Clinical trial NCT06136702: ELEVATE Acceptability Study
Official title: EarLy dEtection of cerVical cAncer in Hard-to-reach Populations of Women Through Portable and Point-of-care HPV TEsting Acceptability Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
HPV Infection
Acceptability of Health Care
Keywords: cervical cancer
screening
self-sampling
HPV
acceptability
hard-to-reach
underscreened
community-based
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Horizon 2020 - European Commission
name: Universidade Nova de Lisboa
name: Universidad de Cuenca
name: Hospital de Cancer de Barretos - Fundacao Pio XII
First posted: 2023-11-18
Enrollment: 1048
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal
Primary purpose: PREVENTION

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of cervical cancer screening
timeFrame: First encounter (day 0) and 3 months follow-up (day 90)
Secondary outcomes:
measure: Attitudes towards HPV self-sampling
timeFrame: First encounter (day 0)
measure: User's experiences of HPV self-sampling
timeFrame: First encounter (day 0)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: International centre for reproductive health
state: East-Flanders
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital - Fundação Pio XII
city: Cuenca
country: Ecuador
facility: Universidad de Cuenca
city: Lisboa
country: Portugal
facility: Escola Nacional de Saúde Pública da Universidade NOVA de Lisboa
Study officials:
affiliation: Universidad de Cuenca
name: Bernardo Vega Crespo
role: PRINCIPAL_INVESTIGATOR
affiliation: Barretos Cancer Hospital
name: Adhemar Longatto
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Nova de Lisboa
name: Sónia Dias
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Olivier Degomme
role: PRINCIPAL_INVESTIGATOR
References: