Cervical CancerELEVATE ASNCT06136702
ELEVATE Acceptability Study
A study testing Educational session, Self-sampling and Follow-up assessment in people with Cervical Cancer and HPV Infection, run by University Ghent at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, HPV Infection, Acceptability of Health Care
- What is being tested?
- Educational session, Self-sampling and Follow-up assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,048 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 7 Dec 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- younger than 25 years old or older than 65 years old
- diagnosed or in treatment for cervical cancer
- having had a hysterectomy
- being pregnant
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Belgium1 site
- Completed
International centre for reproductive health
Ghent, East-Flanders, 9000
Brazil1 site, 1 recruiting
- Not yet recruiting
Barretos Cancer Hospital - Fundação Pio XII
Barretos
Adhemar Longatto Filho, longatto@med.uminho.pt
Priscila Grecca Pedrão
Portugal1 site, 1 recruiting
- Recruiting
Escola Nacional de Saúde Pública da Universidade NOVA de Lisboa
Lisbon
Sónia Dias, 217512100, sonia.dias@ensp.unl.pt
Sónia Dias
About this study
Official title: EarLy dEtection of cerVical cAncer in Hard-to-reach Populations of Women Through Portable and Point-of-care HPV TEsting Acceptability Study
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).
Read the 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).
- Conditions
- Cervical Cancer, HPV Infection, Acceptability of Health Care
- Being tested
- Educational session, Self-sampling, Follow-up assessment
- Keywords
- cervical cancer, screening, self-sampling, HPV, acceptability, hard-to-reach, underscreened, community-based
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational sessionBehavioural
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.
Self-samplingBehavioural
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.
Follow-up assessmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational session and follow-up assessment | Active comparator | 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 Receives: Behavioral: Educational session; Behavioral: Follow-up assessment |
| Educational session, self-sampling and follow-up assessment | Experimental | 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. In addition, 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. The researcher will collect all samples for analysis by an HPV test in a lab. Sample analysis is expected to take 2 weeks time. Receives: Behavioral: Educational session; Behavioral: Self-sampling; Behavioral: Follow-up assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of cervical cancer screening
Compare the on-site uptake of self-sampling (arm2) with uptake of standard care (follow-up of arm1)
Measured: First encounter (day 0) and 3 months follow-up (day 90)
Secondary outcomes (2)
Attitudes towards HPV self-sampling
Attitudes towards self-sampling: reasons to accept/decline the self-sample; advantages and disadvantages versus conventional screening.
Measured: First encounter (day 0)
User's experiences of HPV self-sampling
User experiences among those who took a self-sample (easy/difficult; painless/painfull; trustworthy/untrusty; etc.)
Measured: First encounter (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start7 Dec 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal
- Masking
- None (open label)
- Enrolment
- 1,048 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon 2020 - European Commission, Universidade Nova de Lisboa, Universidad de Cuenca, Hospital de Cancer de Barretos - Fundacao Pio XII
- Responsible party
- Sponsor
- Investigators
- Bernardo Vega Crespo, Principal investigator, Universidad de CuencaAdhemar Longatto, Principal investigator, Barretos Cancer HospitalSónia Dias, Principal investigator, Universidade Nova de LisboaOlivier Degomme, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136702
- Sponsor's protocol ID
- ONZ-2022-0326
- Acronym
- ELEVATE AS
- Status last verified
- Nov 2023
- First submitted
- 20 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EarLy dEtection of cerVical cAncer in Hard-to-reach Populations of Women Through Portable and Point-of-care HPV TEsting Acceptability Study
- ClinicalTrials.gov ID
- NCT06136702
- Acronym / sponsor ID
- ELEVATE AS / ONZ-2022-0326
- Conditions
- Cervical Cancer, HPV Infection, Acceptability of Health Care
- Keywords
- cervical cancer, screening, self-sampling, HPV, acceptability, hard-to-reach, underscreened, community-based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,048 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Horizon 2020 - European Commission, Universidade Nova de Lisboa, Universidad de Cuenca, Hospital de Cancer de Barretos - Fundacao Pio XII
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Nov 2023 (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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Longitudinal
| Arm | Type | Receives |
|---|---|---|
| Educational session and follow-up assessment | Active comparator | Behavioral: Educational session, Behavioral: Follow-up assessmentA 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 |
| Educational session, self-sampling and follow-up assessment | Experimental | Behavioral: Educational session, Behavioral: Self-sampling, Behavioral: Follow-up assessmentA community-based researcher will educate women about sexual health and cervical cancer by using the materials that will be developed by the ELEVATE team. In addition, 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. The researcher will collect all samples for analysis by an HPV test in a lab. Sample analysis is expected to take 2 weeks time. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- younger than 25 years old or older than 65 years old
- diagnosed or in treatment for cervical cancer
- having had a hysterectomy
- being pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational sessionA 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. | Behavioural | Educational session and follow-up assessment, Educational session, self-sampling and follow-up assessment |
| Self-samplingWomen 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. | Behavioural | Educational session, self-sampling and follow-up assessment |
| Follow-up assessmentTo 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. | Behavioural | Educational session and follow-up assessment, Educational session, self-sampling and follow-up assessment |
Primary outcome
Uptake of cervical cancer screening
Time frame: First encounter (day 0) and 3 months follow-up (day 90)
Compare the on-site uptake of self-sampling (arm2) with uptake of standard care (follow-up of arm1)
2 secondary outcomes
Attitudes towards HPV self-sampling
Time frame: First encounter (day 0)
User's experiences of HPV self-sampling
Time frame: First encounter (day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Bernardo Vega Crespo principal investigator
Universidad de Cuenca
Adhemar Longatto principal investigator
Barretos Cancer Hospital
Sónia Dias principal investigator
Universidade Nova de Lisboa
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational session, Self-sampling and Follow-up assessment in people with Cervical Cancer and HPV Infection, run by University Ghent at 4 sites in 4 countries.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Brazil, Ecuador, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heleen Vermandere, PhD (+32-9-332.35.64, heleen.vermandere@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of cervical cancer screening (time frame: First encounter (day 0) and 3 months follow-up (day 90)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.