NCT00877695

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 4, 2013

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

April 6, 2009

Last Update Submit

March 1, 2013

Conditions

Keywords

HIVHIV SeronegativitypreventionHispanicLatinoMSMmen

Outcome Measures

Primary Outcomes (1)

  • 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).

    16 months

Secondary Outcomes (1)

  • acceptability and feasibility of the intervention

    16 months

Study Arms (4)

Motive8 2 Change FtF

EXPERIMENTAL

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

Motive8 2Change -Internet

EXPERIMENTAL

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

delayed

NO INTERVENTION

Motiv8 2Change Careers

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Young Hispanic MSM, HIV prevention interventions, Motiv8 2Change
Motiv8 2Change CareersMotive8 2 Change FtFMotive8 2Change -Internet

Eligibility Criteria

Age18 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \. living with HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Southeastern University (Miami Office)

Miami, Florida, 33137, United States

Location

MeSH Terms

Conditions

HIV InfectionsMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • M. Isabel Fernandez, PhD

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 8, 2009

Study Start

August 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 4, 2013

Record last verified: 2013-02

Locations