Clinical trial NCT01520194: The Psychosocial and Economic Burden of Genital Warts
Official title: The Psychosocial and Economic Burden of Genital Warts for Women Attending Six Reproductive Health Clinics in Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Genital Warts
Keywords: genital warts
HPV
psychosocial burden
economic burden
female genital warts
Lead sponsor: BEMFAM-Bem Estar Familiar
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-01-27
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reproductive health clinics

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.

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

Primary outcomes:
measure: psychosocial burden of genital warts
timeFrame: January 2012 until March 2013
Secondary outcomes:
measure: economic burden of genital warts
timeFrame: January 2009 until December 2010
Other outcomes:
Locations:
Study officials:
affiliation: BEMFAM Bem Estar Familiar no Brasil
name: Monica G Almeida, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: