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                             Where We Were and Where We Go Next 
 
In 2003, the United States launched the largest government-funded public health initiative the world had ever seen—the President’s Emergency Plan for AIDS Relief (PEPFAR) to address the HIV/AIDS crisis that was affecting millions around the world.

Twenty years and $110 billion later, PEPFAR has saved 25 million lives in 50 countries. It has prevented 7 million infections, and 5.5 million children have been born free of HIV throughout Africa, Asia, and Latin America. Today, thanks to PEPFAR, 65 million people on these continents have access to HIV/AIDS prevention services, testing, and another 20 million are supported on antiretroviral therapy.

ASCP got involved in PEPFAR very early on. In 2003, the Society began discussions with the Centers for Disease Control and Prevention (CDC), one of several federal agencies tasked with implementing the PEPFAR program; a year later, ASCP signed its first cooperative agreement with the CDC to take part in the PEFAR initiative.  

“We were one of the first laboratory organizations the CDC reached out to, to support PEPFAR because the Agency leaders realized if its goals were to offer lifesaving treatment, it needed to have laboratory services in place to diagnose and monitor patients.,” says Ken Landgraf, MSc, Executive Director of ASCP’s Center for Global Health. At the time, ASCP worked with Dr. John Nkengasong, who led the CDC’s International Laboratory Branch, in Atlanta, GA. 

The beginning of change  
When PEPFAR began, there were fewer than 50,000 people in Sub-Saharan Africa receiving antiretroviral therapy for HIV/AIDS, which accounted for less than 2 percent of the population living with HIV/AIDS at the time. This presented a stark contrast to the United States, where treatment had become widely accessible and where there were dedicated public health programs designed to identify and provide services to individuals who didn’t yet know their status. People in the U.S. who had been diagnosed with HIV/AIDS were receiving effective treatment and living longer, healthier lives.  

“There was awareness among the administration and public health leaders that the inequity in other parts of the world was not right, and that a whole-of-government approach would be required to provide access to live saving treatments in the hardest-hit parts of the world,” Mr. Landgraf says. 

Early on in the program, ASCP focused its efforts on providing training for laboratory professionals in PEPFAR countries to administer HIV rapid tests, to strengthen their basic laboratory techniques, and to perform CD4+ testing to monitor disease progression.  

As PEPFAR continued, the focus shifted to ensuring the quality of testing and laboratory processes. In 2009, ASCP, in cooperation with the CDC, the World Health Organization, and the Clinton Health Access Initiative, developed a novel program called Strengthening Laboratory Management Toward Accreditation (SLMTA) to reinforce the management skills of laboratory leaders and provide them with the tools needed to improve the quality of the laboratory testing. The SLMTA program is still around today and has been spun off in many different versions around the globe. 

To date, PEPFAR implementing partners have trained more than 70,000 healthcare workers in Africa, Asia, and Latin America to deliver care to HIV/AIDS patients. Of those, ASCP has trained more than 10,000 laboratory professionals. ASCP relied on more than 200 member volunteers who donated their time to develop curricula, and traveled to PEPFAR countries to present training sessions and provide mentoring and coaching for laboratory professionals. 
 
Change continues  
Over the next five years, as healthcare systems improved and HIV/AIDS patients were placed on therapy, there was recognition that using CD4+ testing to monitor patient progression was inadequate.  

“In the U.S., patients with HIV are monitored by measuring their viral load—the amount of viral particles circulating in your blood at a given time. It is a more direct measure than CD4 testing for determining if your treatment is effective,” Mr. Landgraf explains. “During treatment failure, viral load spikes well before CD4 levels drop. So if you are relying on CD4 testing alone to monitor treatment adherence or efficacy, decisions to provide adherence counseling or switch a patient to second-line therapy could be delayed, leading to worse patient outcomes.” 

Yet molecular testing, in general, is very complex and requires well-trained personnel, expensive testing platforms, well-designed laboratory facilities, and strict quality control. ASCP was one of many groups involved in supporting the roll out viral load testing in PEPFAR countries. The Society developed a molecular biology training curricula and led mentorship programs geared toward laboratories that conducted viral load testing. Viral load is now the standard monitoring test in PEPFAR countries and CD4 testing is used to diagnose advanced AIDS disease. This shift was a major improvement for patients and has improved treatment adherence and patient outcomes. 

A key to PEPFAR’s success has been a big focus on accountability and transparency, as well as on impact and equity. The program collects a lot of data and uses that data to identify underserved regions, vulnerable population groups, and design programs to meet patients where they are.    

PEPFAR has also strengthened health systems and helped create local organizations that are taking leadership on their population’s health issues. The health systems that were reinforced and strengthened with PEPFAR support are so resilient that when the COVID-19 pandemic hit those regions, because of PEPFAR’s investment in the viral load testing laboratories, those countries already had the testing platforms and skilled workforce needed to conduct testing for COVID-19 very quickly. They were able to respond rapidly to COVID-19 challenges while still addressing the needs of their patients with HIV/AIDS.   

The future of PEPFAR 
Under the administration of President Joe Biden, Dr. Nkengasong now directs the PEPFAR program. He recently released a five-year strategy for PEPFAR going forward. The plan focuses on collaboration and transformative partnerships, as well as ending inequities in service gaps that prevent patients from accessing care, specifically adolescent girls and vulnerable populations.  

“This strategy is well-aligned with ASCP’s patient-centered mission and the Society’s commitment to health equity and the global laboratory community,” Mr. Landgraf says. “We’ve had the pleasure of working with John Nkengasong since he was with the CDC International Laboratory Branch in Atlanta, and again when he took on the role as head of Africa CDC. Now he has returned to serve as the Global AIDS Coordinator. ASCP is thrilled to continue our collaborative with him to see that this five-year strategy is realized.”