Thermocoagulation for Treatment of Precancerous Cervical Lesions

NCT04191967 | Completed Results DMC FDA Device

• 2 other identifiers: 194055D43TW009343
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus; HPV Infection; CIN 2/3

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Frequency of Pain Score Category

  Day of Treatment, approximately 1 day

• Percentage of Participants Reporting Treatment-related Adverse Events (AE)

  Up to 6 weeks following treatment

• Frequency of Positive Participant Satisfaction Responses

  Up to 6 weeks following treatment

Study Arms (1)

Thermocoagulation

EXPERIMENTAL

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

Interventions

Thermocoagulation DEVICE

Treatment of positive screening results will be performed using the Liger Thermocoagulator device

Also known as: Liger thermocoagulator

Thermocoagulation

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institutes of Health (NIH): collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Kenya Medical Research Institute

Kisumu, Kenya

Location

Related Publications (3)

• 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.

  PMID: 32634066 RESULT

• 2022 ASCCP Poster Presentations. J Low Genit Tract Dis. 2022 Apr 1;26(2S):6-13. doi: 10.1097/LGT.0000000000000671. No abstract available.

  PMID: 35350043 DERIVED

• 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.

  PMID: 33999653 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Papillomavirus Infections

Interventions

Electrocoagulation

Condition Hierarchy (Ancestors)

HIV Infections; 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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Chemtai Mungo, MD, MPH
• Organization: Univerisity of North Carolina (UNC)

cmungo@email.unc.edu

(984) 974-1000

Study Officials

• Chemtai Mungo, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: September 25, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: January 25, 2023
• Results First Posted: January 25, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)