Paul K. Drain, MD, on Point-of-Care HIV Viral Load Testing Plus Task Shifting

A new study published in The Lancet HIV showed that point-of-care viral load testing combined with task shifting may help significantly improve viral suppression and treatment retention when caring for patients with HIV.

According to the authors of the study, these findings demonstrate that point-of-care testing can help simplify treatment and improve outcomes among adults with HIV being treated with antiretroviral therapy (ART) in areas with limited resources.

The researchers arrived at their conclusion after performing an open-label, non-inferiority, randomized controlled trial (N = 390) of adults with HIV aged 18 years or older in a public clinic in Durban, South Africa. Participants were randomly assigned to receive point-of-care viral load testing at baseline and 6 months with task shifting to enrolled nurses (n = 195) or standard-of-care laboratory viral load testing (n = 195).

The primary outcome was defined as a combination of viral suppression, or fewer than 200 copies per mL, and retention in care at 12 months.

The results of the study indicated that the primary outcome had been achieved in 175 (90%) participants who received point-of-care testing compared with 148 (76%) participants who received standard-of-care testing. A total of 182 (93%) participants who received point-of-care testing had viral suppression compared with 162 (83%) participants who received standard-of-care testing. A total of 180 (92%) patients who received point-of-care testing were retained in care compared with 162 (85%) patients who received standard-of-care testing.

No adverse events associated with point-of-care HIV viral load testing or task shifting were observed, the researchers noted.

Infectious Diseases Consultant discussed these findings and their potential clinical implications further with lead author Paul K. Drain, MD, assistant professor of Global Health and Allergy and Infectious Diseases, and assistant director of the Tuberculosis Research and Training Center at the University of Washington.

ID CON: In your study, you and your colleagues noted that “monitoring HIV treatment with laboratory testing introduces delays for providing appropriate care in resource-limited settings.” Could you discuss how these delays currently interfere with adherence to viral load testing guidelines?

Dr Drain: Barriers at the patient and clinic levels currently interfere with the ability to meet current viral load testing guidelines. Patient-level barriers include travel to a clinic, wait times in the clinic, interactions with health care workers and other staff, and any perceived stigma patients may feel while at the clinic.

Clinic-level barriers include limited access and costly use of centralized laboratory machines. All viral load tests are currently performed at a centralized laboratory, which is usually in a different location than testing centers. Health care workers collect and ship blood samples to the laboratory. Laboratory workers then have to send those results back to the clinic, which must have a patient notification system to deliver testing results to patients.

The laboratory used in our study was located offsite from the clinic in South Africa. Although the laboratory was able to receive and complete viral load testing over a period of 2 to 3 days, patients were not notified of their results until they returned to the clinic. We found that, on average, it took approximately 1 to 2 months after the results were known in the laboratory for patients to be notified.

ID Con: What example was your study able to provide regarding a strategy to overcome these barriers?

Dr Drain: In our study, patients in the intervention arm received point-of-care HIV viral load testing and were notified of their results on the same day as their clinic visit. It is important to note that patients, health care workers, and laboratory workers alike were satisfied with this testing approach. Thus, we were able to demonstrate in this study, and other work we have conducted, that point-of-care testing can not only simplify treatment but also improve health outcomes among ART-treated adults with HIV living in areas with limited resources.

ID Con: How might your findings be applied in clinical practice?

Dr Drain: Currently, my colleagues and I are performing cost-effectiveness analyses of our data to examine the practicality of implementing this approach to testing on a larger scale. We have found from some of our prior studies that this intervention may especially benefit larger clinics, which tend to have up-front costs associated with use of point-of-care viral load testing machines. We believe that our intervention can be cost-effective for almost any clinic if the cost is lowered or shared with tuberculosis programs. My colleagues and I are currently working with the National Health Laboratory Service in South Africa to determine what the best course of action would be for distributing and implementing point-of-care viral load testing in clinics.

We are also engaging in discussions with the World Health Organization regarding the importance of notifying patients with HIV of their viral load testing results in a timely manner. Discussions include potentially updating viral load monitoring guidelines, but we are hoping to first collect additional data. 

ID CON: What is the next step in terms of future research in this area?

Dr Drain: My colleagues and I are performing a follow-up randomized clinical trial among South African participants (the STREAM HIV study) who have been initiated on dolutegravir-based ART.

Over the past few years, my colleagues and I have also been developing a point-of-care test that would detect the presence of HIV therapies, which would help monitor treatment adherence among patients. Specifically, we developed a rapid test to detect tenofovir in urine samples. We will be assessing this test in a new trial to determine its utility, along with appropriate adherence counseling, in improving short-term treatment adherence and long-term viral suppression outcomes.

—Christina Vogt

Reference:
Drain PK, Dorward J, Violette LR, et al. Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial [Published online February 24, 2020]. Lancet HIV. https://doi.org/10.1016/S2352-3018(19)30402-3.