Case Study: Research and Development
AmpliCare: Combating HIV/AIDS in Developing Countries, Roche
AmpliCare began in 2002 and is a multi-faceted program to address barriers that prevent early diagnosis of infants born to HIV positive mothers along with HIV viral load monitoring of people on anti-retroviral therapies.
It includes adaptive R&D to address specific conditions in developing countries, building laboratory capacity and enhancing the skills of lab technicians, along with differential pricing for HIV diagnostic tests.
Diagnosis and monitoring are as essential to effective HIV/AIDS treatment as medicines. In infants, early diagnosis is critical in determining HIV exposure of infants born of HIV-positive mothers, and initiating intervention as soon as possible. Doctors also need to monitor disease progression and efficacy of treatment so they can prescribe the most effective treatment and make adjustments if their patients’ virus levels increases.
The AmpliCare program operates in sub-Saharan Africa, South America and parts of Asia and runs in partnership with the Clinton Health Access Initiative, UNICEF, UNITAID, local governments, healthcare professionals and multi-lateral organisations.
Limited healthcare infrastructure, distances, socio-economic constraints, logistical bottlenecks and technological limitations often results in people not returning to collect their test results, or not even being tested in the first place. Two key contributors are the need for fresh blood samples along with the delay in the turn-around time (TAT) of HIV results (can vary from 6-12 weeks).
Due to rapid scale-up of the AmpliCare program, a number of clinics were struggling to manage the laboratory results in a timely fashion. To address this, Roche developed a special dried blood spot collection device to save people from having to travel to the clinic, along with a SMS printer and capabilities to deliver test results to local villages through mobile technology, overcoming issues related to time and transport. The pilot project is under-going feasibility for scalability to other resource-limited settings.
Results to Date
Through AmpliCare, local authorities and hospitals have built and equipped laboratories, trained lab workers and diagnosed and monitored many of their HIV/AIDS patients. An education program trains local doctors and nurses to carry out viral load testing with limited resources, and keeps them fully informed about the latest advances in HIV/AIDS care.
Since 2002, over:
- 1,350,000 infants have been tested for HIV;
- 2,100,000 patients on HIV/AIDS therapy have had their viral levels monitored;
- 600 Healthcare professionals trained on diagnostic testing;
- 30 testing centres established, including a number of national testing laboratories in Sth Africa Cambodia, Thailand and Myanmar;
- Over 100 laboratories are trained annually at Roche's Science Academy training facilities in Sth Africa.
Research & Development (pediatric R&D):
- Developed an innovative Dried Blood Spot sample collection method for infant diagnosis and viral load monitoring for patients on therapy.
- Developed special SMS printer and capabilities to report patient lab results to remote clinics by text message (SMS) to save patients from having to return to the lab.
Innovative funding mechanisms:
- In 2011 we worked with health ministries and funding agencies to secure financing for AmpliCare’s Early Infant Diagnosis initiative. By year-end 23% of participating countries were self-financing the programme, 46% were accessing the Global Fund’s resources or other third party funders, while 31% remained dependent on UNITAID.
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