Loss to follow up of pregnant women with HIV and infant HIV outcomes in the prevention of maternal to child transmission of HIV programme in two high-burden provinces in Papua New Guinea: A retrospective clinical audit

BMJ Open, Volume 10, No. 12, Year 2020

Interpretação

Introduction Despite early adoption of the WHO guidelines to deliver lifelong antiretroviral (ARV) regimen to pregnant women on HIV diagnosis, the HIV prevention of mother to child transmission programme in Papua New Guinea remains suboptimal. An unacceptable number of babies are infected with HIV and mothers not retained in treatment. This study aimed to describe the characteristics of this programme and to investigate the factors associated with programme performance outcomes. Methods We conducted a retrospective analysis of clinical records of HIV-positive pregnant women at two hospitals providing prevention of mother to child transmission services. All women enrolled in the prevention of mother to child transmission programme during the study period (June 2012-June 2015) were eligible for inclusion. Using logistic regression, we examined the factors associated with maternal loss to follow-up (LTFU) before birth and before infant registration in a paediatric ARV programme. Results 763 of women had records eligible for inclusion. Demographic and clinical differences existed between women at the two sites. Almost half (45.1%) of the women knew their HIV-positive status prior to the current pregnancy. Multivariate analysis showed that women more likely to be LTFU by the time of birth were younger (adjusted OR (AOR)=2.92, 95% CI 1.16 to 7.63), were newly diagnosed with HIV in the current/most recent pregnancy (AOR=3.50, 95% CI 1.62 to 7.59) and were in an HIV serodiscordant relationship (AOR=2.94, 95% CI 1.11 to 7.84). Factors associated with maternal LTFU before infant registration included being primipara at the time of enrolment (AOR=3.13, 95% CI 1.44 to 6.80) and being newly diagnosed in that current/most recent pregnancy (AOR=2.49, 95% CI 1.31 to 4.73). 6.6% (50 of 763) of exposed infants had a positive HIV DNA test. Conclusions Our study highlighted predictors of LTFU among women. Understanding these correlates at different stages of the programme offers important insights for targets and timing of greater support for retention in care. The two sites were selected as they were both in high-burden HIV provinces, were the longest running sites for prevention of mother to child transmission in the country, and were well supported through donor funding and non-governmental organisations, such as the Clinton Health Access Initiative. Port Moresby is the national capital city, on the southern coast of the country, and is a melting pot of people from across the country. It is one of only three cities in the country. Goroka is a town and the provincial capital of the Eastern Highlands Province, in the lower highlands region of the country. The geographical, sociocultural and economic contexts of these two sites are diverse. Unlike Port Moresby, Goroka is much smaller and people access the town from across the province, travelling by foot and road. Travel between these two sites is only possible by air. HIV testing is available at numerous ANC clinics in each province; however, there is only one prevention of mother to child transmission clinic in each province. The implementation model for the prevention of mother to child transmission programme differed between the two sites. In Port Moresby, prevention of mother to child transmission services were integrated in antenatal, delivery and postnatal care services for the first 6 weeks. After the 6-week postnatal period, HIV-exposed infants were referred for enrolment in the paediatric HIV clinic for ongoing HIV prophylaxis, confirmatory HIV testing and treatment as required, while mothers were referred to the adult ART outpatient clinic. The adult and paediatric HIV clinics were not co-located and operated on different days, and clinical records were not linked manually or electronically. In Goroka, prevention of mother to child transmission services were integrated in antenatal, delivery and postnatal care, and the mother-infant pair is cared for by the same clinical team until the confirmatory HIV test for the infant was conducted at 18 months. Despite its co-location infants were still enrolled in the paediatric HIV clinic at 6 weeks. At 18 months after birth, the mother was transferred (back) to the adult ART clinic, while the HIV-infected infant/s remained in the clinic for ongoing clinical care and management. All healthcare was provided by staff who were employed as government healthcare workers or were supported and funded by the Clinton Health Access Initiative, funded by the Australian government. The clinical audit used a ‘capture all’ approach, documenting all women with HIV enrolled in the prevention of mother to child transmission programme for the 3-year time period spanning June 2012 (when Option B+ was formally adopted in PNG) until June 2015. Data sources included paper-based antenatal records of HIV-positive women and their infants’ medical records