The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
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 model the comparative cost-effectiveness of the two screening and treatment
 strategies.

 2,000 HIV positive women 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 are HPV positive 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. All women who
 were HPV-positive (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.
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)