Clinical trial NCT04794660: The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
Official title: The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: HPV Infection
Keywords: VIA triage
HIV serostatus
Lead sponsor: International Agency for Research on Cancer
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: University of KwaZulu
name: Cheikh Anta Diop University, Senegal
name: Walter Sisulu University
First posted: 2021-03-12
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of women treated with high grade lesions in both arms
timeFrame: up top 1 month
measure: Percentage of women treated with low grade lesions in both arms
timeFrame: up to 1 month
Secondary outcomes:
measure: Persistence of HPV infection and lesions at one year
timeFrame: up to 14 months
Other outcomes:
Locations:
city: Dakar
country: Senegal
facility: Roi Baudoin hospital
city: Durban
country: South Africa
facility: Wentworth Hospital
city: East London
country: South Africa
facility: Frere Hospital
Study officials:
affiliation: World Health Organization
name: Nathalie Broutet, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: IARC
name: Maribel Almonte, Dr
role: PRINCIPAL_INVESTIGATOR
References: