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The Psychosocial and Economic Burden of Genital Warts (GWburden)

This study has been completed.
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: May 8, 2016
Last verified: May 2016
  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 Intervention
Female Genital Warts
Other: women attending reproductive health clinics
Other: medical records

Study Type: Observational
Study Design: Observational Model: Case-Only
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:

Primary Outcome Measures:
  • psychosocial burden of genital warts [ Time Frame: January 2012 until March 2013 ] [ Designated as safety issue: No ]
    122 individuals filled the self-administered questionnaire. Women with normal Pap smear presented lower scores of worries and concerns about gynecological health than women with cervical intraepithelial neoplasia or genital warts and higher scores of satisfaction with sexual life. Feelings of anxiety and surprise with the last exam were higher in genital warts group than for normal Pap smear and CIN groups


Secondary Outcome Measures:
  • economic burden of genital warts [ Time Frame: January 2009 until December 2010 ] [ Designated as safety issue: No ]
    Each genital wart episode lasted on average 132 ays, had 6 medical visits and costs US$ 139.


Enrollment: 224
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
psychosocial burden
122 women attending reproductive health clinics were interwied using HPV Impact Profile (HIP) and a socio-economic characteristics questionnaire.
Other: women attending reproductive health clinics
women visiting BEMFAM´s clinics from January 2012 until Narch 2013 filled a self-administered questionnaire based on psychometric scale developes by Zhu TC et al
economic burden
Medical records of 102 patients diagnosed with genital warts were reviewed in the six BEMFAM's participating reproductive health clinics
Other: medical records
medical chart review of patients assisted January 2009 to December 2010

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   (Adult)
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

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

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: May 8, 2016
Health Authority: Brazil: National Committee of Ethics in Research
Individual Participant Data  
Plan to Share IPD: No

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
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on December 08, 2016