Primary HPV-based Cervical Cancer Screening Algorithms in Botswana

Cervical Cancer Clinical Trial

Official title:

Performance of Two-stage Cervical Cancer Screening Algorithms Using Primary High-risk Human Papillomavirus Testing in Botswana

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04242823
• Other study ID #: 2019P001130
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: February 1, 2027

Study information

• Verified date: April 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Prevention
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• Automated visual evaluation
Participants will undergo primary hrHPV testing and if positive will be referred for VIA per Botswana and WHO guidelines. Participants will also undergo colposcopy, image capture for automated visual evaluation and biopsy at the time of VIA.

Locations

Country	Name	City	State
Botswana	Bamalete Lutheran Hospital	Ramotswa

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Botswana Harvard AIDS Institute Partnership, University of Botswana

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 years
Primary	Determine the persistence of HPV infection in WLHIV at the pre-specified follow-up interval		5 years
Primary	Determine the clearance of HPV infection in WLHIV at the pre-specified follow-up interval		5 years
Primary	Determine the incidence of HPV infection in WLHIV at the pre-specified follow-up interval		5 years
Primary	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		5 years
Primary	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		5 years
Primary	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		5 years
Primary	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		5 years
Primary	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		5 years
Primary	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		5 years
Primary	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		5 years
Primary	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		5 years
Primary	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		5 years
Primary	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		5 years
Primary	Analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.		5 years
Secondary	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.		6 years
Secondary	Evaluate the performance of a novel HPV assay as a stand-alone screening tool in our high-prevalence HIV population		3 years
Secondary	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		5 years
Secondary	Evaluate the impact of patient characteristics and and risk factors on the risk for cervical disease		5 years