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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01277458
Other study ID # EthMSM01
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 2011
Est. completion date March 2011

Study information

Verified date December 2010
Source Public Health England
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Guy's and St Thomas' NHS Foundation Trust London

Sponsors (1)

Lead Sponsor Collaborator
Public Health England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of misclassification of ethnicity for non-White MSM with HIV living in London end of study (2 months)
Secondary • Prevalence of individual non-White self-identified ethnicity groups in MSM with HIV in London End of study (2 months)
Secondary Description of current clinic practice for ethnicity data recording End of study (2 months)
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