Motiv82Change: an HIV Prevention Study for Young Latino Men (Motiv82Change)
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ClinicalTrials.gov Identifier: NCT00877695 |
Recruitment Status
:
Completed
First Posted
: April 8, 2009
Last Update Posted
: March 4, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Behavioral: Entre Culturas: Navigating Culture, Identity, and HIV Risk | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | Young Hispanic Men "Entre Culturas": Navigating Culture, Identity and HIV Risk |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
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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.
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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:
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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:
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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.
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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:
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- 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 ]
- acceptability and feasibility of the intervention [ Time Frame: 16 months ]

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Ages Eligible for Study: | 18 Years to 29 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877695
United States, Florida | |
Nova Southeastern University (Miami Office) | |
Miami, Florida, United States, 33137 |
Principal Investigator: | M. Isabel Fernandez, PhD | Nova Southeastern University |
Responsible Party: | Nova Southeastern University |
ClinicalTrials.gov Identifier: | NCT00877695 History of Changes |
Other Study ID Numbers: |
Entre Culturas |
First Posted: | April 8, 2009 Key Record Dates |
Last Update Posted: | March 4, 2013 |
Last Verified: | February 2013 |
Keywords provided by Nova Southeastern University:
HIV HIV Seronegativity prevention Hispanic |
Latino MSM men |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |