Thermocoagulation for Treatment of Abnormalities after Screening for Cervical Cancer in HIV-Infected Patients in Western Kenya
- Enrolled in HIV care at Family Acquired Immunodeficiency Syndrome Care and Education Services (FACES)-supported clinics in Kisumu County
- Able to understand a written informed consent document, and willing to sign it
- Speaks a language that the consent form and data collection instruments are written in
- Has a history of cervical cancer
- Has received any treatment for cervical precancer after screening positive for precancer
- Has evidence of cervical infection
- Pregnant women are excluded from this study
I. To evaluate the efficacy of thermal coagulation for the treatment of HIV-positive, human papillomavirus (HPV)-positive women by assessing rates of HPV persistence and cervical intraepithelial neoplasia grade 2 and 3 (CIN2/3) rate at 12 months after treatment.
I. To evaluate patient safety of thermal coagulation for the treatment of abnormal cervical lesions within a screen-and-treat program among HIV-positive women in Western Kenya.
II. To evaluate patient satisfaction with thermal coagulation for the treatment of abnormal cervical lesions within a screen-and-treat program among HIV-positive women in Western Kenya.
I. To evaluate provider acceptability of thermal coagulation for the treatment of precancerous cervical lesion within a screen-and-treat program in Western Kenya.
II. To evaluate the acceptability of digital cervicography for cervical cancer screening among HIV-positive women in Western Kenya.
Participants undergo HPV testing at baseline using a self-collection kit. Patients with a positive HPV screening test undergo an additional collection of HPV samples using a cervical brush, a pelvic exam, a visual inspection with acetic acid (VIA) exam using acetic acid applied to the cervix, a cervicography consisting of taking pictures of the cervix, and a colposcopy exam followed by a directed biopsy of abnormal areas. All eligible HPV-positive patients will then undergo thermocoagulation treatment over 20 seconds.
After completion of study treatment, patients are followed up at 4-6 weeks and 12 months.
Trial Phase Phase NA
Trial Type Prevention
UCSF Medical Center-Mount Zion
- Primary ID 19405
- Secondary IDs NCI-2019-06774, 19-27188
- Clinicaltrials.gov ID NCT04191967