at either the same prevention of mother to child transmission clinic (Goroka) or the paediatric HIV clinic elsewhere in the hospital (Port Moresby). For all available records, two research midwives manually extracted data related to patient demographics, pregnancy care, HIV and other sexually transmitted infection testing, prevention of mother to child transmission enrolment, ART initiation and clinic appointments, and these were recorded on preprinted study clinical research forms. Infants’ HIV DNA test results were obtained from infant records. Infant records in Goroka were physically co-located with the mothers. In Port Moresby, mother-infant pairs were linked manually by extracting the name of the mother, the birth date of the infant on her ANC record, and if recorded the sex of the newborn. Staff at the paediatric HIV clinic then identified infant records to link the mother-infant pairs. Research midwives cross-checked each other’s completed data forms to ensure all forms were completed as accurately as possible. After reviewing each form for validity and completeness, de-identified data were double-entered into a purposely developed study database and stored on a password-protected computer at the Papua New Guinea Institute of Medical Research. All electronic data were merged into a single study database and analysed using STATA V.13.1. At enrolment into the prevention of mother to child transmission programme, sociodemographic, obstetric and HIV-related characteristics were recorded and laboratory assessments conducted. In our analysis we only included the first pregnancy when assessing maternal characteristics and outcomes. However, for infant characteristics and outcomes, all live births were included. LTFU was measured and defined at two timepoints. First, pregnant women enrolled in the prevention of mother to child transmission programme were categorised as ‘lost to follow-up before delivery’ if they did not return to the health facility for delivery, and could include scheduled antenatal prevention of mother to child transmission visits. Second, pregnant enrolled women in the prevention of mother to child transmission programme were defined as ‘lost to follow-up before infant registration’ if they did not register the newborn child at the respective clinics for prevention of mother to child transmission services and were lost from the programme either during antenatal, peripartum or early postnatal services. Although the study sponsor originally sought to have the audit measure maternal LTFU at 2 years after lifetime ART initiation in the prevention of mother to child transmission programme (Option B+), this was not possible. In PNG, paper-based adult ART records were used and there was no system that linked women in prevention from mother to child transmission programmes to adult ART service records. At the time the audit was undertaken, only two ART sites in Port Moresby were using an electronic database, which was manually updated into a national database by staff at the National Department of Health every few months. Enrolment of a child into paediatric HIV programmes shows ongoing engagement in HIV care. The fact that so many women did not enrol their children in these clinics shows disengagement. Like prevention of mother to child transmission programmes, there is only one paediatric HIV clinic in each province. Descriptive analyses were conducted to describe the women enrolled in the prevention of mother to child transmission programmes at the sites and the HIV outcomes of their infants. χ2 tests, two-sample t-tests and Wilcoxon rank-sum tests were performed to examine differences in sociodemographic and other behavioural characteristics of women and infants in the sites. Multivariate logistic regression analysis was undertaken to investigate factors associated with maternal LTFU before birth and the mean time before the infant was registered in a paediatric ART programme. Based on findings from previous research24 and data available from this study, we selected variables that might influence the outcome of interest (maternal LTFU) to be included in the predictive models. For the analysis of factors associated with maternal LTFU before birth, we used Firth’s logistic regression25 26 to account for bias due to rare event data, which are known to produce substantial bias estimates with conventional logistic regression.27 Assumption of rare event data was made based on few outcome events per variable (EPV) guideline with at least five EPV in models used for confounding adjustment.28 Infant HIV testing and results were quantified and described. This was a retrospective cohort study and women were no longer attending the ANC. Consent from the participating hospitals was granted to access clinical records on the condition that no identifiable information, including names, was recorded on the clinical research forms. We did not invite patient and public involvement in the design of the study due to the nature of the study, being a retrospective clinical audit commissioned by UNICEF. All study results were disseminated to stakeholders at the conclusion of the study.

