The Psychosocial and Economic Burden of Genital Warts
GWburden
1 other identifier
observational
224
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 25, 2012
CompletedFirst Posted
Study publicly available on registry
January 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMay 10, 2016
May 1, 2016
1.2 years
January 25, 2012
May 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
economic burden of genital warts
January 2009 until December 2010
Study Arms (2)
psychosocial burden
122 women attending reproductive health clinics were interwied using HPV Impact Profile (HIP) and a socio-economic characteristics questionnaire.
economic burden
Medical records of 102 patients diagnosed with genital warts were reviewed in the six BEMFAM's participating reproductive health clinics
Interventions
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 chart review of patients assisted January 2009 to December 2010
Eligibility Criteria
Reproductive health clinics
You may qualify if:
- 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
You may not qualify if:
- women self reported HIV-positive
- women undergoing antiretro-viral treatment
- illiteracy
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BEMFAM-Bem Estar Familiarlead
- Merck Sharp & Dohme LLCcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monica G Almeida, MD, MS
BEMFAM Bem Estar Familiar no Brasil
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2012
First Posted
January 27, 2012
Study Start
January 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
May 10, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share