Trial record 9 of 38 for:    " December 15, 2010":" January 14, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Ethnicity Data in HIV Positive Men Who Have Sex With Men

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Health Protection Agency, United Kingdom.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT01277458
First received: January 14, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Accuracy of Ethnicity Recording in MSM Patients With HIV of Non-White Ethnicity in London

Resource links provided by NLM:


Further study details as provided by Health Protection Agency, United Kingdom:

Primary Outcome Measures:
  • Proportion of misclassification of ethnicity for non-White MSM with HIV living in London [ Time Frame: end of study (2 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Prevalence of individual non-White self-identified ethnicity groups in MSM with HIV in London [ Time Frame: End of study (2 months) ] [ Designated as safety issue: No ]
  • Description of current clinic practice for ethnicity data recording [ Time Frame: End of study (2 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2011
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non white HIV positive men who have sex with men

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

400 Non-White HIV positive Men who have sex with men

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277458

Contacts
Contact: Helen Williams, MBBS 07990721580 zchard7@hotmail.com

Locations
United Kingdom
Guy's and St Thomas' NHS Foundation Trust Not yet recruiting
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Health Protection Agency, United Kingdom
  More Information

No publications provided

Responsible Party: Dr Helen Williams, HPA / BASHH Scholarship Fellow, Health Protection Agency
ClinicalTrials.gov Identifier: NCT01277458     History of Changes
Other Study ID Numbers: EthMSM01
Study First Received: January 14, 2011
Last Updated: January 14, 2011
Health Authority: Research Ethics Committee UK:

Keywords provided by Health Protection Agency, United Kingdom:
HIV
MSM
Ethnicity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014