Human Papilloma Virus (HPV) VaccineNCT06743880
Knowledge, Attitude &Practice on Human Papilloma Virus Vaccination Among Healthcare Providers and General Population
An observational study of Human Papilloma Virus (HPV) Vaccine, run by Assiut University.
Trial summary
Cervical cancer is caused by persistent infection with certain strains of the human papillomavirus (HPV), which is a very common virus transmitted through sexual activity. HPV infections can lead to the development of precancerous lesions on the cervix, which if left untreated, can progress to invasive cervical cancer… Read more about this study
- Who is it for?
- Ages 9 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus (HPV) Vaccine
- Type of treatment
- Vaccines
- How many people
- 323 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 9 to 79 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Physicians, nurses, and other healthcare workers employed in the Obstetrics and Gynecology, and Family Medicine departments at Assiut University Hospital.
Who may be able to join
- 1. general population:
- Eligibility criteria:
- Age: 9-79 years old
- patients and their relatives
- Attending the Obstetrics and Gynecology, or Family Medicine clinics at Assiut University Hospital
- Recruitment strategy:
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- Using a systematic random sampling method, every nth patient (based on the average patient load) will be approached and invited to participate in the study.
- The target sample size for patients is a minimum of 384 participants.
- 2. Healthcare providers:
- Eligibility criteria:
- Physicians, nurses, and other healthcare workers employed in the Obstetrics and Gynecology, and Family Medicine departments at Assiut University Hospital.
Who cannot join
- -Previous HPV Vaccination:
- Exclude participants who have already received the complete HPV vaccination series, as their knowledge, attitudes, and practices may differ from those who are unvaccinated.
- The study aims to understand the KAP of the unvaccinated population, which is the primary target group for intervention.
- 2-Severe Cognitive or Mental Impairment:
- Exclude participants who have severe cognitive or mental impairments that may prevent them from understanding and responding to the questionnaire accurately.
- This could include individuals with advanced dementia, severe intellectual disabilities, or acute psychiatric conditions.
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- 3-. Inability to Provide Informed Consent:
- Exclude participants who are unable to provide informed consent due to language barriers, literacy issues, or other factors that may compromise their ability to understand the study and its implications 4- Severe Illness or Hospitalization:
- Exclude participants who are currently hospitalized or experiencing severe illness, as their focus may be on their immediate health concerns rather than the KAP questionnaire.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Knowledge,Attitude &Practice on Human Papilloma Virus Vaccination Among Healthcare Providers and General Population
- Cervical cancer is caused by persistent infection with certain strains of the human papillomavirus (HPV), which is a very common virus transmitted through sexual activity.
- HPV infections can lead to the development of precancerous lesions on the cervix, which if left untreated, can progress to invasive cervical cancer over time.
- Cervical cancer is the second most common cancer among women in Egypt, after breast cancer.
- According to the latest available data, the age-standardized incidence rate of cervical cancer in Egypt is approximately 6.3 per 100,000 women.
- However, the actual burden of cervical cancer in Egypt is likely underestimated, as many cases may go undetected or unreported, especially in rural and underserved areas.
The main objectives of this KAP study are:
- To assess the level of knowledge about HPV and HPV vaccination among the target population.
- To investigate the attitudes and perceptions towards HPV vaccination.
- To identify the current practices and uptake of HPV vaccination.
- To explore the factors influencing the knowledge, attitudes, and practices related to HPV vaccination.
Read the detailed description
- Cervical cancer mortality rates in Egypt are also relatively high, with an age-standardized mortality rate of around 3.2 per 100,000 women.
Risk Factors and Epidemiology:
- The primary risk factor for cervical cancer in Egypt is persistent infection with high-risk strains of the human papillomavirus (HPV), particularly HPV 16 and 18.
- Other risk factors include early age of first sexual intercourse, multiple sexual partners, high parity, smoking, and lack of regular cervical cancer screening.
- Socioeconomic factors, such as low education levels and limited access to healthcare services, also contribute to the cervical cancer burden in Egypt.
- Cervical cancer disproportionately affects women in rural and disadvantaged areas, where screening and preventive services are less accessible.
Screening and Prevention Efforts:
- Cervical cancer screening through Pap smears or HPV testing is the primary method for early detection and prevention of the disease.
- However, cervical cancer screening coverage in Egypt remains low, with only around 10-20% of eligible women being regularly screened.
- The Egyptian Ministry of Health and Population has implemented various initiatives to improve cervical cancer screening and awareness, but more efforts are needed to reach underserved populations.
