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

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


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.

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


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
Serious pre-existing medical conditions (e.g. history of bleeding disorders, serious physical or mental disease)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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.

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

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