AI Digest

Study Justification:

This study aimed to investigate the factors associated with the suboptimal performance of the prevention of mother to child transmission (PMTCT) program for HIV in Papua New Guinea. The study focused on the loss to follow-up of pregnant women with HIV and the impact on infant HIV outcomes. By understanding the characteristics of the program and identifying factors contributing to poor performance, the study aimed to provide insights for improving retention in care and reducing HIV transmission from mother to child.

Study Highlights:

– The study analyzed clinical records of 763 HIV-positive pregnant women enrolled in the PMTCT program in two high-burden provinces in Papua New Guinea.
– Demographic and clinical differences were observed between the two sites.
– Factors associated with maternal loss to follow-up (LTFU) before birth included younger age, newly diagnosed HIV during pregnancy, and being in an HIV serodiscordant relationship.
– Factors associated with maternal LTFU before infant registration included being a first-time mother at enrollment and being newly diagnosed during the current pregnancy.
– 6.6% of exposed infants had a positive HIV DNA test.
– The study highlighted the need for targeted support and interventions to improve retention in care and reduce HIV transmission.

Recommendations:

– Enhance support and counseling services for younger pregnant women, newly diagnosed HIV-positive women, and those in serodiscordant relationships to improve retention in care.
– Develop strategies to address the specific needs and challenges faced by first-time mothers in the PMTCT program.
– Strengthen the integration and coordination of services between antenatal, delivery, postnatal, and pediatric HIV clinics to ensure seamless care for mother-infant pairs.
– Improve data linkage and information systems to track and monitor the progress of women enrolled in the PMTCT program and their infants.
– Increase access to HIV testing and prevention of mother to child transmission services in high-burden provinces.

Key Role Players:

– Government healthcare workers
– Clinton Health Access Initiative
– Non-governmental organizations involved in HIV prevention and treatment
– National Department of Health
– Antenatal clinics
– Prevention of mother to child transmission clinics
– Pediatric HIV clinics

Cost Items for Planning Recommendations:

– Training and capacity building for healthcare workers
– Counseling and support services for pregnant women with HIV
– Integration and coordination of services between clinics
– Strengthening data linkage and information systems
– Expansion of HIV testing and prevention services
– Monitoring and evaluation of program outcomes

Força da prova

The strength of evidence for this abstract is 7 out of 10.
The evidence in the abstract is moderately strong, but there are some areas for improvement. The study design is a retrospective analysis of clinical records, which may limit the ability to establish causality. However, the study includes a large sample size of 763 women and uses logistic regression analysis to examine factors associated with maternal loss to follow-up (LTFU) and infant HIV outcomes. The study also provides important insights into predictors of LTFU among women in the prevention of mother to child transmission programme. To improve the strength of the evidence, future studies could consider using a prospective design to establish causality and include a control group for comparison. Additionally, the study could benefit from providing more details on the data collection methods and statistical analysis techniques used.

