The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa" (CESTA)

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    1500
  • sponsor
    International Agency for Research on Cancer
Updated on 19 April 2022
Accepts healthy volunteers

Summary

The main objectives of CESTA are (1) to compare the efficacy of two cervical cancer screening algorithms: HPV test followed by visual inspection with acetic acid (VIA) and treatment (HPV + VIA + treat) and HPV test followed by immediate treatment (HPV + treat). The study will be conducted to address its objectives in women living with HIV (from now on called HIV positive women); and 2) To evaluate the performance of other techniques for primary screening and as triage for HPV positives WLHIV.

1,500 women living with HIV WLHIV will be recruited from HIV care clinics, also called antiretrovirals (ARV) clinics in South Africa. After giving informed consent, women will be screened with HPV testing and those that have a HPV positive test will be randomized at a 4:1 ratio into HPV + VIA + treat (Arm 1) and HPV + treat (Arm 2). Women in Arm 1 will receive VIA and only positive for VIA will be treated. In Arm 2, all HPV positive women will be treated. Women that are eligible for ablative treatment will be randomized into treatment with TA or cryotherapy in both arms. Others will be referred to colposcopy. After VIA in Arm 1 or before treatment in Arm 2, the nurses will collect 2-4 biopsies on all HPV positive women. The biopsies will be used as gold standard for disease detection. Treated women will be called by telephone after 1 week and 1 month to assess side-effects and satisfaction with the procedures. Cervical samples from women will be tested with HPV DNA test and HPV mRNA test to evaluate different screening tests for WLHIV. All women with a positive HPV test (treated or not) will be called back after 1 year for a follow-up visit. At this visit, women will be screened with HPV testing and VIA and 2-4 colposcopy-directed biopsies will be taken from all HPV positive women. Women with remaining/recurrent CIN2+ disease will receive appropriate management.

Details
Condition HPV Infection
Treatment colposcopy, Screening and treatment algorithm, HPV test + VIA triage + Ablative treatment, HPV test + Ablative treatment, HPV DNA Test, HPV DNA Test, VIA triage test, Treatment by ablative treatment
Clinical Study IdentifierNCT04794660
SponsorInternational Agency for Research on Cancer
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Willing to disclose HIV status
HIV negative women aged 30-54 years; HIV positive women aged 25-54 years
Mentally competent to give informed consent
Physically able to have a pelvic exam

Exclusion Criteria

Women reporting no previous sexual activity
History of cervical cancer
Treatment for cervical precancer in the last six months
Hysterectomy
Pregnancy
Serious pre-existing medical conditions (e.g. history of bleeding disorders, serious physical or mental disease)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note