Point-of-care testing and treatment of sexually transmitted and genital infections during pregnancy in Papua New Guinea (WANTAIM trial): protocol for an economic evaluation alongside a cluster-randomised trial

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Abstract

Introduction

Left untreated, sexually transmitted and genital infections (henceforth STIs) in pregnancy can lead to serious adverse outcomes for mother and child. Papua New Guinea (PNG) has among the highest prevalence of curable STIs including syphilis, chlamydia, gonorrhoea, trichomoniasis and bacterial vaginosis, and high neonatal mortality rates. Diagnosis and treatment of these STIs in PNG rely on syndromic management. Advances in STI diagnostics through point-of-care (PoC) testing using GeneXpert technology hold promise for resource-constrained countries such as PNG. This paper describes the planned economic evaluation of a cluster-randomised cross-over trial comparing antenatal PoC testing and immediate treatment of curable STIs with standard antenatal care in two provinces in PNG.

Methods and analysis

Cost-effectiveness of the PoC intervention compared with standard antenatal care will be assessed prospectively over the trial period (2017–2021) from societal and provider perspectives. Incremental cost-effectiveness ratios will be calculated for the primary health outcome, a composite measure of the proportion of either preterm birth and/or low birth weight; for life years saved; for disability-adjusted life years averted; and for non-health benefits (financial risk protection and improved health equity). Scenario analyses will be conducted to identify scale-up options, and budget impact analysis will be undertaken to understand short-term financial impacts of intervention adoption on the national budget. Deterministic and probabilistic sensitivity analysis will be conducted to account for uncertainty in key model inputs.

Ethics and dissemination

This study has ethical approval from the Institutional Review Board of the PNG Institute of Medical Research; the Medical Research Advisory Committee of the PNG National Department of Health; the Human Research Ethics Committee of the University of New South Wales; and the Research Ethics Committee of the London School of Hygiene and Tropical Medicine. Findings will be disseminated through national stakeholder meetings, conferences, peer-reviewed publications and policy briefs.

Trial registration number

ISRCTN37134032.

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Most cited references 84

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Global, regional, and national levels and causes of maternal mortality during 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013

Nicholas J. Kassebaum, Amelia Bertozzi-Villa, Megan S Coggeshall … (2014)

The fifth Millennium Development Goal (MDG 5) established the goal of a 75% reduction in the maternal mortality ratio (MMR; number of maternal deaths per 100,000 livebirths) between 1990 and 2015. We aimed to measure levels and track trends in maternal mortality, the key causes contributing to maternal death, and timing of maternal death with respect to delivery. We used robust statistical methods including the Cause of Death Ensemble model (CODEm) to analyse a database of data for 7065 site-years and estimate the number of maternal deaths from all causes in 188 countries between 1990 and 2013. We estimated the number of pregnancy-related deaths caused by HIV on the basis of a systematic review of the relative risk of dying during pregnancy for HIV-positive women compared with HIV-negative women. We also estimated the fraction of these deaths aggravated by pregnancy on the basis of a systematic review. To estimate the numbers of maternal deaths due to nine different causes, we identified 61 sources from a systematic review and 943 site-years of vital registration data. We also did a systematic review of reports about the timing of maternal death, identifying 142 sources to use in our analysis. We developed estimates for each country for 1990-2013 using Bayesian meta-regression. We estimated 95% uncertainty intervals (UIs) for all values. 292,982 (95% UI 261,017-327,792) maternal deaths occurred in 2013, compared with 376,034 (343,483-407,574) in 1990. The global annual rate of change in the MMR was -0·3% (-1·1 to 0·6) from 1990 to 2003, and -2·7% (-3·9 to -1·5) from 2003 to 2013, with evidence of continued acceleration. MMRs reduced consistently in south, east, and southeast Asia between 1990 and 2013, but maternal deaths increased in much of sub-Saharan Africa during the 1990s. 2070 (1290-2866) maternal deaths were related to HIV in 2013, 0·4% (0·2-0·6) of the global total. MMR was highest in the oldest age groups in both 1990 and 2013. In 2013, most deaths occurred intrapartum or postpartum. Causes varied by region and between 1990 and 2013. We recorded substantial variation in the MMR by country in 2013, from 956·8 (685·1-1262·8) in South Sudan to 2·4 (1·6-3·6) in Iceland. Global rates of change suggest that only 16 countries will achieve the MDG 5 target by 2015. Accelerated reductions since the Millennium Declaration in 2000 coincide with increased development assistance for maternal, newborn, and child health. Setting of targets and associated interventions for after 2015 will need careful consideration of regions that are making slow progress, such as west and central Africa. Bill & Melinda Gates Foundation. Copyright © 2014 Elsevier Ltd. All rights reserved.

