scholarly journals Design and protocol for a pragmatic randomised study to optimise screening, prevention and care for tuberculosis and HIV in Malawi (PROSPECT Study)

2018 ◽  
Vol 3 ◽  
pp. 61 ◽  
Author(s):  
Peter MacPherson ◽  
Emily L Webb ◽  
David G. Lalloo ◽  
Marriott Nliwasa ◽  
Hendramoorthy Maheswaran ◽  
...  

Background: Adults seeking diagnosis and treatment for tuberculosis (TB) and HIV in low-resource settings face considerable barriers and have high pre-treatment mortality. Efforts to improve access to prompt TB treatment have been hampered by limitations in TB diagnostics, with considerable uncertainty about how available and new tests can best be implemented. Design and methods: The PROSPECT Study is an open, three-arm pragmatic randomised study that will investigate the effectiveness and cost-effectiveness of optimised HIV and TB diagnosis and linkage to care interventions in reducing time to TB diagnosis and prevalence of undiagnosed TB and HIV in primary care in Blantyre, Malawi. Participants (≥ 18 years) attending a primary care clinic with TB symptoms (cough of any duration) will be randomly allocated to one of three groups: (i) standard of care; (ii) optimised HIV diagnosis and linkage; or (iii) optimised HIV and TB diagnosis and linkage. We will test two hypotheses: firstly, whether prompt linkage to HIV care should be prioritised for adults with TB symptoms; and secondly, whether an optimised TB triage testing algorithm comprised of digital chest x-ray evaluated by computer-aided diagnosis software and sputum GeneXpert MTB/Rif can outperform clinician-directed TB screening. The primary trial outcome will be time to TB treatment initiation by day 56, and secondary outcomes will include prevalence of undiagnosed TB and HIV, mortality, quality of life, and cost-effectiveness. Conclusions: The PROSPECT Study will provide urgently-needed evidence under “real-life” conditions to inform clinicians and policy makers on how best to improve TB/HIV diagnosis and treatment in Africa. Clinical trial registration: NCT03519425 (08/05/2018)

2018 ◽  
Vol 3 ◽  
pp. 61
Author(s):  
Peter MacPherson ◽  
Emily L Webb ◽  
David G. Lalloo ◽  
Marriott Nliwasa ◽  
Hendramoorthy Maheswaran ◽  
...  

Background: Adults seeking diagnosis and treatment for tuberculosis (TB) and HIV in low-resource settings face considerable barriers and have high pre-treatment mortality. Efforts to improve access to prompt TB treatment have been hampered by limitations in TB diagnostics, with considerable uncertainty about how available and new tests can best be implemented. Design and methods: The PROSPECT Study is an open, three-arm pragmatic randomised study that will investigate the effectiveness and cost-effectiveness of optimised HIV and TB diagnosis and linkage to care interventions in reducing time to TB diagnosis and prevalence of undiagnosed TB and HIV in primary care in Blantyre, Malawi. Participants (≥ 18 years) attending a primary care clinic with TB symptoms (cough of any duration) will be randomly allocated to one of three groups: (i) standard of care; (ii) optimised HIV diagnosis and linkage; or (iii) optimised HIV and TB diagnosis and linkage. We will test two hypotheses: firstly, whether prompt linkage to HIV care should be prioritised for adults with TB symptoms; and secondly, whether an optimised TB triage testing algorithm comprised of digital chest x-ray evaluated by computer-aided diagnosis software and sputum GeneXpert MTB/Rif can outperform clinician-directed TB screening. The primary trial outcome will be time to TB treatment initiation by day 56, and secondary outcomes will include prevalence of undiagnosed TB and HIV, mortality, quality of life, and cost-effectiveness. Conclusions: The PROSPECT Study will provide urgently-needed evidence under “real-life” conditions to inform clinicians and policy makers on how best to improve TB/HIV diagnosis and treatment in Africa. Clinical trial registration: NCT03519425 (08/05/2018)


2018 ◽  
Vol 3 ◽  
pp. 61
Author(s):  
Peter MacPherson ◽  
Emily L Webb ◽  
David G. Lalloo ◽  
Marriott Nliwasa ◽  
Hendramoorthy Maheswaran ◽  
...  

Background: Adults seeking diagnosis and treatment for tuberculosis (TB) and HIV in low-resource settings face considerable barriers and have high pre-treatment mortality. Efforts to improve access to prompt TB treatment have been hampered by limitations in TB diagnostics, with considerable uncertainty about how available and new tests can best be implemented. Design and methods: The PROSPECT Study is an open, three-arm pragmatic randomised study that will investigate the effectiveness and cost-effectiveness of optimised HIV and TB diagnosis and linkage to care interventions in reducing time to TB diagnosis and prevalence of undiagnosed TB and HIV in primary care in Blantyre, Malawi. Participants (≥ 18 years) attending a primary care clinic with TB symptoms (cough of any duration) will be randomly allocated to one of three groups: (i) standard of care; (ii) optimised HIV diagnosis and linkage; or (iii) optimised HIV and TB diagnosis and linkage. We will test two hypotheses: firstly, whether prompt linkage to HIV care should be prioritised for adults with TB symptoms; and secondly, whether an optimised TB triage testing algorithm comprised of digital chest x-ray evaluated by computer-aided diagnosis software and sputum GeneXpert MTB/Rif can outperform clinician-directed TB screening. The primary trial outcome will be time to TB treatment initiation by day 56, and secondary outcomes will include prevalence of undiagnosed TB and HIV, mortality, quality of life, and cost-effectiveness. Conclusions: The PROSPECT Study will provide urgently-needed evidence under “real-life” conditions to inform clinicians and policy makers on how best to improve TB/HIV diagnosis and treatment in Africa. Clinical trial registration: NCT03519425 (08/05/2018)


PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0246523
Author(s):  
Eva Van Ginderdeuren ◽  
Jean Bassett ◽  
Colleen F. Hanrahan ◽  
Lillian Mutunga ◽  
Annelies Van Rie

Background Tuberculin skin test (TST) for guiding initiation of tuberculosis preventive therapy poses major challenges in high tuberculosis burden settings. Methods At a primary care clinic in Johannesburg, South Africa, 278 HIV-positive adults self-read their TST by reporting if they felt a bump (any induration) at the TST placement site. TST reading (in mm) was fast-tracked to reduce patient wait time and task-shifted to delegate tasks to lower cadre healthcare workers, and result was compared to TST reading by high cadre research staff. TST reading and placement cost to the health system and patients were estimated. Simulations of health system costs were performed for 5 countries (USA, Germany, Brazil, India, Russia) to evaluate generalizability. Results Almost all participants (269 of 278, 97%) correctly self-identified the presence or absence of any induration [sensitivity 89% (95% CI 80,95) and specificity 99.5% (95% CI 97,100)]. For detection of a positive TST (induration ≥ 5mm), sensitivity was 90% (95% CI 81,96) and specificity 99% (95% CI 97,100). TST reading agreement between low and high cadre staff was high (kappa 0.97, 95% CI 0.94, 1.00). Total TST cost was 2066 I$ (95% UI 594, 5243) per 100 patients, 87% (95% UI 53, 95) of which were patient costs. Combining fast-track and task-shifting, reduced total costs to 1736 I$ (95% UI 497, 4300) per 100 patients, with 31% (95% UI 15, 42) saving in health system costs. Combining fast-tracking, task-shifting and self-reading, lowered the TST health system costs from 16% (95% UI 8, 26) in Russia to 40% (95% UI 18, 54) in the USA. Conclusion A TST strategy where only patients with any self-read induration are asked to return for fast-tracked TST reading by lower cadre healthcare workers is a promising strategy that could be effective and cost-saving, but real-life cost-effectiveness should be further examined.


2020 ◽  
Vol 11 (03) ◽  
pp. 442-451
Author(s):  
Mark V. Mai ◽  
Evan W. Orenstein ◽  
John D. Manning ◽  
Anthony A. Luberti ◽  
Adam C. Dziorny

Abstract Objective Patient attribution, or the process of attributing patient-level metrics to specific providers, attempts to capture real-life provider–patient interactions (PPI). Attribution holds wide-ranging importance, particularly for outcomes in graduate medical education, but remains a challenge. We developed and validated an algorithm using EHR data to identify pediatric resident PPIs (rPPIs). Methods We prospectively surveyed residents in three care settings to collect self-reported rPPIs. Participants were surveyed at the end of primary care clinic, emergency department (ED), and inpatient shifts, shown a patient census list, asked to mark the patients with whom they interacted, and encouraged to provide a short rationale behind the marked interaction. We extracted routine EHR data elements, including audit logs, note contribution, order placement, care team assignment, and chart closure, and applied a logistic regression classifier to the data to predict rPPIs in each care setting. We also performed a comment analysis of the resident-reported rationales in the inpatient care setting to explore perceived patient interactions in a complicated workflow. Results We surveyed 81 residents over 111 shifts and identified 579 patient interactions. Among EHR extracted data, time-in-chart was the best predictor in all three care settings (primary care clinic: odds ratio [OR] = 19.36, 95% confidence interval [CI]: 4.19–278.56; ED: OR = 19.06, 95% CI: 9.53–41.65' inpatient: OR = 2.95, 95% CI: 2.23–3.97). Primary care clinic and ED specific models had c-statistic values > 0.98, while the inpatient-specific model had greater variability (c-statistic = 0.89). Of 366 inpatient rPPIs, residents provided rationales for 90.1%, which were focused on direct involvement in a patient's admission or transfer, or care as the front-line ordering clinician (55.6%). Conclusion Classification models based on routinely collected EHR data predict resident-defined rPPIs across care settings. While specific to pediatric residents in this study, the approach may be generalizable to other provider populations and scenarios in which accurate patient attribution is desirable.


2020 ◽  
Vol 10 (3) ◽  
pp. 92-96
Author(s):  
G. McHugh ◽  
A. Brunskill ◽  
E. Dauya ◽  
T. Bandason ◽  
T. Bwakura ◽  
...  

Setting: Decentralisation of HIV care to nurse-led primary care services is being implemented across low- and middle-income countries in sub-Saharan Africa.Objective: To compare services offered to clients attending for HIV care at a physician-led and a nurse-led service in Harare, Zimbabwe.Design: A cross-sectional study was performed at Harare Central Hospital (HCH) and Budiriro Primary Care Clinic (PCC) from June to August 2018. An interviewer-administered questionnaire was used to collect sociodemographics, HIV treatment and clinical history from clients attending for routine HIV care. The Mann-Whitney U-test was used to evaluate for differences between groups for continuous variables. For categorical variables, the χ2 test was used.Results: The median age of the 404 participants recruited was 38 years (IQR 28–47); 69% were female. Viral suppression was comparable between sites (HCH, 70% vs. PCC, 80%; P = 0.07); however, screening for comorbidities such as cervical cancer screening (HCH, 61% vs. PCC, 41%; P = 0.001) and provision of referral services (HCH, 23% vs. PCC, 13%; P = 0.01) differed between sites.Conclusion: Efforts to improve service provision in primary care settings are needed to ensure equity for users of health services.


PEDIATRICS ◽  
2016 ◽  
Vol 137 (Supplement 3) ◽  
pp. 93A-93A
Author(s):  
Lwbba Chait ◽  
Angeliki Makri ◽  
Rawan Nahas ◽  
Gwen Raphan

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