Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial

Nadine Tschumi, Malebanye Lerotholi, Mathebe Kopo, Mpho Kao, Blaise Lukau, Bienvenu Nsakala, Ntoiseng Chejane, Lipontso Motaboli, Tristan Lee, Ruanne Barnabas, Adrienne E Shapiro, Alastair van Heerden, Thabo I Lejone, Alain Amstutz, Jennifer A Brown, Jesse Heitner, Jennifer M Belus, Frédérique Chammartin, Niklaus D Labhardt, Nadine Tschumi, Malebanye Lerotholi, Mathebe Kopo, Mpho Kao, Blaise Lukau, Bienvenu Nsakala, Ntoiseng Chejane, Lipontso Motaboli, Tristan Lee, Ruanne Barnabas, Adrienne E Shapiro, Alastair van Heerden, Thabo I Lejone, Alain Amstutz, Jennifer A Brown, Jesse Heitner, Jennifer M Belus, Frédérique Chammartin, Niklaus D Labhardt

Abstract

Introduction: To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery must shift from a "one-size-fits-all" approach to differentiated service delivery models. Such models should reallocate resources from PLHIV who are doing well to groups of PLHIV who may need more attention, such as those with treatment failure. The VIral load Triggered ART care Lesotho (VITAL) trial assesses a viral load (VL)-, participant's preference-informed, electronic health (eHealth)-supported, automated differentiated service delivery model (VITAL model). With VITAL, we aim to assess if the VITAL model is at least non-inferior to the standard of care in the proportion of participants engaged in care with viral suppression at 24 months follow-up and if it is cost-saving.

Methods: The VITAL trial is a pragmatic, multicenter, cluster-randomized, non-blinded, non-inferiority trial with 1:1 allocation conducted at 18 nurse-led, rural health facilities in two districts of northern Lesotho, enrolling adult PLHIV taking ART. In intervention clinics, providers are trained to implement the VITAL model and are guided by a clinical decision support tool, the VITALapp. VITAL differentiates care according to VL results, clinical characteristics, sub-population and participants' and health care providers' preferences.

Expected outcomes: Evidence on the effect of differentiated service delivery for PLHIV on treatment outcomes is still limited. This pragmatic cluster-randomized trial will assess if the VITAL model is at least non-inferior to the standard of care and if it is cost saving.

Trial registration: The study has been registered with clinicaltrials.gov (Registration number NCT04527874; August 27, 2020).

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Spirit flow diagram: Schedule of…
Fig 1. Spirit flow diagram: Schedule of enrolment, interventions, and assessment procedures.
Symbols correspond to the responsible person for the assessment or task: X: VITAL study team, •: Clinic staff, ◊: VITAL data management team, ‡: Other VITAL study team members. * in VITAL intervention clinics only; ** 12 months window; *** 24 months window. TB: Tuberculosis; TPT: Tuberculosis preventive therapy; VL: Viral load; EAC: Enhanced adherence counselling.
Fig 2. Flow chart of study protocol.
Fig 2. Flow chart of study protocol.
Fig 3. Differentiated service delivery building blocks…
Fig 3. Differentiated service delivery building blocks of the VITAL model.
VL: Viral load; TB: Tuberculosis; TPT: Tuberculosis preventive therapy; ART: Antiretroviral therapy.

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