Project Lead(s): Andre Isaac
East Africa has the highest cervical cancer (HPV) incidence and mortality rate (50%) in the world.
Vaccination and screening are the most effective modes of prevention, exemplified by high-income countries where pap smear screening has resulted in prevention or early diagnosis of cervical cancer.
In Kenya, less than 4% of at-risk women are undergoing cervical cancer screening resulting in a high disease burden nationally.
The project developed an innovative assay based on cervicovaginal swabs and a process called digital polymerase chain reaction (ddPCR) that aimed help make self-screening for cervical cancer possible and accessible.
The technique used self-administered cervicovaginal swabs to detect oncogenic HPV, the virus that causes cervical cancer. The assay cost less than a pap smear at high throughput and could be performed by women in their own homes as it did not require a pathologist to analyze results.
A pilot study was run in Canada to validate the technology before running an implementation study in Nairobi, Kenya. The lab in Kenya was setup in partnership with AMREF Kenya.
The study in Kenya included women with and without cervical cancer in order to determine the validity, sensitivity, and specificity of the technology.
The study successfully validated the ddPCR technology as a reliable test for cervical cancer and early diagnosis. The study achieved desirable sensitivity (91%) and specificity (95%) scores during physician-administered ddPCR tests.
For self-administered tests, results showed sensitivity and specificity scores for cervical cancer to be 89% and 96% respectively. The self-administered tests also displayed sensitivity and specificity scores of 87% and 96% for cervical dysplasia. These are the highest numbers reported in the literature for a self-screening assay.
Self-administered tests were well-received. 94% of patients reported improved cervical exam comfort and 77% reported they were more likely to undergo cervical cancer screening.
Patient surveys found the largest barriers to HPV screening were lack of awareness and access.