ELEVATE Acceptability Study

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).

Conditions

• Cervical Cancer
• HPV Infection
• Acceptability of Health Care

Interventions

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.

Sponsors & Collaborators

• Horizon 2020 - European Commission

  collaborator OTHER

• Universidade Nova de Lisboa

  collaborator OTHER

• Universidad de Cuenca

  collaborator OTHER

• Hospital de Cancer de Barretos - Fundacao Pio XII

  collaborator OTHER

• University Ghent

  lead OTHER

Principal Investigators

• Bernardo Vega Crespo · Universidad de Cuenca

• Adhemar Longatto · Barretos Cancer Hospital

• Sónia Dias · Universidade Nova de Lisboa

• Olivier Degomme · University Ghent

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-07

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Belgium
• Brazil
• Ecuador
• Portugal

Study Locations