Motiv82Change: an HIV Prevention Study for Young Latino Men - Full Text View

Purpose

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).

Condition	Intervention
HIV Infections	Behavioral: Entre Culturas: Navigating Culture, Identity, and HIV Risk


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	Young Hispanic Men "Entre Culturas": Navigating Culture, Identity and HIV Risk

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Nova Southeastern University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

acceptability and feasibility of the intervention [ Time Frame: 16 months ] [ Designated as safety issue: No ]


Enrollment:	200
Study Start Date:	August 2010
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	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. Other Names: Young Hispanic MSM HIV prevention interventions Motiv8 2Change
Experimental: 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.	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. Other Names: Young Hispanic MSM HIV prevention interventions Motiv8 2Change
No Intervention: delayed
Active Comparator: 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.	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. Other Names: Young Hispanic MSM HIV prevention interventions Motiv8 2Change

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.

Eligibility


Ages Eligible for Study:	18 Years to 29 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

To be eligible, participants must:

be male;
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:

1. living with HIV infection

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877695

Locations


United States, Florida
Nova Southeastern University (Miami Office)
Miami, Florida, United States, 33137

Sponsors and Collaborators

Nova Southeastern University

Investigators


Principal Investigator:	M. Isabel Fernandez, PhD	Nova Southeastern University

More Information

No publications provided


Responsible Party:	Nova Southeastern University
ClinicalTrials.gov Identifier:	NCT00877695 History of Changes
Other Study ID Numbers:	Entre Culturas
Study First Received:	April 6, 2009
Last Updated:	March 1, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Nova Southeastern University:


HIV HIV Seronegativity prevention Hispanic	Latino MSM men

Additional relevant MeSH terms:


Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections	Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases

ClinicalTrials.gov processed this record on February 25, 2015