{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T19:57:31Z","timestamp":1792612651290,"version":"4.5.0"},"reference-count":44,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2023,4,20]],"date-time":"2023-04-20T00:00:00Z","timestamp":1681948800000},"content-version":"unspecified","delay-in-days":19,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["225468\/Z\/22\/Z"],"award-info":[{"award-number":["225468\/Z\/22\/Z"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,3,27]]},"published-print":{"date-parts":[[2023,4]]},"abstract":"\n Introduction<\/jats:title>\n Sexually transmitted infections (STIs) can cause serious morbidity, including pelvic inflammatory disease, and adverse pregnancy outcomes. In low\/middle-income countries, limited laboratory infrastructure has resulted in a syndrome-based approach being used for management of STIs, which has poor sensitivity and specificity, leading to considerable underdiagnosis and overtreatment. The WHO has called for development and evaluation of strategies to inform replacement of syndromic management by diagnostic testing.<\/jats:p>\n The aim of this project is to evaluate a strategy of point-of-care testing for six STIs in antenatal care (ANC) in Zimbabwe.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n \n A prospective interventional study will be conducted in ANC clinics in Harare province, Zimbabwe. One thousand pregnant women will be recruited when registering for routine ANC. Alongside routine HIV and syphilis testing, participants will be offered an integrated screening package including testing for\n Chlamydia trachomatis<\/jats:italic>\n (CT),\n Neisseria gonorrhoeae<\/jats:italic>\n (NG),\n Trichomonas vaginalis<\/jats:italic>\n (TV) and hepatitis B. All individuals with STIs will receive treatment, partner notification services, risk reduction counselling and referral if needed according to national guidelines. Gonorrhoea samples will be cultured and tested for antimicrobial resistance as per WHO enhanced gonococcal antimicrobial surveillance programme guidelines.\n <\/jats:p>\n The primary outcome measure is the composite prevalence of CT, NG, TV, syphilis and hepatitis B. A mixed-methods process evaluation and economic evaluation will be conducted to understand the acceptability, feasibility and cost-effectiveness of integrated STI testing, compared with standard of care (syndromic management).<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n The study protocol was approved by the Medical Research Council of Zimbabwe, the Biomedical Research and Training Institute Institutional Review Board, and the London School of Hygiene & Tropical Medicine Research Ethics Committee. Results will be submitted to open-access peer-reviewed journals, presented at academic meetings and shared with participating communities and with national and international policymaking bodies.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n NCT05541081<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-070889","type":"journal-article","created":{"date-parts":[[2023,4,20]],"date-time":"2023-04-20T11:38:28Z","timestamp":1681990708000},"page":"e070889","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":11,"title":["Investigating point-of-care diagnostics for sexually transmitted infections and antimicrobial resistance in antenatal care in Zimbabwe (IPSAZ): protocol for a mixed-methods study"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct05541081","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6561-1353","authenticated-orcid":false,"given":"Kevin","family":"Martin","sequence":"first","affiliation":[{"name":"Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK"},{"name":"The Health Research Unit Zimbabwe, Biomedical Research and Training Institute, Harare, Zimbabwe"},{"name":"Department of Global Health and Infection, Brighton and Sussex Medical School, Brighton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1617-3603","authenticated-orcid":false,"given":"Chido","family":"Dziva Chikwari","sequence":"additional","affiliation":[{"name":"The Health Research Unit Zimbabwe, Biomedical Research and Training Institute, Harare, Zimbabwe"},{"name":"Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ethel","family":"Dauya","sequence":"additional","affiliation":[{"name":"The Health Research Unit Zimbabwe, Biomedical Research and Training Institute, Harare, Zimbabwe"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9725-7931","authenticated-orcid":false,"given":"Constance R S","family":"Mackworth-Young","sequence":"additional","affiliation":[{"name":"The Health Research Unit Zimbabwe, Biomedical Research and Training Institute, Harare, Zimbabwe"},{"name":"Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Bath","sequence":"additional","affiliation":[{"name":"Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Tucker","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4897-458X","authenticated-orcid":false,"given":"Victoria","family":"Simms","sequence":"additional","affiliation":[{"name":"The Health Research Unit Zimbabwe, Biomedical Research and Training Institute, Harare, Zimbabwe"},{"name":"Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsitsi","family":"Bandason","sequence":"additional","affiliation":[{"name":"The Health Research Unit Zimbabwe, Biomedical Research and Training Institute, Harare, Zimbabwe"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francis","family":"Ndowa","sequence":"additional","affiliation":[{"name":"Skin & Genito-Urinary Medicine Clinic, Harare, Zimbabwe"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leolin","family":"Katsidzira","sequence":"additional","affiliation":[{"name":"Internal Medicine Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Owen","family":"Mugurungi","sequence":"additional","affiliation":[{"name":"AIDS and TB Unit, Ministry of Health and Child Care, Harare, Zimbabwe"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Machiha","sequence":"additional","affiliation":[{"name":"AIDS and TB Unit, Ministry of Health and Child Care, Harare, Zimbabwe"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7585-4743","authenticated-orcid":false,"given":"Michael","family":"Marks","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK"},{"name":"Hospital for Tropical Diseases, University College London Hospital, London, UK"},{"name":"Division of Infection and Immunity, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katharina","family":"Kranzer","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK"},{"name":"The Health Research Unit Zimbabwe, Biomedical Research and Training Institute, Harare, Zimbabwe"},{"name":"Division of Infectious and Tropical Medicine, Medical Centre of the University of Munich, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rashida","family":"Ferrand","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK"},{"name":"The Health Research Unit Zimbabwe, Biomedical Research and Training Institute, Harare, Zimbabwe"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,4,20]]},"reference":[{"key":"2025121220275349000_13.4.e070889.1","unstructured":"World Health Organization . Global health sector strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections for the period 2022-2030; 2022."},{"key":"2025121220275349000_13.4.e070889.2","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.18.228486"},{"key":"2025121220275349000_13.4.e070889.3","doi-asserted-by":"publisher","DOI":"10.1136\/sti.75.1.3"},{"key":"2025121220275349000_13.4.e070889.4","unstructured":"World Health Organization . Guidelines for the management of symptomatic sexually transmitted infections; 2021."},{"key":"2025121220275349000_13.4.e070889.5","doi-asserted-by":"publisher","DOI":"10.1016\/S0091-7435(02)00058-0"},{"issue":"Suppl 5","key":"2025121220275349000_13.4.e070889.6","doi-asserted-by":"crossref","first-page":"v1","DOI":"10.1136\/sti.2006.024265","article-title":"Rapid tests for sexually transmitted infections (stis): the way forward","volume":"82 Suppl 5","author":"Peeling","year":"2006","journal-title":"Sex Transm Infect"},{"key":"2025121220275349000_13.4.e070889.7","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2016-053073"},{"key":"2025121220275349000_13.4.e070889.8","unstructured":"World Health Organization . Global health sector strategy on sexually transmitted infections 2016-2021; 2016."