title: Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial.
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.
  
  
  RESULTS
  RapIT (Rapid Initiation of Treatment) 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 y old), non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Patients in the rapid-initiation arm of the study ("rapid arm") received a point-of-care (POC) CD4 count if needed; those who were ART-eligible received a POC tuberculosis (TB) test if symptomatic, POC blood tests, physical exam, education, counseling, and antiretroviral (ARV) dispensing. Patients in the standard-initiation arm of the study ("standard arm") followed standard clinic procedures (three to five additional clinic visits over 2-4 wk 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) within 10 mo of study enrollment. Secondary outcomes included initiation of ART ≤90 d 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 d. Three hundred and seventy-seven 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 treatment and were virally suppressed at 10 mo, compared to 96/190 (51%) in the standard arm (relative risk [RR] 1.26 [1.05-1.50]). In the rapid arm 182/187 (97%) initiated ART ≤90 d, compared to 136/190 (72%) in the standard arm (RR 1.36, 95% confidence interval [CI], 1.24-1.49). Among 318 patients who did initiate ART within 90 d, the hazard of attrition within the first 10 mo did not differ between the treatment arms (hazard ratio [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%. This intervention should be considered for adoption in the public sector in Africa.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01710397, and South African National Clinical Trials Register DOH-27-0213-4177.
authors.affiliation: Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, United States of America.|Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Sydney
authors.initials: S
authors.lastname: Rosen
authors.affiliation: Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Mhairi
authors.initials: M
authors.lastname: Maskew
authors.affiliation: Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.|Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, United States of America.
authors.forename: Matthew P
authors.initials: MP
authors.lastname: Fox
authors.affiliation: Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Nyoni
authors.affiliation: Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Constance
authors.initials: C
authors.lastname: Mongwenyana
authors.affiliation: Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Given
authors.identifier: http://orcid.org/0000-0003-1473-880X
authors.initials: G
authors.lastname: Malete
authors.affiliation: Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Ian
authors.initials: I
authors.lastname: Sanne
authors.affiliation: Health Department, City of Johannesburg, Johannesburg, South Africa.
authors.forename: Dorah
authors.identifier: http://orcid.org/0000-0001-5800-1960
authors.initials: D
authors.lastname: Bokaba
authors.affiliation: Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Celeste
authors.initials: C
authors.lastname: Sauls
authors.affiliation: Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, United States of America.
authors.forename: Julia
authors.identifier: http://orcid.org/0000-0002-1180-8764
authors.initials: J
authors.lastname: Rohr
authors.affiliation: Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Long
mesh_terms: D000328:Adult; D000553:Ambulatory Care / Q000706:statistics & numerical data*; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count / Q000706:statistics & numerical data; D005260:Female; D006761:Hospitals / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000067716:Point-of-Care Testing / Q000706:statistics & numerical data; D011320:Primary Health Care / Q000379:methods*; D017150:Public Sector; D013019:South Africa; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents