Point-of-care testing and treatment of sexually transmitted and genital infections to improve birth outcomes in high-burden, low-resource settings (WANTAIM): a pragmatic cluster randomised crossover trial in Papua New Guinea.

BACKGROUND: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and bacterial vaginosis have been associated with adverse maternal and perinatal outcomes, but there is conflicting evidence on the benefits of antenatal screening and treatment for these conditions. We aimed to determine the effect of antenatal point-of-care testing and immediate treatment of C trachomatis, N gonorrhoeae, T vaginalis, and bacterial vaginosis on preterm birth, low birthweight, and other adverse maternal and perinatal outcomes compared with current standard of care, which included symptom-based treatment without laboratory confirmation. METHODS: In this pragmatic cluster randomised crossover trial, we enrolled women (aged ≥16 years) attending an antenatal clinic at 26 weeks' gestation or earlier (confirmed by obstetric ultrasound), living within approximately 1 h drive of a study clinic, and able to provide reliable contact details at ten primary health facilities and their catchment communities (clusters) in Papua New Guinea. Clusters were randomly allocated 1:1 to receive either the intervention or control (standard care) in the first phase of the trial. Following an interval (washout period) of 2-3 months at the end of the first phase, each cluster crossed over to the other group. Randomisation was stratified by province. Individual participants were informed about trial group allocation only after completing informed consent procedures. The primary outcome was a composite of preterm birth (livebirth before 37 weeks' gestation), low birthweight (<2500 g), or both, analysed according to the intention-to-treat population. This study is registered with ISRCTN Registry, ISRCTN37134032, and is completed. FINDINGS: Between July 26, 2017, and Aug 30, 2021, 4526 women were enrolled (2210 [63·3%] of 3492 women in the intervention group and 2316 [62·8%] of 3687 in the control group). Primary outcome data were available for 4297 (94·9%) newborn babies of 4526 women. The proportion of preterm birth, low birthweight, or both, in the intervention group, expressed as the mean of crude proportions across clusters, was 18·8% (SD 4·7%) compared with 17·8% in the control group (risk ratio [RR] 1·06, 95% CI 0·78-1·42; p=0·67). There were 1052 serious adverse events reported (566 in the intervention group and 486 in the control group) among 929 trial participants, and no differences by trial group. INTERPRETATION: Point-of-care testing and treatment of C trachomatis, N gonorrhoeae, T vaginalis, and bacterial vaginosis did not reduce preterm birth or low birthweight compared with standard care. Within the subgroup of women with N gonorrhoeae, there was a substantial reduction in the primary outcome. FUNDING: UK Department of Health and Social Care; UK Foreign, Commonwealth and Development Office; UK Medical Research Council; the Wellcome Trust; the Australian National Health and Medical Research Council; and Swiss National Science Foundation.

Community perspectives and experiences of quality maternal and newborn care in East New Britain, Papua New Guinea.

BACKGROUND: Quality maternal and newborn care is essential for improving the health of mothers and babies. Low- and middle-income countries, such as Papua New Guinea (PNG), face many barriers to achieving quality care for all. Efforts to improve the quality of maternal and newborn care must involve community in the design, implementation, and evaluation of initiatives to ensure that interventions are appropriate and relevant for the target community. We aimed to describe community members' perspectives and experiences of maternal and newborn care, and their ideas for improvement in one province, East New Britain, in PNG. METHODS: We undertook a qualitative descriptive study in partnership with and alongside five local health facilities, health care workers and community members, using a Partnership Defined Quality Approach. We conducted ten focus group discussions with 68 community members (identified through church, market and other community-based groups) in East New Britain PNG to explore perspectives and experiences of maternal and newborn care, identify enablers and barriers to quality care and interventions to improve care. Discussions were transcribed verbatim. A mixed inductive and deductive analysis was conducted including application of the World Health Organisation (WHO) Quality Maternal and Newborn Care framework. RESULTS: Using the WHO framework, we present the findings in accordance with the five experience of care domains. We found that the community reported multiple challenges in accessing care and facilities were described as under-staffed and under resourced. Community members emphasised the importance of good communication and competent, caring and respectful healthcare workers. Both women and men expressed a strong desire for companionship during labor and birth. Several changes were suggested by the community that could immediately improve the quality of care. CONCLUSIONS: Community perspectives and experiences are critical for informing effective and sustainable interventions to improve the quality of maternal and newborn care and increasing facility-based births in PNG. A greater understanding of the care experience as a key component of quality care is needed and any quality improvement initiatives must include the user experience as a key outcome measure.

