Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT04587050
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2020-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'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': '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'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'te04@ic.ac.uk', 'phone': '02075946230', 'title': 'Dr Tamara Elliott', 'organization': 'Imperial College london'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'No intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1:Women With HIV Sexually Active', 'description': 'Women with perinatally acquired HIV aged 18 or over who are sexually active\n\nHuman papillomavirus testing: HPV test from cervical sample using Cepheid GeneXpert HPV\n\nCervical cytology: Cervical cytology\n\nHPV serology: HPV type specific serology using ELISA from serum samples', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2: Women With HIV Not Sexually Active', 'description': 'Women with perinatally acquired HIV aged 18 or over who are not sexually active\n\nHPV serology: HPV type specific serology using ELISA from serum samples', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevalence of Abnormal Cervical Cytology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Women Living With HIV Who Are Sexually Active', 'description': 'Women with perinatally acquired HIV aged 18 or over who are sexually active\n\nHuman papillomavirus testing: HPV test from cervical sample using Cepheid GeneXpert HPV\n\nCervical cytology: Cervical cytology\n\nHPV serology: HPV type specific serology using ELISA from serum samples'}, {'id': 'OG001', 'title': 'Cohort 2: Women Living With HIV Who Are Not Sexually Active', 'description': 'Women living with HIV who are not sexually active (no cervical sample taken)'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Cervical sample taken in the clinic setting and sent to the laboratory for cytological examination. Prevalence of abnormal cytology is reported as the number of samples that had a non-normal cytology result (e.g. dyskaryotic cells) out of the total number tested', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero women analysed in cohort 2 as these women were not sexually active and so cervical sample was not taken as per the protocol'}, {'type': 'SECONDARY', 'title': 'Prevalence of High Risk HPV by Subtype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1:Women Living With HIV Who Are Sexually Active', 'description': 'Women with perinatally acquired HIV aged 18 or over who are sexually active\n\nHuman papillomavirus testing: HPV test from cervical sample using Cepheid GeneXpert HPV\n\nCervical cytology: Cervical cytology\n\nHPV serology: HPV type specific serology using ELISA from serum samples'}, {'id': 'OG001', 'title': 'Cohort 2: Women Living With HIV Who Are Not Sexually Active', 'description': 'Women living with HIV who are not sexually active (no cervical sample taken)'}], 'classes': [{'categories': [{'title': 'HPV 16', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'HPV 18/45', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Other high-risk HPV', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Negative', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Cervical sample taken in the clinic setting and tested for high-risk HPV on site using the Cepheid GeneXpert. Prevalence reported as the number of samples that were positive for any high-risk HPV out of all those tested', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero samples analysed in cohort 2 as no cervical sample taken as these participants were not sexually active (as per protocol)'}, {'type': 'SECONDARY', 'title': 'Prevalence of CIN2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1:Women With HIV Sexually Active', 'description': 'Women with perinatally acquired HIV aged 18 or over who are sexually active\n\nHuman papillomavirus testing: HPV test from cervical sample using Cepheid GeneXpert HPV\n\nCervical cytology: Cervical cytology\n\nHPV serology: HPV type specific serology using ELISA from serum samples'}, {'id': 'OG001', 'title': 'Cohort 2: Women Living With HIV Who Are Not Sexually Active', 'description': 'Women living with HIV who are not sexually active (no cervical sample taken)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Participants with abnormal cytology and/or tested positive for high-risk HPV were referred for colposcopy. Prevalence reported as the number of participants who were diagnosed with CIN2+', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero samples analysed in cohort 2 as no cervical sample taken as these participants were not sexually active (as per protocol)'}, {'type': 'SECONDARY', 'title': 'HPV Serology (16/18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Women Living With HIV Who Are Not Sexually Active', 'description': 'Women with perinatally acquired HIV aged 18 or over who are sexually active\n\nHuman papillomavirus testing: HPV test from cervical sample using Cepheid GeneXpert HPV\n\nCervical cytology: Cervical cytology\n\nHPV serology: HPV type specific serology using ELISA from serum samples'}, {'id': 'OG001', 'title': 'Cohort 2: Women Living With HIV Who Are Not Sexually Active', 'description': 'Women with perinatally acquired HIV aged 18 or over who are not sexually active\n\nHPV serology: HPV type specific serology using ELISA from serum samples'}], 'classes': [{'title': 'HPV 16 positive serology', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV 18 positive serology', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Number of participants testing positive for HPV 16 and 18 antibodies out of the those tested', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Women Living With HIV Who Are Sexually Active', 'description': 'Women with perinatally acquired HIV aged 18 or over who are sexually active\n\nHuman papillomavirus testing: HPV test from cervical sample using Cepheid GeneXpert HPV\n\nCervical cytology: Cervical cytology\n\nHPV serology: HPV type specific serology using ELISA from serum samples'}, {'id': 'FG001', 'title': 'Cohort 2: Women Living