- The introduction and widespread uptake of the HPV vaccine could significantly reduce the burden of cervical cancer in Egypt, but vaccine coverage remains suboptimal.
- Cervical cancer is a significant public health concern, as it is the fourth most common cancer in women worldwide, with a high mortality rate, especially in developing countries.
- Early detection through regular cervical cancer screening (e.g., Pap smears) and treatment of precancerous lesions can effectively prevent the development of cervical cancer.
Role of the HPV Vaccine:
- The HPV vaccine is a highly effective way to prevent cervical cancer and other HPV-related diseases, such as anal, penile, and oropharyngeal cancers.
- The vaccine targets the HPV strains (primarily HPV 16 and 18) that are responsible for approximately 70% of cervical cancer cases globally.
- The HPV vaccine is recommended for both girls and boys, typically starting at 11-12 years of age, as it is most effective when administered before the onset of sexual activity and potential HPV exposure.
- Widespread HPV vaccination, coupled with regular cervical cancer screening, has the potential to significantly reduce the burden of cervical cancer worldwide.
Importance of a KAP Questionnaire in Egypt:
- In Egypt, cervical cancer is the second most common cancer among women, and HPV infection is a major risk factor.
- However, HPV vaccination rates in Egypt remain relatively low, indicating a need to better understand the factors that influence vaccination uptake in the country.
- A KAP questionnaire can provide valuable insights into:
- The level of awareness and knowledge about cervical cancer and the HPV vaccine among the Egyptian population.
- Attitudes, beliefs, and misconceptions that may be hindering or promoting HPV vaccination.
- Current vaccination practices and barriers to accessing the vaccine.
- This information can then be used to develop targeted educational campaigns, address misconceptions, and implement strategies to improve HPV vaccination coverage in Egypt.
- By understanding the KAP of HPV vaccination, policymakers and healthcare providers can work to increase cervical cancer prevention efforts and improve the overall public health outcomes in the country.
- Conditions
- Human Papilloma Virus (HPV) Vaccine
- Keywords
- Knowledge,attitude &practice
- Medical subject headings
- Papillomavirus Infections, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| health care provider group | - Healthcare providers at the Gynecologic Oncology Unit have direct interactions with patients and can significantly influence their knowledge, attitudes, and decision-making regarding HPV vaccination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge about HPV
Proportion of participants with adequate knowledge about HPV
Measured: baseline
Knowledge about HPV Vaccination
Proportion of participants with adequate knowledge about the HPV vaccine
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papilloma Virus (HPV) VaccineStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelaaziz Mohamed Fathi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743880
- Sponsor's protocol ID
- KAP ON HPV vaccination
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brewer NT, Fazekas KI. Predictors of HPV vaccine acceptability: a theory-informed, systematic review. Prev Med. 2007 Aug-Sep;45(2-3):107-14. doi: 10.1016/j.ypmed.2007.05.013. Epub 2007 Jun 2.
PubMed 17628649
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge,Attitude &Practice on Human Papilloma Virus Vaccination Among Healthcare Providers and General Population
- ClinicalTrials.gov ID
- NCT06743880
- Acronym / sponsor ID
- KAP ON HPV vaccination
- Conditions
- Human Papilloma Virus (HPV) Vaccine
- Keywords
- Knowledge,attitude &practice
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 20 Dec 2024 (actual)
- 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.
- Cervical cancer is caused by persistent infection with certain strains of the human papillomavirus (HPV), which is a very common virus transmitted through sexual activity.
- HPV infections can lead to the development of precancerous lesions on the cervix, which if left untreated, can progress to invasive cervical cancer over time.
- Cervical cancer is the second most common cancer among women in Egypt, after breast cancer.
- According to the latest available data, the age-standardized incidence rate of cervical cancer in Egypt is approximately 6.3 per 100,000 women.
- However, the actual burden of cervical cancer in Egypt is likely underestimated, as many cases may go undetected or unreported, especially in rural and underserved areas.
The main objectives of this KAP study are:
- To assess the level of knowledge about HPV and HPV vaccination among the target population.
- To investigate the attitudes and perceptions towards HPV vaccination.
- To identify the current practices and uptake of HPV vaccination.
- To explore the factors influencing the knowledge, attitudes, and practices related to HPV vaccination.
Detailed description
- Cervical cancer mortality rates in Egypt are also relatively high, with an age-standardized mortality rate of around 3.2 per 100,000 women.
Risk Factors and Epidemiology:
- The primary risk factor for cervical cancer in Egypt is persistent infection with high-risk strains of the human papillomavirus (HPV), particularly HPV 16 and 18.
