Not Surprisingly, PopART Study Showed Community-Based Services Reduce HIV Incidence
March 15, 2019
PopART (Population Effects of Antiretroviral Therapy to Reduce HIV Transmission) is a large, randomized, controlled trial that included a whopping 1 million study participants and cost over $140 million over about five years. It seems unlikely that I could be critical of a study that showed a 30% decrease in HIV incidence and, basically, proves the value of community-based approaches to HIV testing and linkage to care. But the study has puzzled me from the start -- and, despite the mostly good results, it continues to puzzle me. Did we need to spend $140 million to basically prove the obvious?
First, some background:
The PopART study took place between 2013 and 2018 and included 21 urban communities in Zambia and South Africa, covering a total population of 1 million people, the largest study of its kind. The goal of the study was to see if "enhanced" HIV services improved use of HIV testing and linkage to care, leading to a reduction in HIV incidence. There were three arms in the study. Arms A and B delivered the enhanced PopART package of services, which included:
The door-to-door PopART services were delivered by trained lay health workers called Community HIV-care Providers (CHiPs), while treatment and clinical care were provided by existing health systems in-country, with support from PopART.
In the control arm, Arm C, people received the "standard of care," meaning that they found their way to HIV testing on their own and, if positive, received a referral to go to a clinic. So, in other words, we've now learned that when compared to basically doing nothing and waiting for you to show up, HIV testing and linkage to care work better if someone comes to your house and offers you information, HIV testing, and assistance in getting to a clinic for ART and/or HIV prevention services. The good news is that the study showed that by increasing the services for testing and linkage, HIV incidence declined by as much as 30%. That's a significant decrease, real progress. I just don't see how the "enhanced" services needed this study -- to me, they are all just common sense. Of course things work better when you provide real assistance to people.
This is just one of a number of studies presented at CROI in which, lo and behold, we see that providing people with help in getting to a doctor, assistance to stay in care, and support for adherence to treatment is more effective than not providing this assistance. And in almost every instance in which the services are provided, it is done so by a community-based worker, often a peer who is living with HIV. I guess I appreciate the validation of everything AIDS activists have said and fought for since the 1980s, but is this really the best use of our research dollars? To be fair, PopART also produced several valuable sub-studies and will continue to provide valuable information about treatment use and cost-effectiveness. But, community-based services have lived at the heart of successful HIV responses since the beginning of the epidemic. It's taken way too long for the research establishment to catch up to us.
Despite the growing evidence that community-based and peer-based services are effective in lowering HIV incidence and increasing viral suppression rates, funding for these efforts has never been sufficient and, instead of being increased, it's being cut -- by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), the Global Fund, and governments around the world. Instead of building the needed infrastructure of community support services, the global public health establishment seems to want to just throw pills at us and make us gobble them down from the moment we test positive. No support services, no human rights protection, no treatment education. Get your test result and start on the pills right then and there.
Community-Based Support Even Beat Early ART Start
The PopART study also compared differences in treatment and prevention outcomes depending on when someone starts treatment. Initially, the three arms compared different start times. In Arm A, people received the "package" of services described above and started ART immediately. In Arm B, people also received the expanded services but started ART according to the "when to start" guidelines in place at the time in their respective countries. People in Arm C did not receive the expanded services and also started treatment according to standard of care. Over the course of the study, the "when to start" standard of care changed, and eventually, every arm of the study started people on treatment immediately. Viral suppression was high and basically equal across all three groups. But, oddly, HIV incidence decreased by 30% in Arm B (the group that got expanded services but mostly waited to start treatment), and incidence only decreased by 7% in Arm A, in which everyone started treatment immediately. Retention in care and viral suppression were equivalent across the two arms. The presenters here at CROI cannot explain why incidence reduction was inferior in the "immediate start" arm of the study.
"Same-day start" -- being urged to start treatment on the same day as you get your test results -- is being pushed aggressively now. The World Health Organization (WHO) recommends it in their guidelines. PEPFAR is strongly urging countries to adopt this approach. I have a visceral reaction against this idea. Maybe I'm out of date (I got my HIV diagnosis in 1989), but I still think that for most people, finding out you are HIV positive remains a traumatic event. Maybe it isn't really the best moment to learn about treatment and make an informed decision to start taking pills every day for the rest of your life. I'm sure some people are fine with it, and everyone should have the option to start (or not start) treatment whenever they like. But, I remain unconvinced that a whole lot of people are in the right place to make such a decision upon hearing that they have HIV.
The argument for "same-day start" has been that people often test positive but don't come in for care and treatment. The docs say, "We lose them," and seem to think that the only way to engage people in care is by giving them pills. The SLATE study, also presented at CROI, tested "same-day start" against delayed ART initiation. The large majority of people offered treatment upon getting their positive test result agreed to take it, and this was considered a success. But six months later, the number of people still engaged in care was no different between the early and late initiation arms -- and, more important, the retention rate was a very poor 50%. So, immediate initiation is probably not the best way to ensure ongoing engagement in care and sustained viral suppression.
We don't need to spend another $140 million to find out how to retain people in care. We need to invest in the kinds of services people need so that they can use treatment easily and effectively. We need service providers who are kind and do not stigmatize people living with HIV. We need community-based treatment literacy and adherence support services. We need peer-based support services to address nutrition, housing, psycho-social support, and gender-based violence. We need to make it easy for people to get their medicine and make certain there are no drug stock-outs or shortages.
In other words, we need what we've always said we need -- and have rarely gotten.
David Barr is a native New Yorker who has been working as an AIDS activist since 1985. He's worked with the International Treatment Preparedness Coalition, ACT UP, GMHC and many other organizations. He is currently working with the Joep Lange Institute.
This article was provided by TheBodyPRO.
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