Point-of-care viral load testing among adolescents and youth living with HIV in Haiti: a protocol for a randomised trial to evaluate implementation and effect

Lindsey K Reif, Marie Elmase Belizaire, Grace Seo, Vanessa Rouzier, Patrice Severe, Joseph Marie Joseph, Bernadette Joseph, Sandra Apollon, Elaine J Abrams, Stephen M Arpadi, Batya Elul, Jean W Pape, Margaret L McNairy, Daniel W Fitzgerald, Louise Kuhn, Lindsey K Reif, Marie Elmase Belizaire, Grace Seo, Vanessa Rouzier, Patrice Severe, Joseph Marie Joseph, Bernadette Joseph, Sandra Apollon, Elaine J Abrams, Stephen M Arpadi, Batya Elul, Jean W Pape, Margaret L McNairy, Daniel W Fitzgerald, Louise Kuhn

Abstract

Introduction: Adolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes. Viral load (VL) monitoring could reinforce adherence but standard VL testing requires strong laboratory capacity often only available in large central laboratories. Thus, coordinated transport of samples and results between the clinic and laboratory is required, presenting opportunities for delayed or misplaced results. Newly available point-of-care (POC) VL testing systems return test results the same day and could simplify VL monitoring so that adolescents receive test results faster which could strengthen adherence counselling and improve ART adherence and viral suppression.

Methods and analysis: This non-blinded randomised clinical trial is designed to evaluate the implementation and effectiveness of POC VL testing compared with standard laboratory-based VL testing among adolescents and youth living with HIV in Haiti. A total of 150 participants ages 10-24 who have been on ART for >6 months are randomised 1:1 to intervention or standard arms. Intervention arm participants receive a POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling. Standard care participants receive a laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1 month later, at which time they receive ART adherence counselling. VL testing is repeated 6 months later for both arms. The primary objective is to describe the implementation of POC VL testing compared with standard laboratory-based VL testing. The secondary objective is to evaluate the effect of POC VL testing on VL suppression at 6 months and participant comprehension of the correlation between VL and ART adherence.

Ethics and dissemination: This study is approved by GHESKIO, Weill Cornell Medicine and Columbia University ethics committees. This trial will provide critical data to understand if and how POC VL testing may impact adolescent ART adherence and viral suppression. If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.

Trial registration number: NCT03288246.

Keywords: HIV & AIDS; clinical trials; paediatrics.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
(A) Standard laboratory-based VL testing steps. (B) POC VL testing steps. EMR, electronic medical record; POC, point-of-care; VL, viral load.
Figure 2
Figure 2
Study schema. *Month 4 VL test administered only to those with a VL >1000 copies/μL at month 1. ART, antiretroviral therapy; VL, viral load.

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