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Thermocoagulation for Treatment of Precancerous Cervical Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04191967
Recruitment Status : Completed
First Posted : December 10, 2019
Last Update Posted : February 24, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Fogarty International Center of the National Institute of Health
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus HPV Infection CIN 2/3 Device: Thermocoagulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 379 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : September 25, 2019
Actual Primary Completion Date : November 30, 2021
Actual Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Thermocoagulation
Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive women
Device: Thermocoagulation
Treatment of positive screening results will be performed using the Liger Thermocoagulator device
Other Name: Liger thermocoagulator




Primary Outcome Measures :
  1. Proportion of women with no evidence of cervical dysplasia at 12-months [ Time Frame: 12 months ]
    The proportion of women with no evidence of cervical dysplasia at 12-months follow-up, including 95% confidence intervals. We will extrapolate the rate of disease among those with normal colposcopy based on the rate of disease among the 25% in this group who will receive biopsy, and this will be incorporated in calculating persistence. We will perform a logistic regression to examine predictors of treatment success, using clinical and demographic variables as predictor variables.

  2. Proportion of women with persistent HPV at 12-month follow-up [ Time Frame: 12 months ]
    We will also report the rate of persistence of HPV at follow-up and compare with rates reported in the literature in this same population. We will compare efficacy rates for clearance of CIN2/3 to historical results following cryotherapy treatment in similar settings. A one-sample exact test will be used to compare the obtained efficacy proportion to that of historical controls.


Secondary Outcome Measures :
  1. Average pain score on the pain VAS [ Time Frame: Day of Treatment, approximately 1 day ]

    The average pain score and confidence intervals will be calculated immediately after treatment, as reported using the Visual analog scale (VAS) for pain assessment. The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme.

    The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between 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) (11). Normative values are not available.


  2. Rate of Adverse Events (AE) [ Time Frame: Up to 6 weeks following treatment ]
    We will determine the proportion of women who experience grade 2 and 3 AEs, and severe adverse events (SAEs) during follow-up and calculate confidence intervals. Rates of AEs and SAEs will be compared to published rates for cryotherapy amongst this population (2.1% with mild pain or cramping, 1.6%with malodorous excessive vaginal discharge, 0.7% with mild bleeding or spotting, and no severe adverse events)

  3. Frequency of Patient Satisfaction Responses [ Time Frame: Up to 6 weeks following treatment ]
    Patient 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191967


Locations
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Kenya
Kenya Medical Research Institute
Kisumu, Kenya
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
Fogarty International Center of the National Institute of Health
Investigators
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Principal Investigator: Chemtai Mungo, MD, MPH University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Informed Consent Form  [PDF] July 16, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04191967    
Other Study ID Numbers: 19405
5D43TW009343 ( U.S. NIH Grant/Contract )
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Papillomavirus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
DNA Virus Infections
Tumor Virus Infections