Thermocoagulation for Treatment of Precancerous Cervical Lesions
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 400
Summary
- Conditions
- CIN 2/3
- HPV Infection
- Human Immunodeficiency Virus
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 25 years and 65 years
- Gender
- Only males
Description
Thermocoagulation is endorsed as an alternative to Cryotherapy for treatment of Visual Inspection with Acetic Acid (VIA) or Human Papillomavirus (HPV)-positive women by the 2018 Kenya national cancer guidelines.32 Data primary from Western countries demonstrate similar efficacy for the treatment of ...
Thermocoagulation is endorsed as an alternative to Cryotherapy for treatment of Visual Inspection with Acetic Acid (VIA) or Human Papillomavirus (HPV)-positive women by the 2018 Kenya national cancer guidelines.32 Data primary from Western countries demonstrate similar efficacy for the treatment of precancerous lesions between Cryotherapy and Thermocoagulation. Data on safety, acceptability, and efficacy, particularly linked to gold-standard pathology, among HIV-positive women in low-resource settings are scare. Given the demonstrated benefits over cryotherapy including increased portability and availability hence easier implementation, use of thermal coagulation for the treatment of precancerous lesions in low resource settings could significantly improve access to treatment compared with cryotherapy. This study seeks to fill a critical data gap by evaluating the efficacy of thermocoagulation among HIV-positive positive women using gold-standard biopsy for disease verification at baseline and follow-up, as indicated. We will also assess the safety and acceptability of this treatment modality among patients and providers Aim 1: To evaluate the efficacy of thermal coagulation for the treatment of HIV-positive, HPV-positive women by assessing rates of HPV persistence and CIN2/3 rate at 12 months after treatment Aim 2: To evaluate the safety and acceptability of thermal coagulation for treatment of abnormal cervical lesions within a screen-and-treat program among HIV-positive women in Western Kenya. Aim 3: Evaluate provider acceptability of thermal coagulation for the treatment of precancerous cervical lesion within a screen-and-treat program in Western Kenya.
Tracking Information
- NCT #
- NCT04191967
- Collaborators
- National Institutes of Health (NIH)
- Fogarty International Center of the National Institute of Health
- Investigators
- Principal Investigator: Chemtai Mungo, MD, MPH University of California, San Francisco
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