Resumo

The two sites were selected as they were both in high-burden HIV provinces, were the longest running sites for prevention of mother to child transmission in the country, and were well supported through donor funding and non-governmental organisations, such as the Clinton Health Access Initiative. Port Moresby is the national capital city, on the southern coast of the country, and is a melting pot of people from across the country. It is one of only three cities in the country. Goroka is a town and the provincial capital of the Eastern Highlands Province, in the lower highlands region of the country. The geographical, sociocultural and economic contexts of these two sites are diverse. Unlike Port Moresby, Goroka is much smaller and people access the town from across the province, travelling by foot and road. Travel between these two sites is only possible by air. HIV testing is available at numerous ANC clinics in each province; however, there is only one prevention of mother to child transmission clinic in each province. The implementation model for the prevention of mother to child transmission programme differed between the two sites. In Port Moresby, prevention of mother to child transmission services were integrated in antenatal, delivery and postnatal care services for the first 6 weeks. After the 6-week postnatal period, HIV-exposed infants were referred for enrolment in the paediatric HIV clinic for ongoing HIV prophylaxis, confirmatory HIV testing and treatment as required, while mothers were referred to the adult ART outpatient clinic. The adult and paediatric HIV clinics were not co-located and operated on different days, and clinical records were not linked manually or electronically. In Goroka, prevention of mother to child transmission services were integrated in antenatal, delivery and postnatal care, and the mother-infant pair is cared for by the same clinical team until the confirmatory HIV test for the infant was conducted at 18 months. Despite its co-location infants were still enrolled in the paediatric HIV clinic at 6 weeks. At 18 months after birth, the mother was transferred (back) to the adult ART clinic, while the HIV-infected infant/s remained in the clinic for ongoing clinical care and management. All healthcare was provided by staff who were employed as government healthcare workers or were supported and funded by the Clinton Health Access Initiative, funded by the Australian government. The clinical audit used a ‘capture all’ approach, documenting all women with HIV enrolled in the prevention of mother to child transmission programme for the 3-year time period spanning June 2012 (when Option B+ was formally adopted in PNG) until June 2015. Data sources included paper-based antenatal records of HIV-positive women and their infants’ medical records at either the same prevention of mother to child transmission clinic (Goroka) or the paediatric HIV clinic elsewhere in the hospital (Port Moresby). For all available records, two research midwives manually extracted data related to patient demographics, pregnancy care, HIV and other sexually transmitted infection testing, prevention of mother to child transmission enrolment, ART initiation and clinic appointments, and these were recorded on preprinted study clinical research forms. Infants’ HIV DNA test results were obtained from infant records. Infant records in Goroka were physically co-located with the mothers. In Port Moresby, mother-infant pairs were linked manually by extracting the name of the mother, the birth date of the infant on her ANC record, and if recorded the sex of the newborn. Staff at the paediatric HIV clinic then identified infant records to link the mother-infant pairs. Research midwives cross-checked each other’s completed data forms to ensure all forms were completed as accurately as possible. After reviewing each form for validity and completeness, de-identified data were double-entered into a purposely developed study database and stored on a password-protected computer at the Papua New Guinea Institute of Medical Research. All electronic data were merged into a single study database and analysed using STATA V.13.1. At enrolment into the prevention of mother to child transmission programme, sociodemographic, obstetric and HIV-related characteristics were recorded and laboratory assessments conducted. In our analysis we only included the first pregnancy when assessing maternal characteristics and outcomes. However, for infant characteristics and outcomes, all live births were included. LTFU was measured and defined at two timepoints. First, pregnant women enrolled in the prevention of mother to child transmission programme were categorised as ‘lost to follow-up before delivery’ if they did not return to the health facility for delivery, and could include scheduled antenatal prevention of mother to child transmission visits. Second, pregnant enrolled women in the prevention of mother to child transmission programme were defined as ‘lost to follow-up before infant registration’ if they did not register the newborn child at the respective clinics for prevention of mother to child transmission services and were lost from the programme either during antenatal, peripartum or early postnatal services. Although the study sponsor originally sought to have the audit measure maternal LTFU at 2 years after lifetime ART initiation in the prevention of mother to child transmission programme (Option B+), this was not possible. In PNG, paper-based adult ART records were used and there was no system that linked women in prevention from mother to child transmission programmes to adult ART service records. At the time the audit was undertaken, only two ART sites in Port Moresby were using an electronic database, which was manually updated into a national database by staff at the National Department of Health every few months. Enrolment of a child into paediatric HIV programmes shows ongoing engagement in HIV care. The fact that so many women did not enrol their children in these clinics shows disengagement. Like prevention of mother to child transmission programmes, there is only one paediatric HIV clinic in each province. Descriptive analyses were conducted to describe the women enrolled in the prevention of mother to child transmission programmes at the sites and the HIV outcomes of their infants. χ2 tests, two-sample t-tests and Wilcoxon rank-sum tests were performed to examine differences in sociodemographic and other behavioural characteristics of women and infants in the sites. Multivariate logistic regression analysis was undertaken to investigate factors associated with maternal LTFU before birth and the mean time before the infant was registered in a paediatric ART programme. Based on findings from previous research24 and data available from this study, we selected variables that might influence the outcome of interest (maternal LTFU) to be included in the predictive models. For the analysis of factors associated with maternal LTFU before birth, we used Firth’s logistic regression25 26 to account for bias due to rare event data, which are known to produce substantial bias estimates with conventional logistic regression.27 Assumption of rare event data was made based on few outcome events per variable (EPV) guideline with at least five EPV in models used for confounding adjustment.28 Infant HIV testing and results were quantified and described. This was a retrospective cohort study and women were no longer attending the ANC. Consent from the participating hospitals was granted to access clinical records on the condition that no identifiable information, including names, was recorded on the clinical research forms. We did not invite patient and public involvement in the design of the study due to the nature of the study, being a retrospective clinical audit commissioned by UNICEF. All study results were disseminated to stakeholders at the conclusion of the study.

Materiais

Inovações

Based on the provided information, here are some potential innovations that could improve access to maternal health:

1. Mobile Health (mHealth) Solutions: Implementing mobile health technologies, such as SMS reminders and appointment notifications, can help improve communication and ensure that pregnant women are aware of their appointments and follow-up care.

2. Telemedicine: Introducing telemedicine services can enable remote consultations and follow-up care for pregnant women, especially in areas where access to healthcare facilities is limited. This can help overcome geographical barriers and improve access to maternal health services.

3. Community Health Workers: Training and deploying community health workers who can provide education, support, and follow-up care to pregnant women in their communities can help bridge the gap between healthcare facilities and remote areas.

4. Integrated Care Models: Implementing integrated care models that combine antenatal, delivery, and postnatal care services can improve continuity of care and reduce the risk of loss to follow-up. This can involve co-locating services and ensuring seamless transitions between different stages of care.

