KnowledgePhase 4NCT01043341
Knowledge and Attitude About HPV Vaccines
A Phase 4 study testing educative folder in people with Knowledge and Attitude, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- What is being tested?
- educative folder
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2006to Oct 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women
Who cannot join
- previous CIN or cervical cancer treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knowledge and Attitude About HPV Vaccines Among Women
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.
Read the detailed 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.
- Being tested
- educative folder
- Keywords
- HPV, vaccines, knowledge, attitude
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educative folderBehavioural
Also called HPV vaccines information
folder about HPV infection and vaccines
| Study group | Role | What they receive |
|---|---|---|
| behavioral | Active comparator | the women received a folder about HPV infection and vaccines and answered a questionaire about sexual behavior, HPV infection and vaccines. Receives: Behavioral: educative folder |
| no intervention | No intervention | the women answered a questionaire about sexual behavior, HPV infection and vaccines Receives: Behavioral: educative folder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
The acceptance of HPV vaccines by the women was depended on the sponsor by the public heath services
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startOct 2006
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KnowledgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Sylvia MF Brenna, MD, PHD, Study director, Universidade Cidade de São PauloKari J Sirjanen, MD, PhD, Study chair, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043341
- Sponsor's protocol ID
- HPV vaccines
- Status last verified
- Jan 2010
- First submitted
- 5 Jan 2010
- Last updated
- 11 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Attitude About HPV Vaccines Among Women
- ClinicalTrials.gov ID
- NCT01043341
- Acronym / sponsor ID
- HPV vaccines
- Keywords
- HPV, vaccines, knowledge, attitude
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| behavioral | Active comparator | Behavioral: educative folderthe women received a folder about HPV infection and vaccines and answered a questionaire about sexual behavior, HPV infection and vaccines. |
| no intervention | No intervention | Behavioral: educative folderthe women answered a questionaire about sexual behavior, HPV infection and vaccines |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy women
Key exclusion criteria (1 listed)
- previous CIN or cervical cancer treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educative folderAlso: HPV vaccines informationfolder about HPV infection and vaccines | Behavioural | behavioral, no intervention |
Primary outcome
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.
Time frame: 2 years
1 secondary outcome
The acceptance of HPV vaccines by the women was depended on the sponsor by the public heath services
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia MF Brenna, MD, PHD study director
Universidade Cidade de São Paulo
Kari J Sirjanen, MD, PhD study chair
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing educative folder in people with Knowledge and Attitude, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2010.