Trial Title:
ELEVATE Acceptability Study
NCT ID:
NCT06136702
Condition:
Cervical Cancer
HPV Infection
Acceptability of Health Care
Conditions: Official terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Conditions: Keywords:
cervical cancer
screening
self-sampling
HPV
acceptability
hard-to-reach
underscreened
community-based
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Longitudinal
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Educational session
Description:
A community-based researcher will educate women about sexual health and cervical cancer
by using the materials that will be developed by the ELEVATE team. Women will be informed
about cervical cancer screening (pap smear) and about where they can obtain these
services off-site (health facilities). Furthermore, a self-administrated questionnaire is
applied to assess current knowledge, willingness to get screened (clinically collected
sample) and uptake.
Arm group label:
Educational session and follow-up assessment
Arm group label:
Educational session, self-sampling and follow-up assessment
Intervention type:
Behavioral
Intervention name:
Self-sampling
Description:
Women will receive information about self-sampling and will be instructed by the
community-based researcher on how to take a self-sample using an illustrative cartoon.
Women will then be invited to take a sample on-site, to measure the uptake of the
self-sampling test (% of women who take the self-sample). Furthermore, two
self-administrated questionnaires are applied to 1) assess attitudes regarding
self-sampling (pre-intervention), and 2) assess users' experience regarding self-sampling
(post-intervention). The researcher will collect all samples for analysis by an HPV test
in a lab. Sample analysis is expected to take 2 weeks time. All women will be contacted
1-2 weeks after the self-sample taking to inform them on their test result.
Arm group label:
Educational session, self-sampling and follow-up assessment
Intervention type:
Behavioral
Intervention name:
Follow-up assessment
Description:
To gauge the knowledge on cervical cancer screening after the educational session and to
verify whether they got a pap smear, a 3-month follow-up is proposed for all women
receiving an educational session (arm 1) and all women receiving an educational session
and a self-sample (arm 2), because all women, whether or not invited for self-sampling,
are provided information on where to get screened, although there is no formal referral
to screening services.
Arm group label:
Educational session and follow-up assessment
Arm group label:
Educational session, self-sampling and follow-up assessment
Summary:
This study includes a community-based, two-arm prospective acceptability study, whereby
arm 1 consists of an educational session on sexual health and cervical cancer (screening)
and a follow-up assessment after 3 months. Arm 2 consists of an educational session on
sexual health and cervical cancer (screening) and self-sampling, additionally women will
be asked to take a self-sample on-site, followed by a follow-up assessment after 3
months. Attitudes, uptake and users' experiences related to the use of a HPV
self-sampling test will be assessed, additionally, the impact on looking for follow up
care of self-sampling with standard cervical screening strategies will be assessed and
finally the feasibility of an HPV self-sampling in hard-to-reach groups versus
educational sessions and standard care will be compared (arm 1 and 2).
Detailed description:
ELEVATE, a five-year project conducted by an international research alliance led by Ghent
University, aims to develop a new test and approach for cervical cancer screening in
hard-to-reach populations. The test will combine self-sampling with a new low-cost,
portable measurement device and will be validated in dedicated screening trials in
Belgium, Brazil, Ecuador, and Portugal. The ELEVATE project targets women in Europe and
Latin America who have never been screened or are not regularly screened. These women
have a higher risk of developing cervical cancer. The project is supported by the
European Union's Horizon 2020 Framework Programme for Research and Innovation Action,
project number 825747.
To address the gaps in cervical cancer screening, the ELEVATE project is developing a
screening strategy to make cervical screening more accessible to hard-to-reach women.
This strategy will include the introduction of a new on-site HPV self-sampling screening
tool and a portable testing device, able to detect the presence of HPV and cancer
biomarker proteins. This portable, low-cost, on-site HPV testing tool will allow to
streamline follow-up care for women at risk of developing cervical cancer.
This study is part of the ELEVATE project and takes place in hard-to-reach communities,
focusing on socio-economically vulnerable women to assess the acceptability of
educational sessions and self-sampling in these communities. This study includes a
two-arm prospective acceptability study, whereby arm 1 consists of an educational session
on sexual health and cervical cancer (screening) and a follow-up assessment after 3
months. Arm 2 consists of an educational session on sexual health and cervical cancer
(screening) and self-sampling, additionally women will be asked to take a self-sample
on-site, followed by a follow-up assessment after 3 months. Attitudes, uptake and users'
experiences related to the use of a HPV self-sampling test will be assessed,
additionally, the impact on looking for follow up care of self-sampling with standard
cervical screening strategies will be assessed and finally the feasibility of an HPV
self-sampling in hard-to-reach groups versus educational sessions and standard care will
be compared (arm 1 and 2).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- are between the ages of 25 to 65 years of age, in line with the European Guidelines
for initiating and stopping cervical cancer screening
- (ever been) sexually active;
- not diagnosed or in treatment for cervical cancer;
- not having had a hysterectomy
- not being pregnant
- Speaking the local language
Exclusion Criteria:
- younger than 25 years old or older than 65 years old
- diagnosed or in treatment for cervical cancer
- having had a hysterectomy
- being pregnant
Gender:
Female
Minimum age:
25 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
International centre for reproductive health
Address:
City:
Ghent
Zip:
9000
Country:
Belgium
Status:
Completed
Facility:
Name:
Barretos Cancer Hospital - Fundação Pio XII
Address:
City:
Barretos
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Adhemar Longatto Filho
Email:
longatto@med.uminho.pt
Investigator:
Last name:
Priscila Grecca Pedrão
Email:
Sub-Investigator
Investigator:
Last name:
Anna Karolina da Silva Oliveira
Email:
Sub-Investigator
Investigator:
Last name:
Ricardo dos Reis
Email:
Sub-Investigator
Investigator:
Last name:
Rui Manuel Reis
Email:
Sub-Investigator
Investigator:
Last name:
Adhemar Longatto Filho
Email:
Principal Investigator
Facility:
Name:
Universidad de Cuenca
Address:
City:
Cuenca
Country:
Ecuador
Status:
Completed
Facility:
Name:
Escola Nacional de Saúde Pública da Universidade NOVA de Lisboa
Address:
City:
Lisboa
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Sónia Dias
Phone:
217512100
Email:
sonia.dias@ensp.unl.pt
Investigator:
Last name:
Sónia Dias
Email:
Principal Investigator
Investigator:
Last name:
Ana Gama
Email:
Sub-Investigator
Start date:
December 7, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
University Ghent
Agency class:
Other
Collaborator:
Agency:
Horizon 2020 - European Commission
Agency class:
Other
Collaborator:
Agency:
Universidade Nova de Lisboa
Agency class:
Other
Collaborator:
Agency:
Universidad de Cuenca
Agency class:
Other
Collaborator:
Agency:
Hospital de Cancer de Barretos - Fundacao Pio XII
Agency class:
Other
Source:
University Ghent
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06136702
