Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study)
Brief Summary: 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.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Procedure: Early antiretroviral treatment | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Late antiretroviral treatment | Intervention Type: PROCEDURE; Name: Early antiretroviral treatment; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Late antiretroviral treatment; Assigned to Arm(s): 2
B: Arm Label: Combination intervention + incentives; Type: EXPERIMENTAL; Interventions: Other: Point of care CD4+ after HIV diagnosis, Other: Accelerated ART initiation, Behavioral: SMS appointment reminders, Other: Non-cash Financial Incentives | Arm Label: Combination intervention strategy(CIS); Type: EXPERIMENTAL; Interventions: Other: Point of care CD4+ after HIV diagnosis, Other: Accelerated ART initiation, Behavioral: SMS appointment reminders | Arm Label: Standard of care (SOC); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Point of care CD4+ after HIV diagnosis; Assigned to Arm(s): Combination intervention + incentives, Combination intervention strategy(CIS) | Intervention Type: OTHER; Name: Accelerated ART initiation; Assigned to Arm(s): Combination intervention + incentives, Combination intervention strategy(CIS) | Intervention Type: BEHAVIORAL; Name: SMS appointment reminders; Assigned to Arm(s): Combination intervention + incentives, Combination intervention strategy(CIS) | Intervention Type: OTHER; Name: Non-cash Financial Incentives; Assigned to Arm(s): Combination intervention + incentives
C: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: Efavirenz, Drug: Lamivudine/Zidovudine | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Efavirenz, Drug: Lamivudine/Zidovudine | Intervention Type: DRUG; Name: Efavirenz; Assigned to Arm(s): A, B | Intervention Type: DRUG; Name: Lamivudine/Zidovudine; Assigned to Arm(s): A, B
D: Arm Label: Standard group, non-pregnant adults; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Standard group, pregnant women; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Rapid group, non-pregnant adults; Type: EXPERIMENTAL; Interventions: Other: Rapid ART initiation | Arm Label: Rapid group, pregnant women; Type: EXPERIMENTAL; Interventions: Other: Rapid ART initiation | Intervention Type: OTHER; Name: Rapid ART initiation; Assigned to Arm(s): Rapid group, non-pregnant adults, Rapid group, pregnant women

Answer: D