Evidence map›Paper›PMID 35550621›Full record

ArticleTrials2022

Tuberculosis screening improves preventive therapy uptake (TB SCRIPT) trial among people living with HIV in Uganda: a study protocol of an individual randomized controlled trial.

Fred C Semitala, Lelia H Chaisson, David W Dowdy, Derek T Armstrong, Bishop Opira, Kyomugisha Aman, Moses Kamya, Patrick P J Phillips, Christina Yoon

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04557176 (TB Screening Improves Preventive Therapy Uptake Trial), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 31% 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.

NCT04557176 naactive not recruitingnot on this map

TB Screening Improves Preventive Therapy Uptake Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2020 to 2025Enrolled1,719ConditionsTuberculosis, Latent Tuberculosis, Tuberculosis Prevention, HIVArmsCRP, point-of-care assay
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. 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

9 authors at 4 institutions in 2 countries.

Fred C SemitalaDepartment of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
Lelia H ChaissonDivision of Infectious Diseases, Department of Medicine, University of Illinois Chicago, Chicago, IL, USA.
David W DowdyDepartments of Epidemiology, International Health, and Medicine, Johns Hopkins University, Baltimore, MD, USA.
Derek T ArmstrongDepartment of Pathology, Johns Hopkins University, Baltimore, MD, USA.
Bishop OpiraInfectious Diseases Research Collaboration, Kampala, Uganda.
Kyomugisha AmanInfectious Diseases Research Collaboration, Kampala, Uganda.
Moses KamyaDepartment of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
Patrick P J PhillipsDivision of Pulmonary and Critical Care Medicine, University of California San Francisco, 1001 Potrero Ave, 5K1, San Francisco, CA, 94110, USA.
Christina YoonDivision of Pulmonary and Critical Care Medicine, University of California San Francisco, 1001 Potrero Ave, 5K1, San Francisco, CA, 94110, USA. Christina.yoon@ucsf.edu.ORCID http://orcid.org/0000-0003-0865-4108
Infectious Diseases Research Collaboration · UGJohns Hopkins University · USUniversity of California, San Francisco · USUniversity of Illinois Chicago · US

Funding

Point-of-care C-reactive protein-based tuberculosis screening in people living with HIV: a randomized trialR61HL146365 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DOWDY, DAVID WESLEY, PHILLIPS, PATRICK PJ · 2019 to 2019
$964k
Point-of-care C-reactive protein-based tuberculosis screening among people living with HIV: planning a comparative effectiveness trialR34AI134589 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI YOON, CHRISTINA · 2017 to 2017
$236k
NHLBI NIH HHS 1R61HL146365NHLBI NIH HHS R61 HL146365NIAID NIH HHS R34 AI134589
6 · The paper itself

Abstract

backgroundPeople living with HIV (PLHIV) have an increased risk of developing active tuberculosis (TB). To reduce the burden of TB among PLHIV, the World Health Organization (WHO) recommends systematic TB screening followed by (1) confirmatory TB testing for all who screen positive and (2) TB preventive therapy (TPT) for all TPT-eligible PLHIV who screen negative. Symptom-based screening remains the standard of care in most high TB burden settings, including Uganda. Despite having high sensitivity for active TB among antiretroviral-naïve PLHIV, symptom screening has poor specificity; as such, many high-risk PLHIV without active TB are not referred for TPT. C-reactive protein (CRP) is a promising alternative strategy for TB screening that has comparable sensitivity and higher specificity than symptom screening, and was endorsed by WHO in 2021. However, the impact of CRP-based TB screening on TB burden for PLHIV remains unclear.

methodsTB SCRIPT (TB Screening Improves Preventive Therapy Uptake) is a phase 3, multi-center, single-blinded, individual (1:1) randomized controlled trial evaluating the effectiveness of CRP-based TB screening on clinical outcomes of PLHIV. The trial aims to compare the effectiveness of a TB screening strategy based on CRP levels using a point-of-care (POC) assay on 2-year TB incidence and all-cause mortality (composite primary trial endpoint) and prevalent TB case detection and uptake of TPT (intermediate outcomes), relative to symptom-based TB screening (current practice). DISCUSSION: This study will be critical to improving selection of eligible PLHIV for TPT and helping guide the scale-up and integration of TB screening and TPT activities. This work will enable the field to improve TB screening by removing barriers to TPT initiation among eligible PLHIV, and provide randomized evidence to inform and strengthen WHO guidelines.

trial registrationClinicalTrials.gov NCT04557176. Registered on September 21, 2020.

Indexed as

HIV InfectionsTuberculosisAnti-Retroviral AgentsAntitubercular AgentsClinical Trials, Phase III as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicUgandaAnti-Retroviral AgentsAntitubercular AgentsC-reactive proteinHIVRandomized controlled trialScreeningTuberculosisTuberculosis preventive therapy

Identifiers

PMID35550621
PMCPMC9096738
OpenAlexW4280500557

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.