Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial

dc.contributor.authorMedina-Marino, Andrew
dc.contributor.authorCleary, Susan
dc.contributor.authorMuzny, Christina A
dc.contributor.authorTaylor, Christopher
dc.contributor.authorTamhane, Ashutosh
dc.contributor.authorNgwepe, Phuti
dc.contributor.authorBezuidenhout, Charl
dc.contributor.authorFacente, Shelley N
dc.contributor.authorMlisana, Koleka
dc.contributor.authorPeters, Remco P H
dc.contributor.authorKlausner, Jeffrey D
dc.date.accessioned2022-08-31T20:35:38Z
dc.date.available2022-08-31T20:35:38Z
dc.date.issued2022-05-24
dc.date.updated2022-05-30T09:16:19Z
dc.description.abstractBackground Sexually transmitted infections (STIs) during pregnancy are associated with adverse birth outcomes, including preterm birth, low birth weight, perinatal death, and congenital infections such as increased mother-to-child HIV transmission. Prevalence of STIs among pregnant women in South Africa remains high, with most women being asymptomatic for their infection(s). Unfortunately, most STIs remain undetected and untreated due to standard practice syndromic management in accordance with World Health Organization (WHO) guidelines. Although lab-based and point-of-care molecular tests are available, optimal screening strategies during pregnancy, their health impact, and cost-effectiveness are unknown. Methods We will implement a 3-arm (1:1:1) type-1 hybrid effectiveness-implementation randomized-controlled trial (RCT). We will enroll 2500 pregnant women attending their first antenatal care (ANC) visit for their current pregnancy at participating health facilities in Buffalo City Metro District, Eastern Cape Province, South Africa. Participants allocated to arms 1 and 2 (intervention) will receive GeneXpert® point-of-care diagnostic testing for Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis, with same-day treatment for detected infection(s). Arm 1 will additionally receive a test-of-cure 3 weeks post-treatment, while Arm 2 will receive a repeat test at 30–34 weeks’ gestation. Those allocated to Arm 3 will receive syndromic management (standard-of-care). The RE-AIM framework will be used to guide collection of implementation indicators to inform potential future scale up. Primary outcome measures include (1) frequency of adverse birth outcomes among study arms, defined by a composite measure of low birth weight and pre-term delivery, and (2) change in STI prevalence between baseline and birth outcome among intervention arms and compared to standard-of-care. Estimates and comparative costs of the different screening strategies relative to standard-of-care and the costs of managing adverse birth outcomes will be calculated. Cost-effectiveness will be assessed per STI and disability-adjusted life year averted. Discussion This trial is the first RCT designed to identify optimal, cost-effective screening strategies that decrease the burden of STIs during pregnancy and reduce adverse birth outcomes. Demonstrating the impact of diagnostic screening and treatment, compared to syndromic management, on birth outcomes will provide critical evidence to inform changes to WHO guidelines for syndromic management of STIs during pregnancy. Trial registration ClinicalTrials.gov NCT04446611 . Registered on 25 June 2020.en_US
dc.identifier.apacitationMedina-Marino, A., Cleary, S., Muzny, C. A., Taylor, C., Tamhane, A., Ngwepe, P., ... Klausner, J. D. (2022). Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial. <i>Trials</i>, 23(1), 441. http://hdl.handle.net/11427/36790en_ZA
dc.identifier.chicagocitationMedina-Marino, Andrew, Susan Cleary, Christina A Muzny, Christopher Taylor, Ashutosh Tamhane, Phuti Ngwepe, Charl Bezuidenhout, et al "Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial." <i>Trials</i> 23, 1. (2022): 441. http://hdl.handle.net/11427/36790en_ZA
dc.identifier.citationMedina-Marino, A., Cleary, S., Muzny, C.A., Taylor, C., Tamhane, A., Ngwepe, P., Bezuidenhout, C. & Facente, S.N. et al. 2022. Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial. <i>Trials.</i> 23(1):441. http://hdl.handle.net/11427/36790en_ZA
dc.identifier.ris TY - Journal Article AU - Medina-Marino, Andrew AU - Cleary, Susan AU - Muzny, Christina A AU - Taylor, Christopher AU - Tamhane, Ashutosh AU - Ngwepe, Phuti AU - Bezuidenhout, Charl AU - Facente, Shelley N AU - Mlisana, Koleka AU - Peters, Remco P H AU - Klausner, Jeffrey D AB - Background Sexually transmitted infections (STIs) during pregnancy are associated with adverse birth outcomes, including preterm birth, low birth weight, perinatal death, and congenital infections such as increased mother-to-child HIV transmission. Prevalence of STIs among pregnant women in South Africa remains high, with most women being asymptomatic for their infection(s). Unfortunately, most STIs remain undetected and untreated due to standard practice syndromic management in accordance with World Health Organization (WHO) guidelines. Although lab-based and point-of-care molecular tests are available, optimal screening strategies during pregnancy, their health impact, and cost-effectiveness are unknown. Methods We will implement a 3-arm (1:1:1) type-1 hybrid effectiveness-implementation randomized-controlled trial (RCT). We will enroll 2500 pregnant women attending their first antenatal care (ANC) visit for their current pregnancy at participating health facilities in Buffalo City Metro District, Eastern Cape Province, South Africa. Participants allocated to arms 1 and 2 (intervention) will receive GeneXpert® point-of-care diagnostic testing for Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis, with same-day treatment for detected infection(s). Arm 1 will additionally receive a test-of-cure 3 weeks post-treatment, while Arm 2 will receive a repeat test at 30–34 weeks’ gestation. Those allocated to Arm 3 will receive syndromic management (standard-of-care). The RE-AIM framework will be used to guide collection of implementation indicators to inform potential future scale up. Primary outcome measures include (1) frequency of adverse birth outcomes among study arms, defined by a composite measure of low birth weight and pre-term delivery, and (2) change in STI prevalence between baseline and birth outcome among intervention arms and compared to standard-of-care. Estimates and comparative costs of the different screening strategies relative to standard-of-care and the costs of managing adverse birth outcomes will be calculated. Cost-effectiveness will be assessed per STI and disability-adjusted life year averted. Discussion This trial is the first RCT designed to identify optimal, cost-effective screening strategies that decrease the burden of STIs during pregnancy and reduce adverse birth outcomes. Demonstrating the impact of diagnostic screening and treatment, compared to syndromic management, on birth outcomes will provide critical evidence to inform changes to WHO guidelines for syndromic management of STIs during pregnancy. Trial registration ClinicalTrials.gov NCT04446611 . Registered on 25 June 2020. DA - 2022-05-24 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - Trials KW - Sexually transmitted infections KW - STIs; Pregnancy KW - Preterm birth KW - Low birth weight KW - Antenatal care KW - STI screening KW - Syndromic management KW - Cost-effectiveness LK - https://open.uct.ac.za PY - 2022 T1 - Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial TI - Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial UR - http://hdl.handle.net/11427/36790 ER - en_ZA
dc.identifier.urihttps://doi.org/10.1186/s13063-022-06400-y
dc.identifier.urihttp://hdl.handle.net/11427/36790
dc.identifier.vancouvercitationMedina-Marino A, Cleary S, Muzny CA, Taylor C, Tamhane A, Ngwepe P, et al. Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial. Trials. 2022;23(1):441. http://hdl.handle.net/11427/36790.en_ZA
dc.language.isoenen_US
dc.language.rfc3066en
dc.publisher.departmentDesmond Tutu HIV Centreen_US
dc.publisher.facultyFaculty of Health Sciencesen_US
dc.rights.holderThe Author(s)
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.sourceTrialsen_US
dc.source.journalissue1en_US
dc.source.journalvolume23en_US
dc.source.pagination441en_US
dc.source.urihttps://trialsjournal.biomedcentral.com/
dc.subjectSexually transmitted infectionsen_US
dc.subjectSTIs; Pregnancyen_US
dc.subjectPreterm birthen_US
dc.subjectLow birth weighten_US
dc.subjectAntenatal careen_US
dc.subjectSTI screeningen_US
dc.subjectSyndromic managementen_US
dc.subjectCost-effectivenessen_US
dc.titleSexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trialen_US
dc.typeJournal Articleen_US
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