Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT01520194 |
| Other study ID # |
BEMFAM 421 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
January 25, 2012 |
| Last updated |
January 25, 2012 |
| Start date |
January 2012 |
| Est. completion date |
October 2012 |
Study information
| Verified date |
January 2012 |
| Source |
BEMFAM-Bem Estar Familiar |
| Contact |
Monica G Almeida, MD, MS |
| Phone |
55 21 38612439 |
| Email |
monica[@]bemfam.org.br |
| Is FDA regulated |
No |
| Health authority |
Brazil: National Committee of Ethics in Research |
| Study type |
Observational
|
Clinical Trial 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.
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.
