Motiv82Change: an HIV Prevention Study for Young Latino Men

NCT ID: NCT00877695

Last Updated: 2013-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-06-30

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Motive8 2 Change FtF

This arm of the motivational enhancement intervention (MEI) will be delivered face to face (FtF) using a real-time, dynamic implementation approach. The intervention consisted of 2 sessions lasting approximately 60 to 90 minutes. The sessions focused on increasing participants' awareness of the multiple influences on behaviors from self, family, culture and community and how these influences impact the way we think and behave including sexually. Through a series of exercises the participant develops strategies for understanding and managing his own triggers that helps them to make healthy life choices. Both Motiv8 2Change arms used the exact same intervention, with the exception that one was delivered face to face and the other through the internet.

Group Type: EXPERIMENTAL

Entre Culturas: Navigating Culture, Identity, and HIV Risk

Intervention Type: BEHAVIORAL

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.

Motive8 2Change -Internet

This arm of the motivational enhancement intervention (MEI) will be delivered via the Internet face to face (FtF) using a real-time, dynamic implementation approach.The intervention consisted of 2 sessions lasting approximately 60 to 90 minutes. The sessions focused on increasing participants' awareness of the multiple influences on behaviors from self, family, culture and community and how these influences impact the way we think and behave including sexually. Through a series of exercises the participant develops strategies for understanding and managing his own triggers that helps them to make healthy life choices. Both Motiv8 2Change arms used the exact same intervention, with the exception that one was delivered face to face and the other through the internet.

Group Type: EXPERIMENTAL

Entre Culturas: Navigating Culture, Identity, and HIV Risk

Intervention Type: BEHAVIORAL

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.

delayed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Motiv8 2Change Careers

Comparable in number of sessions and duration to the experimental arms, but focused on resume development and interviewing skills. This arm consisted of 2 sessions. In the first session participants reviewed different career choices and created a winning resume. The second session focused on job interviewing skills. It included role plays with feedback. It also contains ethically mandated information regarding HIV prevention. It was delivered on line by a trained facilitator.

Group Type: ACTIVE_COMPARATOR

Entre Culturas: Navigating Culture, Identity, and HIV Risk

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Young Hispanic MSM; HIV prevention interventions; Motiv8 2Change

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Southeastern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M. Isabel Fernandez, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

Nova Southeastern University (Miami Office)

Miami, Florida, United States

Countries

United States

Other Identifiers

Entre Culturas

Identifier Type: -

Identifier Source: org_study_id