HPV Infection
Conditions
Keywords
VIA triage, HIV serostatus
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.
Interventions
DIAGNOSTIC_TESTHPV DNA Test
Screening for HPV using a HPV DNA test
DIAGNOSTIC_TESTVIA triage test
VIA is a technique in which cervical neoplastic lesions are visually diagnosed after application of 3-5% acetic acid without using any magnification device. After application of 3 - 5% acetic acid, using the naked eye, the cervix is examined for the presence of an aceto-white lesion located in the transformation zone. The results are classified as either positive or negative, inadequate or suspicion of cancer
PROCEDURETreatment by ablative treatment
Cryotherapy or Thermal Ablation are performed on the cervix.
PROCEDUREColposcopy
Colposcopy visit are offered to women with non visible squamous columnar junction or ineligible for ablative treatment.
Sponsors
World Health Organization
University of KwaZulu
Cheikh Anta Diop University, Senegal
Walter Sisulu University
International Agency for Research on Cancer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Caregiver)
Masking description
Care providers and participants are masked to the intervention ahead of the intervention. However, the strategy delivery is not blinded.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 54 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of women treated with high grade lesions in both arms | up top 1 month |
| Percentage of women treated with low grade lesions in both arms | up to 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistence of HPV infection and lesions at one year | up to 14 months | all HPV positive women at screening will be asked to come back at one year to be tested for HPV. HPV positive women at one year will be refered to colposcopy and biopsies will be taken |
Countries
Senegal, South Africa
Outcome results
None listed