Evidence map›Paper›PMID 35511950›Full record

ArticlePloS one2022

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 and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04527874 (Assessment of a Viral Load Result-driven Automated Differentiated Service Delivery Model for Participants Taking Antiretroviral Therapy in Lesotho), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.5field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04527874 nacompletednot on this map

Assessment of a Viral Load Result-driven Automated Differentiated Service Delivery Model for Participants Taking Antiretroviral Therapy in Lesotho

TypeinterventionalSponsorSwiss Tropical & Public Health InstituteRan2020 to 2024Enrolled5,809ConditionsHIV InfectionsArmsVITAL model
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 5 institutions in 4 countries.

Nadine TschumiSwiss Tropical and Public Health Institute, Allschwil, Switzerland.
Malebanye LerotholiSwiss Tropical and Public Health Institute, Allschwil, Switzerland.
Mathebe KopoSolidarmed Lesotho, Maseru, Lesotho.
Mpho KaoSolidarmed Lesotho, Maseru, Lesotho.
Blaise LukauSolidarmed Lesotho, Maseru, Lesotho.
Bienvenu NsakalaSolidarmed Lesotho, Maseru, Lesotho.
Ntoiseng ChejaneSolidarmed Lesotho, Maseru, Lesotho.
Lipontso MotaboliSolidarmed Lesotho, Maseru, Lesotho.
Tristan LeeSwiss Tropical and Public Health Institute, Allschwil, Switzerland.
Ruanne BarnabasDivision of Infectious Diseases, Massachusetts General Hospital, Boston, MA, United States of America.ORCID 0000-0002-1793-6003
Adrienne E ShapiroUniversity of Washington, Seattle, Washington, United States of America.ORCID 0000-0002-3106-1258
Alastair van HeerdenCenter for Community Based Research, Human Sciences Research Council, Pietermaritzburg, South Africa.
Thabo I LejoneSwiss Tropical and Public Health Institute, Allschwil, Switzerland.
Alain AmstutzSwiss Tropical and Public Health Institute, Allschwil, Switzerland.ORCID 0000-0003-1716-993X
Jennifer A BrownSwiss Tropical and Public Health Institute, Allschwil, Switzerland.ORCID 0000-0003-1874-6153
Jesse HeitnerUniversity of Washington, Seattle, Washington, United States of America.
Jennifer M BelusSwiss Tropical and Public Health Institute, Allschwil, Switzerland.ORCID 0000-0003-4091-4889
Frédérique ChammartinDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, University of Basel, Basel, Switzerland.
Niklaus D LabhardtSwiss Tropical and Public Health Institute, Allschwil, Switzerland.ORCID 0000-0003-3599-1791
Swiss Tropical and Public Health Institute · CHUniversity of Washington · USHuman Sciences Research Council · ZAMassachusetts General Hospital · USUniversity of Basel · CH

Funding

Novel clinic-based TB diagnostics and testing algorithms for persons with HIVK23AI140918 · NIAID · UNIVERSITY OF WASHINGTON · PI SHAPIRO, ADRIENNE E · 2019 to 2024
$937k
NIAID NIH HHS K23 AI140918
6 · The paper itself

Abstract

introductionTo 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.

methodsThe 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 registrationThe study has been registered with clinicaltrials.gov (Registration number NCT04527874; August 27, 2020).

Indexed as

Anti-HIV AgentsHIV InfectionsAdultDelivery of Health CareEquivalence Trials as TopicHumansLesothoMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicViral LoadAnti-HIV Agents

Identifiers

PMID35511950
PMCPMC9071137
OpenAlexW4229058798

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.