The Psychosocial and Economic Burden of Genital Warts (GWburden)
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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 |
| 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.
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economic burden
Medical records of 100 patients diagnosed with genital warts will be reviewed in the six BEMFAM's participating reproductive health clinics
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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 |
Reproductive health clinics
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| 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 |
| 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 Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013