Condition category
Infections and Infestations
Date applied
13/12/2017
Date assigned
09/01/2018
Last edited
02/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The World Health Organization (WHO) says Universal Health Coverage is achieved when everybody receives the quality health services needed without suffering financial hardship. The WHO also promotes people-centered healthcare that is best for patients, health care workers and the community.
To this end, point-of-care (POC) testing is when patient specimens are tested quickly, allowing healthcare workers to use the result there and then to give the patient the right care and treatment. There are many new POC tests being developed that can help both patients and healthcare workers. HIV is an incurable sexually transmitted disease and may be transmitted from a mother to her child in the womb, during birth and through breast milk. HIV causes disease and suffering worldwide but especially in Africa where the most people with HIV live. Antiretroviral treatment (ART) is given to people who are HIV positive to control the virus and help them to stay healthy. If a mother takes ART during pregnancy and breastfeeding her child is protected from getting HIV from her. Before ART availability, 30 in 100 babies born to HIV positive mothers would get HIV. Now only 1 or 2 in 100 are getting HIV as ART is given to all pregnant mothers. However, all babies of HIV-positive mothers still need to be tested for HIV. Babies who get HIV do best when started on ART as soon as possible after they become infected. Without ART half will die in the first year of life and many before 3 months of age. It is also reassuring for a mother to know her babies result even if it is negative. Babies cannot be tested with the same tests as adults as these test for HIV antibodies which are passed from mothers to their babies, so the babies would all test falsely positive. Babies have to have expensive tests that detect the actual HIV virus. Presently in South Africa, the baby’s blood is sent to a central laboratory using a dried blood spot (DBS) and the HIV result is available after a few days. The WHO has approved some rapid HIV tests that can give the babies' HIV result in 1-2 hours, which means positive babies can be started on treatment immediately. Mothers of negative babies can know that their baby is negative there and then. South Africa has by far the highest number of people with HIV in the world and Durban, where the study is conducted, has the highest HIV prevalence (4 out of 10 pregnant mothers have HIV). The aim of this study is to use a POC HIV test for babies of HIV-positive mothers and determine the accuracy of the POC test, if mothers and healthcare workers like it, and if it is able to be introduced into a hospital and clinic.

Who can participate?
Mothers with HIV are invited to allow their babies to participate in the study

What does the study involve?
Babies are tested for HIV using the Alereq Detect HIV test. One drop of the baby’s blood from a heel-prick goes into a cartridge and into a machine, which gives the result in 50 minutes. Testing is performed during office hours while study staff are present. Routine dry blood spot tests are still done on each baby where 3-5 wells are filled with blood on a card and sent to the laboratory at Inkosi Albert Luthuli Hospital. This result is put onto a central computer register and can be collected at the hospital or clinic in 1-2 weeks. This is so the tests can be compared for accuracy. Study counselors also ask the mothers some questions about their background and how they feel about the test. The hospital and clinic staff are trained how to use the Alereq machine and encouraged to do the new POC test. They also complete a questionnaire at the end to understand how they found the testing. Study staff are always present to get consent from patients and administer the study questionnaire. They also perform the DBS testing so as not to increase the workload of the healthcare workers.

What are the possible benefits and risks of participating?
The benefit of participating is that mothers get the baby’s HIV result on the same day. There is a chance that the POC test may give an error, which means it is repeated, but mothers still get the result as soon as possible on the same day. The heel-prick may cause a little discomfort to the baby and some bruising, as may occur if babies just had the routine DBS test. If a baby is positive mothers are counselled, supported and cared for and the baby can be started on ART straight away with the paediatricians at the hospital or clinic doctors at the clinic. Staff can ensure mothers receive adequate counseling and help with the ART for the baby before they go home. The study staff includes a doctor and an HIV/breastfeeding counselor who can give mothers any additional advice and counseling if required.

Where is the study run from?
Addington Hospital and Lancers Road Clinic in Durban (South Africa)

When is the study starting and how long is it expected to run for?
August 2015 to January 2018

Who is funding the study?
The South African Medical Research Council (SAMRC) (South Africa)

Who is the main contact?
Dr Elizabeth Spooner
bethspoons@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr Elizabeth Spooner

ORCID ID

Contact details

Department of Paediatrics and Child Health
College of Health Sciences
University of KwaZulu Natal
Durban
4001
South Africa
+27 (0)723510284
bethspoons@ukan.ac.za

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KZ_2015RP43_313

Study information

Scientific title

Testing the specificity, operational feasibility and acceptability of point-of-care (POC) HIV testing compared to conventional laboratory testing for early infant diagnosis (EID) in Durban, South Africa

Acronym

EID study

Study hypothesis

Point of care testing for early infant diagnosis is accurate, acceptable and feasible.

Ethics approval

1. Biomedical Research Ethics Committee of the University of Kwa-Zulu Natal, 05/04/2016, ref: BF461/15
2. Kwa-Zulu Natal Department of Health, Health Research and Knowledge Management Directorate, 14/03/2016, ref: KZ_2015RP43_313

Study design

Implementation study observing the accuracy, feasibility and acceptability of point-of-care HIV testing on infants at birth in a hospital and at follow up in a primary health clinic compared to laboratory based testing performed on the same infants at the same time

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 to request a patient information sheet

Condition

HIV-exposed infants and their mothers

Intervention

Point-of-care HIV PCR testing is performed on HIV exposed infants around birth in Addington hospital and at Lancers rd primary health care clinic using the Alere™q HIV-1/2 Detect test which is performed from a 25μl drop of blood into a test cartridge and processed in the Alereq machine in 50min. This is compared with the standard of care dry-blood-spot specimen which is sent to the central National Health Laboratory Services laboratory for testing with the Roche COBAS Ampliprep/COBAS Taqman (CAP/CTM) HIV-1 Qualitative test v2.0. Questionnaires are administered to the mothers and healthcare workers.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Sensitivity and specificity of the point of care testing compared to the standard of care laboratory testing, measured at the time of testing

Secondary outcome measures

Acceptability of POC testing to mothers and health care workers and operational feasibility of POC testing in both settings, measured using a quantitative/qualitative questionnaire that the mothers are asked at an interview on the day of testing with open and closed ended questions. The staff were interviewed after study completion and a quantitative/qualitative questionnaire with open and closed ended questions is completed at one timepoint.

Overall trial start date

01/08/2015

Overall trial end date

31/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infants delivered to HIV infected mothers at Addington hospital
2. Infants presenting for HIV PCR testing at Lancers rd clinic

Participant type

Mixed

Age group

Neonate

Gender

Both

Target number of participants

452 infants

Participant exclusion criteria

1. HIV unexposed infants
2. Infants whose mothers do not give written, informed consent to participate in the study

Recruitment start date

07/02/2017

Recruitment end date

22/08/2017

Locations

Countries of recruitment

South Africa

Trial participating centre

Addington Hospital
Durban
4001
South Africa

Trial participating centre

Lancers Road Primary Healthcare Clinic
Durban
4001
South Africa

Sponsor information

Organisation

University of KwaZulu-Natal, School of Clinical Medicine, Department of Paediatrics and Child Health

Sponsor details

4th Floor
Main Building
Nelson R Mandela School of Medicine Campus
719 Umbilo Rd
Durban
4001
South Africa
+27 (0)31 260 4489
coutsoud@ukzn.ac.za

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

South African Medical Research Council

Alternative name(s)

SAMRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

South Africa

Results and Publications

Publication and dissemination plan

To be submitted to BMC Public Health in January 2018 with the intention to publish in early 2018.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/02/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes