Human Papillomavirus (HPV) Genotypes in Genital Warts in Colombian Population (GWprofamilia)

March 19, 2012 updated by: Gustavo Hernandez-Suarez, La Fundacion para la Investigacion y el Desarrollo

Prevalence of HPV Genotypes in Genital Warts in Colombian Male and Female Population Attending Medical Services.

HPV infection has been recognized as the most prevalent sexual transmitted infection worldwide. Burden of many HPV related diseases is well known particularly regarding the different associated cancers (cervical, anal, vaginal, vulvar, oro-pharyngeal) (3) ; however, there is much less available information on the general burden of genital warts, the associated HPV types, the costs of related medical treatments and the knowledge and perceptions towards the disease and its prevention.

Objectives:

  1. To determine the HPV genotypes distribution in genital warts in the study population.
  2. To assess the knowledge about transmission & prevention of HPV infection related diseases
  3. To determine the direct medical costs of genital warts attention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study population

Female and male between 18 - 45 years of age living in Bogota, Colombia

Sample frame

Patients attending to gynecologic or STD consult in a mayor out patient clinic in Bogotá (PROFAMILIA)

Analysis

Analysis of the information will be exhaustive. We will calculate prevalence of HPV genotypes in the GW in both sexes separately. Analyses of the survey will include simple frequencies, percentages, and comparison of results related to HPV knowledge with sociodemographic and clinical information. Explorative analysis using parametric or non parametric statistics of the items included in the questionnaire and clinical forms will be done as appropriate. We will calculate the medical cost of patients enrolled in the study. The treatment protocols used for this protocol will reflect the current clinical practice accepted for the treatment of genital warts. We will use national reference cost list (SOAT) to determine the cost of procedures included.

Study Type

Observational

Enrollment (Actual)

342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients attending to gynecologic or STD consult in a mayor out patient clinic in Bogotá (PROFAMILIA).

Female and male between 18 - 45 years of age living in Bogota, Colombia.

Description

Inclusion Criteria:

  • Age between 18-45 years.
  • Lesions suspicious of being HPV related.

  • The main manifestations of anogenital warts include:

    • Cauliflower-like condylomata acuminata lesions that usually involve moist surfaces
    • keratotic and smooth papular warts, usually on dry surfaces
    • subclinical "flat" warts, that can be found on any mucosal or cutaneous surface and, which are probably overseen in the majority of cases.
  • Lesions other than the described above, are not to be biopsied, according to the investigator criteria.

Exclusion Criteria:

  • Not willing to participate
  • To be a participant in any HPV vaccine clinical trial study
  • Known immune suppressive disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

La Fundacion para la Investigacion y el Desarrollo

Investigators

  • Principal Investigator: Gustavo J. Hernandez-Suarez, MD, Research & Development Fundation (FID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • protocol V profamilia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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