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Thermocoagulation for Treatment of Abnormalities after Screening for Cervical Cancer in HIV-Infected Patients in Western Kenya

Trial Status: Active

This trial studies how well thermocoagulation works for treatment of abnormalities (pre-cancer) after screening for cervical cancer in human immunodeficiency virus (HIV)-infected patients in Western Kenya. Thermocoagulation uses heat to destroy the abnormal cells on the cervix and may be a useful treatment method for cervical pre-cancer.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

California

San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: Chemtai Mungo
Phone: 562-310-6762

Kenya

Nairobi
Kenya Medical Research Institute
Status: ACTIVE
Contact: Cirillus Ogollah
Phone: 254 724 717472

PRIMARY OBJECTIVE:

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.

SECONDARY OBJECTIVES:

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.

EXPLORATORY OBJECTIVES:

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.

OUTLINE:

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

Lead Organization
UCSF Medical Center-Mount Zion

Principal Investigator
Chemtai Mungo

  • Primary ID 19405
  • Secondary IDs NCI-2019-06774, 19-27188
  • Clinicaltrials.gov ID NCT04191967