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
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 bac...
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BMJ Publishing Group
2021-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/8/e046308.full |
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| author | Lisa M Vallely Peter M Siba Rosanna W Peeling John Kaldor Suzanne Garland Olga PM Saweri David M Whiley Stephen Rogerson Sepehr N Tabrizi Caroline Homer Leanne J Robinson Pamela J Toliman |
| author_facet | Lisa M Vallely Peter M Siba Rosanna W Peeling John Kaldor Suzanne Garland Olga PM Saweri David M Whiley Stephen Rogerson Sepehr N Tabrizi Caroline Homer Leanne J Robinson Pamela J Toliman |
| author_sort | Lisa M Vallely |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-66bb0bccbc36419f99034697c587bdec |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-66bb0bccbc36419f99034697c587bdec2025-08-20T01:55:57ZengBMJ Publishing GroupBMJ Open2044-60552021-08-0111810.1136/bmjopen-2020-046308Point-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 trialLisa M Vallely0Peter M Siba1Rosanna W Peeling2John Kaldor3Suzanne Garland4Olga PM Saweri5David M Whiley6Stephen Rogerson7Sepehr N Tabrizi8Caroline Homer9Leanne J Robinson10Pamela J Toliman111 Public Health Interventions Research Group, Kirby Institute, UNSW Sydney, Sydney, New South Wales, AustraliaThe Papua New Guinea Institute of Medical Research, Goroka, Papua New GuineaDepartment of Clinical Research, London School of Hygiene and Tropical Medicine, London, UKThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia5 The Royal Women`s Hospital, Parkville, Victoria, AustraliaThe Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea10 UQ Centre for Clinical Research, The University of Queensland and Pathology Queensland, Brisbane, Queensland, AustraliaDepartment of Infectious Diseases, The University of Melbourne, Melbourne, Victoria, AustraliaThe Royal Women’s Hospital, Parkville, Victoria, Australia23 Burnet Institute, Melbourne, Victoria, AustraliaThe Burnet Institute, Melbourne, Victoria, AustraliaThe Papua New Guinea Institute of Medical Research, Goroka, Papua New GuineaIntroduction 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.https://bmjopen.bmj.com/content/11/8/e046308.full |
| spellingShingle | Lisa M Vallely Peter M Siba Rosanna W Peeling John Kaldor Suzanne Garland Olga PM Saweri David M Whiley Stephen Rogerson Sepehr N Tabrizi Caroline Homer Leanne J Robinson Pamela J Toliman 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/11/8/e046308.full |
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