TY - JOUR
T1 - Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study)
T2 - Study protocol of a cluster-randomized trial
AU - Tschumi, Nadine
AU - Lerotholi, Malebanye
AU - Kopo, Mathebe
AU - Kao, Mpho
AU - Lukau, Blaise
AU - Nsakala, Bienvenu
AU - Chejane, Ntoiseng
AU - Motaboli, Lipontso
AU - Lee, Tristan
AU - Barnabas, Ruanne
AU - Shapiro, Adrienne E
AU - van Heerden, Alastair
AU - Lejone, Thabo I
AU - Amstutz, Alain
AU - Brown, Jennifer A
AU - Heitner, Jesse
AU - Belus, Jennifer M
AU - Chammartin, Frédérique
AU - Labhardt, Niklaus D
PY - 2022/5/5
Y1 - 2022/5/5
N2 - 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).
AB - 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).
KW - Adult
KW - Anti-HIV Agents/therapeutic use
KW - Delivery of Health Care
KW - HIV Infections/drug therapy
KW - Humans
KW - Lesotho
KW - Multicenter Studies as Topic
KW - Randomized Controlled Trials as Topic
KW - Viral Load
U2 - 10.1371/journal.pone.0268100
DO - 10.1371/journal.pone.0268100
M3 - Article (Academic Journal)
C2 - 35511950
SN - 1932-6203
VL - 17
JO - PLOS ONE
JF - PLOS ONE
IS - 5
M1 - e0268100
ER -
