The Psychosocial and Economic Burden of Genital Warts

Completed

• Conditions: Female Genital Warts
• Interventions: Other: medical records; Other: women attending reproductive health clinics

• Registration Number: NCT01520194
• Lead Sponsor: BEMFAM-Bem Estar Familiar

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-27
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-08
• Last Update Posted: 2016-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
economic burden	medical records	Medical records of 102 patients diagnosed with genital warts were reviewed in the six BEMFAM's participating reproductive health clinics
psychosocial burden	women attending reproductive health clinics	122 women attending reproductive health clinics were interwied using HPV Impact Profile (HIP) and a socio-economic characteristics questionnaire.

Primary Outcome Measures

Name	Time	Method
psychosocial burden of genital warts	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

Secondary Outcome Measures

Name	Time	Method
economic burden of genital warts	January 2009 until December 2010	Each genital wart episode lasted on average 132 ays, had 6 medical visits and costs US$ 139.