Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT01277458
Status:
WITHDRAWN
Last Update Posted:
2020-03-04
First Post:
2011-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ethnicity Data in HIV Positive Men Who Have Sex With Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to recruit participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2011-01-14', 'studyFirstSubmitQcDate': '2011-01-14', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of misclassification of ethnicity for non-White MSM with HIV living in London', 'timeFrame': 'end of study (2 months)'}], 'secondaryOutcomes': [{'measure': '• Prevalence of individual non-White self-identified ethnicity groups in MSM with HIV in London', 'timeFrame': 'End of study (2 months)'}, {'measure': 'Description of current clinic practice for ethnicity data recording', 'timeFrame': 'End of study (2 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'MSM', 'Ethnicity'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': "Are there differences between the way that non-White men who have sex with men living in London with HIV describe their own ethnicity and the way in which their ethnic group is recorded in NHS clinics? We aim to describe the way in which clinics in London currently record a patient's ethnic group. Without accurate data for an individual's ethnic group we are unable to draw meaningful conclusions about their experiences of HIV care. It may be the case that patients from particular ethnic groups require specific ways of monitoring and treating their HIV but without knowing if these people are in a particular group any services directed to them may be wasted or underused.", 'detailedDescription': "HIV Doctors will be identified at each of the London HIV treatment centres and details of the project will be communicated to them via email.\n\nThese doctors will then be sent paper copies of the patient information sheets (PIS), patient questionnaires and clinician questionnaires.\n\nEligible patients (i.e. men having sex with men with HIV from non-white ethnic groups) will be identified by their doctors and will be asked to read the PIS and complete the questionnaire. This will be a single questionnaire and no follow up for the patient will be required. No personal information (e.g. date of birth, hospital number) will be recorded. Eligible patients will be all those coming to clinic for HIV care between 1st June and 31st of July 2011. Based on estimates from 2009 data held by the HPA, each doctor will on average be asked to recruit 30 patients over the two month period.\n\nThe questionnaire will ask questions regarding self description of ethnicity, sexuality, parents' ethnicity, country of birth and other countries of residency (if relevant). It is anticipated that to read the PIS and complete the questionnaire should take no longer than 15 minutes.\n\nThe doctor will then return the paper questionnaire (in an addressed envelope supplied) to Dr Williams. Dr Williams will then bring together and analyse the data from the questionnaires and write up her findings for publication and presentation at a national conference."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '400 Non-White HIV positive Men who have sex with men', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with HIV\n* Male patients who have ever had sex with other men (bi- or homosexual to both be included)\n* Patients of non-white ethnicity (patients described as being of "mixed" or "other" ethnicity are to be included)\n\nExclusion Criteria:\n\n* Female patients\n* Male patients who have only ever had sex with women\n* Patients whose ethnicity is described as "White"\n* Patients unable to read or understand the written questionnaire'}, 'identificationModule': {'nctId': 'NCT01277458', 'briefTitle': 'Ethnicity Data in HIV Positive Men Who Have Sex With Men', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Public Health England'}, 'officialTitle': 'Accuracy of Ethnicity Recording in MSM Patients With HIV of Non-White Ethnicity in London', 'orgStudyIdInfo': {'id': 'EthMSM01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non white HIV positive men who have sex with men'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Public Health England', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}