Improving the care provided to, and experienced by, women and their families during pregnancy and childbirth is important for improving the health of mothers and babies. Community members should be involved in thinking about appropriate ways to improve care. Papua New Guinea (PNG) is a country in the Pacific which faces multiple challenges to improving care during pregnancy and birth. We aimed to understand what community members think about care provided and experienced during labour and birth in East New Britain, a rural province of PNG. We worked with five health facilities, health workers and community members in East New Britain to develop a qualitative research project. We carried out 10 focus group discussions with community members in East New Britain to understand what the provision and experience of care was like during labour and birth, and ways that it could be improved. We found that community members identified multiple challenges in getting to facilities and many facilities were found to have not enough supplies, equipment, or staff. Community members wanted staff that were good at their work but also caring and respectful. Women wanted to have support people present during labour and birth and many men wanted to be present too. Our results show that it is important to understand what the community thinks about the quality of care during labour and birth and this information is helpful to design effective activities to improve the care provided and experienced.

Improving maternal and newborn health and reducing stillbirths in the Western Pacific Region - current situation and the way forward.

Despite positive trends in many indicators, there remains an unacceptable burden of preventable maternal, newborn deaths and stillbirths every year. This paper provides an overview of the maternal and perinatal outcomes across 22 Pacific Island Countries and Territories, including Papua New Guinea. We highlight some unique challenges and provide examples of initiatives in three of the larger countries to contribute to safer childbirth. There are high maternal and perinatal morbidity and mortality rates in many of the countries, although reliable data are limited. There are currently no data relating to the burden of intrapartum-related maternal and perinatal morbidity or stillbirth or the quality of intrapartum care. Varying definitions across countries for perinatal indicators mean that meaningful comparisons are difficult and unreliable. There is need for midwives and other maternal and newborn health providers to improve maternal and newborn indicators as countries advance towards the 2030 Sustainable Development Goals.

Point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation for the early detection and treatment of cervical pre-cancer in women in Papua New Guinea: a prospective, single-arm intervention trial (HPV-STAT).

BACKGROUND: WHO recommends human papillomavirus (HPV) testing and same-day treatment for cervical screening in low-income and middle-income countries (LMICs); however, few published data exist on the validity of the strategy. We aimed to evaluate the clinical performance, treatment completion rates, adverse events profile, and acceptability of a fully integrated strategy, comprising point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation, for screening of cervical cancer in women in Papua New Guinea. METHODS: HPV-STAT was a large-scale, prospective, single-arm intervention trial conducted at two clinical sites in Papua New Guinea. Cervical screening clinics with an on-site consultant gynaecologist were selected in consultation with national and provincial health authorities, church health services, and local stakeholders. Eligible participants were women aged 30-59 years attending cervical screening services at the two clinics, who were willing to comply with study procedures and able to provide written informed consent. Women self-collected vaginal specimens for point-of-care GeneXpert testing (Cepheid, Sunnyvale, CA, USA) for oncogenic HPV types. Women testing positive for HPV underwent pelvic examination followed by same-day thermal ablation or referral for gynaecology review. All HPV-positive women and a 15% random sample of HPV-negative women provided a clinician-collected cervical specimen for liquid-based cytology. The primary outcome was clinical performance (ie, sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) of the strategy for the detection of high-grade squamous intraepithelial lesion (HSIL) or worse. This trial is registered with ISRCTN, ISRCTN13476702. FINDINGS: Between June 5, 2018, and Jan 6, 2020, we recruited 4285 women, 3638 (84·9%) of whom tested negative for HPV and 647 (15·1%) tested positive for one or more oncogenic HPV type. Sensitivity of the algorithm to detect HSIL or worse was 85·4% (95% CI 81·0-89·6), with specificity 89·6% (88·6-90·6), PPV 35·2% (31·6-39·0), and NPV 98·9% (98·6-99·2). Among HPV-positive women, 602 (93·0%) received same-day thermal ablation and 42 (6·5%) were referred for gynaecology review, 37 (88·1%) of whom attended. Acceptability was high among both HPV-positive and HPV-negative women. Among the 329 HPV-positive women who attended a 3-month follow-up visit, 51 (15·5%) reported mild adverse symptoms that resolved in all cases by the follow-up visit. There were no serious adverse events. INTERPRETATION: We conducted the first real-world evaluation of a fully integrated point-of-care HPV self-collect, test, and treat strategy for same-day cervical screening in a LMIC and found it to be effective, acceptable, and safe when implemented at scale in primary health-care facilities in Papua New Guinea. Our findings support the introduction and scale-up of HPV screening and treatment for the control and elimination of cervical cancer in LMICs, as recommended by WHO. FUNDING: Australian National Health and Medical Research Council.

