Investigating chronic breathlessness in people living with HIV

Recruiting

• Conditions: Breathlessness in HIV positive and HIV negative participants; Infections and Infestations

• Registration Number: ISRCTN13866813
• Lead Sponsor: Royal Free London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-23
• Last Update Posted: 14 January 2019
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

HIV positive participants:
1. HIV positive
2. Aged 18 years or older
3. Informed consent given
4. Chronic breathlessness (defined as MRC breathlessness score =2 persisting for at least 4 weeks and not due to an acute illness)
5. No definitive diagnosis to explain breathlessness (definitive diagnosis defined as patient or physician reported diagnosis substantiated by recent physiological investigations)
6. Able to participate for the duration of the study

HIV negative participants:
1. Negative HIV test (performed as part of routine care)
2. Aged 18 years or older
3. Informed consent given
4. Chronic breathlessness (defined as MRC breathlessness score =2 persisting for at least 4 weeks and not due to an acute illness)
5. No definitive diagnosis to explain breathlessness (definitive diagnosis defined as patient or physician reported diagnosis substantiated by recent physiological investigations)
6. Able to participate for the duration of the study

Exclusion Criteria

All participants:
1. Unable to perform lung function tests.
2. Physical disability precluding the ability to complete a cardiopulmonary exercise test (for example wheelchair bound)
3. Pregnant
4. Unable to attend for investigations and review

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Proportion of participants with breathlessness in HIV positive and HIV negative groups due to:<br> 1. Cardiac disease<br> 2. Respiratory disease<br> 3. Psychological causes<br> 4. Deconditioning<br> 5. Other<br> For each participant group, the causes of breathlessness will be reported as a proportion due to each of the causes above at the end of the study.<br>

Secondary Outcome Measures

Name	Time	Method
<br> The following are assessed at the baseline and at the end of the study?<br> 1. Prevalence of depression in HIV positive and negative groups as defined by Patient Health Questionnaire (PHQ-9) score =5, assessed using the PHQ-9<br> 2. Prevalence of severe depression in HIV positive and negative groups as defined by PHQ-9 score =20, assessed using the PHQ-9<br> 3. Prevalence of anxiety in HIV positive and negative groups as defined by Generalised Anxiety Disorder assessment (GAD-7) score =5, assessed using the GAD-7<br> 4. Prevalence of severe anxiety in HIV positive and negative groups as defined by GAD-7 score =15, assessed using the GAD-7<br>