Evidence map›Paper›PMID 34610939›Full record

ArticleBMJ open2021

Simplifying TREAtment and Monitoring for HIV (STREAM HIV): protocol for a randomised controlled trial of point-of-care urine tenofovir and viral load testing to improve HIV outcomes.

Ashley R Bardon, Jienchi Dorward, Yukteshwar Sookrajh, Fathima Sayed, Justice Quame-Amaglo, Cheryl Pillay, Erika Feutz, Hope Ngobese, Jane M Simoni, Monisha Sharma and 11 more

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

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04341779 (Simplifying Treatment and Monitoring for HIV), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-weighted citation impact, top 28% 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.

NCT04341779 naactive not recruitingnot on this map

Simplifying Treatment and Monitoring for HIV (STREAM HIV): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa

TypeinterventionalSponsorUniversity of WashingtonRan2021 to 2026Enrolled539ConditionsHIV/AIDS, HIV-1-infectionArmsPoint-of-care viral load testing and tenofovir adherence testing
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 16 citations in OpenAlex.

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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

21 authors at 6 institutions in 4 countries.

Ashley R BardonDepartment of Epidemiology, University of Washington, Seattle, Washington, USA abardon@uw.edu.ORCID 0000-0002-2404-9568
Jienchi DorwardNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0001-6072-1430
Yukteshwar SookrajheThekwini Municipality Health Unit, Durban, KwaZulu-Natal, South Africa.
Fathima SayedCentre for the AIDS Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa.
Justice Quame-AmagloDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Cheryl PillayCentre for the AIDS Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa.
Erika FeutzDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Hope NgobeseeThekwini Municipality Health Unit, Durban, KwaZulu-Natal, South Africa.
Jane M SimoniDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Monisha SharmaDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Tim R CresseyFaculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.
Monica GandhiDivision of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California San Francisco, San Francisco, California, USA.
Richard LessellsCentre for the AIDS Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa.
Pravi MoodleyNational Health Laboratory Service, Durban, KwaZulu-Natal, South Africa.
Nivashnee NaickerCentre for the AIDS Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa.
Kogieleum NaidooCentre for the AIDS Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa.
Katherine ThomasDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Connie CelumDepartment of Epidemiology, University of Washington, Seattle, Washington, USA.
Salim Abdool KarimCentre for the AIDS Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa.
Nigel GarrettCentre for the AIDS Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa.
Paul K DrainDepartment of Epidemiology, University of Washington, Seattle, Washington, USA.
Centre for the AIDS Programme of Research in South Africa · ZAUniversity of Washington · USeThekwini Municipality · ZANational Health Laboratory Service · ZAUniversity of California, San Francisco · USUniversity of Liverpool · GB

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI CONNIE L CELUM · 1988 to 2026
$104.9M
NRSA Training CoreTL1TR002318 · NCATS · UNIVERSITY OF WASHINGTON · PI Megan Moore · 2017 to 2026
$8.4M
University of Washington Developmental AIDS Research Center for Mental Health (UW ARCH)P30MH123248 · NIMH · UNIVERSITY OF WASHINGTON · PI CHWASTIAK, LYDIA ANN · 2021 to 2024
$5.8M
Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING-PUMA)R01AI143340 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 2018 to 2026
$5.6M
The ITZA Program: Indigenous HIV/AIDS Research Training 3 (IHART3) ProgramR25MH084565 · NIMH · UNIVERSITY OF WASHINGTON · PI Teresa A Evans-Campbell, Michelle D Johnson-Jennings · 2009 to 2026
$3.7M
Simplifying HIV Treatment and Monitoring (STREAM2): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South AfricaR01AI147752 · NIAID · UNIVERSITY OF WASHINGTON · PI DRAIN, PAUL K, GARRETT, NIGEL JOEL · 2019 to 2024
$3.5M
NCATS NIH HHS TL1 TR002318NIAID NIH HHS P30 AI027757NIAID NIH HHS R01 AI143340NIAID NIH HHS R01 AI147752NIMH NIH HHS P30 MH123248NIMH NIH HHS R25 MH084565
6 · The paper itself

Abstract

introductionSubstantial improvements in viral suppression among people living with HIV (PLHIV) are needed to end the HIV epidemic, requiring extensive scale-up of low-cost HIV monitoring services. Point-of-care (POC) tests for monitoring antiretroviral therapy (ART) adherence and viral load (VL) may be efficient and effective tools for real-time clinical decision making. We aim to evaluate the effects of a combined intervention of POC ART adherence and VL testing compared with standard-of-care on ART adherence, viral suppression and retention at 6 and 18 months post-ART initiation among PLHIV. METHODS AND ANALYSIS: Simplifying TREAtment and Monitoring for HIV (STREAM HIV) is a two-arm, open-label, randomised controlled superiority trial of POC urine tenofovir (POC TFV) and VL monitoring in PLHIV. We aim to enrol 540 PLHIV initiating a first-line ART regimen at a public HIV clinic in South Africa. Participants will be randomised 1:1 to the intervention or control arm. Intervention arm participants will receive monthly POC TFV testing for the first 5 months and POC VL testing at months 6 and 12. Intervention arm participants will also receive reflex POC TFV testing if viraemic and reflex HIV drug resistance testing for those with viraemia and detectable TFV. Control arm participants will receive standard-of-care, including laboratory-based VL testing at months 6 and 12. Primary outcomes include ART adherence (TFV-diphosphate concentration) at 6 months and viral suppression and retention at 18 months. Secondary outcomes include viral suppression and retention at 6 months, TFV-diphosphate concentration at 18 months, cost and cost-effectiveness of the intervention and acceptability of the intervention among PLHIV and healthcare workers. ETHICS AND DISSEMINATION: STREAM HIV has received ethical approval from the University of Washington Institutional Review Board (STUDY00007544), University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC/00000833/2019) and Division of AIDS Regulatory Support Center (38509). Findings will be disseminated at international conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04341779.

Indexed as

Anti-HIV AgentsHIV InfectionsAnti-Retroviral AgentsEquivalence Trials as TopicHumansPoint-of-Care SystemsPoint-of-Care TestingRandomized Controlled Trials as TopicSouth AfricaTenofovirViral LoadAnti-HIV AgentsAnti-Retroviral AgentsTenofovirclinical trialsepidemiologyHIV & AIDSinternational health servicespublic health

Identifiers

PMID34610939
PMCPMC8493905
OpenAlexW3202903328

What OpenQuestion holds

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LicenceCC BY-NC
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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.