ELEVATE AS: ELEVATE Acceptability Study

Sponsor

University Ghent (Other)

Overall Status

Recruiting

CT.gov ID

NCT06136702

Collaborator

Horizon 2020 - European Commission (Other), Universidade Nova de Lisboa (Other), Universidad de Cuenca (Other), Hospital de Cancer de Barretos - Fundacao Pio XII (Other)

1,048

Enrollment

Locations

Arms

23.8

Anticipated Duration (Months)

262

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer HPV Infection Acceptability of Health Care	Behavioral: Educational session Behavioral: Self-sampling Behavioral: Follow-up assessment	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

1048 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

LongitudinalLongitudinal

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

EarLy dEtection of cerVical cAncer in Hard-to-reach Populations of Women Through Portable and Point-of-care HPV TEsting Acceptability Study

Actual Study Start Date :

Dec 7, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Educational session and follow-up assessment 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	Behavioral: Educational session 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. Behavioral: Follow-up assessment 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.
Experimental: Educational session, self-sampling and follow-up assessment 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.	Behavioral: Educational session 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. Behavioral: Self-sampling 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. Behavioral: Follow-up assessment 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

Intervention/Treatment

Active Comparator: Educational session and follow-up assessment

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

Behavioral: Educational session

Behavioral: Follow-up assessment

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.

Experimental: Educational session, self-sampling and follow-up assessment

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.

Behavioral: Educational session

Behavioral: Self-sampling

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.

Behavioral: Follow-up assessment

Outcome Measures

Primary Outcome Measures

Uptake of cervical cancer screening [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)

Secondary Outcome Measures

Attitudes towards HPV self-sampling [First encounter (day 0)]
Attitudes towards self-sampling: reasons to accept/decline the self-sample; advantages and disadvantages versus conventional screening.
User's experiences of HPV self-sampling [First encounter (day 0)]
User experiences among those who took a self-sample (easy/difficult; painless/painfull; trustworthy/untrusty; etc.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International centre for reproductive health	Ghent	East-Flanders	Belgium	9000
2	Barretos Cancer Hospital - Fundação Pio XII	Barretos		Brazil
3	Universidad de Cuenca	Cuenca		Ecuador
4	Escola Nacional de Saúde Pública da Universidade NOVA de Lisboa	Lisboa		Portugal