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) [version 2; peer review: 1 approved, 1 approved with reservations]

  • Wellcome Open Research, Volume 4, Year 2019

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Study Justification:
– Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and bacterial vaginosis are highly prevalent among pregnant women in low- and middle-income settings.
– These infections have been associated with preterm birth and low birth weight.
– There is conflicting evidence on the benefits of screening and treating these infections during pregnancy.
– New diagnostic technologies allow for definitive field trials to fill this knowledge gap.
Study Highlights:
– The study, called the WANTAIM trial, aims to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) can reduce preterm birth and low birth weight.
– The trial will compare point-of-care STI testing and treatment with standard antenatal care, which includes the WHO-endorsed STI ‘syndromic’ management strategy based on clinical features alone.
– The trial will be conducted in Papua New Guinea and will use a cluster-randomized crossover design.
– The primary outcome measure is a composite measure of preterm birth and low birth weight.
– The trial will also evaluate neonatal outcomes, cost-effectiveness, acceptability, and health system requirements of the intervention.
Recommendations for Lay Reader:
– The study aims to determine if testing and treating certain infections during pregnancy can improve birth outcomes.
– The study will compare a new testing and treatment approach with the current standard care.
– The study will be conducted in Papua New Guinea and will evaluate various outcomes and costs.
– If the new approach is proven effective, it could improve maternal and neonatal health in similar settings worldwide.
Recommendations for Policy Maker:
– Consider implementing antenatal point-of-care testing and immediate treatment of curable STIs to reduce preterm birth and low birth weight.
– Evaluate the cost-effectiveness, acceptability, and health system requirements of this strategy compared to standard care.
– If the intervention is proven effective, prioritize access to these technologies to improve maternal and neonatal health in high-burden settings.
Key Role Players:
– Researchers and scientists conducting the study
– Primary health care facilities and their catchment communities
– Pregnant women participating in the study
– Health care providers and staff involved in antenatal care
Cost Items for Planning Recommendations:
– Diagnostic technologies and testing kits
– Training and capacity building for health care providers
– Implementation and operational costs of the new strategy
– Monitoring and evaluation of the intervention
– Data collection and analysis
– Communication and dissemination of study findings

The strength of evidence for this abstract is 7 out of 10.
The evidence in the abstract is moderately strong. The study protocol describes a cluster-randomized crossover trial in Papua New Guinea to evaluate the effectiveness of point-of-care testing and immediate treatment of sexually transmitted infections (STIs) in reducing preterm birth and low birth weight. The study aims to fill a knowledge gap and includes a primary outcome measure, as well as evaluation of neonatal outcomes, cost-effectiveness, acceptability, and health system requirements. However, the abstract does not provide specific details on the sample size, statistical analysis plan, or potential limitations of the study. To improve the evidence, the abstract could include more information on these aspects, as well as any potential biases or confounding factors that may impact the results.

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 New born 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 new borns 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.

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The innovation described in the study is the use of point-of-care testing and immediate treatment of sexually transmitted infections (STIs) in pregnant women. This approach aims to improve birth outcomes, specifically reducing the risk of preterm birth and low birth weight. The study, called the WANTAIM trial, is a cluster-randomized crossover trial conducted in Papua New Guinea. It compares the effectiveness, cost-effectiveness, acceptability, and health system requirements of point-of-care STI testing and treatment with standard antenatal care. The primary outcome measure is a composite measure of preterm birth and low birth weight. The trial also evaluates neonatal outcomes and the potential impact of this strategy on improving maternal and neonatal health in high-burden settings worldwide.
AI Innovations Description
The recommendation to improve access to maternal health is to implement point-of-care testing and treatment of sexually transmitted infections (STIs) in high-burden, low-income settings. This recommendation is based on the findings that STIs such as Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and bacterial vaginosis are associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income countries.

The proposed study, called the WANTAIM trial, aims to evaluate whether antenatal point-of-care testing and immediate treatment of these curable STIs can lead to a reduction in preterm birth and low birth weight. The trial will be conducted in Papua New Guinea and will compare point-of-care STI testing and treatment with standard antenatal care, which currently relies on clinical features alone without laboratory confirmation.

The primary outcome of the trial is a composite measure of two events: the proportion of women and their newborns in each trial arm who experience either preterm birth (delivery before 37 completed weeks of gestation) or low birth weight (less than 2500 grams measured within 72 hours of birth). The trial will also evaluate neonatal outcomes, cost-effectiveness, acceptability, and health system requirements of this strategy compared to standard care.

If the intervention is proven to be effective, the WANTAIM trial could have a significant impact on improving birth outcomes and maternal and neonatal health in high-burden settings worldwide. It may also lead to increased access to point-of-care testing and treatment technologies for STIs in these settings.
AI Innovations Methodology
Based on the description provided, the innovation being considered is the implementation of point-of-care testing and treatment of sexually transmitted infections (STIs) during pregnancy to improve birth outcomes in high-burden, low-income settings. The study protocol, known as the WANTAIM trial, aims to evaluate whether antenatal point-of-care testing and immediate treatment of curable STIs can reduce the incidence of preterm birth and low birth weight.

To simulate the impact of these recommendations on improving access to maternal health, a methodology could be developed as follows:

1. Study Design: The methodology would involve a cluster-randomized crossover trial design. Primary health care facilities and their catchment communities would be randomly assigned to either the intervention group (point-of-care testing and immediate treatment) or the control group (standard antenatal care without laboratory confirmation).

2. Sample Selection: Participants would be pregnant women attending the selected primary health care facilities for antenatal care. The sample size would be determined based on statistical power calculations to ensure sufficient statistical significance.

3. Data Collection: Data on maternal and neonatal outcomes would be collected for both the intervention and control groups. This would include information on preterm birth (delivery before 37 completed weeks of gestation) and low birth weight (less than 2500g within 72 hours of birth). Other neonatal outcomes, such as neonatal mortality and morbidity, could also be assessed.

4. Point-of-Care Testing and Treatment: The intervention group would receive point-of-care testing for STIs during antenatal visits. If any infections are detected, immediate treatment would be provided. The control group would receive standard antenatal care, which may include syndromic management based on clinical features alone.

5. Data Analysis: The collected data would be analyzed using appropriate statistical methods. A comparison would be made between the intervention and control groups to assess the impact of point-of-care testing and treatment on the primary outcome (composite measure of preterm birth and low birth weight). Secondary outcomes, cost-effectiveness, acceptability, and health system requirements would also be evaluated.

6. Ethical Considerations: Ethical approval would be obtained to ensure the study is conducted in accordance with ethical guidelines. Informed consent would be obtained from all participants, and measures would be taken to protect their privacy and confidentiality.

By following this methodology, the impact of implementing point-of-care testing and treatment for STIs during pregnancy can be simulated and evaluated in terms of its effectiveness, cost-effectiveness, acceptability, and health system requirements. The findings of the study could inform future interventions and improve access to maternal health in high-burden settings worldwide.

Statistics:
Citations: 13
Authors: 31
Identifiers:
DOI: 10.12688/wellcomeopenres.15173.1
Research Areas:
Community Interventions, Health System and Policy, Maternal Access, Maternal and Child Health, Sexual and Reproductive Health, Social Determinants
Study Countries:
Guinea
Study Design:
randomised-control-trial
Participants Gender:
Female
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