Clinical trial · Interventional
ELEVATE Acceptability Study
EarLy dEtection of cerVical cAncer in Hard-to-reach Populations of Women Through Portable and Point-of-care HPV TEsting Acceptability Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acceptability of Health Care | — | UNRESOLVED | — |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational session | Behavioral | — | UNRESOLVED |
| Follow-up assessment | Behavioral | — | UNRESOLVED |
| Self-sampling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Educational session and follow-up assessment
- description
- 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
- interventionNames
- Behavioral: Educational session
- Behavioral: Follow-up assessment
- type
- EXPERIMENTAL
- label
- Educational session, self-sampling and follow-up assessment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available