Clinical trial NCT04242823: Primary HPV-based Cervical Cancer Screening Algorithms in Botswana
Official title: Performance of Two-stage Cervical Cancer Screening Algorithms Using Primary High-risk Human Papillomavirus Testing in Botswana
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Cancer
Prevention
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: University of Botswana
name: Botswana Harvard AIDS Institute Partnership
First posted: 2020-01-27
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Compare the sensitivity, specificity, PPV and NPV of triage of primary human papillomavirus testing with automated visual evaluation to visual inspection with acetic acid and colposcopy
timeFrame: 3 years
measure: Determine the persistence of HPV infection in WLHIV at the pre-specified follow-up interval
timeFrame: 5 years
measure: Determine the clearance of HPV infection in WLHIV at the pre-specified follow-up interval
timeFrame: 5 years
measure: Determine the incidence of HPV infection in WLHIV at the pre-specified follow-up interval
timeFrame: 5 years
measure: Quantify the persistence of cervical intraepithelial lesion grade 3 or worse in women living with HIV who were baseline HPV positive but with benign pathology at 2 year interval screening
timeFrame: 5 years
measure: Quantify the progression of cervical intraepithelial lesion grade 3 or worse in women living with HIV who were baseline HPV positive but with benign pathology at 2 year interval screening
timeFrame: 5 years
measure: Quantify the regression of cervical intraepithelial lesion grade 3 or worse in women living with HIV who were baseline HPV positive but with benign pathology at 2 year interval screening
timeFrame: 5 years
measure: Quantify the cure of cervical intraepithelial lesion grade 3 or worse in women living with HIV who were baseline HPV positive but with benign pathology at 2 year interval screening
timeFrame: 5 years
measure: Quantify the incidence of cervical intraepithelial lesion grade 3 or worse in women living with HIV who were baseline HPV positive but with benign pathology at 2 year interval screening
timeFrame: 5 years
measure: Quantify the persistence of cervical intraepithelial lesion grade 3 or worse in women living with HIV who were baseline HPV negative at 3 year interval screening
timeFrame: 5 years
measure: Quantify the progression of cervical intraepithelial lesion grade 3 or worse in women living with HIV who were baseline HPV negative at 3 year interval screening
timeFrame: 5 years
measure: Quantify the regression of cervical intraepithelial lesion grade 3 or worse in women living with HIV who were baseline HPV negative at 3 year interval screening
timeFrame: 5 years
measure: Quantify the cure of cervical intraepithelial lesion grade 3 or worse in women living with HIV who were HPV negative at 3 year interval screening
timeFrame: 5 years
measure: Quantify the incidence of cervical intraepithelial lesion grade 3 or worse in women living with HIV who were baseline HPV negative at 3 year interval screening
timeFrame: 5 years
measure: Analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 6 years
measure: Evaluate the performance of a novel HPV assay as a stand-alone screening tool in our high-prevalence HIV population
timeFrame: 3 years
measure: Evaluate the impact of patient demographic and clinical factors, such as number of sexual partners, smoking, HIV status and related HIV immune markers, on risk of cervical dysplasia
timeFrame: 5 years
measure: Evaluate the impact of patient characteristics and and risk factors on the risk for cervical disease
timeFrame: 5 years
Other outcomes:
Locations:
city: Ramotswa
country: Botswana
facility: Bamalete Lutheran Hospital
Study officials:
References: