Evidence map›Paper›PMID 28963304›Full record

Trial reportBMJ open2017

Protocol for a randomised controlled implementation trial of point-of-care viral load testing and task shifting: the Simplifying HIV TREAtment and Monitoring (STREAM) study.

Jienchi Dorward, Nigel Garrett, Justice Quame-Amaglo, Natasha Samsunder, Hope Ngobese, Noluthando Ngomane, Pravikrishnen Moodley, Koleka Mlisana, Torin Schaafsma, Deborah Donnell and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03066128 (Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 11% 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.

NCT03066128 nacompletednot on this map

Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care

TypeinterventionalSponsorUniversity of WashingtonRan2017 to 2018Enrolled390ConditionsChronic HIV InfectionArmsPoint-of-care viral load testing, Lab-based viral load testing
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
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  15. Treatment as Prevention: Concepts and Challenges for Reducing HIV Incidence.Journal of acquired immune deficiency syndromes (1999) · 2019
    Article
  16. Review
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  18. Propelling the Pediatric HIV Therapeutic Agenda With Science, Innovation, and Collaboration.Journal of acquired immune deficiency syndromes (1999) · 2018
    Article
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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

15 authors at 3 institutions in 2 countries.

Jienchi DorwardCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.ORCID http://orcid.org/0000-0001-6072-1430
Nigel GarrettCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
Justice Quame-AmagloDepartment of Global Health, Schools of Medicine and Public Health, University of Washington, Seattle, Washington, USA.
Natasha SamsunderCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
Hope NgobesePrince Cyril Zulu Communicable Disease Clinic, Durban Municipality, Durban, KwaZulu-Natal, South Africa.
Noluthando NgomanePrince Cyril Zulu Communicable Disease Clinic, Durban Municipality, Durban, KwaZulu-Natal, South Africa.
Pravikrishnen MoodleyDepartment of Virology, Inkosi Albert Luthuli Central Hospital, Durban, KwaZulu-Natal, South Africa.
Koleka MlisanaSchool of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
Torin SchaafsmaDepartment of Global Health, Schools of Medicine and Public Health, University of Washington, Seattle, Washington, USA.
Deborah DonnellDepartment of Global Health, Schools of Medicine and Public Health, University of Washington, Seattle, Washington, USA.
Ruanne BarnabasDepartment of Global Health, Schools of Medicine and Public Health, University of Washington, Seattle, Washington, USA.
Kogieleum NaidooCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
Salim Abdool KarimCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
Connie CelumDepartment of Global Health, Schools of Medicine and Public Health, University of Washington, Seattle, Washington, USA.
Paul K DrainDepartment of Global Health, Schools of Medicine and Public Health, University of Washington, Seattle, Washington, USA.
University of Washington · USCentre for the AIDS Programme of Research in South Africa · ZANational Health Laboratory Service · ZA

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI CONNIE L CELUM · 1988 to 2026
$104.9M
Point-of-care viral load testing to enable task shifting for chronic HIV careR21AI124719 · NIAID · UNIVERSITY OF WASHINGTON · PI DRAIN, PAUL K, GARRETT, NIGEL JOEL · 2016 to 2017
$336k
NIAID NIH HHS P30 AI027757NIAID NIH HHS R21 AI124719
6 · The paper itself

Abstract

introductionAchieving the Joint United Nations Programme on HIV and AIDS 90-90-90 targets requires models of HIV care that expand antiretroviral therapy (ART) coverage without overburdening health systems. Point-of-care (POC) viral load (VL) testing has the potential to efficiently monitor ART treatment, while enrolled nurses may be able to provide safe and cost-effective chronic care for stable patients with HIV. This study aims to demonstrate whether POC VL testing combined with task shifting to enrolled nurses is non-inferior and cost-effective compared with laboratory-based VL monitoring and standard HIV care. METHODS AND ANALYSIS: The STREAM (Simplifying HIV TREAtment and Monitoring) study is an open-label, non-inferiority, randomised controlled implementation trial. HIV-positive adults, clinically stable at 6 months after ART initiation, will be recruited in a large urban clinic in South Africa. Approximately 396 participants will be randomised 1:1 to receive POC HIV VL monitoring and potential task shifting to enrolled nurses, versus laboratory VL monitoring and standard South African HIV care. Initial clinic follow-up will be 2-monthly in both arms, with VL testing at enrolment, 6 months and 12 months. At 6 months (1 year after ART initiation), stable participants in both arms will qualify for a differentiated care model involving decentralised ART pickup at community-based pharmacies. The primary outcome is retention in care and virological suppression at 12 months from enrolment. Secondary outcomes include time to appropriate entry into the decentralised ART delivery programme, costs per virologically suppressed patient and cost-effectiveness of the intervention compared with standard care. Findings will inform the scale up of VL testing and differentiated care in HIV-endemic resource-limited settings. ETHICS AND DISSEMINATION: Ethical approval has been granted by the University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC296/16) and University of Washington Institutional Review Board (STUDY00001466). Results will be presented at international conferences and published in academic peer-reviewed journals.

trial registrationNCT03066128; Pre-results.

Indexed as

Point-of-Care TestingAnti-Retroviral AgentsCD4 Lymphocyte CountCost-Benefit AnalysisHIV InfectionsHumansLogistic ModelsMultivariate AnalysisResearch DesignSouth AfricaViral LoadAnti-Retroviral Agentsinternational health servicesvirology

Identifiers

PMID28963304
PMCPMC5623564
OpenAlexW2759962078

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.