Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 5:00 PM
Study NCT ID:
NCT04155294
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2019-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-22', 'releaseDate': '2024-10-03'}], 'estimatedResultsFirstSubmitDate': '2024-10-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'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': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Mucosal cells obtained by a vaginal swabs will be stored in Microbiology lab before analysis. Specimens will be destroyed after the study analysis if performed according to local regulation.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2019-10-18', 'studyFirstSubmitQcDate': '2019-11-04', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of HR HPV in WLWH aged 25-64 years in the UK', 'timeFrame': 'baseline', 'description': 'HPV DNA detected by PCR on vaginal self-taken swab'}], 'secondaryOutcomes': [{'measure': 'Rates of enrolment', 'timeFrame': 'baseline', 'description': 'Proportion of eligible women on all the women attending the Clinic'}, {'measure': 'Response rate to questionnaires', 'timeFrame': '1 year', 'description': 'Proportion of questionnaires completed'}, {'measure': 'Feasibility of self-sampling', 'timeFrame': '1 year', 'description': 'Proportion of HR-HPV self-sample tests returned'}, {'measure': 'Participants retention rate', 'timeFrame': '1 year', 'description': 'Proportion of patients who complete the study procedures'}, {'measure': 'Acceptability of study procedures including self-taken vaginal swabs', 'timeFrame': '1 year', 'description': 'questionnaire containing closed and opened questions and visual scale from 0 to 100, higher score indicate a better outcome'}, {'measure': 'Awareness of cervical cancer risk', 'timeFrame': 'baseline', 'description': 'questionnaire containing closed and opened questions and visual scale from 0 to 100, where higher scores indicate a better outcome'}, {'measure': 'Compliance to standard screening procedures', 'timeFrame': 'baseline', 'description': 'questionnaire containing closed and opened questions and visual scale from 0 to 100, where higher scores indicate a better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HPV infection', 'Women', 'HIV Infection', 'Cervical cancer', 'Screening'], 'conditions': ['Cervical Cancer', 'HPV Infection', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'Current British HIV Association (BHIVA) guidelines recommend annual cervical screening (with a cervical smear) for women living with HIV (WLWH). NHS guidelines for women in England will, however, change soon. Women will initially be tested for human papilloma virus (HPV), a virus which causes virtually all cervical cancer. Only those who are infected with HPV will then undergo the smear testing. The BHIVA guidelines, however, taking the view that HIV infection (and its ability to weaken the immune system) increases the risk of persistent HPV infection and of cancer in those who are infected, consider safer for all WLWH to go straight to annual smear testing. Most WLWH in the UK are now receiving treatment which protects their immune system - this suggests that less WLWH could be HPV infected. The identification of a group of WLWH who could benefit from less frequent screening could improve quality of life, and allow the NHS to reduce unnecessary tests and costs. A large study is needed to collect robust evidence that would support changes to standard practice. Before investing huge resources, the investigators need to know if a study would be feasible, conducting a pilot study on 70 WLWH aged 25-64, regularly attending clinics for HIV care. Participants will be asked to complete an entry survey and they will undergo routine cervical smears (baseline and after 1 year). At baseline, after six months, and one year women will take their own vaginal swabs for the detection of HR-HPV. An exit questionnaire will be undertaken at the last visit.', 'detailedDescription': "This pilot study will enrol 70 WLWH aged 25-64, with no history of cervical abnormalities attending 4 HIV clinics in the UK. Participants will be asked to complete an entry survey in which behavioural information, gynaecological and sexual history, will be collected, with the aim of characterising the study population for the risk factors of HPV infection. Women's attitude towards the current cervical screening and their view on a change to HPV testing will also be assessed. Participants' relevant clinical data will be collected form their medical notes. Women will be instructed to perform a self-taken vaginal swab for the detection of HR HPV while in clinic, and they will be reminded of the annual cervical smear (which can be offered in clinic or performed at their GP practice as per local policy). After six months, women will be asked to take another vaginal swab; this can be offered in clinic, during the regular HIV follow up, or can be sent via the post. Another sample for HR-HPV testing will be collected one year later, at the next routine HIV appointment. The annual smear test will be due and this will be offered in clinic or done at the GP practice, according to local policies. After this visit, an exit questionnaire will be undertaken to evaluate the acceptability of the study procedures."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '25 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women aged 25-64 years living with HIV for at least 6 months with annual cervical smear due, in accordance with national guidelines. The majority of HIV women \\>25 years in 2019 will not have been vaccinated against HPV.', 'genderDescription': 'gender at birth', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* Women aged 25-64\n* HIV diagnosis ≥ 6 months\n* No previous diagnosis of CIN 2/3 and/or treatment for cervical dysplasia\n* Last smear test done ≥1 year before baseline\n* Able to speak and understand English\n* Willing and able to provide informed consent\n\nEXCLUSION CRITERIA\n\n* Suspected or known invasive cervical malignancy\n* Currently pregnant or breast-feeding\n* Any other condition, which, in the opinion of the Investigator, would make participation in the study unsafe or interfere with interpretation of the study outcomes.'}, 'identificationModule': {'nctId': 'NCT04155294', 'acronym': 'REACH-UP', 'briefTitle': 'Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention (REACH-UP): a Feasibility Study in Women Living With HIV', 'orgStudyIdInfo': {'id': 'IRAS Reference 259611'}}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Oxford University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'High Wycombe', 'country': 'United Kingdom', 'facility': 'Buckinghamshire Healthcare NHS Trust', 'geoPoint': {'lat': 51.62907, 'lon': -0.74934}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital Nhs Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "GUY's AND ST THOMAS' NHS FOUNDATION TRUSTS", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Milton Keynes', 'country': 'United Kingdom', 'facility': 'Milton Keynes University NHS Foundation Trust', 'geoPoint': {'lat': 52.04172, 'lon': -0.75583}}, {'zip': 'SL1 2BJ', 'city': 'Slough', 'country': 'United Kingdom', 'facility': 'ROYAL BERKSHIRE NHS FOUNDATION TRUST, Upton Hospital, Albert Street', 'geoPoint': {'lat': 51.50949, 'lon': -0.59541}}], 'overallOfficials': [{'name': 'Paola Cicconi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'British HIV Association (BHIVA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-10-03', 'type': 'RELEASE'}, {'date': '2024-11-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Oxford'}}}}