HIVNCT01277458
Ethnicity Data in HIV Positive Men Who Have Sex With Men
An observational study of HIV, run by Public Health England at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 400 Non-White HIV positive Men who have sex with men
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
Official title: Accuracy of Ethnicity Recording in MSM Patients With HIV of Non-White Ethnicity in London
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.
Read the 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.
- Conditions
- HIV
- Keywords
- HIV, MSM, Ethnicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non white HIV positive men who have sex with men | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of misclassification of ethnicity for non-White MSM with HIV living in London
Measured: end of study (2 months)
Secondary outcomes (2)
• Prevalence of individual non-White self-identified ethnicity groups in MSM with HIV in London
Measured: End of study (2 months)
Description of current clinic practice for ethnicity data recording
Measured: End of study (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startMar 2011 (estimated)
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Why it stopped: Unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277458
- Sponsor's protocol ID
- EthMSM01
- Status last verified
- Dec 2010
- First submitted
- 14 Jan 2011
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Ethnicity Recording in MSM Patients With HIV of Non-White Ethnicity in London
- ClinicalTrials.gov ID
- NCT01277458
- Acronym / sponsor ID
- EthMSM01
- Conditions
- HIV
- Keywords
- HIV, MSM, Ethnicity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Mar 2011 (estimated)
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non white HIV positive men who have sex with men | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 400 Non-White HIV positive Men who have sex with men
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of misclassification of ethnicity for non-White MSM with HIV living in London
Time frame: end of study (2 months)
2 secondary outcomes
• 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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Public Health England at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of misclassification of ethnicity for non-White MSM with HIV living in London (time frame: end of study (2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.