Quality newborn care in East New Britain, Papua New Guinea: measuring early newborn care practices and identifying opportunities for improvement.

BACKGROUND: Renewed attention and investment is needed to improve the quality of care during the early newborn period to address preventable newborn deaths and stillbirths in Papua New Guinea (PNG). We aimed to assess early newborn care practices and identify opportunities for improvement in one province (East New Britain) in PNG. METHODS: A mixed-methods study was undertaken in five rural health facilities in the province using a combination of facility audits, labour observations and qualitative interviews with women and maternity providers. Data collection took place between September 2019 and February 2020. Quantitative data were analysed descriptively, whilst qualitative data were analysed using content analysis. Data were triangulated by data source. RESULTS: Five facility audits, 30 labour observations (in four of the facilities), and interviews with 13 women and eight health providers were conducted to examine early newborn care practices. We found a perinatal mortality rate of 32.2 perinatal deaths per 1000 total births and several barriers to quality newborn care, including an insufficient workforce, critical infrastructure and utility constraints, and limited availability of essential newborn medicines and equipment. Most newborns received at least one essential newborn care practice in the first hour of life, such as immediate and thorough drying (97%). CONCLUSIONS: We observed high rates of essential newborn care practices including immediate skin-to-skin and delayed cord clamping. We also identified multiple barriers to improving the quality of newborn care in East New Britain, PNG. These findings can inform the development of effective interventions to improve the quality of newborn care. Further, this study demonstrates that multi-faceted programs that include increased investment in the health workforce, education and training, and availability of essential equipment, medicines, and supplies are required to improve newborn outcomes.

Partnership-defined quality approach to companionship during labour and birth in East New Britain, Papua New Guinea: A mixed-methods study.

Companionship during labour and birth is a critical component of quality maternal and newborn care, resulting in improved care experiences and better birth outcomes. Little is known about the preferences and experiences of companionship in Papua New Guinea (PNG), and how it can be implemented in a culturally appropriate way. The aim of this study was to describe perspectives and experiences of women, their partners and health providers regarding labour and birth companionship, identify enablers and barriers and develop a framework for implementing this intervention in PNG health facilities. A mixed methods study was conducted with five facilities in East New Britain, PNG. Data included 5 facility audits, 30 labour observations and 29 in-depth interviews with women who had recently given birth, partners and maternity care providers. A conceptual framework was developed drawing on existing quality care implementation frameworks. Women and partners wanted companions to be present, whilst health providers had mixed views. Participants described benefits of companionship including encouragement and physical support for women, better communication and advocacy, improved labour outcomes and assistance with workforce issues. Adequate privacy and space constraints were highlighted as key barriers to address. Of the women observed, only 30% of women had a companion present during labour, and 10% had a companion at birth. A conceptual framework was used to highlight the interconnected inputs required at community, facility and provincial health system levels to improve the quality of care. Key elements to address included attitudes towards companionship, the need for education and training and restrictive hospital policies. Supporting women to have their companion of choice present during labour and birth is critical to improving women's experiences of care and improving the quality of maternal and newborn care. In order to provide companionship during labour and birth in PNG, a complex, intersecting, multi-faceted approach is required.

Perinatal death audit and classification of stillbirths in two provinces in Papua New Guinea: A retrospective analysis.

OBJECTIVE: To undertake a retrospective perinatal death audit and assessment of avoidable factors associated with stillbirths among a cohort of women in two provinces in Papua New Guinea. METHODS: We used data from an ongoing cluster-randomized crossover trial in 10 sites among 4600 women in Papua New Guinea (from 2017 to date). The overarching aim is to improve birth outcomes. All stillbirths from July 2017 to January 2020 were identified. The Perinatal Problem Identification Program was used to analyze each stillbirth and review associated avoidable factors. RESULTS: There were 59 stillbirths among 2558 births (23 per 1000 births); 68% (40/59) were classified "fresh" and 32% as "macerated". Perinatal cause of death was identified for 63% (37/59): 30% (11/37) were due to intrapartum asphyxia and traumatic breech birth and 19% (7/37) were the result of pre-eclampsia. At least one avoidable factor was identified for 95% (56/59) of stillbirths. Patient-associated factors included lack of response to reduced fetal movements and delay in seeking care during labor. Health personnel-associated factors included poor intrapartum care, late diagnosis of breech presentation, and prolonged second stage with no intervention. CONCLUSION: Factors associated with stillbirths in this setting could be avoided through a package of interventions at both the community and health-facility levels.

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).

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.