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Consolidated Health Economic Evaluation Reporting Standards (CHEERS)--explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force.

Don Husereau, Michael Drummond, Stavros Petrou … (2013)

Economic evaluations of health interventions pose a particular challenge for reporting because substantial information must be conveyed to allow scrutiny of study findings. Despite a growth in published reports, existing reporting guidelines are not widely adopted. There is also a need to consolidate and update existing guidelines and promote their use in a user-friendly manner. A checklist is one way to help authors, editors, and peer reviewers use guidelines to improve reporting. The task force's overall goal was to provide recommendations to optimize the reporting of health economic evaluations. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines into one current, useful reporting guidance. The CHEERS Elaboration and Explanation Report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force facilitates the use of the CHEERS statement by providing examples and explanations for each recommendation. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. Previously published checklists or guidance documents related to reporting economic evaluations were identified from a systematic review and subsequent survey of task force members. A list of possible items from these efforts was created. A two-round, modified Delphi Panel with representatives from academia, clinical practice, industry, and government, as well as the editorial community, was used to identify a minimum set of items important for reporting from the larger list. Out of 44 candidate items, 24 items and accompanying recommendations were developed, with some specific recommendations for single study-based and model-based economic evaluations. The final recommendations are subdivided into six main categories: 1) title and abstract, 2) introduction, 3) methods, 4) results, 5) discussion, and 6) other. The recommendations are contained in the CHEERS statement, a user-friendly 24-item checklist. The task force report provides explanation and elaboration, as well as an example for each recommendation. The ISPOR CHEERS statement is available online via Value in Health or the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices - CHEERS Task Force webpage (http://www.ispor.org/TaskForces/EconomicPubGuidelines.asp). We hope that the ISPOR CHEERS statement and the accompanying task force report guidance will lead to more consistent and transparent reporting, and ultimately, better health decisions. To facilitate wider dissemination and uptake of this guidance, we are copublishing the CHEERS statement across 10 health economics and medical journals. We encourage other journals and groups to consider endorsing the CHEERS statement. The author team plans to review the checklist for an update in 5 years. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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Sexually transmitted infections: challenges ahead.

Magnus Unemo, Catriona S. Bradshaw, Jane Hocking … (2017)

WHO estimated that nearly 1 million people become infected every day with any of four curable sexually transmitted infections (STIs): chlamydia, gonorrhoea, syphilis, and trichomoniasis. Despite their high global incidence, STIs remain a neglected area of research. In this Commission, we have prioritised five areas that represent particular challenges in STI treatment and control. Chlamydia remains the most commonly diagnosed bacterial STI in high-income countries despite widespread testing recommendations, sensitive and specific non-invasive testing techniques, and cheap effective therapy. We discuss the challenges for chlamydia control and evidence to support a shift from the current focus on infection-based screening to improved management of diagnosed cases and of chlamydial morbidity, such as pelvic inflammatory disease. The emergence and spread of antimicrobial resistance in Neisseria gonorrhoeae is globally recognised. We review current and potential future control and treatment strategies, with a focus on novel antimicrobials. Bacterial vaginosis is the most common vaginal disorder in women, but current treatments are associated with frequent recurrence. Recurrence after treatment might relate to evidence that suggests sexual transmission is integral to the pathogenesis of bacterial vaginosis, which has substantial implications for the development of effective management approaches. STIs disproportionately affect low-income and middle-income countries. We review strategies for case management, focusing on point-of-care tests that hold considerable potential for improving STI control. Lastly, STIs in men who have sex with men have increased since the late 1990s. We discuss the contribution of new biomedical HIV prevention strategies and risk compensation. Overall, this Commission aims to enhance the understanding of some of the key challenges facing the field of STIs, and outlines new approaches to improve the clinical management of STIs and public health.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2021

