Abstract
BackgroundGlobally, the majority of people living with HIV have no or only limited access to HIV drug resistance testing to guide the selection of antiretroviral drugs. This is of particular concern for children and adolescents, who experience high rates of treatment failure. The GIVE MOVE trial assesses the clinical impact and cost-effectiveness of routinely providing genotypic resistance testing (GRT) to children and adolescents living with HIV who have an unsuppressed viral load (VL) while taking antiretroviral therapy (ART).MethodsGIVE MOVE is an open-label randomised clinical trial enrolling children and adolescents (≥6 months to <19 years) living with HIV with a VL ≥400 copies/mL (c/mL) while taking first-line ART. Recruitment takes place at sites in Lesotho and Tanzania. Participants are randomised in a 1:1 allocation to a control arm receiving the standard of care (3 sessions of enhanced adherence counselling, a follow-up VL test, continuation of the same regimen upon viral resuppression or empiric selection of a new regimen upon sustained elevated viremia) and an intervention arm (GRT to inform onward treatment). The composite primary endpoint is the occurrence of any one or more of the following events during the 36 weeks of follow-up period: i) death due to any cause; ii) HIV- or ART-related hospital admission of ≥24 h duration; iii) new clinical World Health Organisation stage 4 event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis); and iv) no documented VL <50 c/mL at 36 weeks follow-up. Secondary and exploratory endpoints assess additional health-related outcomes, and a nested study will assess the cost-effectiveness of the intervention. Enrolment of a total of 276 participants is planned, with an interim analysis scheduled after the first 138 participants have completed follow-up.DiscussionThis randomised clinical trial will assess if the availability of resistance testing improves clinical outcomes in children and adolescents with elevated viremia while taking ART.Trial registrationThis trial is registered with ClinicalTrials.gov (NCT04233242; registered 18.01.2020). More information: www.givemove.org.
Highlights
The majority of people living with Human immunodeficiency virus (HIV) have no or only limited access to HIV drug resistance testing to guide the selection of antiretroviral drugs
Enrolment of a total of 276 participants is planned, with an interim analysis scheduled after the first 138 participants have completed follow-up. This randomised clinical trial will assess if the availability of resistance testing improves clinical outcomes in children and adolescents with elevated viremia while taking antiretroviral therapy (ART)
While substantial progress has been made towards providing antiretroviral therapy (ART) to all people living with HIV, which can suppress viral replication and prevent onward transmission of HIV [2,3,4], children and adolescents suffer high rates of treatment failure: among those younger than 15 years who receive ART, reported rates of treatment failure in Eastern and Southern Africa range from 10% (Eswatini) to over 50% (Eritrea, Mozambique, South Sudan) [5]
Summary
Aim The GIVE MOVE trial assesses whether timely provision of GRT upon detection of viremia improves health outcomes for children and adolescents on first-line ART. Proportion of participants among all participants enrolled experiencing any one or more of the events i) death due to any cause within 24 weeks of the decision on onward treatment, ii) HIV- or ART-related hospital admission of ≥24 h duration (possibly, probably or definitely related to HIV or ART, judged by the endpoint committee blinded to the study arm) within 24 weeks of the decision on onward treatment, iii) new clinical WHO stage IV event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis; judged by the endpoint committee blinded to the study arm) within 24 weeks of the decision on onward treatment, and iv) no documentation of a suppressed VL (
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