Thermocoagulation for Treatment of Precancerous Cervical Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Human Immunodeficiency Virus, HPV Infection, CIN 2/3

Intervention / Treatment
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* Device: Thermocoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 25-65 years. Enrolled in HIV care at 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermocoagulation<br>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<br>* Treatment of positive screening results will be performed using the Liger Thermocoagulator device<br>* Other names: Liger thermocoagulator;|

What is the study measuring?
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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 |