Clinical Trial Comparing the Self-test for Cervicovaginal Sample Versus Samples From Service Provider (Xyto-Ro)

Problem Description When cervical cancer screening is needed, the Pap test (or Pap smears) is still the most common, although there are challenges that continue to prevent effective screening services in many countries, poor quality testing, long delays until screening is available, they give the results to women, poor population coverage and insufficient follow-up treatment. HPV testing can remove barriers related to access to screening services, since the woman can obtain the sample herself. Women's self-sampling for HPV testing has been used in a programmatic context in some countries. For a good impact, screening coverage must reach at least 70% of the target population. In the Region of the Americas, only seven countries have reported this level of coverage, so there is a great need for improvement. Several factors make it difficult to improve coverage: most screening programs are unorganized, available mainly in urban areas, and based on the Pap test, which has been shown to have low sensitivity, limited and requires multiple consultations. However, screening alone is not enough to prevent cervical cancer. Follow-up treatment of women with abnormal screening test results is necessary and remains a challenge. Main objective To evaluate the effectiveness of cervicovaginal self-test in comparison with direct sampling by the service provider, for the identification of HR-HPV DNA via real-time PCTR and triage with dual staining biomarker p16 \& ki67. Methodology Under inclusion and exclusion criteria and signed informed consent, cervical sample will be taken with the corresponding method according to the randomization (self-test or service provider) and certify that the device did not cause damage or lacerations in the vaginal canal. In addition, an acceptability survey will be completed. All women with positive p16 \& ki67 will be referred for colposcopy and biopsy. Patients will be informed her results with a specialist physician for guidance and indications. Clinical study design is crossover, monocentric, randomized, open, and non-inferiority. Statistical differences between self-test and service rpovider will be assesed.

Sex

Female

Minimum age

25 Years

Maximum age

64 Years

Inclusion Criteria:

* Signature of informed consent
* Women with an active sex life
* Women 25 to 64 years old
* Patients without hysterectomy, conization of the cervix.
* Patients without radiotherapy treatment, cervical chemotherapy.
* 24 hours before taking the sample, they should not use douches, ovules, lubricants or gels.

Exclusion Criteria:

* Patients who have not started a sexual life
* Patients with uterine surgery.
* Patients pregnant.
* Patients with vaginal bleeding.
* Patients who have had sexual activity 24 hours prior to taking the sample.