EID technology promises to be a game-changer in paediatric AIDS diagnosis

Testing children under 18 months of age for HIV is a little more difficult than testing older children and adults because antibodies from the mother are found in the child’s blood for up to 18 months after birth. PHOTO| FOTOSEARCH

What you need to know:

  • If infants are born with HIV, there is need to diagnose them early and most importantly start them on ARVs.
  • An infant is considered HIV-exposed if the mother is positive and can get the virus during pregnancy, at birth or while breastfeeding.
  • For medics to take the appropriate action, they would need to first and foremost establish the status of the child as early as possible, which is six weeks from birth in Kenya.

When Dolphine Bondo, a middle-aged mother of one from Mbita Sub-county, of Homa Bay County, was asked the one word that would aptly describe the anxiety she felt during the one-month she had to wait before she got the HIV test results for her baby, she hesitated, as if lost for words, then said: “Endless.”

And then, on second thought, almost as if the word did no justice to the feeling she had then, she gave “controlling”.

Ms Bondo works as a cashier in a local savings and credit co-operative (Sacco). She tested positive for HIV in 2012 and got married in 2015, determined to raise Aids-free children.

When she got pregnant with her first child, in 2017, she ensured that she attended all her antenatal clinics, besides taking her antiretroviral drugs religiously. She thus managed to suppress the virus in her body significantly.

ANTITEROVIRAL DRUGS

These efforts, she had been informed by a nurse, would ensure her baby does not get the HIV during pregnancy.

An infant is considered HIV-exposed if the mother is positive and can get the virus during pregnancy, at birth or while breastfeeding. But efforts such as the mother’s adherence to antiretroviral drugs, and skilled delivery, among others, can greatly reduce the risk of the child contracting HIV.

Ms Bondo gave birth to a bouncing baby girl in November 2017, happy to become a mother and hoping that all would well with the baby. So when the baby turned six weeks, she was eager to know her status.

She took the baby to Mbita Sub-county Hospital for testing. But after the healthcare worker pricked the child’s heel and drew some blood, her expectations were dashed when she was informed that she would get the results in a month’s time.

“I know that if someone is tested for HIV they should get the results immediately. Why do I have to wait? Is it that my baby is positive and they don’t want to tell me?” she kept wondering.

Back home, her husband was also growing anxious and panicky to the point that Ms Bondo contemplated stopping her baby from breastfeeding.

Worried, she called a nurse at the hospital who explained to her why the results would take a month.

NOT THE USUAL SCREENING

Testing children under 18 months of age for HIV is a little more difficult than testing older children and adults. This is because antibodies from the mother are found in the child’s blood for up to 18 months after birth.

Ideally, for doctors to ascertain the HIV status, an infant has to undergo a cascade of four tests, done at six weeks, six months, one year and the final one at 18 months.

Dr Collins Otieno, a laboratory specialist and Elizabeth Glaser Paediatric Aids Foundation (Egpaf) country implementation manager for a project that has been implementing a technology to reduce turnaround time for HIV diagnosis among infants, told DN2 that while every child born to an HIV positive mother will test HIV antibody positive, not every child born to an HIV positive mother is infected with HIV.

The presence of HIV antibodies in the child is an indication that the maternal HIV antibodies were passively transmitted across the placenta to the unborn baby during pregnancy, he said.

But if no action is taken, research has shown that one in every three children born to an HIV positive mother will be infected with HIV.

Ms Dolphine Bondo shares a light moment with her friend Jecinta Atieno and a nurse in the middle at Mbita Sub-county Hospital. PHOTO| DELFHIN MUGO

For medics to take the appropriate action, they would need to first and foremost establish the status of the child as early as possible, which is six weeks from birth in Kenya. But since the normal antibody test cannot be relied upon to give a conclusive answer, then the need for a test that directly detects the virus itself arises.

“You need to know that HIV infections among infants is actually a public health emergency. If they are born with HIV, then you need to diagnose them very early and most importantly initiate them on ARVs,” says Egpaf country director Eliud Mwangi.

According to Dr Otieno, research done worldwide has shown that three in 10 children (30 per cent) infected with HIV will die before their first birthday, 50 per cent before their second while eight in 10 children representing 80 per cent will not live to see their fifth birthday, if not put on treatment immediately.

In South Africa, a study that sought to establish a mortality peak period and dubbed Emergence of a peak in early infant mortality due to HIV/AIDS in South Africa found out that “A peak in HIV-related deaths was observed, centred at two-three months of age, rising monotonically over time.”

