Performance evaluation of a point-of-care whole blood viral load test (SAMBA II HIV-1 Semi-Q Whole Blood) to optimise HIV treatment
| ISRCTN | ISRCTN12803987 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12803987 |
| Secondary identifying numbers | MRC SAMBA II WB Semi-Q |
- Submission date
- 31/08/2016
- Registration date
- 02/09/2016
- Last edited
- 25/09/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
The human immunodeficiency virus (HIV) is a type of virus known as a retrovirus. HIV attacks and weakens the immune system, making it more difficult for a sufferer to fight infections. It is a highly contagious disease, through bodily fluids such as blood, semen and vaginal fluids. There is currently no cure for HIV, but there are a range of drug treatments that can allow people who are HIV positive to lead a long and full life. Antiretroviral therapy (ART) is the standard treatment for HIV, where at least three different antiretroviral (ARV) drugs are given at the same time. This treatment is very effective at suppressing the virus and stopping the development of the disease. When a person has been on ART, the amount of HIV present in the blood (viral load) is reduced. Routinely monitoring the viral load (VL) through regular blood testing is a vital part of this treatment strategy, as it is able to identify treatment failure so the drugs used can be changed. Current HIV VL tests are limited to centralised laboratories, as they require high organization and trained personnel. HIV patients living outside of major cities in developing countries often do not have access to VL testing. Even when VL testing is available, there are often delays in obtaining test results or loss of samples during shipment, leading to high loss to follow-up. Point-of-care VL testing (testing samples there and then) in lower healthcare facilities may overcome these limitations, improving patient outcomes and preventing spread of the disease. The aim of this study is to find out whether point-of-care HIV viral load testing with SAMBA II HIV-1 Whole Blood SemiQ is as accurate as centralised HIV viral load testing.
Who can participate?
HIV positive adults
What does the study involve?
HIV positive patients who attend the clinics for routine VL monitoring are invited to provide an additional blood sample for VL testing with SAMBA II HIV-1 Whole Blood Semi-Q at the same time as they provide blood samples for their routine VL testing. The clinic processes the blood for the routine HIV VL test and informs patients of the results according to normal clinic procedures. The additional blood sample is tested with SAMBA II HIV-1 Whole Blood Semi-Q, but patients are not given the results. The results from the two tests are then compared in order to find out whether the point-of-care testing is as accurate as the normal procedure.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved to participants taking part in this study.
Where is the study run from?
The study will be conducted in 4 countries: United Kingdom, Ukraine, Cameroon and Uganda. There will be one clinic in each of the United Kingdom (Central Middlesex Hospital, London) and Ukraine (National Medical Academy, Kiev) and up to 6 rural lower healthcare clinics in Uganda and Cameroon.
When is the study starting and how long is it expected to run for?
June 2016 to August 2017
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Dr Sarah Oakley-Mudge
Contact information
Scientific
-
Cambridge
-
United Kingdom
Study information
| Study design | Multi-centre non-randomised diagnostic accuracy study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparing a new point-of-care whole blood viral load test (SAMBA II HIV-1 Whole Blood Semi-Q) to a gold standard test in HIV positive patients in the UK, Ukraine and Africa: A diagnostic accuracy study |
| Study objectives | Point-of-care HIV viral load testing with SAMBA II HIV-1 Whole Blood SemiQ is concordant with Gold Standard centralised HIV viral load testing. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | HIV |
| Intervention | HIV positive patients who attend the clinic for routine VL monitoring will be invited to provide an additional blood sample for VL testing with SAMBA II HIV-1 Whole Blood Semi-Q. Trained clinic staff will collect venous blood required for the routine clinic tests together with one additional blood sample (either venous or capillary). The clinic will process the blood for the routine HIV VL test and inform patients of the results according to normal clinic procedures. The additional blood sample will be tested with SAMBA II HIV-1 Whole Blood Semi-Q. Patients will not receive the results from the SAMBA II HIV-1 Whole Blood Semi-Q assay. There is no follow up for participants. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Diagnostic accuracy of the SAMBA HIV-1 Whole Blood Semi-Q test determined by concordance to the Gold Standard HIV viral load test (within 0.3 log10 copies/ml). |
| Secondary outcome measures | Association between collected clinical covariates (age, country and gender) with the concordance between test is determined using the Wald test statistic of parameter associated with clinical covariate in logistic regression with concordance as outcome. |
| Overall study start date | 01/06/2016 |
| Completion date | 15/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2300 |
| Key inclusion criteria | 1. HIV sero-positive 2. Aged 18 years and over 3. Able to understand patient information sheet and consent form |
| Key exclusion criteria | 1.Below 18 years old or unable to understand forms or procedure 2. Pregnant women 3. Co-infection with active TB |
| Date of first enrolment | 01/11/2016 |
| Date of final enrolment | 02/06/2017 |
Locations
Countries of recruitment
- Cameroon
- England
- Uganda
- Ukraine
- United Kingdom
Study participating centres
Park Royal
London
NW10 7NS
United Kingdom
Ukraine
Uganda
Cameroon
Sponsor information
Industry
Suite 8
Science Village
Chesterford Research Park
Cambridge
CB10 1XL
United Kingdom
"ROR" |
https://ror.org/04e2ayg86 |
|---|
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan |
Editorial Notes
25/09/2018: The overall trial end date was updated from 01/08/2017 to 15/10/2018.