Publication date (Electronic): 12 August 2021

Volume: 11

Issue: 8

Electronic Location Identifier: e046308

Affiliations

[1 ]departmentInstitute for Global Health , University College London , London, UK

[2 ]departmentThe Kirby Institute , University of New South Wales , Sydney, New South Wales, Australia

[3 ]The Papua New Guinea Institute of Medical Research , Goroka, Papua New Guinea

[4 ]The Burnet Institute , Melbourne, Victoria, Australia

[5 ]departmentFaculty of Health , University of Technology Sydney , Sydney, New South Wales, Australia

[6 ]departmentDepartment of Public Health and Preventive Medicine , Ghent University , Ghent, Belgium

[7 ]departmentDepartment of Population Health, Medical College , Aga Khan University , Nairobi, Kenya

[8 ]departmentDepartment of Epidemiology and Preventive Medicine , Monash University , Monash, Victoria, Australia

[9 ]departmentSchool of Medicine and Health Sciences , University of Papua New Guinea , Port Moresby, Papua New Guinea

[10 ]Milne Bay Provincial Health Authority , Alotau, Papua New Guinea

[11 ]departmentDepartment of Medicine, The Doherty Institute , University of Melbourne , Melbourne, Victoria, Australia

[12 ]The Royal Women’s Hospital , Parkville, Victoria, Australia

[13 ]departmentThe University of Queensland Centre for Clinical Research, Faculty of Medicine , The University of Queensland , Brisbane, Queensland, Australia

[14 ]departmentInstitute of Social and Preventive Medicine , University of Bern , Bern, Switzerland

[15 ]departmentDepartment of Clinical Research , London School of Hygiene and Tropical Medicine , London, UK

[16 ]Papua New Guinea Institute of Medical Research , Madang, Papua New Guinea

[17 ]Madang Provincial Health Authority , Madang, Papua New Guinea

[18 ]departmentMicrobiology and Infectious Diseases Department , The Royal Women's Hospital , Parkville, Victoria, Australia

[19 ]departmentDepartment of Global Health and Development , London School of Hygiene and Tropical Medicine , London, UK

Author notes

[Correspondence to ] Dr Neha Batura; n.batura@ 123456ucl.ac.uk

Author information

Neha Batura http://orcid.org/0000-0002-8175-8125

Olga PM Saweri http://orcid.org/0000-0001-5142-8355

Andrew Vallely http://orcid.org/0000-0003-1558-4822

Lisa M Vallely http://orcid.org/0000-0002-8247-7683

Nicola Low http://orcid.org/0000-0003-4817-8986

Article

Publisher ID: bmjopen-2020-046308

DOI: 10.1136/bmjopen-2020-046308

PMC ID: 8362726

PubMed ID: 34385236

SO-VID: 9cd7f392-8e1f-4cb0-9a69-7ab4ddcf4a00

License:

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

History

Date received : 26 October 2020

Date accepted : 09 July 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100000265, Medical Research Council;

Funded by: FundRef http://dx.doi.org/10.13039/100010269, Wellcome;

Funded by: Joint Global Health Trials scheme (UK Department for International Development, Medical Research Council, Wellcome Trust);

Award ID: MR/N006089/1

Funded by: Swiss National Science Foundation Research for Development;

Award ID: IZ07Z0_160909/1

Funded by: FundRef http://dx.doi.org/10.13039/501100000925, National Health and Medical Research Council;

Award ID: 1084429

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ScienceOpen disciplines: Medicine

Keywords: health economics,public health,protocols & guidelines

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ScienceOpen disciplines: Medicine

Keywords: health economics, public health, protocols & guidelines

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Point-of-care testing and treatment of sexually transmitted and genital infections during pregnancy in Papua New Guinea (WANTAIM trial): protocol for an economic evaluation alongside a cluster-randomised trial

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Related collections

UCL: UN SDG 03 Good Health and Well-Being

Most cited references 84

Global, regional, and national levels and causes of maternal mortality during 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013

Consolidated Health Economic Evaluation Reporting Standards (CHEERS)--explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force.

Sexually transmitted infections: challenges ahead.

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