ELEVATE Acceptability Study

NCT06136702 | Unknown

• 1 other identifier: ONZ-2022-0326
• Study Type: interventional
• Target: 1,048
• Locations: 4 countries
• Sites: 4

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).

Conditions

Cervical Cancer; HPV Infection; Acceptability of Health Care

Keywords

cervical cancer; screening; self-sampling; HPV; acceptability; hard-to-reach; underscreened; community-based

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Attitudes towards HPV self-sampling

  First encounter (day 0)

• User's experiences of HPV self-sampling

  First encounter (day 0)

Study Arms (2)

Educational session and follow-up assessment

ACTIVE COMPARATOR

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

Educational session, self-sampling and follow-up assessment

EXPERIMENTAL

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; Behavioral: Follow-up assessment

Interventions

Educational session BEHAVIORAL

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 and follow-up assessment; Educational session, self-sampling and follow-up assessment

Self-sampling BEHAVIORAL

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.

Educational session, self-sampling and follow-up assessment

Follow-up assessment BEHAVIORAL

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.

Educational session and follow-up assessment; Educational session, self-sampling and follow-up assessment

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• younger than 25 years old or older than 65 years old
• diagnosed or in treatment for cervical cancer
• having had a hysterectomy
• being pregnant

Sponsors & Collaborators

• University Ghent: lead
• Horizon 2020 - European Commission: collaborator
• Universidade Nova de Lisboa: collaborator
• Universidad de Cuenca: collaborator
• Hospital de Cancer de Barretos - Fundacao Pio XII: collaborator

Study Sites (4)

International centre for reproductive health

Ghent, East-Flanders, 9000, Belgium

COMPLETED

Barretos Cancer Hospital - Fundação Pio XII

Barretos, Brazil

NOT YET RECRUITING

Universidad de Cuenca

Cuenca, Ecuador

COMPLETED

Escola Nacional de Saúde Pública da Universidade NOVA de Lisboa

Lisbon, Portugal

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heleen Vermandere, PhD

CONTACT

+32-9-332.35.64; heleen.vermandere@ugent.be

Marie Hendrickx, MSC

CONTACT

+32-9-332.35.64; marie.hendrickx@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 18, 2023
• Study Start: December 7, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

BE (1); EC (1); BR (1); PT (1)