},{"key":"2025121220275349000_13.4.e070889.9","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0000000000000460"},{"key":"2025121220275349000_13.4.e070889.10","doi-asserted-by":"publisher","DOI":"10.1136\/sti.2002.004077"},{"key":"2025121220275349000_13.4.e070889.11","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.20.272559"},{"key":"2025121220275349000_13.4.e070889.12","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0000000000000219"},{"key":"2025121220275349000_13.4.e070889.13","doi-asserted-by":"crossref","first-page":"1282","DOI":"10.1177\/0956462420949789","article-title":"Partner notification and treatment for sexually transmitted infections among pregnant women in Cape town, South Africa","volume":"31","author":"Green","year":"2020","journal-title":"Int J STD AIDS"},{"key":"2025121220275349000_13.4.e070889.14","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2020-054631"},{"key":"2025121220275349000_13.4.e070889.15","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0218349","article-title":"Prevalence and correlates of sexually transmitted infections in pregnancy in HIV-infected and- uninfected women in Cape town, South Africa","volume":"14","author":"Joseph Davey","year":"2019","journal-title":"PLoS One"},{"key":"2025121220275349000_13.4.e070889.16","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.16-0370"},{"key":"2025121220275349000_13.4.e070889.17","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2334-10-127","article-title":"The burden and risk factors of sexually transmitted infections and reproductive tract infections among pregnant women in Zimbabwe","volume":"10","author":"Kurewa","year":"2010","journal-title":"BMC Infect Dis"},{"key":"2025121220275349000_13.4.e070889.18","doi-asserted-by":"crossref","first-page":"122","DOI":"10.1016\/S2352-4642(20)30335-7","article-title":"Uptake of and factors associated with testing for sexually transmitted infections in community-based settings among youth in zimbabwe: a mixed-methods study","volume":"5","author":"Martin","year":"2021","journal-title":"Lancet Child Adolesc Health"},{"key":"2025121220275349000_13.4.e070889.19","doi-asserted-by":"crossref","DOI":"10.1186\/s12879-021-06937-4","article-title":"Identifying youth at high risk for sexually transmitted infections in community-based settings using a risk prediction tool: a validation study","volume":"21","author":"Kranzer","year":"2021","journal-title":"BMC Infect Dis"},{"key":"2025121220275349000_13.4.e070889.20","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0181267","article-title":"Point-Of-Care screening for hepatitis B virus infection in pregnant women at an antenatal clinic: a South African experience","volume":"12","author":"Chotun","year":"2017","journal-title":"PLoS One"},{"key":"2025121220275349000_13.4.e070889.21","doi-asserted-by":"crossref","first-page":"5579","DOI":"10.1016\/j.vaccine.2013.08.028","article-title":"The epidemiology of hepatitis B virus infection in HIV-infected and HIV-uninfected pregnant women in the western cape, south africa","volume":"31","author":"Andersson","year":"2013","journal-title":"Vaccine"},{"key":"2025121220275349000_13.4.e070889.22","doi-asserted-by":"crossref","first-page":"307","DOI":"10.7196\/SAMJ.7299","article-title":"Hepatitis B and HIV co-infection in pregnant women: indication for routine antenatal hepatitis B virus screening in a high HIV prevalence setting","volume":"104","author":"Thumbiran","year":"2014","journal-title":"S Afr Med J"},{"key":"2025121220275349000_13.4.e070889.23","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1002344","article-title":"Antimicrobial resistance in Neisseria gonorrhoeae: global surveillance and a call for international collaborative action","volume":"14","author":"Wi","year":"2017","journal-title":"PLoS Med"},{"key":"2025121220275349000_13.4.e070889.24","doi-asserted-by":"publisher","DOI":"10.3201\/eid2313.170443"},{"key":"2025121220275349000_13.4.e070889.25","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2016-053090"},{"key":"2025121220275349000_13.4.e070889.26","doi-asserted-by":"crossref","first-page":"412","DOI":"10.1071\/SH19023","article-title":"World Health organization global gonococcal antimicrobial surveillance program (who GASP): review of new data and evidence to inform international collaborative actions and research efforts","volume":"16","author":"Unemo","year":"2019","journal-title":"Sex Health"},{"key":"2025121220275349000_13.4.e070889.27","doi-asserted-by":"crossref","first-page":"713","DOI":"10.1097\/OLQ.0000000000000204","article-title":"Etiology and antimicrobial susceptibility of pathogens responsible for urethral discharge among men in Harare, Zimbabwe","volume":"41","author":"Takuva","year":"2014","journal-title":"Sex Transm Dis"},{"key":"2025121220275349000_13.4.e070889.28","unstructured":"WHO Global Health Observatory . WHO gonococcal AMR surveillance programme. n.d. Available: