Acceptability of HPV Self-Sampling for Cervical Cancer Screening
EarLy dEtection of cerVical cAncer in Hard-to-reach Populations of Women Through Portable and Point-of-care HPV TEsting Acceptability Study
NA · University Ghent · NCT06136702
This study is testing whether women from low-income backgrounds find it easy and acceptable to use a self-sampling method for HPV testing to help with cervical cancer screening.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1048 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | Female |
| Sponsor | University Ghent (other) |
| Locations | 4 sites (Ghent, East-Flanders and 3 other locations) |
| Trial ID | NCT06136702 on ClinicalTrials.gov |
What this trial studies
The ELEVATE Acceptability Study is a community-based, two-arm prospective study aimed at assessing the acceptability of HPV self-sampling for cervical cancer screening among socio-economically vulnerable women. Participants in Arm 1 will receive an educational session on sexual health and cervical cancer, followed by a follow-up assessment after three months. Arm 2 will include the same educational session, but participants will also perform a self-sampling test on-site. The study will evaluate attitudes, uptake, and user experiences related to self-sampling, as well as its feasibility compared to standard care in hard-to-reach populations across Belgium, Brazil, Ecuador, and Portugal.
Who should consider this trial
Good fit: Ideal candidates are women aged 25 to 65 who are sexually active and have not been diagnosed with cervical cancer.
Not a fit: Patients who have been diagnosed with cervical cancer, have had a hysterectomy, or are currently pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve cervical cancer screening rates and early detection among women who are currently underserved.
How similar studies have performed: Other studies have shown promise in using self-sampling for HPV testing, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent, East-Flanders and 3 other locations
- International centre for reproductive health — Ghent, East-Flanders, 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 — Lisboa, Portugal (RECRUITING)
Study contacts
- Principal investigator: Bernardo Vega Crespo — Universidad de Cuenca
- Study coordinator: Heleen Vermandere, PhD
- Email: heleen.vermandere@ugent.be
- Phone: +32-9-332.35.64
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Cancer, HPV Infection, Acceptability of Health Care, cervical cancer, screening, self-sampling, HPV, acceptability