May 18, 2016
Credit: mareks7 for iStock via Thinkstock
The human immunodeficiency virus (HIV) continues to take a tremendous toll on human health, with 37 million people infected and 1.2 million deaths worldwide in 2014. In sub-Saharan Africa, where the HIV epidemic has been most devastating, more than 25 million people are HIV-infected, about 70 percent of the global total.
But as of 2014, only about 11 million people infected with the virus in Africa were receiving treatment with antiretroviral therapy (ART) medications, which can stop the progression of disease and reduce the risk of HIV transmission.
That leaves 14 million people with HIV in sub-Saharan Africa untreated. This is partly because, until recently, most countries have provided ART only for patients who reached a specific threshold in HIV disease progression. And starting ART can be a lengthy and complicated process, leading many patients to drop out of care before they even begin treatment.
However, in late 2015, based on new scientific findings, the World Health Organization (WHO) recommended that everyone with HIV be offered ART as soon as they are diagnosed. This is a strategy known as "treat all" or "test and treat."
With so many more people eligible for ART under the new WHO guidelines, finding ways to get people started on treatment without long waiting times or multiple clinic visits is critical.
Antiretroviral therapy is a combination of drugs (usually three) that stop the human immunodeficiency virus from making copies of itself in the body. While ART cannot cure HIV, it has turned HIV into a manageable chronic disease for millions of people worldwide and dramatically reduced deaths from HIV.
Until 2015, the WHO's treatment guidelines were based on earlier research that said patients did not have to start treatment until the disease had progressed to a certain point, typically when the patient's CD4 count, which is a measure of how well the immune system is functioning, reached a certain threshold.
But new studies have found that starting ART immediately after a positive HIV test prevents some serious HIV-related illnesses, such as tuberculosis and invasive bacterial diseases. Because ART reduces the amount of the virus in a patient's body, it reduces the risk that it can be transmitted to sexual partners.
The WHO hopes this "treat all" strategy of offering ART to everyone as soon as they are diagnosed will simplify the process of getting on treatment, meaning that more people will start ART.
In many places in sub-Saharan Africa, health system procedures impose long waits and multiple clinic visits on patients. For instance, a patient may visit a clinic for a CD4 count, and have to come back again to get the results. Older forms of ART were more expensive and harder to tolerate, so patients often made additional clinic visits for counseling and education before receiving medication. And, until now, there hasn't been a lot of momentum to speed things up.
In South Africa, which has the world's largest HIV treatment program, patients must typically make five or six clinic visits, starting with an HIV test, before they receive medications.
In 2011, I and my colleagues at Boston University and the University of the Witwatersrand in Johannesburg estimated that more than a third of all patients across sub-Saharan Africa who have a positive HIV test drop out of care before they start ART. More recent research has found that many patients in South Africa are still dropping out of treatment before starting ART.
So we decided to do a study to see if speeding up the process for starting ART could encourage more patients to start treatment, thus improving overall health outcomes for all those with HIV. We thought that if this change was successful in South Africa, it might also help improve treatment programs worldwide.
We conducted the "RapIT" study from 2013 to 2015 at two clinics in Johannesburg. We randomly assigned 377 adult patients who had come to the clinics either to have an HIV test or to get the results of their first CD4 count to one of two groups. All of the patients in the study were HIV-infected and eligible to start ART under the guidelines then in place. One group followed the usual schedule for starting treatment. The other group followed a rapid version of that procedure, and were offered the chance to start treatment on the same day as their first clinic visit.
Patients in the rapid group received a physical exam, education and counseling, and laboratory test results from "point-of-care" diagnostic instruments all in single visit and started ART at that same visit. Starting treatment under this new procedure took roughly two and a half hours from start to finish. The standard procedure, on the other hand, typically required 3-5 additional clinic visits over a 2-4 week period to complete the steps above and receive laboratory tests from the regular laboratory, before patients could start ART.
To give the patients in the standard arm plenty of time to get through all their clinic visits, we waited 90 days after the first visit to see if patients in both groups had started ART.
By 90 days after the initial clinic visit 72 percent of patients in the standard group had started ART. For those who actually started ART, the median time between that first clinic visit and actually beginning treatment was 17 days. And 28 percent of patients in this group never started treatment.
Time to starting ART, by study arm (Credit: Sydney Rosen, Mhairi Maskew, Matthew P. Fox, Cynthia Nyoni, Constance Mongwenyana, Given Malete, Ian Sanne, Dorah Bokaba, Celeste Sauls, Julia Rohr, Lawrence Long, CC BY)
The rapid group had much better results. We found that 97 percent of patients this group had started treatment by 90 days after their first clinic visit. In fact about three-quarters of these patients began treatment on the same day as their first clinic visit, and nearly all the rest started within one month.
By 10 months after study enrollment, 81 percent of patients in the rapid group were still on treatment, compared to 64 percent of patients in the standard group. And 64 percent of those in the rapid group had reached the "gold standard" ART outcome -- viral suppression. This means that 10 months after their first HIV-related clinic visit very little evidence of the virus could be found in their blood. By contrast, just 51 percent of the standard group reached the same outcome.
The RapIT trial showed that it is possible to start nearly all patients on HIV in a much shorter time frame than previously required, and that offering patients the chance to start ART during their first HIV-related clinic visit can be an effective strategy for improving health outcomes.
Although RapIT took place in only two clinics in one city in South Africa, the results of the trial have implications for HIV programs throughout Africa, and globally.
Several other recent studies using different approaches than RapIT, but with the same goal of simplifying and speeding up the process of treatment initiation, have also shown promising results, in countries ranging from Uganda to China to the United States.
Taken together, these studies suggest that once people are diagnosed with HIV, there is no reason to delay starting the treatment that will both save their lives and protect others from infection.
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