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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01043341
Other study ID # HPV vaccines
Secondary ID
Status Completed
Phase Phase 4
First received January 5, 2010
Last updated January 8, 2010
Start date October 2006
Est. completion date October 2009

Study information

Verified date January 2010
Source Universidade Cidade de Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study was to analyze the knowledge and attitude about HPV vaccines among Brazilian women after an educative intervention. The knowledge was measured on sexual behavior and HPV infection. The attitude was measured on acceptance of vaccines.


Description:

Two hundred Brazilian women were selected ranged 18 to 30 years old. They were randomized on two groups: 1) One hundred received a brief educative intervention about HPV infection and vaccines and answered a questionaire about sexual behavior, HPV infection and vaccines and 2)one hundred not received anything and answered the same questionaire.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- healthy women

Exclusion Criteria:

- previous CIN or cervical cancer treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
educative folder
folder about HPV infection and vaccines

Locations

Country Name City State
Brazil Universidade Cidade de São Paulo São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incorrect knowledge about HPV vaccines was detected on more than 50% women, however the attitude to accept the HPV vaccine was improved after educative intervention. 2 years Yes
Secondary The acceptance of HPV vaccines by the women was depended on the sponsor by the public heath services 2 years Yes
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