Primary HPV-based Cervical Cancer Screening Algorithms in Botswana

Beth Israel Lahey Health

Status: Active, not recruiting

Conditions: Prevention; Cervical Cancer

Treatments: Diagnostic Test: 8-type HPV genotype restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT04242823

2019P001130

Details and patient eligibility

About

Primary high-risk human papillomavirus (HPV) testing has become first line screening for cervical cancer in high-income countries. The feasibility of this approach in low- and middle-income countries (LMICs) is less clear, as is the role of HPV testing among women living with human immunodeficiency virus (HIV). The proposed study seeks to evaluate the accuracy of cervical cancer screening algorithms using primary HPV testing followed by various forms of visual evaluation, including visual inspection with acetic acid (VIA), colposcopy and automated visual evaluation (AVE) for the detection of high-grade cervical dysplasia, using histology as the gold standard. We will validate the AmpFire Assay for HPV self-sampling in our setting. We will determine safe screening intervals in women living with HIV (WLHIV) in an HPV-based cervical cancer screening program and compare triage strategies for positive HPV results at WHO recommended screening intervals for WLHIV. We also seek to understand in-depth the attitudes, acceptability and preferences regarding cervical cancer screening, HPV testing, and self-sampling, for women in Botswana through interviews of a sub-set of women recruited for the cervical cancer screening study. Finally, we will analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.

Enrollment: 3,000 patients

Sex: Female

Ages: 25 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Cis-gender female or transgender male (must have a cervix)
2. ≥25 years of age
3. Competent to understand study procedures and give informed consent.

Exclusion criteria

1. Currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy)
2. Previous hysterectomy
3. Previous diagnosis of cervical cancer

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,000 participants in 1 patient group

Baseline screening cohort

Other group

Description:

This group undergoes HPV testing using self-collected swabs. Triage evaluation occurs in all women who test HPV positive which includes visual inspection with acetic acid and colposcopy. The WLHIV in the cohort who test HPV positive at baseline but who have concurrent benign histopathology results will be invited back for re-screening at a 2-year interval, and undergo similar HPV testing and triage procedures. The WLHIV in the cohort who test HPV negative at baseline will be invited back for re-screening at a 3-year interval and undergo similar HPV testing and triage procedures.

Treatment:

Diagnostic Test: 8-type HPV genotype restriction