iThemba_Kenya Cervical Cancer Screening Program
iThemba Kenya Cervical Cancer Screening program is a pilot evaluation of the iThemba app for improving referrals, care, and retention in a large cervical cancer screening program using HPV and VIA co-testing at ICI-affiliated sites in Kenya. This program is a joint venture between International Cancer Institute and Roche Pharmaceuticals.
The study will be conducted in four Kenyan counties. Uasin Gishu, Bungoma, Kisumu and Meru. A convenience sample of up to 6,000 women (3,000 in each arm,) aged 25-69 years who are attending clinics for cervical screening will be enrolled in the study. Women who agree to participate and sign the approved consent forms will undergo a pelvic examination, collection of cervical cells for primary screening with cobas® 4800 HPV Test and VIA/VILI.
At the same visit, women who have an Android smartphone will be invited to download the iThemba app at no cost onto their smartphone. After collection of the sample for HPV testing, the participant will scan the sample barcode with their phone to link the specimen and the app. With the assistance of study staff, participants will also scan a barcode indicating their VIA/VILI result. If they are unable to scan, then an option for manual entry of the barcode will be provided.
In the following days, participants will receive notification of test result availability and can log into the app to view their results. The laboratory result will be presented clearly with information explaining the result and the recommended action for the user to take.
COBAS 4800 HPV and VIA/VILI Test
All women who are HPV-positive by Cobas® 4800 HPV Test or VIA/VILI positive will be referred for a standardized colposcopy examination for diagnosis. The results of the VIA/VILI or HPV test will not be disclosed to the colposcopist. At the colposcopy visit, but before colposcopy is performed, a risk factor assessment interview will be administered and collection of additional cervical cells and a blood specimen. During colposcopy, the colposcopist will obtain (2-4) biopsies from any abnormally-appearing areas to ascertain neoplastic outcomes (CIN3+) and to direct treatment as required. The participant will be assisted to scan a barcode indicating colposcopy normal, treatment provided, or scan the barcode associated with their biopsy sample to link the outcome of the visit and the app.
Participants who had biopsy specimens collected will receive notification of result availability and can log into the app to view their results. All women who have CIN2+ or greater will be referred for treatment. At the treatment visit, the participant will be assisted to scan a barcode indicating that treatment was provided.
Women who are not able to download the app will receive the same cervical cancer screening as women who download the app. Non-app users will receive their test results at their next clinic visit and be encouraged by routine practices to adhere to follow-up visits. App-users will receive their test results without coming to the clinic and will receive digital reminders to adhere to follow-up visits.
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