Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06129253
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-10-17
Brief Title:
Global Burden Estimation of Human Papillomavirus GLOBE-HPV
Sponsor:
International Vaccine Institute
Organization:
International Vaccine Institute
Study Overview
Official Title:
Global Burden Estimation of Human Papillomavirus GLOBE-HPV
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPV
Brief Summary:
This study is a multi-country and multi-site project to estimate the point-prevalence of high-risk HR HPV genotype infections among representative samples of girls and women aged 9-50 years and among specific sub-populations to estimate the incidence of persistent HPV infection among sexually active young women The data to fulfill the objectives will be collected through a series of Cross-Sectional Surveys CSS and Longitudinal Studies LS in all 8 countries 3 South Asian countries including Bangladesh Pakistan Nepal and 5 sub-Saharan African countries including Sierra Leone Tanzania Ghana Zambia and DR Congo Qualitative sub-studies QS will be conducted in selected countries and populations following the CSS to further understand and unpack risk factors for HPV infection as well as to explore how gender-related dynamics including perceptions of gender norms and stigma influence HPV burden andor create barriers that shape girlswomen access to and uptake of HPV prevention screening and treatment services Specific study protocols and corresponding ethical applications for the qualitative sub-studies will be developed separately
Detailed Description:
The study will incorporate a harmonized protocol among the 8 countries to estimate point-prevalence of high-risk HPV HR HPV in low socio-economic populations and among specific sub-populations the incidence of persistent HPV infection Due to differences in study settings study population targeted age-group and eligibility criteria country-specific protocols will be developed to complement the multi-country master protocol In the master protocol general principles on study design and methodology will be described while the country-specific protocol will elaborate in more detail on methodology in each country related to subject identification the enrolment process and laboratory analysis A standardized survey questionnaire with some minor country-specific adaptations and laboratory assays will be implemented throughout the participating countries in order to generate comparable data
Two separate approaches will be implemented to estimate prevalence and incidence respectively in each participating country First cross-sectional surveys CSS will be conducted in both urban and rural areas of selected countries in order to estimate the point prevalence of HPV infection in sub-Saharan Africa and South Asia The CSS will enrol girls and women aged 9-50 years with equal sample size from four age-strata 9-14 15-20 21- 30 31-50 For specific populations age-strata will be modified to include 12-35 years olds considering the target population characteristics and local context Multi-stage cluster random sampling or another applicable sampling strategy will be applied to ensure representativeness Urine samples will be collected for HPV testing along with data on demographics socioeconomic status sexual and reproductive history attitudes towards and awareness and uptake of cervical cancer screening and HPV vaccination and potential risk factors for HPV infection and cervical cancer Additional data will be collected on knowledge of HPV and attitudes uptake and use of vaccines using standardized questionnaires and case report forms
Second Longitudinal studies LS will estimate the incidence of persistent HPV infection in sexually active girls and young women in geographically defined communities and special populations Depending on the country setting the LS will enroll sexually active girls and women who are aged between 15-35 years and follow them up to 24 months Participants will be tested every 6 months for 24 months to determine incident persistent HR HPV infection In selected countries urine and self-collected vaginal swabs SCVS will be collected at the first visit to determine the comparability of HPV genotyping results from both sample types For all the other visits only SCVS will be collected Data on demographics socioeconomic status sexual and reproductive history cervical screening HPV vaccination and other potential risk factors will be collected using standardized questionnaires
Furthermore the qualitative sub-studies in five selected countries Bangladesh Nepal Pakistan Sierra Leone DR Congo will follow and draw on findings from the CSS focusing on girls and women of different age strata as well as community members including boys and men and key informants in the health care system in each study site Qualitative study methods will vary depending on the site and CSS findings but will include both individual in- depth interviews IDIs up to 30 individuals per site key informant interviews as well as multiple focus group discussions FGDs with 6-8 participantsgroup Detailed qualitative study methodology will be developed separately as another study protocol and adapted according to the procedures for each site
Two separate approaches will be implemented to estimate prevalence and incidence respectively in each participating country First cross-sectional surveys CSS will be conducted in both urban and rural areas of selected countries in order to estimate the point prevalence of HPV infection in sub-Saharan Africa and South Asia The CSS will enrol girls and women aged 9-50 years with equal sample size from four age-strata 9-14 15-20 21- 30 31-50 For specific populations age-strata will be modified to include 12-35 years olds considering the target population characteristics and local context Multi-stage cluster random sampling or another applicable sampling strategy will be applied to ensure representativeness Urine samples will be collected for HPV testing along with data on demographics socioeconomic status sexual and reproductive history attitudes towards and awareness and uptake of cervical cancer screening and HPV vaccination and potential risk factors for HPV infection and cervical cancer Additional data will be collected on knowledge of HPV and attitudes uptake and use of vaccines using standardized questionnaires and case report forms
Second Longitudinal studies LS will estimate the incidence of persistent HPV infection in sexually active girls and young women in geographically defined communities and special populations Depending on the country setting the LS will enroll sexually active girls and women who are aged between 15-35 years and follow them up to 24 months Participants will be tested every 6 months for 24 months to determine incident persistent HR HPV infection In selected countries urine and self-collected vaginal swabs SCVS will be collected at the first visit to determine the comparability of HPV genotyping results from both sample types For all the other visits only SCVS will be collected Data on demographics socioeconomic status sexual and reproductive history cervical screening HPV vaccination and other potential risk factors will be collected using standardized questionnaires
Furthermore the qualitative sub-studies in five selected countries Bangladesh Nepal Pakistan Sierra Leone DR Congo will follow and draw on findings from the CSS focusing on girls and women of different age strata as well as community members including boys and men and key informants in the health care system in each study site Qualitative study methods will vary depending on the site and CSS findings but will include both individual in- depth interviews IDIs up to 30 individuals per site key informant interviews as well as multiple focus group discussions FGDs with 6-8 participantsgroup Detailed qualitative study methodology will be developed separately as another study protocol and adapted according to the procedures for each site
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None