GIM 2007 -
POSTED ON: 01 Apr 2007
RESEARCHERS: Ernie Chan, Denise Lee, Lisa Tan, and John Whittaker
Public health experts agree that early diagnosis of children at risk for contracting HIV/AIDS from HIV-positive mothers in sub-Saharan Africa is vital to reducing the disease’s terrible toll. Detecting HIV early can help prevent transmission during birth or breastfeeding and improve outcomes for children carrying the virus. Each year, mother-to-child transmission of HIV/AIDS causes the vast majority of the estimated 700,000 new HIV infections in children.
Unfortunately, existing diagnostic tests cannot accurately distinguish whether a newborn has HIV or is carrying the mother’s antibodies. As a result, most of the children in the region are not tested—or identified as HIV-positive--even though current guidelines require all at-risk infants to receive HIV tests when they are six weeks old. Lack of an infant diagnostic HIV test and other obstacles, such as government healthcare policy, social stigma surrounding HIV/AIDS, and underfunded healthcare facilities, stand in the way of testing those who need it most.
In this context, extensive interviews and research on policies affecting at-risk children in South Africa and Zambia were conducted. The resulting analysis points to a simple solution that could potentially save tens of thousands of children’s lives in the region: a rapid HIV tests for infants. Such a test could provide families information necessary to be more responsible about breastfeeding and to avoid passing HIV on to a child at a much earlier stage than is possible today. These potential results should motivate governments in southern Africa to make available a rapid HIV test for all newborns as soon as possible. Here, the crucial need for a rapid HIV test for infants is demonstrated in detail, along with information on the current systems, infrastructures, and stakeholders that would be involved in developing and distributing HIV tests in South Africa and Zambia.
HIV/AIDS Testing in Sub-Saharan Africa
Current statistics on HIV/AIDS in sub-Saharan Africa are grim. At the end of 2005 an estimated 24.5 million adults and children in the region were living with HIV. During that year, an estimated two million people died from AIDS. The epidemic has left behind about twelve million orphaned African children.
The situation appears to be getting worse. The number of children who died from HIV/AIDS in South Africa rose from 35,441 in 1997 to 62,212 in 2004, a 76 percent increase. Without intervention HIV-infected mothers have a 35 percent overall risk of transmitting HIV to their children during pregnancy, delivery, and breastfeeding.
Rapid HIV tests currently used in developing countries can only detect HIV antibodies, which are the body’s immune response to an antigen. Thus the tests cannot accurately distinguish whether a child is actually infected with HIV or is only carrying the mother’s antibodies, which can remain in the blood for as long as eighteen months after birth. This test ambiguity, partnered with the stigma associated with HIV/AIDS, prevents many women in southern Africa from having their babies tested. A baby who tests positive for the HIV antibody must have received it from its mother, who faces abandonment by her partner and discrimination from her community if people know she is HIV-positive.
There is clearly an urgent need for a rapid HIV test that identifies antigens, which are actual components of the virus, and that can be administered easily to infants. Development of such a test may be on the horizon within the next few years, thanks to the technological advances of groups such as Global Health Initiative (GHI). GHI was started by Northwestern University’s Kellogg School of Management and McCormick School of Engineering, whose mission is to promote a partnership between private industry, non-profit donors and academia to develop products that address health issues facing underserved communities around the world (for more information visit www.kellogg.northwestern.edu/research/ghi
).Challenges for HIV Testing Programs and Advances in Africa
GHI staff members have their work cut out for them, based largely on the heartbreaking number of South Africans and Zambians affected by HIV/AIDS. In both countries about 15 to 20 percent of adults are infected with HIV. South Africa has the largest number of people living with HIV/AIDS in the world: 5.5 million at the end of 2005. In South Africa most HIV testing and treatment takes place in government-funded, public clinics that provide a broad variety of healthcare services. In recent years, however, the number of private hospitals, which treat mainly affluent patients, has grown.
Across South African provinces, rural clinics have a higher rate of infection than their urban counterparts and are more likely to suffer personnel and supply shortages. Public urban clinics tend to have greater resources and better-trained staff, but rural clinics provide the majority of antenatal care to South African women. Overall, South Africa faces a severe shortage of trained healthcare workers, including nurses, physicians, midwives, and pharmacists. The South African government does not require women to receive HIV testing, and many women forgo it because of the social stigma.
The South African government currently distributes four kinds of rapid, blood-based antibody tests as part of its Prevention of Mother-to-Child Transmission (PMTCT) program begun in 2001. The PMTCT program involves voluntary counseling and testing of pregnant women, administration of an antiretroviral (ARV) to the mother in labor and to the infant within seventy-two hours of delivery, counseling about breastfeeding, free infant formula, and prophylactic treatment for the newborn starting at six weeks. The effectiveness of this regimen depends on the severity of the mother’s HIV infection.
Public health experts acknowledge that the PMTCT program has not been successful so far. Government guidelines stipulate that all children of HIV-positive mothers should receive a polymerase chain reaction (PCR) test, but the decision to test or not depends on mothers, who often refuse it. For those who opt to take the PCR test, a healthcare worker draws blood from the infant’s heel and sends the dried blood sample to a laboratory for processing, which can take weeks. Only three South African labs currently process PCR tests.
In contrast, a rapid antigen test would significantly increase the rate of infant testing at six weeks of age by providing a more efficient way to collect and screen blood. The diagnostic would also eliminate the need for tracking at-risk infants for eighteen months. Healthcare workers could either immediately begin administering ARVs to infected infants or counsel HIV-positive mothers to stop breastfeeding their babies if they do not carry the virus.
HIV testing is even more of a challenge in Zambia, which has an estimated 1.6 million infected adults. Zambia’s Health Ministry estimates that of 500,000 births each year about 40,000 infants are infected, and of those between 30 and 50 percent die within two years. Mother-to-child transmission accounts for more than 90 percent of HIV infections in children. A high percentage of Zambia’s population lives in rural areas and is nearing childbearing age, which increases the need for an effective and freely accessible HIV rapid antigen test for infants.
Unfortunately, Zambia does not have the healthcare infrastructure in place that South Africa does, and the large proportion of rural communities in Zambia creates a greater hurdle for both testing and treatment, in part because of the ongoing social stigma of HIV/AIDS. In Zambia there is a lack of HIV rapid testing for infants and a severe shortage of specialized medical staff: in 2004 there were only 10,000 registered nurses for a population of ten million. Zambia’s highly political and bureaucratic government poses another barrier for delivering HIV tests. As in South Africa, women can refuse HIV testing for themselves and their babies.
As would be expected, conducting useful market research for HIV rapid tests for infants depends on navigating the political environment and hierarchies of organizations involved in the HIV/AIDS pandemic. Five groups exert the most influence over the political environment around HIV/AIDS policy and social action in southern Africa: the government, doctors/clinics, non-governmental organizations, the private sector, and activists. Clearly, these groups must continue to be involved in the pursuit of a rapid HIV antigen test for infants, as well as sustained market research supporting such a product. Such measures, along with promoting education, furthering development of PMTCT programs, and building relationships with key stakeholders in each country, will help ensure that infants and children in sub-Saharan Africa receive the HIV-related testing and care that they need.