Lay Health Advisors for Sexually Transmitted Disease Prevention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00207506
First received: September 13, 2005
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Syphilis
Gonorrhea
Chlamydia Infections
HIV Infections
Behavioral: HoMBReS: A lay health advisor approach to STD prevention
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HoMBReS: A Lay Health Advisor Approach to Sexually Transmitted Disease Prevention

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Reduced STD morbidity
  • Reduced risk behavior

Secondary Outcome Measures:
  • Improved access to services

Enrollment: 354
Study Start Date: October 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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:

    1. self-identify as Latino or Hispanic;
    2. work as a migrant or seasonal farmworker;
    3. be a member of the Liga Hispana de Fútbol de NC;
    4. be 18 years of age;
    5. be literate in Spanish; and
    6. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207506

Locations
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Investigators
Principal Investigator: Scott Rhodes, PhD Wake Forest University
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00207506     History of Changes
Other Study ID Numbers: CDC-NCHSTP-4337, U36/CCU300860
Study First Received: September 13, 2005
Last Updated: September 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Latino
Lay Health
Access
Prevention
HIV Seronegativity
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Chlamydia Infections
Gonorrhea
Sexually Transmitted Diseases
Syphilis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections
Treponemal Infections
Spirochaetales Infections

ClinicalTrials.gov processed this record on March 14, 2013