Motiv82Change: an HIV Prevention Study for Young Latino Men

HIV Infections Clinical Trial

— Motiv82Change  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877695
• Other study ID #: Entre Culturas
• Status: Completed
• Phase: N/A
• First received: April 6, 2009
• Last updated: March 1, 2013
• Start date: August 2010
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Entre Culturas: Navigating Culture, Identity, and HIV Risk
A pilot test of a culturally and developmentally tailored MEI to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM) to be delivered face-to-face (FtF) and through the Internet using a real-time implementation approach. A tailored MEI for two delivery modalities, and a health education control (HEALTH) comparable in time and number of sessions. We will test the MEI's acceptability and feasibility, obtain effect size estimates of the intervention's strength to reduce risky sex, and determine if it is ready for efficacy testing.

Locations

Country	Name	City	State
United States	Nova Southeastern University (Miami Office)	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	acceptability and feasibility of the intervention		16 months	No