The Psychosocial and Economic Burden of Genital Warts (GWburden)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by BEMFAM-Bem Estar Familiar.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
BEMFAM-Bem Estar Familiar
ClinicalTrials.gov Identifier:
NCT01520194
First received: January 25, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

Considering the importance of HPV(human papilomavirus) and related diseases in Brazil, and the lack of studies about both the economic and the psychosocial burden of these diseases, BEMFAM, a Brazilian non-governmental organization that provides reproductive health services and technical support to local governments proposes a study to measure the psychosocial and economic burden of genital warts.


Condition
Female Genital Warts

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Psychosocial and Economic Burden of Genital Warts for Women Attending Six Reproductive Health Clinics in Brazil

Resource links provided by NLM:


Further study details as provided by BEMFAM-Bem Estar Familiar:

Estimated Enrollment: 220
Study Start Date: January 2012
Estimated Study Completion Date: October 2012
Groups/Cohorts
psychosocial burden
120 women attending reproductive health clinics will be interwied using HPV Impact Profile (HIP) and a socio-economic characteristics questionnaire.
economic burden
Medical records of 100 patients diagnosed with genital warts will be reviewed in the six BEMFAM's participating reproductive health clinics

Detailed Description:

Cervical cancer is a public health issue in Brazil. The Cancer National Institute estimates that cervical cancer will be the second most incident among women, with 18.430 new cases in 2010. Human papillomavirus (HPV) is related to cervical cancer and is also responsible for benign lesions, such as genital warts.The Brazilian Ministry of Health estimates the prevalence of genital warts to be 5,7% among pregnant women and 21,5% among women attending sexually transmitted infections treatment clinics.The study will measure the psychosocial burden of genital warts using HPV Impact Profile questionnaire and the economic burden of genital warts among women attending its six reproductive health clinics.

There are two study objectives:

1 - to measure the psychosocial burden of genital warts in women attending six reproductive health clinics in Brazil. 2- to measure the economic burden of genital warts treatment for women attending six reproductive health clinics in Brazil.

Hypothesis testing:

For objective 1, the experiment compare differences on psychosocial burden of Genital Warts among subgroups and therefore does not include any formal hypothesis testing about the psychosocial burden of the disease in agreement with the extant literature on the subject (Xingshu Zhu et al., 2009).

Objective 2 aims to measure differentials in the economic burden of the disease among subgroups with different type of genital warts (newly diagnosed, recurrent and resistant), site of the lesion, age, duration of treatment, number of medical visits, type and number of medical procedures. No formal hypothesis will be tested.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Reproductive health clinics

Criteria

Inclusion Criteria:

  • women aged 18 to 45 years, who had a Pap-smear in the preceding 90 days or were diagnosed with genital warts during physical examination.
  • good health

Exclusion Criteria:

  • women self reported HIV-positive
  • women undergoing antiretro-viral treatment
  • illiteracy
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520194

Contacts
Contact: Monica G Almeida, MD, MS 55 21 38612439 monica@bemfam.org.br
Contact: Marcio T Thome, MS 55 21 38612408 mthome@bemfam.org.br

Sponsors and Collaborators
BEMFAM-Bem Estar Familiar
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Monica G Almeida, MD, MS BEMFAM Bem Estar Familiar no Brasil
  More Information

No publications provided

Responsible Party: BEMFAM-Bem Estar Familiar
ClinicalTrials.gov Identifier: NCT01520194     History of Changes
Other Study ID Numbers: BEMFAM 421
Study First Received: January 25, 2012
Last Updated: January 25, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by BEMFAM-Bem Estar Familiar:
genital warts
HPV
psychosocial burden
economic burden
female genital warts

Additional relevant MeSH terms:
Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on October 16, 2014