Scale up of early infant diagnosis in rural Ethiopia successful

Establishing and scaling up early infant HIV diagnosis (EID) programmes is feasible in even the most remote parts of Ethiopia, reported Berhanu Gudetta and colleagues in a study at the HIV Implementers’ Meeting, held in Windhoek, Namibia in early June.

Renovation of two regional laboratories making DNA PCR testing possible, coupled with the successful use of dried blood spot testing (sometimes referred to as DBS), increased the numbers of infants receiving early diagnosis and consequently improved early initiation of antiretroviral therapy (ART) for infants aged nought to 18 months.

The 2008 WHO guidelines recommend all infants infected with HIV under twelve months of age begin ART. Without ART, 50% of children with HIV will die before the age of two. HIV DNA testing is necessary to make a definitive diagnosis in children below 18 months, due to the persistence of maternal antibodies up until this age. The use of dried blood spots has simplified sample collection as it is less invasive for infants, and facilitates storage and transportation to laboratories equipped to carry out DNA testing using polymerase chain reaction (PCR) testing.

Ethiopia has an estimated 1.7 million people infected with HIV, approximately 80% of whom live in rural areas. Free antiretroviral treatment began to be provided in 2005. Currently 20,522 children are estimated to be in need of ART while 7399 are on treatment.

Johns Hopkins University Technical Support for the Ethiopian ART Initiative (JHU TSEHAI) is funded by PEPFAR-Ethiopia to provide technical assistance to 20 ART hospitals with the aim of eventually doubling this number. Currently JHU TSEHAI supports 55 ART sites and 70 PMTCT sites across four regions in Ethiopia, serving approximately 19.3 million people (out of a total population of 77 million).

Challenges common to other resource-poor countries included: limited access to early infant diagnosis; a lack of trained staff; no sample collection, transportation and storage system; a lack of dried blood spot and DNA PCR supplies; no linkage for HIV-infected infants to ART clinics, and a limited number of laboratories capable of performing DNA PCR.

In January 2006, JHU TSEHAI supported the start up of EID programmes in five hospitals in Addis Ababa. Prior to scale up at the end of January 2008, 692 infants had been tested with DNA PCR methods.

As part of the national plan to scale up EID programmes, JHU TSEHAI – in collaboration with the Centers for Disease Control and Prevention (CDC), PEPFAR-Ethiopia, EHNRI (Ethiopian National Laboratories), the Clinton HIV/AIDS Initiative (CHAI) and the regional laboratory staff – renovated two laboratories, one in the capital (Addis Ababa) and one in the South (Hawassa), to perform HIV DNA PCR testing.

The national laboratory programme owns and maintains the two laboratories. Johns Hopkins University, together with its partners, supported the establishment of the following systems: dried blood spot collection and storage; sample referrals for surrounding hospitals and health centres; laboratory standard operating procedures and guidelines; and on-site training.

Dried blood spot samples were transported by laboratory courier service in Addis Ababa and by clinical mentors in remote areas. Future plans are to send dried blood spots through intra-Ethiopian priority mail.

Infants from PMTCT and ART clinics were tested as per the national algorithm for infant diagnosis. Samples were collected and transported weekly to the national laboratory and the regional laboratories for DNA PCR testing, and results were then sent back to each hospital.

An analysis for the period from December 2006 until April 2009 (using fiscal years) reviewed infant age at sample collection, results of DNA PCR testing, turnaround time, EID coverage and changes in PMTCT regimens.

By January 2009, EID programmes had begun in 58 hospitals and 23 health centres. Health workers trained on dried blood spot sample collection and early infant diagnosis protocols increased by 300% (from 85 to 257). The number of infants tested almost doubled (from 692 to 1340). Dried blood spots were used to test all infants referred from PMTCT and ART clinics over six weeks of age and below 12 months and at some sites all aged below 18 months.

Changes in PMTCT regimens from single dose nevirapine to combined prophylaxis for mother and infants happened over the period under review and resulted in a decreased HIV DNA-positive rate, from 19.7% in 2006 to 11.5% in 2007 and 10.9% in 2008 (seven months of data).

HIV DNA-positive rates varied by age: 0-to-6-month age group 12.6% (65 infants); 6-to-12-month age group 29.8% (39) and for those over 12 months of age, 33.3% (7). Average turnaround time was two to four weeks. Testing of older children was due to testing of symptomatic children early in the programme.

Successful scale up of EID programmes depended upon partnerships between government institutions and external partners with specific and complementary areas of expertise. DBS testing enabled infants in remote areas to have access to DNA PCR (EID) services. The authors conclude that “successful use of DBS will optimize early infant diagnosis, thus increasing ART use in infants and decreasing overall morbidity and mortality”.