Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| World Health Organization | OTHER |
| University of KwaZulu | OTHER |
| Cheikh Anta Diop University, Senegal | OTHER |
| Walter Sisulu University |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | In this arm, HPV-positive women will undergo a Visual Inspection with Acetic Acid (VIA) triage test followed by biopsies. Treatment by thermal ablation (or cryotherapy in South Africa) will be applied to VIA positive women eligible for ablative treatment. Non eligible women will be referred to colposcopy. |
|
| Arm 2 | Active Comparator | In this arm, HPV positive women will get biopsies and receive an ablative treatment by thermal ablation (or cryotherapy in South Africa) if they are eligible to ablative treatment. Non eligible women will be referred to colposcopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV DNA Test | Diagnostic Test | Screening for HPV using a HPV DNA test |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence of HPV infection and lesions at one year | 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 | up to 14 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nathalie Broutet, Dr | World Health Organization | Principal Investigator |
| Maribel Almonte, Dr | IARC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roi Baudoin hospital | Dakar | Senegal | ||||
| Wentworth Hospital |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 11, 2019 | Feb 16, 2021 |
Not provided
| OTHER |
Not provided
Not provided
Not provided
Care providers and participants are masked to the intervention ahead of the intervention. However, the strategy delivery is not blinded.
| VIA triage test |
| Diagnostic 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 |
|
| Treatment by ablative treatment | Procedure | Cryotherapy or Thermal Ablation are performed on the cervix. |
|
| Colposcopy | Procedure | Colposcopy visit are offered to women with non visible squamous columnar junction or ineligible for ablative treatment. |
|
| Durban |
| South Africa |
| Frere Hospital | East London | South Africa |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 11, 2019 | Feb 22, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D061809 | Human Papillomavirus DNA Tests |
| D003127 | Colposcopy |
| ID | Term |
|---|---|
| D025202 | Molecular Diagnostic Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
Not provided
Not provided