Trial Title:
Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)
NCT ID:
NCT06129253
Condition:
HPV Infection
Conditions: Official terms:
Papillomavirus Infections
Conditions: Keywords:
HPV Positivity
HPV Infection
High Risk (HR) HPV
Cervical Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Urine Sample Collection
Description:
When urine is collected as a sample in either CSS or LS, first flow urine samples will be
collected
Arm group label:
Cross-Sectional Survey
Arm group label:
Longitudinal Study
Intervention type:
Other
Intervention name:
Self-collected Vaginal Swab
Description:
Self-collected Vaginal Swab will be collected by the participant under the supervision of
a trained nurse or other health care worker.
Arm group label:
Longitudinal Study
Intervention type:
Other
Intervention name:
Blood Samples
Description:
If funding permits, a blood sample may be collected from participants in LS once during
the follow-up period. If blood sample collection was not feasible during a visit, two
additional attempts may be made to collect blood samples from LS participants during the
subsequent follow-up visits.
Arm group label:
Longitudinal Study
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 and/or create
barriers that shape girls/women 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
participants/group. Detailed qualitative study methodology will be developed separately
as another study protocol and adapted according to the procedures for each site.
Criteria for eligibility:
Study pop:
The study will enroll girls and women aged 9-50 years old, with equal distribution across
the following age strata: 9-14, 15-20, 21-30, and 31-50 years.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. 9 to 50 years old (for urban and rural CSSs) at the time of enrollment.
2. Resident in the selected community for at least the past 3 months (with the
exception of pastoralists, refugees, and commercial sex workers).
3. Able to understand the purpose of the study and study procedures.
4. If aged 18 years or older or legally considered an emancipated minor, able and
willing to provide consent to participate in the study including sample collection.
5. If aged <18 years (and not considered an emancipated minor), supported in their
participation by a parent or guardian who is able and willing to provide consent,
and
6. If aged <18 years (and not considered an emancipated minor), able and willing to
provide assent to participate in the study.
Exclusion Criteria:
1. Decline consent to participate any activity of the study.
2. A medical condition or other reason, not directly related to HPV infection or
HPV-related diseases, in the opinion of the investigator, precludes enrolment in the
study.
Gender:
Female
Minimum age:
9 Years
Maximum age:
50 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Diarrhoeal Disease Research, Bangladesh (icddr,b)
Address:
City:
Dhaka
Zip:
1212
Country:
Bangladesh
Status:
Recruiting
Contact:
Last name:
Quamrun Nahar
Phone:
+8801730317652
Email:
quamrun@icddrb.org
Facility:
Name:
Institut National pour la Recherche Biomedicale (INRB)
Address:
City:
Kinshasa
Country:
Congo, The Democratic Republic of the
Status:
Not yet recruiting
Contact:
Last name:
Hugo Kavunga
Phone:
+243823875153
Email:
hugokavunga@gmail.com
Facility:
Name:
University of Health and Allied Sciences (UHAS)
Address:
City:
Ho
Country:
Ghana
Status:
Not yet recruiting
Contact:
Last name:
Frank Baiden
Phone:
+233 (0) 362 196122
Email:
fbaiden@uhas.edu.gh
Facility:
Name:
Dhulikhel Hospital Kathmandu University Hospital (DHKUH)
Address:
City:
Dhulikhel
Zip:
45200
Country:
Nepal
Status:
Not yet recruiting
Contact:
Last name:
Sunila Shakya
Phone:
+97711490497
Email:
sunilashakya@kusms.edu.np
Facility:
Name:
Aga Khan University (AKU)
Address:
City:
Karachi
Zip:
74800
Country:
Pakistan
Status:
Not yet recruiting
Contact:
Last name:
Fyezah Jehan
Phone:
+922134864793
Email:
fyezah.jehan@aku.edu
Facility:
Name:
College of Medicine and Allied Health Sciences (COMAHS)
Address:
City:
Freetown
Country:
Sierra Leone
Status:
Not yet recruiting
Contact:
Last name:
Mohamed Samai
Phone:
+23278841262
Email:
dhmsamai@yahoo.com
Facility:
Name:
Mwanza Intervention Trial Unit (MITU)
Address:
City:
Mwanza
Zip:
11936
Country:
Tanzania
Status:
Not yet recruiting
Contact:
Last name:
John Changalucha
Phone:
+255(0)282500019
Email:
jchangalucha@yahoo.com
Facility:
Name:
ZAMBART
Address:
City:
Lusaka
Country:
Zambia
Status:
Not yet recruiting
Contact:
Last name:
Mwelwa Phiri
Phone:
+260211254710
Email:
mwelwa@zambart.org.zm
Start date:
November 23, 2023
Completion date:
December 2027
Lead sponsor:
Agency:
International Vaccine Institute
Agency class:
Other
Collaborator:
Agency:
London School of Hygiene and Tropical Medicine
Agency class:
Other
Collaborator:
Agency:
Karolinska Institutet
Agency class:
Other
Collaborator:
Agency:
Centers for Disease Control and Prevention
Agency class:
U.S. Fed
Source:
International Vaccine Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06129253
