ELEVATE Acceptability Study

NARecruitingINTERVENTIONAL
Enrollment

1,048

Participants

Timeline

Start Date

December 7, 2022

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Cervical CancerHPV InfectionAcceptability 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.

Trial Locations (4)

9000

COMPLETED

International centre for reproductive health, Ghent

Unknown

NOT_YET_RECRUITING

Barretos Cancer Hospital - Fundação Pio XII, Barretos

COMPLETED

Universidad de Cuenca, Cuenca

RECRUITING

Escola Nacional de Saúde Pública da Universidade NOVA de Lisboa, Lisbon

All Listed Sponsors
collaborator

Horizon 2020 - European Commission

OTHER

collaborator

Universidade Nova de Lisboa

OTHER

collaborator

Universidad de Cuenca

OTHER

collaborator

Hospital de Cancer de Barretos - Fundacao Pio XII

OTHER

lead

University Ghent

OTHER