Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-01 @ 11:47 PM
Study NCT ID:
NCT04092257
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2019-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HPV-Based Screen-and-Treat Demonstration Project in Lilongwe
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': 'Melahat_Canter@med.unc.edu', 'phone': '919-962-0000', 'title': 'Melahat Garipagaoglu', 'organization': 'UNC Lineberger Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The small sample size of women with cervical precancer and the experienced research team may limit the generalizability of findings, especially in national screening programs where providers have multiple tasks.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 4 weeks.', 'description': 'Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.', 'eventGroups': [{'id': 'EG000', 'title': 'HIV Positive -VIA and Thermocoagulation', 'description': 'HIV Positive Participants will undergo the same-day VIA and thermocoagulation were included.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 19, 'seriousNumAtRisk': 22, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'HIV Negative -VIA and Thermocoagulation', 'description': 'HIV HIV-negative participants will undergo the same-day VIA and thermocoagulation were included.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 21, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (v5.0)'}, {'term': 'Vaginal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (v5.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (v5.0)'}, {'term': 'Amenorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (v5.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (v5.0)'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (v5.0)'}, {'term': 'vaginal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (v5.0)'}, {'term': 'vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 14}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (v5.0)'}, {'term': 'Vaginal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (v5.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (v5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Same-day Visual Inspection With Acetic Acid (VIA) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV Positive', 'description': 'All HPV positive women.'}], 'classes': [{'title': 'Visual Inspection with Acetic Acid (VIA) performed', 'categories': [{'measurements': [{'value': '469', 'groupId': 'OG000'}]}]}, {'title': 'Visual Inspection with Acetic Acid (VIA) performed on the same day', 'categories': [{'measurements': [{'value': '459', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'The proportion of women who were HPV-positive and underwent same-day VIA following self-collected vaginal sampling was assessed, including both HIV-positive and HIV-negative participants. As per the study protocol, data were not stratified by HIV status for this outcome due to lack of scientific rationale for a difference in same-day VIA completion by HIV status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who underwent HPV-based primary screening for cervical cancer and tested HPV-positive on self-collected vaginal sample and had VIA triage performed on the same day of self-collection.'}, {'type': 'PRIMARY', 'title': 'Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV Positive', 'description': 'All HPV positive women.'}], 'classes': [{'title': 'HPV-positive participants eligible for thermocoagulation based on colposcopy triage', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}, {'title': 'Thermocoagulation completed among HPV-positive participants on same day of self-collection', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Among women who tested HPV-positive through primary screening, those eligible for thermocoagulation by colposcopy triage received thermocoagulation treatment on the same day as self-collection. As specified in the study protocol, data were not stratified by HIV status for this outcome due to lack of scientific rationale for a difference in same-day colposcopy completion by HIV status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who underwent HPV-based primary screening for cervical cancer and tested HPV-positive and were eligible for thermocoagulation by colposcopy triage and had thermocoagulation performed on the same day of self-collection.'}, {'type': 'PRIMARY', 'title': 'High Risk (hr)-Human Papillomavirus (HPV) Positive Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Positive', 'description': 'Women living with HIV'}, {'id': 'OG001', 'title': 'HIV Negative', 'description': 'Women living without HIV'}], 'classes': [{'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'The proportion of women who tested High risk (hr)-human papillomavirus (HPV) positive on a self-collected vaginal brush among enrolled participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants joined the study and provided self-collected vaginal samples using a Viba-Brush® for HPV testing.'}, {'type': 'SECONDARY', 'title': 'HPV Screen-triage-treat Algorithm for Cervical Cancer Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Positive, HPV Positive, VIA Positive, and Had no High Grade Cervical Intraepithelial Neoplasia', 'description': 'Women living with HIV, human, papillomavirus (HPV) positive, Visual Inspection with Acetic Acid test positive, and had no biopsy-proven cervical precancer but would have received thermocoagulation by VIA triage though without biopsy-proven cervical precancer.'