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Motiv82Change: an HIV Prevention Study for Young Latino Men (Motiv82Change)

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Entre Culturas: Navigating Culture, Identity, and HIV Risk
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, HIV Seronegativity, prevention, Hispanic, Latino, MSM, men

Eligibility Criteria

18 Years - 29 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Nova Southeastern University (Miami Office)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

Active Comparator

Arm Label

Motive8 2 Change FtF

Motive8 2Change -Internet

delayed

Motiv8 2Change Careers

Arm Description

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.

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.

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.

Outcomes

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).

Secondary Outcome Measures

acceptability and feasibility of the intervention

Full Information

First Posted
April 6, 2009
Last Updated
March 1, 2013
Sponsor
Nova Southeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT00877695
Brief Title
Motiv82Change: an HIV Prevention Study for Young Latino Men
Acronym
Motiv82Change
Official Title
Young Hispanic Men "Entre Culturas": Navigating Culture, Identity and HIV Risk
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Southeastern University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, HIV Seronegativity, prevention, Hispanic, Latino, MSM, men

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motive8 2 Change FtF
Arm Type
Experimental
Arm Description
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.
Arm Title
Motive8 2Change -Internet
Arm Type
Experimental
Arm Description
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.
Arm Title
delayed
Arm Type
No Intervention
Arm Title
Motiv8 2Change Careers
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Entre Culturas: Navigating Culture, Identity, and HIV Risk
Other Intervention Name(s)
Young Hispanic MSM, HIV prevention interventions, Motiv8 2Change
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
acceptability and feasibility of the intervention
Time Frame
16 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Isabel Fernandez, PhD
Organizational Affiliation
Nova Southeastern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Southeastern University (Miami Office)
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States

12. IPD Sharing Statement

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Motiv82Change: an HIV Prevention Study for Young Latino Men

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