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Data from: Initiating Antiretroviral Therapy for HIV at a Patient’s First Clinic Visit: The RapIT Randomized Controlled Trial

Citation

Maskew, Mhairi et al. (2020), Data from: Initiating Antiretroviral Therapy for HIV at a Patient’s First Clinic Visit: The RapIT Randomized Controlled Trial, Dryad, Dataset, https://doi.org/10.5061/dryad.vx0k6djp9

Abstract

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 (<=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.

Methods

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.

Usage Notes

All currency values refer to South African Rands (ZAR)

Funding

National Institutes of Health - NIAID, Award: U01 AI100015