The Psychosocial and Economic Burden of Genital Warts

NCT ID: NCT01520194

Last Updated: 2016-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 224 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-03-31

Brief Summary

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.

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.

Conditions

Female Genital Warts

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

psychosocial burden

122 women attending reproductive health clinics were interwied using HPV Impact Profile (HIP) and a socio-economic characteristics questionnaire.

women attending reproductive health clinics

Intervention Type: OTHER

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

medical records

Intervention Type: OTHER

medical chart review of patients assisted January 2009 to December 2010

Interventions

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

Intervention Type: OTHER

medical records

medical chart review of patients assisted January 2009 to December 2010

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

BEMFAM-Bem Estar Familiar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica G Almeida, MD, MS

Role: PRINCIPAL_INVESTIGATOR

BEMFAM Bem Estar Familiar no Brasil

Other Identifiers

BEMFAM 421

Identifier Type: -

Identifier Source: org_study_id