The effect of a customised digital adherence tool on HIV treatment outcomes in young people living with HIV (YPLHIV) in Blantyre, Malawi: a protocol for a randomised controlled trial

Trials

Study Protocol

Tobias F. Rinke de Wit¹  Iraseni Swai²  Kennedy Ngowi²  Rob Aarnoutse³  Marriott Nliwasa⁴  Takondwa Charles Msosa⁵  Marion Sumari-de Boer⁶ 

[1]Amsterdam Institute of Global Health and Development, Amsterdam, the Netherlands

[2]PharmAccess Foundation, Amsterdam, the Netherlands

[3]Department of Global Health, Amsterdam UMC, Location University of Amsterdam, Amsterdam Institute for Global Health and Development, Meibergdreef 9, Amsterdam, the Netherlands

[4]Kilimanjaro Clinical Research Institute, Moshi, Tanzania

[5]Department of Pharmacy, Radboud University Medical Center, Research Institute for Medical Innovation, Nijmegen, the Netherlands

[6]Helse Nord Tuberculosis Initiative, Department of Pathology, Kamuzu University of Health Sciences, Blantyre, Malawi

[7]Helse Nord Tuberculosis Initiative, Department of Pathology, Kamuzu University of Health Sciences, Blantyre, Malawi

[8]Department of Global Health, Amsterdam UMC, Location University of Amsterdam, Amsterdam Institute for Global Health and Development, Meibergdreef 9, Amsterdam, the Netherlands

[9]Kilimanjaro Clinical Research Institute, Moshi, Tanzania

[10]Institute of Public Health, Kilimanjaro Christian Medical University College, Moshi, Tanzania

[11]Knowledge, Innovation and Technology Group, Wageningen University & Research, Droevendaalsesteeg, the Netherlands

[12]Amsterdam Institute of Global Health and Development, Amsterdam, the Netherlands

关键词: Digital health;    HIV;    Young people living with HIV;    ART adherence;    Viral load;   

DOI  :  10.1186/s13063-023-07496-6

 received in 2023-05-18, accepted in 2023-07-05,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPeople living with HIV (PLHIV) have to take lifelong antiretroviral treatment, which is often challenging. Young people living with HIV (YPLHIV) have the lowest viral load suppression rates in Malawi and globally, mostly due to poor treatment adherence. This is a result of complex interactions of multiple factors unique to this demographic group. The use of digital health interventions, such as real-time medication monitor (RTMM)-based digital adherence tools (DATs), could improve ART adherence in YPLHIV and subsequently improve viral load suppression which in turn could lead to reduced HIV-associated morbidity and mortality.AimTo provide the evidence base for a digital adherence intervention to improve treatment outcomes in YPLHIV on ART.Objectives1. The primary objective is to determine the efficacy of a customised DAT compared to the standard of care in improving ART adherence in YPLHIV.2. The secondary objective is to determine the efficacy of the customised DAT compared to the standard of care in improving viral load suppression in YPLHIV.MethodologyThis will be a parallel open-label randomised control controlled two-arm trial in which non-adherent YPLHIV in selected ART facilities in Blantyre will be randomised in a 1:1 ratio to a customised DAT and standard care arms and followed up for 9 months. The primary outcome is the proportion adherent at 9 months (> = 95% by pill count), and the secondary outcome is the proportion with viral load suppressed at 9 months (< 200 copies/ml).DiscussionThere is a paucity of good quality evidence on effective digital health interventions to improve ART adherence and viral load suppression in YPLHIV globally and particularly in HIV high-burden settings like Malawi. This study will provide good-quality evidence on the effectiveness of a customised DAT in improving ART adherence and viral load suppression in this important demographic.Trial registrationThe trial has been registered in the Pan African Clinical Trials Registry number: PACTR202303867267716 on 23 March 2023 and can be accessed through the following URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25424. All items from the WHO Trial Registration Data Set are described in this manuscript.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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