HIV-positive (HIV+) women are at high risk of developing cervical cancer even when treated with antiretroviral therapy. Current World Health Organization guidelines recommend screen-and-treat with human papilloma virus (HPV) DNA testing as the optimal approach for cervical cancer screening in low resource settings. However, HIV+ women have exceptionally high rates of HPV infection which lead, in the screen-and-treat approach, to substantial overtreatment. What is needed is a simple method to triage HPV+HIV+ women. We propose to build on more than two decades of collaboration between the University of Cape Town and Columbia University investigating how to strengthen cervical cancer screening in South Africa. We have recently demonstrated that a point-of-care HPV DNA assay can be adapted for screen-and-treat for HIV-positive women. We propose to extend this work to investigate whether new technologies of automated visual evaluation of digital images of the cervix have clinical utility in conjunction with HPV testing. We propose to utilize our established clinical research platform in Cape Town to recruit HIV-positive and HIV-negative women to address the following two specific aims.
Specific Aim 1 will investigate the clinical utility of automated visual evaluation of digital images taken using the MobileODT platform as a triage assessment method for HPV+HIV+ women compared to other alternatives, including adaptation of HPV DNA tests, cytology and expert colposcopy.
Specific Aim 2 will investigate the clinical utility of automated visual evaluation as an assessment method to detect treatment failure among women who have undergone ablative treatment procedures as part of prior rounds of screening. Over the course of undertaking this clinical study, Specific Aim 3 will support capacity development and training to implement and evaluate effective cervical cancer screening technologies into low resource settings within the Eastern Cape and Limpopo Provinces in South Africa. This will be done through existing capacity development initiatives in the Department of Obstetrics and Gynaecology at the University of Cape Town.

Public Health Relevance

In a collaboration between the University of Cape Town and Columbia University, we will investigate the clinical utility of an automated visual method of assessing the cervix for the purposes of screening for cervical cancer in HIV-positive women in South Africa. We will investigate whether this method can discriminate between true cervical precancerous lesions in need of treatment from those that do not require treatment among women who are positive for human papilloma virus (HPV) DNA and who have undergone treatment as part of prior rounds of screening.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA250011-01
Application #
9983249
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Dominguez, Geraldina
Project Start
2020-06-01
Project End
2025-05-31
Budget Start
2020-06-01
Budget End
2021-05-31
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of Cape Town
Department
Type
DUNS #
568227214
City
Rondebosch
State
Country
South Africa
Zip Code
7700