ELEVATE Acceptability Study (ELEVATE AS)

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).

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; HPV Infection; Acceptability of Health Care
• Intervention / Treatment: Behavioral: Educational session; Behavioral: Follow-up assessment; Behavioral: Self-sampling

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 Type: Interventional
• Enrollment (Estimated): 1048
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heleen Vermandere, PhD; Phone Number: +32-9-332.35.64; Email: heleen.vermandere@ugent.be
• Study Contact Backup: Name: Marie Hendrickx, MSC; Phone Number: +32-9-332.35.64; Email: marie.hendrickx@ugent.be

Study Locations

• Belgium
  • East-Flanders
    • Ghent, East-Flanders, Belgium, 9000
      • Completed
      • International centre for reproductive health
• Brazil
  • Barretos, Brazil
    • Not yet recruiting
    • Barretos Cancer Hospital - Fundação Pio XII
    • Contact: Adhemar Longatto Filho; Email: longatto@med.uminho.pt
    • Sub-Investigator: Priscila Grecca Pedrão
    • Sub-Investigator: Anna Karolina da Silva Oliveira
    • Sub-Investigator: Ricardo dos Reis
    • Sub-Investigator: Rui Manuel Reis
    • Principal Investigator: Adhemar Longatto Filho
• Ecuador
  • Cuenca, Ecuador
    • Completed
    • Universidad de Cuenca
• Portugal
  • Lisboa, Portugal
    • Recruiting
    • Escola Nacional de Saúde Pública da Universidade NOVA de Lisboa
    • Contact: Sónia Dias; Phone Number: 217512100; Email: sonia.dias@ensp.unl.pt
    • Principal Investigator: Sónia Dias
    • Sub-Investigator: Ana Gama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of cervical cancer screening	Compare the on-site uptake of self-sampling (arm2) with uptake of standard care (follow-up of arm1)	First encounter (day 0) and 3 months follow-up (day 90)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attitudes towards HPV self-sampling	Attitudes towards self-sampling: reasons to accept/decline the self-sample; advantages and disadvantages versus conventional screening.	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.)	First encounter (day 0)

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Universidade Nova de Lisboa; Horizon 2020 - European Commission; Hospital de Cancer de Barretos - Fundacao Pio XII; Universidad de Cuenca
• Investigators: Principal Investigator: Bernardo Vega Crespo, Universidad de Cuenca; Principal Investigator: Adhemar Longatto, Barretos Cancer Hospital; Principal Investigator: Sónia Dias, Universidade Nova de Lisboa; Principal Investigator: Olivier Degomme, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: screening; community-based; HPV; cervical cancer; self-sampling; acceptability; hard-to-reach; underscreened
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Papillomavirus Infections
• Other Study ID Numbers: ONZ-2022-0326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No