Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-02 @ 1:04 PM
Study NCT ID:
NCT01277458
Status:
WITHDRAWN
Last Update Posted:
2020-03-04
First Post:
2011-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ethnicity Data in HIV Positive Men Who Have Sex With Men
Sponsor:
Public Health England
Organization:
Study Overview
Official Title:
Accuracy of Ethnicity Recording in MSM Patients With HIV of Non-White Ethnicity in London
Status:
WITHDRAWN
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
These doctors will then be sent paper copies of the patient information sheets (PIS), patient questionnaires and clinician questionnaires.
Eligible 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.
The 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.
The 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.
These doctors will then be sent paper copies of the patient information sheets (PIS), patient questionnaires and clinician questionnaires.
Eligible 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.
The 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.
The 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: