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.

Autor: Tschumi N; Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; University of Basel, Basel, Switzerland., Lerotholi M; Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; University of Basel, Basel, Switzerland.; Ministry of health, Maseru, Lesotho., Kopo M; Solidarmed Lesotho, Maseru, Lesotho., Kao M; Solidarmed Lesotho, Maseru, Lesotho., Lukau B; Solidarmed Lesotho, Maseru, Lesotho., Nsakala B; Solidarmed Lesotho, Maseru, Lesotho., Chejane N; Solidarmed Lesotho, Maseru, Lesotho., Motaboli L; Solidarmed Lesotho, Maseru, Lesotho., Lee T; Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; University of Basel, Basel, Switzerland., Barnabas R; Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, United States of America., Shapiro AE; University of Washington, Seattle, Washington, United States of America., van Heerden A; Center for Community Based Research, Human Sciences Research Council, Pietermaritzburg, South Africa.; Faculty of Health Sciences, SAMRC/WITS Developmental Pathways for Health Research Unit, Department of Paediatrics, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, Gauteng, South Africa., Lejone TI; Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; University of Basel, Basel, Switzerland.; Solidarmed Lesotho, Maseru, Lesotho., Amstutz A; Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; University of Basel, Basel, Switzerland., Brown JA; Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; University of Basel, Basel, Switzerland., Heitner J; University of Washington, Seattle, Washington, United States of America., Belus JM; Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; University of Basel, Basel, Switzerland., Chammartin F; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, University of Basel, Basel, Switzerland., Labhardt ND; Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; University of Basel, Basel, Switzerland.; University Hospital Basel, Basel, Switzerland.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2022 May 05; Vol. 17 (5), pp. e0268100. Date of Electronic Publication: 2022 May 05 (Print Publication: 2022).
DOI: 10.1371/journal.pone.0268100
Abstrakt: 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).
Competing Interests: The authors have declared that no competing interests exist.
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje