Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-04 @ 8:34 AM
Study NCT ID:
NCT04191967
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2019-12-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Thermocoagulation for Treatment of Precancerous Cervical Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004564', 'term': 'Electrocoagulation'}], 'ancestors': [{'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cmungo@email.unc.edu', 'phone': '(984) 974-1000', 'title': 'Dr. Chemtai Mungo, MD, MPH', 'organization': 'Univerisity of North Carolina (UNC)'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months', 'description': 'Adverse events (AEs) were graded using the Division of AIDS, National Institute of Allergy and Infectious Diseases: Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events: Corrected version 2.1. (https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf).', 'eventGroups': [{'id': 'EG000', 'title': 'Thermocoagulation', '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', 'otherNumAtRisk': 293, 'deathsNumAtRisk': 293, 'otherNumAffected': 262, 'seriousNumAtRisk': 293, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vaginal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 99}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DIADS 2.1'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 258}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DIADS 2.1'}, {'term': 'Pain (not associated with study agent injections-not specified elsewhere', 'notes': 'Backache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DIADS 2.1'}, {'term': 'Pelvic Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 46}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DIADS 2.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With no Evidence of Cervical Dysplasia at 12-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thermocoagulation', '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'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': '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.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Proportion of Participants With Persistent HPV at 12-month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thermocoagulation', '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'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The proportion of persistence of HPV at follow-up will be reported defined as treatment failure with persistent biopsy-confirmed CIN2/3.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Pain Score Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thermocoagulation', 'description': 'Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive women\n\nThermocoagulation: Treatment of positive screening results will be performed using the Liger Thermocoagulator device'}], 'classes': [{'title': 'No pain', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Mild pain', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}]}]}, {'title': 'Moderate pain', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Severe pain', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of Treatment, approximately 1 day', 'description': '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).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Treatment-related Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thermocoagulation', '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'}], 'classes': [{'title': 'Bleeding', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Vaginal Discharge', 'categories': [{'measurements': [{'value': '51.2', 'groupId': 'OG000'}]}]}, {'title': 'Pelvic Pain', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Grade 3 or 4 adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 weeks following treatment', 'description': '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Positive Participant Satisfaction Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thermocoagulation', 'description': 'Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive women\n\nThermocoagulation: Treatment of positive screening results will be performed using the Liger Thermocoagulator device'}], 'classes': [{'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 weeks following treatment', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Thermocoagulation', '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'}], 'periods': [{'title': 'Screening & Thermocoagulation (Ablation)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants screened for cervical cancer using HPV testing', 'groupId': 'FG000', 'numSubjects': '379'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '293'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}]}], 'dropWithdraws': [{'type': 'Not considered candidates for thermocoagulation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '86'}]}]}, {'title': '12 Month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Pathology results for 12 month treatment efficacy not available for these participants', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Between August 2019 and February 2020, women enrolled in care at Fostering Advances through Collaboration, Education \\& Sciences (FACES)- supported HIV clinics in western Kenya were recruited to the study.', 'preAssignmentDetails': 'All participants received cervical cancer screening using human papillomavirus (HPV) testing. Participants with positive results received a biopsy and then proceeded to same-day treatment. Thermocoagulation candidates must have a fully visualized, squamocolumnar junction, cervical lesions (if present) covering \\< 75% of cervix, and no endocervical component of lesion, or suspicion for cancer. Participants who were not candidates for ablation were referred to a nearby facility.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Thermocoagulation', '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'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.4', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '293', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '293', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '293', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Kenya', 'categories': [{'measurements': [{'value': '293', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior cervical cancer screening', 'classes': [{'categories': [{'measurements': [{'value': '206', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Candidates for ablation must had had a fully visualized, squamocolumnar junction; cervical lesions, if present, that covered \\< 75% of the cervix; and no endocervical component of the lesion or suspicion for cancer.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-25', 'size': 312399, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-17T20:21', 'hasProtocol': True}, {'date': '2020-07-16', 'size': 208213, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-02-02T16:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 379}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2019-12-06', 'resultsFirstSubmitDate': '2022-11-17', 'studyFirstSubmitQcDate': '2019-12-06', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-05', 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With no Evidence of Cervical Dysplasia at 12-months', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Proportion of Participants With Persistent HPV at 12-month Follow-up', 'timeFrame': '12 months', 'description': 'The proportion of persistence of HPV at follow-up will be reported defined as treatment failure with persistent biopsy-confirmed CIN2/3.'}], 'secondaryOutcomes': [{'measure': 'Frequency of Pain Score Category', 'timeFrame': 'Day of Treatment, approximately 1 day', 'description': '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).'}, {'measure': 'Percentage of Participants Reporting Treatment-related Adverse Events (AE)', 'timeFrame': 'Up to 6 weeks following treatment', 'description': '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.'}, {'measure': 'Frequency of Positive Participant Satisfaction Responses', 'timeFrame': 'Up to 6 weeks following treatment', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Human Immunodeficiency Virus', 'HPV Infection', 'CIN 2/3']}, 'referencesModule': {'references': [{'pmid': '32634066', 'type': 'RESULT', 'citation': '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': '35350043', 'type': 'DERIVED', 'citation': '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': '33999653', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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\n\nAim 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\n\nAim 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.\n\nAim 3: Evaluate provider acceptability of thermal coagulation for the treatment of precancerous cervical lesion within a screen-and-treat program in Western Kenya.\n\nOutline:\n\nCounseling 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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 25-65 years.\n2. Enrolled in HIV care at FACES-supported clinics in Kisumu County.\n3. Able to understand a written informed consent document, and willing to sign it.\n4. Speaks a language that the consent form and data collection instruments are written in.\n\nExclusion Criteria:\n\n1. Has a history of cervical cancer.\n2. Has received any treatment for cervical precancer after screening positive for precancer.\n3. Has evidence of cervical infection.\n4. Pregnant women are excluded from this study.'}, 'identificationModule': {'nctId': 'NCT04191967', 'briefTitle': 'Thermocoagulation for Treatment of Precancerous Cervical Lesions', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '19405'}, 'secondaryIdInfos': [{'id': '5D43TW009343', 'link': 'https://reporter.nih.gov/quickSearch/5D43TW009343', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thermocoagulation', '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', 'interventionNames': ['Device: Thermocoagulation']}], 'interventions': [{'name': 'Thermocoagulation', 'type': 'DEVICE', 'otherNames': ['Liger thermocoagulator'], 'description': 'Treatment of positive screening results will be performed using the Liger Thermocoagulator device', 'armGroupLabels': ['Thermocoagulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisumu', 'country': 'Kenya', 'facility': 'Kenya Medical Research Institute', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}], 'overallOfficials': [{'name': 'Chemtai Mungo, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}