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Ethnicity Data in HIV Positive Men Who Have Sex With Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01277458
Recruitment Status : Unknown
Verified December 2010 by Public Health England.
Recruitment status was:  Not yet recruiting
First Posted : January 17, 2011
Last Update Posted : January 17, 2011
Information provided by:
Public Health England

Tracking Information
First Submitted Date January 14, 2011
First Posted Date January 17, 2011
Last Update Posted Date January 17, 2011
Study Start Date June 2011
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 14, 2011)
Proportion of misclassification of ethnicity for non-White MSM with HIV living in London [ Time Frame: end of study (2 months) ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 14, 2011)
  • • Prevalence of individual non-White self-identified ethnicity groups in MSM with HIV in London [ Time Frame: End of study (2 months) ]
  • Description of current clinic practice for ethnicity data recording [ Time Frame: End of study (2 months) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Ethnicity Data in HIV Positive Men Who Have Sex With Men
Official Title Accuracy of Ethnicity Recording in MSM Patients With HIV of Non-White Ethnicity in London
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 400 Non-White HIV positive Men who have sex with men
Condition HIV Infections
Intervention Not Provided
Study Groups/Cohorts Non white HIV positive men who have sex with men
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 14, 2011)
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2011
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients diagnosed with HIV
  • Male patients who have ever had sex with other men (bi- or homosexual to both be included)
  • Patients of non-white ethnicity (patients described as being of "mixed" or "other" ethnicity are to be included)

Exclusion Criteria:

  • Female patients
  • Male patients who have only ever had sex with women
  • Patients whose ethnicity is described as "White"
  • Patients unable to read or understand the written questionnaire
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
Administrative Information
NCT Number NCT01277458
Other Study ID Numbers EthMSM01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Helen Williams, HPA / BASHH Scholarship Fellow, Health Protection Agency
Study Sponsor Public Health England
Collaborators Not Provided
Investigators Not Provided
PRS Account Public Health England
Verification Date December 2010