Condition category
Infections and Infestations
Date applied
31/08/2016
Date assigned
02/09/2016
Last edited
02/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sarah Oakley-Mudge

ORCID ID

Contact details

Suite 12
Science Village
Chesterford Research Park
Cambridge
CB10 1XL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MRC SAMBA II WB Semi-Q

Study information

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Multi-centre non-randomised diagnostic accuracy study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2016

Overall trial end date

01/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. HIV sero-positive
2. Aged 18 years and over
3. Able to understand patient information sheet and consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2300

Participant exclusion criteria

1.Below 18 years old or unable to understand forms or procedure
2. Pregnant women
3. Co-infection with active TB

Recruitment start date

01/11/2016

Recruitment end date

02/06/2017

Locations

Countries of recruitment

Cameroon, Uganda, Ukraine, United Kingdom

Trial participating centre

Central Middlesex Hospital
Acton Lane Park Royal
London
NW10 7NS
United Kingdom

Trial participating centre

National Academy of Postgraduate Education
04112
Ukraine

Trial participating centre

Ministry of Health
P.O. Box 7272
Uganda

Trial participating centre

Global Health Solutions
Box Limbe L
Cameroon

Sponsor information

Organisation

Diagnostics for the Real World (Europe) Ltd.

Sponsor details

Suite 8
Science Village
Chesterford Research Park
Cambridge
CB10 1XL
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

Intention to publish date

01/08/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes