NCT01043341

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
Last Updated

January 11, 2010

Status Verified

January 1, 2010

Enrollment Period

3 years

First QC Date

January 5, 2010

Last Update Submit

January 8, 2010

Conditions

KnowledgeAttitudeBehavior

Keywords

HPVvaccinesknowledgeattitude

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • The acceptance of HPV vaccines by the women was depended on the sponsor by the public heath services

    2 years

Study Arms (2)

behavioral

ACTIVE COMPARATOR

the women received a folder about HPV infection and vaccines and answered a questionaire about sexual behavior, HPV infection and vaccines.

Behavioral: educative folder

no intervention

NO INTERVENTION

the women answered a questionaire about sexual behavior, HPV infection and vaccines

Behavioral: educative folder

Interventions

educative folderBEHAVIORAL

folder about HPV infection and vaccines

Also known as: HPV vaccines information
behavioralno intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy women

You may not qualify if:

  • previous CIN or cervical cancer treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Cidade de São Paulo

São Paulo, São Paulo, 03071-000, Brazil

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Sylvia MF Brenna, MD, PHD

    Universidade Cidade de São Paulo

    STUDY DIRECTOR

  • Kari J Sirjanen, MD, PhD

    University of Turku

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 6, 2010

Study Start

October 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 11, 2010

Record last verified: 2010-01

Locations

BR(1)