https:\/\/www.who.int\/data\/gho\/data\/themes\/topics\/who-gonococcal-amr-surveillance-programme-who-gasp"},{"key":"2025121220275349000_13.4.e070889.29","doi-asserted-by":"crossref","DOI":"10.1186\/s12913-022-07557-7","article-title":"\u201cIt was difficult to offer same day results\u201d: evaluation of community-based point-of-care testing for sexually transmitted infections among youth using the genexpert platform in zimbabwe","volume":"22","author":"Martin","year":"2022","journal-title":"BMC Health Serv Res"},{"key":"2025121220275349000_13.4.e070889.30","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2016-053063"},{"key":"2025121220275349000_13.4.e070889.31","unstructured":"World Health Organization . Public reports of WHO prequalified ivds. n.d. Available: https:\/\/www.who.int\/diagnostics_laboratory\/evaluations\/pq-list\/hbsag\/public_report\/en\/"},{"key":"2025121220275349000_13.4.e070889.32","unstructured":"Zimbabwe Ministry of Health and Child Care . National STI management guidelines; 2019."},{"key":"2025121220275349000_13.4.e070889.33","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.h1258","article-title":"Process evaluation of complex interventions: medical research council guidance","volume":"350","author":"Moore","year":"2015","journal-title":"BMJ"},{"key":"2025121220275349000_13.4.e070889.34","unstructured":"Linnan L , Steckler A . Process evaluation for public health interventions and research. San Francisco: Jossey-Bass, 2002."},{"key":"2025121220275349000_13.4.e070889.35","unstructured":"Creswell JW . Research design: qualitative, quantitative, and mixed methods. Approaches: Sage, 2011."},{"key":"2025121220275349000_13.4.e070889.36","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30925-9"},{"key":"2025121220275349000_13.4.e070889.37","doi-asserted-by":"crossref","first-page":"56","DOI":"10.1097\/OLQ.0000000000000696","article-title":"The etiology of male urethral discharge in Zimbabwe: results from the Zimbabwe STI etiology study","volume":"45","author":"Rietmeijer","year":"2018","journal-title":"Sex Transm Dis"},{"key":"2025121220275349000_13.4.e070889.38","unstructured":"World Health Organization . Enhanced gonococcal antimicrobial surveillance programme (EGASP): general protocol. 2021."},{"key":"2025121220275349000_13.4.e070889.39","unstructured":"The european committee on antimicrobial susceptibility testing. breakpoint tables for interpretation of mics and zone diameters. version 8.0. 2022. Available: https:\/\/www.eucast.org\/fileadmin\/src\/media\/PDFs\/EUCAST_files\/Breakpoint_tables\/v_12.0_Breakpoint_Tables.pdf"},{"key":"2025121220275349000_13.4.e070889.40","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0196209","article-title":"Beyond syndromic management: opportunities for diagnosis-based treatment of sexually transmitted infections in low- and middle-income countries","volume":"13","author":"Garrett","year":"2018","journal-title":"PLoS ONE"},{"key":"2025121220275349000_13.4.e070889.41","doi-asserted-by":"crossref","first-page":"658","DOI":"10.1016\/S1473-3099(18)30724-2","article-title":"Targeted point-of-care testing compared with syndromic management of urogenital infections in women (WISH): a cross-sectional screening and diagnostic accuracy study","volume":"19","author":"Verwijs","year":"2019","journal-title":"Lancet Infect Dis"},{"key":"2025121220275349000_13.4.e070889.42","doi-asserted-by":"crossref","first-page":"2085","DOI":"10.1093\/infdis\/jiab277","article-title":"Chlamydia, gonorrhea, and incident HIV infection during pregnancy predict preterm birth despite treatment","volume":"224","author":"Ravindran","year":"2021","journal-title":"J Infect Dis"},{"key":"2025121220275349000_13.4.e070889.43","doi-asserted-by":"publisher","DOI":"10.1007\/s10995-013-1423-6"},{"key":"2025121220275349000_13.4.e070889.44","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2013-051118"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2022-070889","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T04:28:05Z","timestamp":1765600085000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2022-070889"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,4]]},"references-count":44,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2023,4,20]]},"published-print":{"date-parts":[[2023,4]]}},"alternative-id":["10.1136\/bmjopen-2022-070889"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2022-070889","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,4]]}}}