The HIV Prevention Trials Network held its annual meeting in Washington, DC this week, and Science Speaks was there, covering Monday, Tuesday and Wednesday sessions.
It sounds obvious, urgent, and ambitious: Make HIV counseling and testing as well as links to subsequent care and prevention services universally available, and watch the numbers of new infections drop steeply.
Increasingly, Richard Hayes of the London School of Hygiene and Tropical Medicine said Monday, it also sounds practical.
“People have gone from saying ‘the idea is mad, and should not even be considered,'” he said. “Now more people are saying ‘let’s just do this. Why is a trial needed?'”
After all, a series of trials, some discussed in sessions at the HPTN Annual meeting that morning, already have shown the role of early antiretroviral treatment in preventing new HIV infections, as well as reducing tuberculosis rates, lowering HIV transmission community wide, and restoring health and employment, as well as the potential for accelerated and widespread provision of early treatment to turn the trajectory of the HIV epidemic,
The long answer, or answers to why another trial is needed has to do with realities on the ground, Hayes said. Can universal testing and treatment be delivered, with uptake and acceptance in the resource poor communities where it is needed? If so, will it have unintended consequences — in toxicity from longer term use of antiretroviral medicine, or drug resistance as people who feel healthy begin but then possibly discontinue treatment? Will the intensified services overload health systems? A shorter answer likely is rooted in an issue that came up frequently during the day — in a budget constrained donor world, proof can be needed to spur policy.
The result is PopART: Population testing and access to immediate Antiretroviral treatment to Reduce Transmission. A trial that will stretch across an anticipated six years, and 21 communities in Zambia and South Africa that are home to about 1.2 million people, it will examine the impact of universal testing and intensified provision of treatment, care, and services on population-level HIV incidence.
In February, ceremonies in Lusaka, Zambia and Cape Town, South Africa marked the randomized selection of clusters that will receive different combination service packages, and in June, field work will begin. One arm of the trial will receive the full “Pop ART” package of services: Universal voluntary HIV testing delivered annually through door-to-door home-based testing, immediate linkage to care and provision of antiretroviral treatment, and support for retention and adherence for those who test positive, and active referral to prevention services, including circumcision and condom provision for those who test negative. Another arm will receive the same, but with treatment initiation tied to the current World Health Organization guideline of an immune cell count under 350. The third arm will receive support for the current community standard of care and services. The study will seek to measure the impact of the two heightened interventions on HIV incidence by enrolling and following a random sample of adults in the communities for three years.Researchers also aim to determine the impact of interventions on incidence of genital herpes, on HIV disease progression and death, retention in care, sexual risk behavior and on uptake of services, including HIV testing and retesting, prevention of mother to child transmission services, and medical circumcision. If additional funding is available, researchers also hope to measure impacts on community viral load, antiretroviral adherence and suppression of the virus, and antiretroviral drug resistance.
The answers to much of that seemed obvious enough already for one audience member to ask, “Is this research, or is it just better health practice?” Another, pointing out that unlike participants in a blinded study, in which whether one enrolled in a group testing the treatment in question or taking a placebo is not known by investigators or participants, the nature of this study makes that impossible. “Isn’t this just a roll out [of services]?” another audience member asked.
On the other hand, another audience member perhaps highlighted why the project is, in fact research, as she asked if current capacities could meet the increased demand for medical circumcision the study could be expected to produce, and if that, in turn could lead to “quacks” supplying the service. And you know what happens then, she added, “you end up losing a penis or two.”
In turn, Hayes pointed out that a full scale roll out of services is, in fact, more expensive than research, and that PopART is the most expensive study with which he has ever been involved. “It keeps me up at night,” he said.
Dr. Myron Cohen, leader of the HPTN 052 study, that proved the role early treatment can play in preventing new infections and reducing tuberculosis rates, reassured Hayes. Early treatment alone has been proven to bring long term economic gains, he pointed out.
“And that is just giving people treatment who are going to need it anyway.”