The Simplifying HIV TREAtment and Monitoring (STREAM) study, led by Global Health professor Paul Drain and recently published in The Lancet HIV, found that point-of-care HIV viral load monitoring and task shifting significantly improved viral suppression and retention in HIV care, as compared to standard laboratory-based HIV viral load testing. This study was the first randomized controlled trial to compare rapid point-of-care HIV viral load testing against standard of care lab-based HIV viral load testing, which usually takes several weeks to return results to patients. Additional co-authors from the Department of Global Health included Deborah Donnell, Ruanne Barnabas, and Connie Celum.
The STREAM study was an open-label, randomized controlled trial to determine if rapid HIV viral load testing changed treatment outcomes for people living with HIV on antiretroviral therapy (ART) in South Africa. The study enrolled adults living with HIV who presented for their first routine HIV viral load test six months after ART initiation at a public clinic in Durban, South Africa. From February to August 2017, the study screened 657 participants, with 390 randomly assigned to one of the two study groups. Participants were assigned to receive either point-of-care viral load testing at enrollment, and again after six months with task shifting to enrolled nurses (intervention group), or laboratory viral load testing (standard-of-care group). All participants were then followed for at least 12 months to determine their retention in HIV care and viral suppression.
At the end of the study, 90% of individuals in the intervention group had achieved the primary outcome of retention with viral suppression, compared to 76% of individuals in the standard-of-care group.
“Monitoring HIV treatment with laboratory testing introduces delays for providing appropriate ART management and care in resource-limited settings,” Drain said. “In this study, we found that providing same-day HIV viral load results to participants significantly improve their retention in care and viral suppression, which is the goal of providing ART. In addition, point-of-care viral load testing led to faster switching to second-line ART, when necessary, as well as more referrals into the community-based ART program. Both the participants and the providers appreciated receiving the viral load results during the same clinical visit, which took an average of 1-2 months in the standard-of-care group.”
The STREAM study had some limitations, including uncertainty about the extent to which point-of-care HIV viral load testing or task shifting was responsible for the improved clinical care. However, the results suggest community-based point-of-care HIV viral load testing will help achieve the UNAIDS target of 73% of people living with HIV being virally suppressed by 2020 by improving viral load testing uptake and reducing costs throughout the HIV cascade of care.
“Since the study was conducted among people receiving efavirenz-based ART, we are now starting a new randomized controlled trial among adults being initiated on dolutegravir-based ART,” Drain said. “The enrollment was scheduled to begin this month, but has now been delayed due to the COVID-19 epidemic. In addition to evaluating the role of point-of-care HIV viral load monitoring, the new randomized trial will also determine if a novel point-of-care test for HIV drug metabolites can help improve adherence to ART. The results from this study are expected in the coming years.”
Drain also pointed out that point-of-care testing can not only simplify treatment and improve outcomes for HIV-positive adults receiving ART in resource-limited settings, but also provide care in easily-accessed community settings to improve the future of HIV care.
“During the STREAM study, we learned that community-based ART delivery was not only successful, but it was also preferred by participants and helped to save costs,” Drain said. “This approach was also deemed cost-effective in a modeling analysis. We are now exploring ways to make HIV viral load monitoring more accessible in community-based settings, and we have a new grant to develop a home-based, self-test for measuring HIV viral load. Finally, the World Health Organization has also taken notice of our trial results, and is now considering changes to recommended guidelines for supporting more point-of-care testing.”