RED ZONE

These findings, albeit from other parts of the world, make the case for early HIV diagnosis among infants not just for their mothers’ peace of mind, but for their own health and well-being.

“The first test is done at six weeks. With the conventional method it is taking at least one month to get the results back, so by that time, the child has already entered the red zone (mortality peak period). This means that the child will be either dead or too sickly to respond to treatment by the time the caregiver gets the results,” Dr Mwangi says.

This is the reason early infant diagnosis (EID) is of great concern to Dr Mwangi, whose organisation, in collaboration with the Ministry of Health (MoH) and donors, has been striving to eliminate mother-to-child-transmission (MTCT) in Kenya for 18 years. The situation is such that the conventional way of diagnosis has proved less effective and done little to save children’s lives.

A Dry Blood Spot (DBS) test has been the conventional laboratory-based Early Infant Diagnosis (EID) for HIV-exposed infants in Kenya. However, only 67 per cent of children have access to the test, according to the MoH.

Additionally, due to the long turnaround times (30-60 days) from sample collection to return of results to providers and caregivers, initiation of antiretroviral treatment for HIV-infected infants is frequently delayed.

Ms Vidah Achieng was all smiles as she waited for the results of her baby's test. PHOTOS| DELFHIN MUGO

This delay is in part due to the limited number of laboratories with capacity to do this test in the country. There are only eight laboratories with the capacity to conduct EID in Kenya, creating a nightmare for mothers such as Ms Bondo with HIV-exposed infants.

For instance, counties in the former North Eastern, Eastern and sections of Rift Valley provinces are served by the Kenya Medical Research Institute (Kemri) laboratory in Nairobi.

The former Central and Nairobi province send their specimen to the National HIV Reference Laboratory in Nairobi.

Ampath Laboratory in Eldoret serves a humongous three-quarters of former Rift Valley province, with a laboratory in Kericho and Kemri Nairobi coming to its rescue.

Located in Mombasa, Coast General Provincial Hospital lab serves all the four counties of the former Coast province, while two labs in Kisumu and Busia respectively serve the vast western Kenya. The Kenyatta National Hospital lab is the eighth in the country.

The test involves a small card that contains a cotton cellulose paper collection pad. To use the card for infant diagnosis of HIV, a small volume of blood from an infant’s heel is applied to the sample collection area and then allowed a night to dry up. The card, complete with the dry blood spot, is then packaged for transportation to a test lab.

“Time is lost during the preparation of sample, where the blood spot is allowed time to dry. Further time will be consumed during transportation to the central lab, but still, it will take a couple of days to conduct the test at the laboratory and for caregivers to get results,” Dr Otieno says.

At Kandiege Hospital, DN2 met with Vidah Achieng’, a 29-year-old mother of three from Oriang’ Village in Homa Bay. Vidah knew she was HIV-positive five years after delivering her first baby, by which time she was pregnant with her second child.

In 2013 after giving birth, when her baby was due for her first test, she went to the hospital, eager to know the baby’s HIV status.

The test was done the conventional way with Ms Achieng’ having to wait for the results for one month.

When she got the results, her baby was HIV-negative, but still, she says, the one-month wait had done less to inspire hope.
“The more I waited, the more I thought the result would be positive,” she said.

EID TECHNOLOGY

“When I delivered my third baby and presented her six weeks later for testing, the nurse informed me that I would get the results the same day, actually in one hour,” she narrates, with a smile.

“I did not believe her, but then I had nothing to lose by waiting and besides, it was better than one month. I felt nice,” Achieng’ describes her joy after receiving the results.

She adds: “I feel happy that my second-born has gone through all the tests and declared HIV-free. I am now looking forward to the final confirmation test for my third baby. It feels good to see them graduate and to know that you can raise HIV-free children. I want to have two more children.”

Meanwhile, when Ms Bondo’s baby was due for the second test, Mbita Sub-county Hospital was part of the facilities earmarked for piloting of an EID technology meant to reduce turnaround time for infant diagnosis. It took one hour to get the results, she says. She is happy that her baby is HIV-negative, even as she awaits the final confirmation test.

“My wish is that these machines are retained in the facility so that more mothers can benefit,” Ms Achieng’ says, in reference to a new-to-market point-of-care (POC) technology that has been placed at Kandiege Level 4 Hospital where she is a client.

The small portable machine called Alere Q has the potential to analyse a blood sample for HIV and give result in 50 minutes, saving mothers such as Ms Achieng’ and Ms Bondo the anxiety of having to wait for weeks.

