HIV Clinical Trial
Official title:
Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study)
One of the most serious challenges facing antiretroviral therapy (ART) programs for HIV/AIDS
in resource-constrained settings is the failure of ART-eligible patients to complete the
steps required to initiate treatment. 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
tuberculosis (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.
This 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 will be randomized 1:1 to rapid ART initiation or to standard care. Those
who are assigned to rapid ART initiation will have the possibility of receiving their first
dose of ARVs as early as the same day, while those who are assigned to standard care will
follow the clinic's usual procedures for starting ART. Rapid ART initiation for HIV-positive
pregnant women, which has recently become the standard of care in South Africa, will also be
assessed in a programmatic evaluation conducted alongside the randomized evaluation, with a
retrospective comparison group. The primary study outcome for non-pregnant adults will be
remaining alive, in care and virally suppressed 10 months after having a positive HIV test at
the study site or making a first HIV-related visit. The primary study outcome for pregnant
women will be adherence to ART until delivery. The cost effectiveness of the rapid initiation
strategy will be assessed as the cost per patient achieving the primary outcome for each
population.
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