Effect of an opt-out point-of-care HIV-1 nucleic acid testing intervention to detect acute and prevalent HIV infection in symptomatic adult outpatients and reduce HIV transmission in Kenya: a randomized controlled trial.

Eduard J Sanders,Deven T Hamilton,Joseph B Babigumira,Elise Elst,Clara Agutu,Amin Hassan,Carey Farquhar,Evanson Gichuru,Martin Sirengo,Wairimu Chege,Susan M Graham,Peter Mugo,Steven M Goodreau,Thumbi Ndung'U

doi:10.1111/hiv.13157

Abstract

BackgroundIn sub‐Saharan Africa, adult outpatients with symptoms of acute infectious illness are not routinely tested for prevalent or acute HIV infection (AHI) when seeking healthcare.MethodsAdult symptomatic outpatients aged 18–39 years were evaluated by a consensus AHI risk score. Patients with a risk score ≥ 2 and no previous HIV diagnosis were enrolled in a stepped‐wedge trial of opt‐out delivery of point‐of‐care (POC) HIV‐1 nucleic acid testing (NAAT), compared with standard provider‐initiated HIV testing using rapid tests in the observation period. The primary outcome was the number of new diagnoses in each study period. Generalized estimating equations with a log‐binomial link and robust variance estimates were used to account for clustering by health facility. The trial is registered with ClinicalTrials.gov NCT03508908.ResultsBetween 2017 and 2020, 13 (0.9%) out of 1374 participants in the observation period and 37 (2.5%) out of 1500 participants in the intervention period were diagnosed with HIV infection. Of the 37 newly diagnosed cases in the intervention period, two (5.4%) had AHI. Participants in the opt‐out intervention had a two‐fold greater odds of being diagnosed with HIV (odds ratio = 2.2, 95% confidence interval: 1.39–3.51) after adjustment for factors imbalanced across study periods.ConclusionsAmong symptomatic adults aged 18–39 years targeted by our POC NAAT intervention, we identified one chronic HIV infection for every 40 patients and one AHI patient for every 750 patients tested. Although AHI yield was low in this population, routinely offered opt‐out testing could diagnose twice as many patients as an approach relying on provider discretion.

Highlights

Kenya has the fifth largest HIV epidemic in the world, with an estimated adult population prevalence of 4.9% and 1.3 million adults living with HIV in 2018 [1]
This study evaluated a targeted HIV-1 nucleic acid amplification testing (NAAT) intervention to detect acute and chronic HIV infection that was systematically offered to adult outpatients aged 18–39 years seeking healthcare for symptoms compatible with acute HIV infection (AHI)
Implementation of this intervention resulted in a 2.2-fold higher odds of new HIV diagnosis among participants in the intervention period compared with the observation period, in which standard provider-initiated testing and counselling (PITC) was conducted, with testing ordered by the primary care clinician

Summary

Introduction

Kenya has the fifth largest HIV epidemic in the world, with an estimated adult population prevalence of 4.9% and 1.3 million adults living with HIV in 2018 [1]. Symptomatic people seeking healthcare are concerned about their health and entitled to a diagnosis or the exclusion thereof. Communities in the catchment areas of health facilities are entitled that all is done to mitigate ongoing transmission of a preventable illness, and lastly, healthcare policy-m akers should expect returns on HIV testing policies targeting the population at large. In sub-Saharan Africa, adult outpatients with symptoms of acute infectious illness are not routinely tested for prevalent or acute HIV infection (AHI) when seeking healthcare. Patients with a risk score ≥ 2 and no previous HIV diagnosis were enrolled in a stepped-wedge trial of opt-out delivery of point-of-care (POC) HIV-1 nucleic acid testing (NAAT), compared with standard provider- initiated HIV testing using rapid tests in the observation period. Of the 37 newly diagnosed cases in the HIV Medicine. 2021;00:1–13

Methods

Results

Conclusion