Lay Health Advisors for Sexually Transmitted Disease Prevention

HIV Infections Clinical Trial

Official title:

HoMBReS: A Lay Health Advisor Approach to Sexually Transmitted Disease Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207506
• Other study ID #: CDC-NCHSTP-4337
• Secondary ID: U36/CCU300860
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: September 10, 2012
• Start date: October 2004
• Est. completion date: October 2007

Study information

• Verified date: September 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chlamydia Infections
• Gonorrhea
• HIV Infections
• Infection
• Sexually Transmitted Diseases
• Syphilis

Intervention

Behavioral:
• HoMBReS: A lay health advisor approach to STD prevention

Locations

Country	Name	City	State
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced STD morbidity
Primary	Reduced risk behavior
Secondary	Improved access to services