ABIDJAN — For infants born with HIV, a rapid introduction to necessary treatment is often the lifeline between whether a child will live or die. The recent introduction of a life-saving, point-of-care diagnostic technology in sub-Saharan Africa could become a global solution to preventing infant deaths from HIV.
According to the World Health Organization, in 2015 more than 1.2 million babies across 21 countries were born to mothers living with HIV. Until recently, less than half of HIV-exposed infants received testing within two months of birth, as recommended by WHO, and only half of those tested received results to know their outcome. Pediatric HIV advocates told Devex that early infant point-of-care diagnostic testing will not only improve health and save lives in resource-limited countries, but also offers same day results for what some call an “incredibly time-bound intervention.”
“Diagnosing HIV in children should be treated as a medical emergency; time is of the essence,” explained Jennifer Cohn, director of innovation at the Elizabeth Glaser Pediatric AIDS Foundation, or EGPAF. “If we don’t diagnose these kids and put them on treatment early, you see an early spike in mortality for those infants who acquire HIV inter-ureteral and by two years, 50 percent of those kids who are HIV-infected who don’t get those diagnoses in time and don’t start on treatment immediately, will die.”
Fewer than half of the infants who need antiretroviral treatment for HIV are getting it in 21 of the world's highest prevalence countries. A new initiative by the Elizabeth Glaser Pediatric AIDS Foundation aims at one of the major obstacles to care: Wait times between testing and results. The foundation's chief executive officer, Chip Lyons, spoke to Devex about promising initial results.
HIV testing facilities in Africa have typically been a centralized facility, where people must travel long distances to major cities to have samples collected, only to have to make a return trip — on average 55 days later — for results. During that time, many patients lost contact, avoided the travel required to get results due to financial or other constraints, and others had died, Cohn told Devex.
For something seen as a medical emergency, this baseline turnaround time had to be addressed, she said. “So with this new point-of-care early infant diagnostic technology came a real opportunity to improve the diagnosis and treatment initiation and really save lives as well as save precious human and financial resources,” Cohn argued.
One-stop care shows early results
Through a UNITAID grant, EGPAF has supported nine countries in the rollout of early infant HIV diagnosis including: Cameroon, Côte d’Ivoire, Kenya, Lesotho, Mozambique, Rwanda, Swaziland and Zimbabwe.
Point-of-care diagnostic brings the laboratory to the clinic in a little box that is incredibly user-friendly and can be used by nurses, clinical officers, and health care workers to collect HIV samples in underserved areas. Working alongside ministries of health, the EGPAF-UNITAID project is employing multiple approaches to enhance national early infant diagnosis according to local needs, implementation contexts, and priorities. In most countries, a “hub and spoke” model placed point-of-care platforms at a centrally-located “hubs” with smaller health outposts serving as “spokes” to quickly deliver samples to hub facilities. Countries also used stand-alone sites to process samples at their own facilities.
As part of post-intervention evaluations, EGPAF noted that the median turnaround times from blood sample collections to receipt of results decreased from 55 days using conventional diagnosis methods to same day results with point-of-care diagnosis. The percentage of newly HIV-infected infants identified with point-of-care diagnostic screening increased from 70 percent initiated on antiretroviral treatment up to 91.8 percent.
Challenges to widespread adoption
Though early infant point-of-care diagnostic has proven effective for the 191 sites and 9,500 infants tested using this new technology — with noticeable improvements in results provided to caregivers and the number of HIV-infected infants initiated on HIV treatment — widespread adoption remains low.
The world is on track to get 30 million HIV patients on treatment by 2030. But the last push will be the hardest, extending care to the most marginalized populations. Here are some of the innovations and strategies that scientists and practitioners are considering to tackle the challenge.
“Right now, we are in a situation where we have fantastic results, we see these point-of-care machines working in real-world conditions used by health care workers who are present in the facility already, but what we have not yet seen is that passion and push from donors, implementers to really say this is what we need and a commitment saying we are going to figure out a way to get it to the children who need it,” Cohn told Devex.
“If we saw a treatment that was this much more effective, we would be going crazy saying this is an absolute necessity for everyone and we need to see that same demand and that same passion and recognition of importance for this diagnostic technology as well,” she added.
Across Africa, countries must consider establishing a policy environment that supports point-of- care usage, Chip Lyons, president and chief executive officer of EGPAF said.
“We can talk about better data, various other important and valid points, the medicine available but the policy to give any positive woman treatment for life, not just the duration of her pregnancy, is particularly relevant for many countries,” he said. “There must be a political urgency and if you want people to come to clinics, it must be as convenient, welcoming, affordable and efficient as possible to avoid obstacles.”
Along with political will, increasing the affordability of point-of-care products could see more sub-Saharan Africa and low-income countries acquiring these diagnostic methods. Currently, products are higher than conventional methods. However, Cohn said the true value should be considered by the percentage of results actually returned versus the numbers of those tests wasted due to lagging turnaround times.
“We have to not look at the price, but look at the value of the product and look at the number of returned results and those numbers becomes much more imperative,” she told Devex. Cohn also noted the importance of keeping machines functional throughout the lifespan of their use through improved service and maintenance provisions for point-of-care machines in the field.
However, diagnostics are not viewed “in the same light as life-saving drugs,” Cohn warned. Diagnostics is the building block that serves as an entry point that confirms necessity of treatment and she said “for whatever reason, haven’t been given the priority in terms of funding in the same way as treatment.”
Today, far fewer children are acquiring HIV due to the accomplishments of the 2011 UNAIDS Global Plan which aimed at keeping mothers healthy and ending new HIV infections in children by 2015. Under this framework, more than 2 million additional pregnant African women started receiving antiretroviral therapy to reduce the mother’s viral load and likelihood of mother-to-child transmission. However, each year roughly 110,000 children are still being newly infected with HIV in the 21 priority Global Plan countries in sub-Saharan Africa, with more than half of new pediatric HIV infections occurring during the breastfeeding period.
The global momentum built on the Global Plan strategy continued for the following 2016 UNAIDS “Start Free, Stay Free, AIDS Free” framework to end AIDS among children, adolescents, and young women by 2020. One goal as part of the “Start Free” component, includes eliminating new HIV infections among children by reducing the number of children newly infected to less than 40,000 by this year, and reaching and sustaining 95 percent of HIV-infected pregnant women with lifelong HIV treatment by year’s end.
While HIV mother-to-child transmission has decreased since the inception of the Global Plan thanks to an increasing number of mothers on antiretroviral treatments, the reality remains that infants will continue to be infected, and therefore, infant diagnostics and treatments still requires global awareness and support, Cohn remarked.
“Thankfully, prevention of mother to child transmission by antiretroviral treatments has been incredibly successful, but it’s not perfect and we are going to see continued transmission of HIV unfortunately and infants [born] with HIV so we can’t take our eye off the ball,” Cohn argued.
“We’ve seen a similar thing happen time and time again with other epidemics, when we get to near elimination, eradication, suddenly the cost per case is so high and the political will goes down, funding goes down and suddenly we’re in a situation where it becomes an abandoned disease and then it comes right back because that’s what infectious diseases do, so we can’t take our eyes off the prize,” she said.