Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536855
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Faster Elimination of HPV Infection and Cervical Cancer Using Concomitant HPV Vaccination and HPV Screening A Demonstration Project in Rwanda
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Faster Elimination of HPV Infection and Cervical Cancer Using Concomitant HPV Vaccination and HPV Screening A Demonstration Project in Rwanda
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cervical cancer is the fourth most frequently diagnosed cancer and the fourth leading cause of cancer death in women with an estimated 604000 new cases and 342000 deaths worldwide in 2020 Rwanda is among countries with a high burden cervical cancer with an annual incidence of 282100000 women 1229 new cases in 2020 and a mortality rate of 201100000 829 deaths in 2018 according to WHO IARC 2020
Cervical cancer is almost completely preventable because of the highly effective primary HPV vaccine and secondary HPV screening prevention measures However these measures have not been equitably implemented across and within LMICs countries
Given the current situation where the screening coverage is still low due to financial and operational challenges it will take many years to achieve the elimination targets as included in the global elimination strategy We are proposing to implement an innovative strategy to accelerate the elimination of cervical cancer in Rwanda consisting of concomitant HPV vaccination and HPV screening for young women aged 23-29 years old
HPV screening and vaccination are complementary preventive options often implemented as separate public health programs This project proposal aims to address this disconnect by combining both strategies with the ultimate purpose of accelerating the reduction of cervical cancer incidence and mortality in Rwanda and making the programs both cost-effective and sustainable
Primary objective
The study aims to evaluate whether organized concomitant HPV vaccination and HPV screening offered to girls and women aged 23-29 years will result in more rapid elimination of HPV infections in the target districts in Rwanda
The study design is a before-after study design of the intervention where the projected incidences and prevalence at the 2-year follow-up visit are modeled using the data from the baseline visit with evaluation using Observedexpected numbers
Secondary objectives
The study will evaluate whether concomitant vaccination and cervical screening result in an improved efficiency andor safety of the cervical cancer screening program These objectives will be examined among women who participated in the combined screening and vaccination study
i Protection of Gardasil 9 against HPV infection and against CIN2 by Gardasil 9 HPV vaccine types in 23 to 29-year-old women from the study districts This analysis will be performed every 2 years and the first analysis will determine the effectiveness of one-dose vaccination incident infections of HPV vaccine types at 2 years whereas all subsequent analysis will determine the effect of 2-dose vaccinations The study will be powered to detect a decline in invasive cervical cancer among the study participants using the cervical cancer incidence in the surrounding districts of Rwanda as the reference
ii Efficiency will also be measured by the yield of histopathologically confirmed high-grade cervical cancer precursors or cancer cervical intraepithelial neoplasia grade 2 3 or cervical cancer in relation to the consumption of resources and convenience for the women using the yield at the baseline visit 10 of women tested as the comparator The hypothesis is that 2 years after vaccination there will be only a few incident infections only some old persistent infections resulting in high PPV and high yield of CIN2 at modest consumption of resources
End of the study
One screening interval 2 years after the last visit of the last subject defined as the day the last study subject receives her second vaccination
The study will be implemented in 4 districts of Rwanda covering 100000 women aged 23 to 29 years old We will use Gardasil 9 the HPV the second generation HPV Vaccine manufactured by Merck
Cervical cancer is almost completely preventable because of the highly effective primary HPV vaccine and secondary HPV screening prevention measures However these measures have not been equitably implemented across and within LMICs countries
Given the current situation where the screening coverage is still low due to financial and operational challenges it will take many years to achieve the elimination targets as included in the global elimination strategy We are proposing to implement an innovative strategy to accelerate the elimination of cervical cancer in Rwanda consisting of concomitant HPV vaccination and HPV screening for young women aged 23-29 years old
HPV screening and vaccination are complementary preventive options often implemented as separate public health programs This project proposal aims to address this disconnect by combining both strategies with the ultimate purpose of accelerating the reduction of cervical cancer incidence and mortality in Rwanda and making the programs both cost-effective and sustainable
Primary objective
The study aims to evaluate whether organized concomitant HPV vaccination and HPV screening offered to girls and women aged 23-29 years will result in more rapid elimination of HPV infections in the target districts in Rwanda
The study design is a before-after study design of the intervention where the projected incidences and prevalence at the 2-year follow-up visit are modeled using the data from the baseline visit with evaluation using Observedexpected numbers
Secondary objectives
The study will evaluate whether concomitant vaccination and cervical screening result in an improved efficiency andor safety of the cervical cancer screening program These objectives will be examined among women who participated in the combined screening and vaccination study
i Protection of Gardasil 9 against HPV infection and against CIN2 by Gardasil 9 HPV vaccine types in 23 to 29-year-old women from the study districts This analysis will be performed every 2 years and the first analysis will determine the effectiveness of one-dose vaccination incident infections of HPV vaccine types at 2 years whereas all subsequent analysis will determine the effect of 2-dose vaccinations The study will be powered to detect a decline in invasive cervical cancer among the study participants using the cervical cancer incidence in the surrounding districts of Rwanda as the reference
ii Efficiency will also be measured by the yield of histopathologically confirmed high-grade cervical cancer precursors or cancer cervical intraepithelial neoplasia grade 2 3 or cervical cancer in relation to the consumption of resources and convenience for the women using the yield at the baseline visit 10 of women tested as the comparator The hypothesis is that 2 years after vaccination there will be only a few incident infections only some old persistent infections resulting in high PPV and high yield of CIN2 at modest consumption of resources
End of the study
One screening interval 2 years after the last visit of the last subject defined as the day the last study subject receives her second vaccination
The study will be implemented in 4 districts of Rwanda covering 100000 women aged 23 to 29 years old We will use Gardasil 9 the HPV the second generation HPV Vaccine manufactured by Merck
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None