}, {'id': 'OG001', 'title': 'HIV Positive,HPV Positive, VIA Positive, and Had Biopsy-proven Cervical Precancer in the Endocervix', 'description': 'Women living with HIV, human, papillomavirus (HPV) positive and, Visual Inspection with Acetic Acid positive, and could have received thermocoagulation by VIA triage but had biopsy-proven cervical precancer in the endocervical epithelium (thermocoagulation might not adequately treat precancer in the endocervix.'}, {'id': 'OG002', 'title': 'HIV Positive, HPV Negative, VIA Positive', 'description': 'Women living with HIV, human, papillomavirus (HPV) negative and Visual Inspection with Acetic Acid test positive.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'description': 'To evaluate the performance of the proposed ICC screen-and-treat strategy for cervical carcinoma screening among women who are HIV- positive, the rates of overtreatment and undertreatment rates were estimated. Overtreatment for women who are HPV-positive VIA- positive/ablation-eligible and would have received thermocoagulation but had no cervical precancer (i.e., high-grade cervical intraepithelial neoplasia), and undertreatment among HPV-positive with high-grade cervical intraepithelial neoplasia but were VIA-positive and eligible for thermocoagulation, and those who were VIA-negative.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who tested HPV-positive for cervical cancer screening in the study and completed the screen-triage-treat algorithm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIV Positive', 'description': 'Women living with HIV'}, {'id': 'FG001', 'title': 'HIV Negative', 'description': 'Women living without HIV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '625'}, {'groupId': 'FG001', 'numSubjects': '625'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '602'}, {'groupId': 'FG001', 'numSubjects': '618'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Participants were recruited from health facilities with outpatient clinics that provide sexual and reproductive health services and/or HIV care services in Lilongwe, Malawi between 6/24/2020- 2/28/2022. The first participant was enrolled on 6/24/2020, and the last participant was enrolled on 2/28/2022.', 'preAssignmentDetails': 'Participants were assigned HIV-positive or HIV-negative groups based on HIV testing result.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HIV Positive', 'description': 'Women living with HIV'}, {'id': 'BG001', 'title': 'HIV Negative', 'description': 'Women living without HIV'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '41'}, {'value': '33', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '38'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '30', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Malawi', 'categories': [{'measurements': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Level of education', 'classes': [{'title': 'No education', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}, {'title': 'Primary', 'categories': [{'measurements': [{'value': '344', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '649', 'groupId': 'BG002'}]}]}, {'title': 'Secondary', 'categories': [{'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '417', 'groupId': 'BG002'}]}]}, {'title': 'Tertiary', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital status', 'classes': [{'title': 'Never married', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Married/Living with partner', 'categories': [{'measurements': [{'value': '395', 'groupId': 'BG000'}, {'value': '475', 'groupId': 'BG001'}, {'value': '870', 'groupId': 'BG002'}]}]}, {'title': 'Widowed/divorced/separated', 'categories': [{'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-18', 'size': 7745829, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-19T12:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2019-09-13', 'resultsFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2019-09-13', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-18', 'studyFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Same-day Visual Inspection With Acetic Acid (VIA) Rate', 'timeFrame': 'Baseline', 'description': 'The proportion of women who were HPV-positive and underwent same-day VIA following self-collected vaginal sampling was assessed, including both HIV-positive and HIV-negative participants. As per the study protocol, data were not stratified by HIV status for this outcome due to lack of scientific rationale for a difference in same-day VIA completion by HIV status.'}, {'measure': 'Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage', 'timeFrame': 'Baseline', 'description': 'Among women who tested HPV-positive through primary screening, those eligible for thermocoagulation by colposcopy triage received thermocoagulation treatment on the same day as self-collection. As specified in the study protocol, data were not stratified by HIV status for this outcome due to lack of scientific rationale for a difference in same-day colposcopy completion by HIV status.'}, {'measure': 'High Risk (hr)-Human Papillomavirus (HPV) Positive Rate', 'timeFrame': 'Baseline', 'description': 'The proportion of women who tested High risk (hr)-human papillomavirus (HPV) positive on a self-collected vaginal brush among enrolled participants.'