- Other risk factors include early age of first sexual intercourse, multiple sexual partners, high parity, smoking, and lack of regular cervical cancer screening.
- Socioeconomic factors, such as low education levels and limited access to healthcare services, also contribute to the cervical cancer burden in Egypt.
- Cervical cancer disproportionately affects women in rural and disadvantaged areas, where screening and preventive services are less accessible.
Screening and Prevention Efforts:
- Cervical cancer screening through Pap smears or HPV testing is the primary method for early detection and prevention of the disease.
- However, cervical cancer screening coverage in Egypt remains low, with only around 10-20% of eligible women being regularly screened.
- The Egyptian Ministry of Health and Population has implemented various initiatives to improve cervical cancer screening and awareness, but more efforts are needed to reach underserved populations.
- The introduction and widespread uptake of the HPV vaccine could significantly reduce the burden of cervical cancer in Egypt, but vaccine coverage remains suboptimal.
- Cervical cancer is a significant public health concern, as it is the fourth most common cancer in women worldwide, with a high mortality rate, especially in developing countries.
- Early detection through regular cervical cancer screening (e.g., Pap smears) and treatment of precancerous lesions can effectively prevent the development of cervical cancer.
Role of the HPV Vaccine:
- The HPV vaccine is a highly effective way to prevent cervical cancer and other HPV-related diseases, such as anal, penile, and oropharyngeal cancers.
- The vaccine targets the HPV strains (primarily HPV 16 and 18) that are responsible for approximately 70% of cervical cancer cases globally.
- The HPV vaccine is recommended for both girls and boys, typically starting at 11-12 years of age, as it is most effective when administered before the onset of sexual activity and potential HPV exposure.
- Widespread HPV vaccination, coupled with regular cervical cancer screening, has the potential to significantly reduce the burden of cervical cancer worldwide.
Importance of a KAP Questionnaire in Egypt:
- In Egypt, cervical cancer is the second most common cancer among women, and HPV infection is a major risk factor.
- However, HPV vaccination rates in Egypt remain relatively low, indicating a need to better understand the factors that influence vaccination uptake in the country.
- A KAP questionnaire can provide valuable insights into:
- The level of awareness and knowledge about cervical cancer and the HPV vaccine among the Egyptian population.
- Attitudes, beliefs, and misconceptions that may be hindering or promoting HPV vaccination.
- Current vaccination practices and barriers to accessing the vaccine.
- This information can then be used to develop targeted educational campaigns, address misconceptions, and implement strategies to improve HPV vaccination coverage in Egypt.
- By understanding the KAP of HPV vaccination, policymakers and healthcare providers can work to increase cervical cancer prevention efforts and improve the overall public health outcomes in the country.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| health care provider group | – | –- Healthcare providers at the Gynecologic Oncology Unit have direct interactions with patients and can significantly influence their knowledge, attitudes, and decision-making regarding HPV vaccination. |
Who may qualify
- Ages
- 9 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Physicians, nurses, and other healthcare workers employed in the Obstetrics and Gynecology, and Family Medicine departments at Assiut University Hospital.
Key inclusion criteria (11 listed)
- 1. general population:
- Eligibility criteria:
- Age: 9-79 years old
- patients and their relatives
- Attending the Obstetrics and Gynecology, or Family Medicine clinics at Assiut University Hospital
Key exclusion criteria (9 listed)
- -Previous HPV Vaccination:
- Exclude participants who have already received the complete HPV vaccination series, as their knowledge, attitudes, and practices may differ from those who are unvaccinated.
- The study aims to understand the KAP of the unvaccinated population, which is the primary target group for intervention.
- Exclude participants who have severe cognitive or mental impairments that may prevent them from understanding and responding to the questionnaire accurately.
- This could include individuals with advanced dementia, severe intellectual disabilities, or acute psychiatric conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knowledge about HPV
Time frame: baseline
Proportion of participants with adequate knowledge about HPV
Knowledge about HPV Vaccination
Time frame: baseline
Proportion of participants with adequate knowledge about the HPV vaccine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Results publication: PubMed 17628649Brewer NT, Fazekas KI. Predictors of HPV vaccine acceptability: a theory-informed, systematic review. Prev Med. 2007 Aug-Sep;45(2-3):107-14. doi: 10.1016/j.ypmed.2007.05.013. Epub 2007 Jun 2.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papilloma Virus (HPV) Vaccine, run by Assiut University.
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 11 inclusion and 9 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: opening soon, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelaaziz Mohamed Fathi, resident doctor (+201005610660, abdelazizmohamed630@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge about HPV (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06743880, which also lists 1 linked publication.
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 20 Dec 2024.