Point-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea)

Abstract

Background: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field trials to fill this knowledge gap. The primary aim of this study is to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) leads to reduction in preterm birth and low birth weight. Methods: The Women and Newborn Trial of Antenatal Interventions and Management (WANTAIM) is a cluster-randomised crossover trial in Papua New Guinea to compare point-of-care STI testing and immediate treatment with standard antenatal care (which includes the WHO-endorsed STI ‘syndromic’ management strategy based on clinical features alone without laboratory confirmation). The unit of randomisation is a primary health care facility and its catchment communities. The primary outcome is a composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery <37 completed weeks of gestation as determined by ultrasound) and/or low birth weight (<2500 g measured within 72 hours of birth). The trial will also evaluate neonatal outcomes, as well as the cost-effectiveness, acceptability and health system requirements of this strategy, compared with standard care. Conclusions: WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings. If the intervention is proven to have an impact, the trial will hasten access to these technologies and could improve maternal and neonatal health in high-burden settings worldwide. Registration: ISRCTN37134032.

Sexually Transmitted Infections in Pregnancy: A Narrative Review of the Global Research Gaps, Challenges, and Opportunities

“…In addition, the physiologic mechanisms by which chlamydial, gonococcal, and trichomonal infection impact birth outcomes are complex and unclear. 21 , 29 …”

“…Table 1 shows the status of ongoing studies on the effectiveness of etiologic screening and treatment in pregnancy. Randomized controlled trials are underway in China 30 and Papua New Guinea, 29 and in the planning stages in Botswana and South Africa. A prospective cohort study was recently completed in Brazil.…”

“…38s,39s However, many studies have reported very high rates of acceptance of partner notification, 38s–41s suggesting that concerns about intimate partner violence and stigma around STIs were not a significant barrier for most women. The trial underway in Papua New Guinea 29 is examining intimate partner violence as an adverse event.…”

“…Studies in Papua New Guinea 29 and South Africa will examine operational feasibility of etiologic screening in select clinics (Table 1 ). In Ethiopia, investigators are examining feasibility at the regional health system level.…”

Mulheres Com Diagnóstico De Hiv: Perfil Das Usuárias De Um Serviço Especializado

“…Embora não seja uma doença relatável na maioria das vezes, por ser mais observadas nos exames Papanicolau, ou as vezes as mulheres só compram o antibiótico sem confirmar a patologia através de exames, os dados disponíveis em um estudo realizado em um hospital na Nova Guiné mostram que a prevalência da vaginose bacteriana entre mulheres não grávidas varia de 15% a 30% e 50% para mulheres grávidas, visto que na gravidez há desequilíbrios constantes da microbiota. No entanto, a maioria dos casos de vaginose são assintomáticas e permanece não reportada e não tratada(VALLELY et al, 2019). vírus do HPV tem sido motivo de muitos estudos e debates, tendo como agente etiológico o Papiloma Vírus Humano que é caracterizado como uma IST, infectando homens e mulheres, valendo ressaltar que uma grande parcela de sorotipos de HPV possuem preferência pelo trato genital feminino, em que os autores relatam que o vírus do HPV possui tropismo por células do trato genital feminino(LIMBERGER et al,2012).…”