With HIV Who Are Not Sexually Active', 'description': 'Women with perinatally acquired HIV aged 18 or over who are not sexually active\n\nHPV serology: HPV type specific serology using ELISA from serum samples'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Opportunistic recruitment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Women Living With HIV Who Are Sexually Active', 'description': 'Women with perinatally acquired HIV aged 18 or over who are sexually active\n\nHuman papillomavirus testing: HPV test from cervical sample using Cepheid GeneXpert HPV\n\nCervical cytology: Cervical cytology\n\nHPV serology: HPV type specific serology (16/18) using ELISA from serum samples'}, {'id': 'BG001', 'title': 'Cohort 2:Women Living With HIV Who Are Not Sexually Active', 'description': 'Women with perinatally acquired HIV aged 18 or over who are not sexually active\n\nHPV serology: HPV type specific serology (16/18) using ELISA from serum samples'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-24 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': '25+ years', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White ethnicity', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Black ethnicity', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Not stated', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-01', 'size': 467097, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-19T08:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2020-10-07', 'resultsFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-02', 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Abnormal Cervical Cytology', 'timeFrame': '1 year', 'description': 'Cervical sample taken in the clinic setting and sent to the laboratory for cytological examination. Prevalence of abnormal cytology is reported as the number of samples that had a non-normal cytology result (e.g. dyskaryotic cells) out of the total number tested'}], 'secondaryOutcomes': [{'measure': 'Prevalence of High Risk HPV by Subtype', 'timeFrame': '1 year', 'description': 'Cervical sample taken in the clinic setting and tested for high-risk HPV on site using the Cepheid GeneXpert. Prevalence reported as the number of samples that were positive for any high-risk HPV out of all those tested'}, {'measure': 'Prevalence of CIN2+', 'timeFrame': '1 year', 'description': 'Participants with abnormal cytology and/or tested positive for high-risk HPV were referred for colposcopy. Prevalence reported as the number of participants who were diagnosed with CIN2+'}, {'measure': 'HPV Serology (16/18)', 'timeFrame': '1 year', 'description': 'Number of participants testing positive for HPV 16 and 18 antibodies out of the those tested'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical screening', 'HPV vaccination'], 'conditions': ['HIV Infections', 'Human Papillomavirus Infection', 'Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'This is a cross-sectional, observational study of high-risk HPV status, cervical cytology and HPV vaccine uptake and response in young women with perinatally acquired HIV.', 'detailedDescription': 'This is an observational study of cervical cytology assessment, high risk human papilloma virus (hr-HPV) status, and HPV antibody titres amongst adult women living with perinatally acquired HIV infection (PaHIV). Eligible consenting participants will have two samples taken; firstly, a cervical sample tested for cytology and Hr-HPV with the Cepheid GeneXpert HPV; secondly serum will be assessed for hr-HPV serology. All women with PaHIV, vaccinated and unvaccinated for HPV, over the age of 18 years will be eligible and will be recruited into one of two cohorts: (1) sexually active women: full study, cervical and blood sampling or (2) non-sexually active women, blood sampling only (total n=80). Follow up for abnormal smear results or hr-HPV positivity will be arranged through colposcopy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women living with perinatally acquired HIV aged 18 years or older', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria - Cohort 1:\n\n* Perinatally acquired HIV aged 18+\n* Sexually active\n* Able to give informed consent\n\nInclusion Criteria - Cohort 2:\n\n* Perinatally acquired HIV aged 18+\n* Able to give informed consent\n\nExclusion Criteria - Cohort 1:\n\n* Pregnancy\n* Not sexually active\n* Previous total abdominal hysterectomy\n* Unable to give informed consent\n\nExclusion Criteria - Cohort 2:\n\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT04587050', 'acronym': 'SHiP', 'briefTitle': 'Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Screening for Human Papillomavirus and Cervical Cancer in Young Women With Perinatally Acquired HIV', 'orgStudyIdInfo': {'id': '19SM5242'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1: Women with HIV sexually active', 'description': 'Women with perinatally acquired HIV aged 18 or over who are sexually active', 'interventionNames': ['Diagnostic Test: Human papillomavirus testing', 'Diagnostic Test: Cervical cytology', 'Diagnostic Test: HPV serology']}, {'label': 'Cohort 2: Women with HIV not sexually active', 'description': 'Women with perinatally acquired HIV aged 18 or over who are not sexually active', 'interventionNames': ['Diagnostic Test: HPV serology']}], 'interventions': [{'name': 'Human papillomavirus testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'HPV test from cervical sample using Cepheid GeneXpert HPV', 'armGroupLabels': ['Cohort 1: Women with HIV sexually active']}, {'name': 'Cervical cytology', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cervical cytology', 'armGroupLabels': ['Cohort 1: Women with HIV sexually active']}, {'name': 'HPV serology', 'type': 'DIAGNOSTIC_TEST', 'description': 'HPV type specific serology (16/18) using ELISA from serum samples', 'armGroupLabels': ['Cohort 1: Women with HIV sexually active', 'Cohort 2: Women with HIV not sexually active']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Tamara Elliott', 'role': 'STUDY_CHAIR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Public Health England', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}