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The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru

NCT01338051 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 642

Last updated 2014-04-21

No results posted yet for this study

Summary

This project will use a community based participatory research orientation to develop a model for large scale "campaign" preventive healthcare interventions. The investigators have considerable expertise with cervical cancer screening and HPV vaccination. The investigators also have well tested methodologies for cervical cancer screening that are highly effective, including self-sampling for HPV and improved specimen transport systems. Therefore, the investigators will use these medical interventions as the model preventive health interventions for this project.

Conditions

  • Cervical Intraepithelial Neoplasia
  • Cervical Cancer
  • Cervical Neoplasm
  • Cervical Dysplasia
  • Human Papillomavirus

Interventions

BIOLOGICAL

Gardasil

Gardasil will be administered to 10-13 year old daughters and granddaughters of study participants according to manufacturers recommended schedule of administration. Gardasil is supplied as 0.5-mL suspension for intramuscular injection at the following schedule: 0, 2 months, 6 months. DOSAGE FORMS AND STRENGTHS • 0.5-mL suspension for injection as a single-dose vial and prefilled syringe.

Sponsors & Collaborators

  • Peru Instituto Nacional de Enfermadades Neoplasticas (INEN)

    collaborator UNKNOWN

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Preventive Oncology International, Inc.

    lead OTHER

Principal Investigators

  • Jerome L Belinson, MD · Preventive Oncology International

  • Carlos Vallejos Sologuren, MD · Instituto Nacional de Enfermadades Neoplasticas (INEN)

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Peru

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01338051 on ClinicalTrials.gov