}], 'secondaryOutcomes': [{'measure': 'HPV Screen-triage-treat Algorithm for Cervical Cancer Screening', 'timeFrame': 'Up to 24 weeks', 'description': 'To evaluate the performance of the proposed ICC screen-and-treat strategy for cervical carcinoma screening among women who are HIV- positive, the rates of overtreatment and undertreatment rates were estimated. Overtreatment for women who are HPV-positive VIA- positive/ablation-eligible and would have received thermocoagulation but had no cervical precancer (i.e., high-grade cervical intraepithelial neoplasia), and undertreatment among HPV-positive with high-grade cervical intraepithelial neoplasia but were VIA-positive and eligible for thermocoagulation, and those who were VIA-negative.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Visual inspection with acetic acid (VIA)'], 'conditions': ['HPV Infection', 'Cervical Cancer', 'HIV Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://unclineberger.org/patientcare/clinical-trials/clinical-trials', 'label': 'Clinical trials at UNC Lineberger'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess completion and performance of the following novel invasive cervical cancer (ICC) screen-and-treat algorithm among 625 HIV-positive women in Lilongwe, Malawi: 1) rapid testing of self-collected vaginal brush for primary high risk (hr)-human papillomavirus (HPV), 2) same-day visual inspection with acetic acid (VIA) for women who are hr-HPV positive, and 3) thermocoagulation for VIA positive/ablation-eligible (by cervical colposcopy) women.', 'detailedDescription': 'This is a single arm, prospective study of 1,250 women (625 HIV-positive and 625 HIV-negative) enrolled from outpatient clinics that provide sexual and reproductive health (SRH) services and/or HIV care services in Lilongwe, Malawi. The primary objectives of this study are to assess completion of a novel ICC screen-and-treat strategy among HIV-positive women in Lilongwe, Malawi, using self-collected vaginal brush for hr-HPV testing, followed by same-day NIA and thermocoagulation for HPV-positive/NIA-positive/ablation-eligible (by colposcopy) women, and to determine the 24-week efficacy of thermocoagulation among HIV-positive women with CIN2/3. The secondary objective will be to evaluate the performance of the ICC screen-and-treat strategy by estimating overtreatment for women who are HPV-positive/NIA-positive/ablation-eligible, and undertreatment among HPV-positive/NIA-negative women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Females ≥ 25 years of age at study entry and ≤ 50 years of age (per current Malawi National Cervical Cancer Control Program guidelines for screening).\n2. Ability and willingness of participant to provide written informed consent.\n\nExclusion Criteria:\n\n1. Current or prior history of cervical, vaginal, or vulvar cancer or dysplasia\n2. Current symptomatic sexually transmitted infection requiring treatment (women will be allowed to be in the study upon successful treatment)\n3. Prior HPV vaccination.\n4. Participants with known allergy to acetic acid.\n5. Participants with a history of total hysterectomy.\n6. Participants who are pregnant or plan on becoming pregnant during the study period.\n7. Participants who are less than 12 weeks postpartum.\n8. Participants with other illnesses that would limit compliance with study requirements or in the opinion of the investigator or designee, have a problem that would make participation in the study unsafe or complicate interpretation of study findings.'}, 'identificationModule': {'nctId': 'NCT04092257', 'briefTitle': 'HPV-Based Screen-and-Treat Demonstration Project in Lilongwe', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'A Novel Cervical Cancer Screen-and-Treat Demonstration Project With HPV Self-testing and Thermocoagulation for Women in Lilongwe Malawi', 'orgStudyIdInfo': {'id': 'LCCC 1905'}, 'secondaryIdInfos': [{'id': 'R21CA236770', 'link': 'https://reporter.nih.gov/quickSearch/R21CA236770', 'type': 'NIH'}, {'id': 'AID-OAA-A-11-00012', 'type': 'OTHER_GRANT', 'domain': 'USAID/NAS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIA and thermocoagulation', 'description': 'Participants will undergo same day VIA and thermocoagulation', 'interventionNames': ['Procedure: VIA and thermocoagulation']}], 'interventions': [{'name': 'VIA and thermocoagulation', 'type': 'PROCEDURE', 'description': 'Participants will self-collect a vaginal brush for hr-HPV testing. HPV-positive women and every 10th consecutive HPV-negative woman will complete same-day VIA with colposcopically-directed cervical biopsy and ECC (if lesion seen), and thermocoagulation if ablation-eligible by colposcopy. If no lesion is seen on colposcopy, the woman will have a cervical pap smear and ECC collected, and no thermocoagulation will be performed. Finally, women who are suspicious for cancer at VIA will undergo colposcopically-directed cervical biopsies.', 'armGroupLabels': ['VIA and thermocoagulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'University of North Carolina (UNC) Project-Malawi', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}], 'overallOfficials': [{'name': 'Lameck Chinula, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}