The Psychosocial and Economic Burden of Genital Warts (GWburden)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01520194|
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : May 10, 2016
|Condition or disease||Intervention/treatment|
|Female Genital Warts||Other: women attending reproductive health clinics Other: medical records|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||224 participants|
|Official Title:||The Psychosocial and Economic Burden of Genital Warts for Women Attending Six Reproductive Health Clinics in Brazil|
|Study Start Date :||January 2012|
|Primary Completion Date :||March 2013|
|Study Completion Date :||March 2013|
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
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
- psychosocial burden of genital warts [ Time Frame: January 2012 until March 2013 ]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
- economic burden of genital warts [ Time Frame: January 2009 until December 2010 ]Each genital wart episode lasted on average 132 ays, had 6 medical visits and costs US$ 139.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520194
|Principal Investigator:||Monica G Almeida, MD, MS||BEMFAM Bem Estar Familiar no Brasil|