Thermocoagulation for Treatment of Precancerous Cervical Lesions

University of California San Francisco (UCSF)

Status: Completed

Conditions: Human Immunodeficiency Virus; HPV Infection; CIN 2/3

Treatments: Device: Thermocoagulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04191967

5D43TW009343 (U.S. NIH Grant/Contract)

19405

Details and patient eligibility

About

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.

Full 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

Enrollment: 379 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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379 participants in 1 patient group

Thermocoagulation

Experimental group

Description:

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

Treatment:

Device: Thermocoagulation