NCT00207506

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
354

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2004

Typical duration for phase_1

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

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

September 10, 2012

Conditions

Keywords

LatinoLay HealthAccessPreventionHIV SeronegativityHIV

Outcome Measures

Primary Outcomes (2)

  • Reduced STD morbidity

  • Reduced risk behavior

Secondary Outcomes (1)

  • Improved access to services

Interventions

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Based on the characteristics of the league population, the researchers anticipate that few potential LHAs or participants will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

SyphilisGonorrheaChlamydia InfectionsHIV Infections

Condition Hierarchy (Ancestors)

Treponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital DiseasesNeisseriaceae InfectionsChlamydiaceae InfectionsBlood-Borne InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Scott Rhodes, PhD

    Wake Forest University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

October 1, 2004

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations