Thermocoagulation for Treatment of Precancerous Cervical Lesions

Cervical Cancer Screening Among HIV-infected Women in Western Kenya: Evaluation of the Safety, Acceptability, and Efficacy of an Alternative Ablation Method for Treatment of Precancerous Lesions

The purpose of this study is to evaluate the safety, acceptability, and efficacy of Thermocoagulation for treatment of precancerous lesions among HIV-positive women in a screen-and-treat program in Western Kenya.

Study Overview

• Status: Completed
• Conditions: HPV Infection; Human Immunodeficiency Virus; CIN 2/3
• Intervention / Treatment: Device: Thermocoagulation

Detailed 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 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.

Outline:

Counseling on HPV, cervical cancer, and the screening process was offered during routine HIV clinics in group and individual settings. Participants will then be provided self-sampling instructions, a collection kit, and a private area to perform self-collection. The self-collected HPV samples will be labeled, stored, and processed for DNA of 14 high-risk HPV types. HPV-positive participants were invited for a return visit, including a pelvic examination and visual inspection with acetic acid (VIA) to determine eligibility for ablative therapy. After ablation, a questionnaire will be administered to participants to evaluate treatment experience. All participants will be given a 4- to 6-week phone or in-person follow-up appointment, per participant preference

• Study Type: Interventional
• Enrollment (Actual): 379
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Kenya Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age 25-65 years.
2. Enrolled in HIV care at FACES-supported clinics in Kisumu County.
3. Able to understand a written informed consent document, and willing to sign it.
4. Speaks a language that the consent form and data collection instruments are written in.

Exclusion Criteria:

1. Has a history of cervical cancer.
2. Has received any treatment for cervical precancer after screening positive for precancer.
3. Has evidence of cervical infection.
4. Pregnant women are excluded from this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermocoagulation; Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive participants will be performed by a trained, non-physician clinician. Thermocoagulation will last approximately 20 seconds and will be performed using the Liger Thermocoagulator device	Device: Thermocoagulation; Treatment of positive screening results will be performed using the Liger Thermocoagulator device; Other Names: Liger thermocoagulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants With no Evidence of Cervical Dysplasia at 12-months	The proportion of participants with no evidence of cervical dysplasia at 12-months follow-up, defined as biopsy-confirmed CIN1 result or normal findings, 12-months following treatment.	12 months
Proportion of Participants With Persistent HPV at 12-month Follow-up	The proportion of persistence of HPV at follow-up will be reported defined as treatment failure with persistent biopsy-confirmed CIN2/3.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Pain Score Category	A 4-point Visual Analog Scale (VAS) for pain assessment was used to evaluate pain immediately after treatment. The pain VAS was comprised of verbal descriptors, one for each symptom extreme. The pain VAS is self-completed by the respondent. The respondent is asked to select the point that represents their pain intensity. The "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).	Day of Treatment, approximately 1 day
Percentage of Participants Reporting Treatment-related Adverse Events (AE)	The percentage of participants reporting grade 2 and higher AEs, and severe adverse events (SAEs) during the 4-week follow-up will be reported by event.	Up to 6 weeks following treatment
Frequency of Positive Participant Satisfaction Responses	Participant satisfaction with thermocoagulation will be evaluated by determining the proportion of participants indicating a response of 'yes' to the question "Do you feel satisfied with the treatment you received?" with an alternative response of 'no' at the 4-6 week follow-up visit.	Up to 6 weeks following treatment

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• 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

Publications and helpful links

General Publications

• 2022 ASCCP Poster Presentations. J Low Genit Tract Dis. 2022 Apr 1;26(2S):6-13. doi: 10.1097/LGT.0000000000000671. No abstract available.
• Mungo C, Osongo CO, Ambaka J, Randa MA, Samba B, Ochieng CA, Barker E, Guliam A, Omoto J, Cohen CR. Feasibility and Acceptability of Smartphone-Based Cervical Cancer Screening Among HIV-Positive Women in Western Kenya. JCO Glob Oncol. 2021 May;7:686-693. doi: 10.1200/GO.21.00013.
• Mungo C, Osongo CO, Ambaka J, Randa MA, Omoto J, Cohen CR, Huchko M. Safety and Acceptability of Thermal Ablation for Treatment of Human Papillomavirus Among Women Living With HIV in Western Kenya. JCO Glob Oncol. 2020 Jul;6:1024-1033. doi: 10.1200/GO.20.00035.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections; Tumor Virus Infections; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Papillomavirus Infections
• Other Study ID Numbers: 19405 (Other Identifier: City of Hope Comprehensive Cancer Center); 5D43TW009343 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes