DOI: 10.5061/dryad.vx0k6djp9
title: Data from: Initiating Antiretroviral Therapy for HIV at a Patient’s First Clinic Visit: The RapIT Randomized Controlled Trial

description: Background: High rates of patient attrition from care between HIV testing
 and antiretroviral therapy (ART) initiation have been documented in
 sub-Saharan Africa, contributing to persistently low CD4 cell counts at
 treatment initiation. One reason for this is that starting ART in many
 countries is a lengthy and burdensome process, imposing long waits and
 multiple clinic visits on patients. We estimated the effect on uptake of
 ART and viral suppression of an accelerated initiation algorithm that
 allowed treatment-eligible patients to be dispensed their first supply of
 antiretroviral medications on the day of their first HIV-related clinic
 visit. Methods and Findings: RapIT was an unblinded randomized controlled
 trial of single-visit ART initiation in two public sector clinics in South
 Africa (a primary health clinic (PHC) and a hospital-based HIV clinic).
 Adult (≥18), non-pregnant patients receiving a positive HIV test or first
 treatment-eligible CD4 count were randomized to standard or rapid
 initiation. Rapid arm patients received a point-of-care (POC) CD4 count if
 needed; those ART-eligible received a POC TB test if symptomatic, POC
 blood tests, physical exam, education, counseling, and ARV
 dispensing. Standard arm patients followed standard clinic
 procedures (3-5 additional clinic visits over 2-4 weeks prior to ARV
 dispensing). Follow up was by record review only. The primary
 outcome was viral suppression, defined as initiated, retained in care, and
 suppressed (&lt;=400 copies/ml) ≤ 10 months of study
 enrollment. Secondary outcomes included initiation of ART ≤ 90
 days of study enrollment; retention in care; time to ART initiation;
 patient-level predictors of primary outcomes; prevalence of TB symptoms;
 and the feasibility and acceptability of the intervention. A survival
 analysis was conducted comparing attrition from care after ART initiation
 between the groups among those who initiated within 90 days. 377 patients
 were enrolled in the study between May 8, 2013 and August 29, 2014 (median
 CD4 count 210 cells/mm3). In the rapid arm, 119/187 patients (64%)
 initiated and were suppressed at 10 months, compared to 96/190 (51%) in
 the standard arm (RR 1.26 [1.05-1.50]. In the rapid arm 182/187 (97%)
 initiated ART ≤ 90 days, compared to 136/190 (72%) in the standard arm
 (relative risk [95% CI] 1.36 [1.24-1.49]. Among 318 patients who did
 initiate ART within 90 days, the hazard of attrition within the first 10
 months did not differ between the treatment arms (HR 1.06; 95% CI
 0.61-1.84). The study was limited by the small number of sites and small
 sample size and the generalizability of the results to other settings and
 to non-research conditions is uncertain. Conclusions: Offering
 single-visit ART initiation to adult patients in South Africa increased
 uptake of ART by 36% and viral suppression by 26%. It should be considered
 for adoption in the public sector in Africa.
description: Enrolled study subjects completed interviewer-administered
 questionnaires captured on hard copy case report forms. Data from these
 questionnaires was then captured onto REDCap by trained data capturers
 using double data entry. Data uploaded to this repository represents data
 exported directly from REDCap after removing any study identifiers
 including visit and laboratory dates.
description: All currency values refer to South African Rands (ZAR)