ELEVATE Acceptability Study

Not Applicable

Recruiting

• Conditions: Acceptability of Health Care; Cervical Cancer; HPV Infection
• Interventions: Behavioral: Educational session; Behavioral: Self-sampling; Behavioral: Follow-up assessment

• Registration Number: NCT06136702
• Lead Sponsor: University Ghent

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).

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 Timeline

• Study Start: 2022-12-07
• Study First Submitted: 2023-10-20
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-14
• Last Update Submitted: 2023-11-14
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1048

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational session and follow-up assessment	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
Educational session, self-sampling and follow-up assessment	Self-sampling	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.
Educational session and follow-up assessment	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
Educational session, self-sampling and follow-up assessment	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. 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.
Educational session, self-sampling and follow-up assessment	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.)

Trial Locations

Locations (4)

International centre for reproductive health; 🇧🇪 Ghent, East-Flanders, Belgium

Escola Nacional de Saúde Pública da Universidade NOVA de Lisboa; 🇵🇹 Lisboa, Portugal

Barretos Cancer Hospital - Fundação Pio XII; 🇧🇷 Barretos, Brazil

Universidad de Cuenca; 🇪🇨 Cuenca, Ecuador