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
Lisa M Vallely,
William Pomat,
Rebecca Guy,
Handan Wand,
Nicola Low,
Peter M Siba,
Rosanna W Peeling,
John Kaldor,
Christopher Morgan,
Angela Kelly-Hanku,
Suzanne Garland,
Andrew Vallely,
Virginia Wiseman,
Neha Batura,
Olga PM Saweri,
Stanley Luchters,
Steven Badman,
David M Whiley,
Moses Laman,
Stephen Rogerson,
Sepehr N Tabrizi,
Elizabeth Peach,
Caroline Homer,
Glen Mola,
Grace Kariwiga,
Michaela Riddell,
John Bolnga,
Leanne J Robinson,
Jacob Morewaya,
Pamela J Toliman,
Wilfred Peter
Affiliations
Lisa M Vallely
Public Health Interventions Research Group, Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia
William Pomat
3 Director, Papua New Guinea Institute of Medical Research, Goroka, Eastern Highlands Province, Papua New Guinea
Rebecca Guy
1 The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
Handan Wand
Biostatistics and Databases program, Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia
Nicola Low
6 Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
Peter M Siba
2 Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea
Rosanna W Peeling
Department of Clinical Research, London School of Hygiene and Tropical Medicine Faculty of Infectious and Tropical Diseases, London, UK
John Kaldor
1 The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
Christopher Morgan
Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia
Angela Kelly-Hanku
Sexual and Reproductive Health Unit, Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea
Suzanne Garland
Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia
Andrew Vallely
The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
Virginia Wiseman
1 The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
Neha Batura
11 Institute for Global Health, University College London, London, UK
Olga PM Saweri
The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
Stanley Luchters
Macfarlane Burnet Institute for Medical Research and Public Health, Melbourne, Victoria, Australia
Steven Badman
The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
David M Whiley
Centre for Clinical Research, The University of Queensland, Herston, Queensland, Australia
Moses Laman
Papua New Guinea Institute of Medical Research, Goroka/Madang, Papua New Guinea
Stephen Rogerson
2Department of Medicine at the Doherty Institute, The University of Melbourne, Parkville, Victoria, Australia
Sepehr N Tabrizi
4Department of Microbiology and Infectious Diseases, The Royal Women`s Hospital, Melbourne, Victoria, Australia
Elizabeth Peach
4Greater Green Triangle University Department of Rural Health, Flinders and Deakin Universities, Warrnambool, Victoria, Australia
Caroline Homer
Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Victoria, Australia
Glen Mola
School of Medicine and Health Sciences, University of Papua New Guinea, Port Moresby, Papua New Guinea
Grace Kariwiga
Milne Bay Provincial Health Authority, Alotau, Papua New Guinea
Michaela Riddell
The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
John Bolnga
The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
Leanne J Robinson
The Burnet Institute, Melbourne, Victoria, Australia
Jacob Morewaya
Milne Bay Provincial Health Authority, Alotau, Papua New Guinea
Pamela J Toliman
The Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea
Wilfred Peter
Madang Provincial Health Authority, Madang, Papua New Guinea
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.
