EarLy dEtection of cerVical cAncer in Hard-to-reach Populations of Women Through Portable and Point-of-care HPV TEsting Acceptability Study

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Belgium
International centre for reproductive health
COMPLETED
Ghent
Brazil
Barretos Cancer Hospital - Fundação Pio XII
NOT_YET_RECRUITING
Barretos
Ecuador
Universidad de Cuenca
COMPLETED
Cuenca
Portugal
Escola Nacional de Saúde Pública da Universidade NOVA de Lisboa
RECRUITING
Lisbon
Contact Information
Primary
Heleen Vermandere, PhD
heleen.vermandere@ugent.be
+32-9-332.35.64
Backup
Marie Hendrickx, MSC
marie.hendrickx@ugent.be
+32-9-332.35.64
Time Frame
Start Date: 2022-12-07
Estimated Completion Date: 2024-12
Participants
Target number of participants: 1048
Treatments
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
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.
Sponsors
Collaborators: Universidad de Cuenca, Universidade Nova de Lisboa, Horizon 2020 - European Commission, Hospital de Cancer de Barretos - Fundacao Pio XII
Leads: University Ghent

This content was sourced from clinicaltrials.gov