Clinical trial NCT00847340: Human Papillomavirus (HPV) Genotypes in Genital Warts in Colombian Population
Official title: Prevalence of HPV Genotypes in Genital Warts in Colombian Male and Female Population Attending Medical Services.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genital Warts
HPV Infections
Keywords: Genital warts
HPV typing
HPV infections
Condyloma Acuminata
Lead sponsor: La Fundacion para la Investigacion y el Desarrollo
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Research & Development Fundation (FID)
name: Gustavo J. Hernandez-Suarez, MD
role: PRINCIPAL_INVESTIGATOR
References: