RapIT: Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa
One of the most serious challenges facing antiretroviral therapy (ART) programs for HIV/AIDS in both sub-Saharan Africa and in the U.S. is the failure of ART-eligible patients to complete the steps required to initiate treatment. In some places, the high rate of loss to care of patients who are treatment-eligible at HIV diagnosis may be due in part to the large number of steps required between receiving an HIV diagnosis and obtaining the first dose of antiretrovirals (ARVs). In South Africa, these steps usually require approximately four clinic visits over a period of 2-8 weeks before a patient can start treatment.
One strategy proposed for reducing losses among those eligible for ART is to simplify and condense the steps required for starting treatment. This is now possible because new, point-of-care (POC) tests for CD4 counts and TB diagnosis are available. These technologies can be combined with changes to clinic schedules to allow all steps required for ART initiation under South African guidelines (lab tests, physical exam, education) to take place on the day the patient presents for an HIV test.
The RapIT study is a randomized strategy evaluation of the feasibility, effectiveness, and cost-effectiveness of rapid ART initiation. Outpatient, non-pregnant, HIV-positive adults who come to a South African clinic for an HIV test, consent to study participation, and are eligible for ART are randomized 1:1 to rapid ART initiation or to standard care. Those who are assigned to rapid ART initiation have the possibility of receiving their first dose of ARVs as early as the same day, while those who are assigned to standard care follow the clinic’s usual procedures for starting ART. A second sample of ART-eligible pregnant women are also being offered rapid ART initiation in a programmatic evaluation conducted alongside the randomized evaluation, with a retrospective comparison group. The cost effectiveness of the rapid initiation strategy is being assessed as the cost per patient achieving the primary outcome for each population (viral suppression within 10 months of study enrollment for non-pregnant adults; initiation of ART within 4 weeks of study enrollment for pregnant women).
The RapIT study aims to identify a way to improve the outcomes of patients diagnosed with HIV, diminish AIDS-related morbidity and mortality, and reduce medical care costs associated with late treatment initiation. If successful, if may offer an important new strategy for reducing the burden of HIV on public health.
A supplemental study under the RapIT grant is examining interactions between ART and noncommunicable diseases (NCDs). South Africa, like many other middle income countries, faces very high rates of NCDs and NCD risks but there are virtually no studies looking at NCDs in ART patients and none that have considered the effect of NCDs and NCD risk factors on long term retention on ART. RapIT-NCD is evaluating the role of NCDs and NCD risk factors on long-term retention of ART patients at the same study site, with outcomes including mortality, loss to follow up, viral suppression and immunologic improvement, and physical functioning, ability to perform normal daily activities, and economic productivity among patients already on ART.
|Principal Investigator||Sydney Rosen|
|Boston University Co-Investigators||Matthew Fox|
|Dates of Research||2012-2015|
|Donor/Funder||National Institutes of Health (NIH)|