- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00877695
Motiv82Change: an HIV Prevention Study for Young Latino Men (Motiv82Change)
March 1, 2013 updated by: Nova Southeastern University
Young Hispanic Men "Entre Culturas": Navigating Culture, Identity and HIV Risk
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33137
- Nova Southeastern University (Miami Office)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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:
|
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.
|
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:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
16 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
acceptability and feasibility of the intervention
Time Frame: 16 months
|
16 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: M. Isabel Fernandez, PhD, Nova Southeastern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
April 6, 2009
First Submitted That Met QC Criteria
April 7, 2009
First Posted (Estimate)
April 8, 2009
Study Record Updates
Last Update Posted (Estimate)
March 4, 2013
Last Update Submitted That Met QC Criteria
March 1, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Entre Culturas
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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