Cervical Cancer, Prevention
Conditions
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 HPV genotype restriction 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 evaluate optimal 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.
Interventions
DIAGNOSTIC_TEST8-type HPV genotype restriction
Participants will undergo primary hrHPV testing and if positive will be referred for VIA per Botswana and WHO guidelines. Participants will also undergo colposcopy and biopsy at the time of VIA. The performance of triage with 8-type HPV genotype restriction will be evaluated.
Sponsors
Beth Israel Deaconess Medical Center
University of Botswana
Botswana Harvard AIDS Institute Partnership
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the sensitivity, specificity, PPV and NPV of triage of primary human papillomavirus testing with 8-type HPV genotype restriction to visual inspection with acetic acid and colposcopy | 3 years |
| Determine the persistence of HPV infection in WLHIV at the pre-specified follow-up interval | 5 years |
| Determine the clearance of HPV infection in WLHIV at the pre-specified follow-up interval | 5 years |
| Determine the incidence of HPV infection in WLHIV at the pre-specified follow-up interval | 5 years |
| Quantify the incidence of cervical intraepithelial lesion grade 2 or worse in women living with HIV who were baseline HPV positive but with benign pathology at 2 year interval screening | 5 years |
| Quantify the incidence of cervical intraepithelial lesion grade 2 or worse in women living with HIV who were baseline HPV negative at 3 year interval screening | 5 years |
| Analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana. | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Evaluate the performance of a novel HPV assay as a stand-alone screening tool in our high-prevalence HIV population | 3 years |
| 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 |
| Evaluate the impact of patient characteristics and and risk factors on the incidence of cervical dysplasia | 5 years |
Countries
Botswana
Outcome results
None listed