The Psychosocial and Economic Burden of Genital Warts

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Psychosocial and Economic Burden of Genital Warts for Women Attending Six Reproductive Health Clinics in Brazil

Conditions
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Female Genital Warts

Intervention / Treatment
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* Other: women attending reproductive health clinics
* Other: medical records


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| psychosocial burden<br>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<br>* 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<br>|
| economic burden<br>Medical records of 102 patients diagnosed with genital warts were reviewed in the six BEMFAM's participating reproductive health clinics | Other: medical records<br>* medical chart review of patients assisted January 2009 to December 2010<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychosocial burden of genital warts | 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 | January 2012 until March 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| economic burden of genital warts | Each genital wart episode lasted on average 132 ays, had 6 medical visits and costs US$ 139. | January 2009 until December 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, genital warts, psychosocial burden, economic burden, female genital warts