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Lay Health Advisors for Sexually Transmitted Disease Prevention

Primary Purpose

Syphilis, Gonorrhea, Chlamydia Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HoMBReS: A lay health advisor approach to STD prevention
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Syphilis focused on measuring Latino, Lay Health, Access, Prevention, HIV Seronegativity, HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: LHA (lay health advisor) and participants: To be eligible for participation in this study as a lay health advisor (LHA), an LHA must: self-identify as Latino or Hispanic; work as a migrant or seasonal farmworker; be a member of the Liga Hispana de Fútbol de NC; be 18 years of age; be literate in Spanish; and provide informed consent. Exclusion Criteria: Based on the characteristics of the league population, the researchers anticipate that few potential LHAs or participants will be excluded.

Sites / Locations

  • Wake Forest University

Outcomes

Primary Outcome Measures

Reduced STD morbidity
Reduced risk behavior

Secondary Outcome Measures

Improved access to services

Full Information

First Posted
September 13, 2005
Last Updated
September 10, 2012
Sponsor
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00207506
Brief Title
Lay Health Advisors for Sexually Transmitted Disease Prevention
Official Title
HoMBReS: A Lay Health Advisor Approach to Sexually Transmitted Disease Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Non-professional community leaders may be at a great advantage in reaching otherwise hard to reach populations for the purpose of advising on sexually transmitted disease (STD) prevention (lay health advisors), health care access, and model health behavior. Latino migrant farm workers are at increased risk for STD and might benefit from such lay health advisors. The study will examine whether this strategy is a useful one for STD prevention in Latino migrant farm workers in rural and small town areas of North Carolina.
Detailed Description
This is a demonstration project which includes the development, implementation, and evaluation of HoMBReS: Hombres Manteniendo Bienestar y Relaciones Saludables (Men Maintaining Wellness and Healthy Relationships). Applying a community-based participatory research (CBPR) approach, this 3-year study uses a quasi-experimental delayed-intervention comparison group design to assess the feasibility of implementing and the potential efficacy of an adult soccer league-based lay health advisor intervention. The intervention is designed to: reduce sexual risk behaviors among Latino seasonal farmworkers; enhance access to sexually transmitted disease/HIV healthcare services; and develop effective data collection methods among Latino men.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syphilis, Gonorrhea, Chlamydia Infections, HIV Infections
Keywords
Latino, Lay Health, Access, Prevention, HIV Seronegativity, HIV

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
354 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
HoMBReS: A lay health advisor approach to STD prevention
Primary Outcome Measure Information:
Title
Reduced STD morbidity
Title
Reduced risk behavior
Secondary Outcome Measure Information:
Title
Improved access to services

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: LHA (lay health advisor) and participants: To be eligible for participation in this study as a lay health advisor (LHA), an LHA must: self-identify as Latino or Hispanic; work as a migrant or seasonal farmworker; be a member of the Liga Hispana de Fútbol de NC; be 18 years of age; be literate in Spanish; and provide informed consent. Exclusion Criteria: Based on the characteristics of the league population, the researchers anticipate that few potential LHAs or participants will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Rhodes, PhD
Organizational Affiliation
Wake Forest University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Lay Health Advisors for Sexually Transmitted Disease Prevention

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