“It is easy to use it, and it does not require trained lab technicians to operate... This hospital is a hub, meaning it receives specimens from other smaller health facilities around, so patients from those referring facilities, which are called spokes, will get results in at most 48 hours, which is a huge improvement compared to the conventional method,” laboratory Manager at Kandiege Level 4 Hospital Collince Kisakwa told DN2.

POLICY
“In 2015, we launched the POC-EID technology, which is executed by Alere Q and GeneXpert machines. This is a multi-county award that is funded by Unitaids. It is being implemented by Egpaf in nine countries and Kenya is one of them,” Dr Mwangi told DN2.

In Homa Bay County alone, where DN2 made site visits during the Moi Day holiday and the day after, Egpaf has installed 11 POC machines in hospitals.

Insisting that his organisation has worked in collaboration with the Ministry of Health, especially in terms of developing the policy guidelines for use of POC, Dr Mwangi said that the technology has been rolled out in 12 counties so far.

Ms Pheny Otieno enters the test results in the register. PHOTOS| DELFHIN MUGO

The GeneXpert, unlike the Alere Q, requires a more sterile lab setting, but the good thing with it is that it comes with four modules. This means that it can carry out four tests at ago, with an average execution time of two hours, unlike the Alere Q, which can handle one test at a time and takes 50 minutes.

With Egpaf-Unitaid project coming to an end next July, after which the infrastructure will be handed over to the government, some nurses in hospitals we visited in Homa Bay are receiving news of transition with cautious optimism.

“I fear for mothers. Sustainability may be an issue when we cross the bridge,” one of the nurses said.

Dr Mwangi, however, said that talks with the government have been ongoing so as to ensure a smooth transition.

But we sought to know the position of the government concerning the technology. Will it overhaul the conventional method, for instance?

“As a government, we have seen that it is working and it is acceptable. Our position is that the POC is complementing the conventional method. It cannot replace it. The reason for that is that there are places where the conventional method is working quite well, and the POC should bridge the gap where the conventional is not able to reach,” Dr George Githuka, prevention of mother-to-child transmission programme manager at the National Aids and STIs Control Programme (Nascop), told DN2.

LIFE-SAVING TREATMENT

He added that the ministry is interested in scaling up POC and that for now, they are working on a criterion to determine which sites qualify for POC and vice versa.

Speaking at his office in Homa Bay Town, Dr Gordon Okomo, county director of health for Homa Bay, said: “Besides transition talks, we’ve inquired about the cost of the technology so that we can include it in our strategic plan and have it rolled out in other facilities in the county.”

Dr Mwangi made a clarion call to the government, saying: “As the project comes to an end, my appeal is for the government to look at how this technology can be scaled up and integrated among key technologies that will help achieve the universal health coverage.”

The POC-EID executed by Alere Q and GeneXpert machines has proven to be a useful intervention in diagnosis and link to care for HIV-exposed infants, significantly reducing anxiety among parents and promising those found positive a lifeline.

If diagnosed early and found to be HIV-positive, infants can be put on life-saving treatment, ensuring that they lead normal lives like many other children.

If found to be negative, HIV-positive mothers will not only have faith in the healthcare system, but the technology will also raise their prospects of giving birth to virus-free children, just like Ms Vidah Achieng’, Ms Dolphine Bondo and many other women from Homa Bay County, who have benefited from the technology.

***

POC technology returned better results compared to conventional laboratory-based

In a bid to compare the effectiveness of the two methods of early infant diagnosis, EGPAF conducted a survey between 2015 and 2018 and the results were startling.

Baseline data on 540 infants tested using conventional, laboratory-based EID were collected in 2017 from health facilities, before introducing POC technology.

On the other hand, between August 2, 2017 and April 30, 2018, data for POC EID tests conducted across 139 health facilities were analysed.

During this period, 2,412 tests were conducted on 2,365 infants using POC. 44 infants tested HIV-positive.

From findings, under conventional method, only two out of ten caregivers received results within 30 days recommended by World Health Organisation, while almost all caregivers (99.6 per cent) received theirs in 30 days, after going through POC technology.

Meanwhile, the median turnaround time from blood sample collection to caregiver receipt of results was a sluggish 52 days with conventional and one day for POC.

With the conventional method, fewer number of infants identified to have HIV were initiated to treatment (7 out of 10) when compared to POC, where all HIV-positive infants were initiated.

Still, more time was taken between sample collection and initiation to treatment for those found positive with the conventional method; a worrying 42 days if compared to the two days it took with POC.