United States