5. Strengthening Health Information Systems: Improving the linkage and sharing of clinical records between different healthcare facilities can help track and monitor pregnant women throughout their pregnancy journey. This can facilitate timely identification of women at risk of loss to follow-up and enable targeted interventions.

6. Addressing Sociocultural Barriers: Developing culturally sensitive approaches to maternal health, including community engagement and awareness campaigns, can help address sociocultural barriers that may prevent women from seeking and accessing maternal health services.

7. Task Shifting and Training: Expanding the roles and responsibilities of healthcare providers, such as midwives and nurses, through task shifting and training programs can help increase the availability of skilled healthcare professionals and improve access to maternal health services.

These innovations should be tailored to the specific context and needs of Papua New Guinea, taking into account the geographical, sociocultural, and economic factors mentioned in the description.

AI Innovations Description

Based on the provided description, the following recommendation can be developed into an innovation to improve access to maternal health:

1. Strengthening HIV testing and counseling services: Implement targeted strategies to increase HIV testing and counseling services for pregnant women, especially those who are younger, newly diagnosed with HIV, or in serodiscordant relationships. This can include community-based testing campaigns, mobile testing units, and integration of HIV testing into antenatal care services.

2. Improving retention in care: Develop interventions to improve retention in care for HIV-positive pregnant women. This can include providing comprehensive support services such as transportation assistance, childcare support, and peer support groups. Additionally, implementing reminder systems for clinic appointments and medication adherence can help ensure that women stay engaged in care throughout their pregnancy and postpartum period.

3. Enhancing integration of services: Strengthen the integration of prevention of mother to child transmission (PMTCT) services with antenatal, delivery, and postnatal care. This can involve co-locating PMTCT services within existing healthcare facilities, ensuring seamless referral and follow-up between different healthcare providers, and integrating PMTCT services into routine maternal and child health programs.

4. Improving data management and tracking: Implement electronic health records systems to improve data management and tracking of HIV-positive pregnant women and their infants. This can help ensure accurate and timely documentation of patient information, facilitate communication between different healthcare providers, and enable monitoring of program performance and outcomes.

5. Enhancing community engagement: Engage communities and community-based organizations in promoting maternal health and PMTCT services. This can involve community education and awareness campaigns, involvement of community health workers in providing support and follow-up care, and collaboration with local leaders and organizations to address cultural and social barriers to accessing maternal health services.

By implementing these recommendations, it is expected that access to maternal health, particularly for HIV-positive pregnant women, can be improved, leading to better outcomes for both mothers and infants.

AI Innovations Methodology

Based on the provided description, here are some potential recommendations to improve access to maternal health in the prevention of mother to child transmission (PMTCT) program in Papua New Guinea:

1. Strengthen HIV testing and counseling services: Increase the availability and accessibility of HIV testing and counseling services in antenatal care clinics to ensure early identification of HIV-positive pregnant women.

2. Improve retention in care: Develop strategies to improve retention in care for HIV-positive pregnant women, such as providing comprehensive support services, including transportation assistance, to overcome barriers to accessing healthcare.

3. Enhance integration of services: Integrate PMTCT services with antenatal, delivery, and postnatal care to provide a continuum of care for HIV-positive pregnant women and their infants. This can help streamline the care process and ensure better coordination between different healthcare providers.

4. Strengthen linkages between adult and pediatric HIV clinics: Improve the coordination and communication between adult and pediatric HIV clinics to ensure smooth transitions of care for HIV-positive mothers and their infants. This can include co-locating the clinics, aligning operating days, and implementing electronic record systems to facilitate data sharing.

5. Increase community engagement: Engage local communities and community-based organizations to raise awareness about PMTCT services, reduce stigma associated with HIV, and promote early antenatal care attendance among pregnant women.

To simulate the impact of these recommendations on improving access to maternal health, a methodology could include the following steps:

1. Define the indicators: Identify specific indicators that measure access to maternal health, such as the percentage of pregnant women tested for HIV, the percentage of HIV-positive pregnant women retained in care, and the percentage of infants receiving appropriate HIV prophylaxis.

2. Collect baseline data: Gather baseline data on the selected indicators from the PMTCT program in Papua New Guinea. This can include reviewing existing records and conducting surveys or interviews with healthcare providers and pregnant women.

3. Develop a simulation model: Create a simulation model that incorporates the identified recommendations and their potential impact on the selected indicators. This model should consider factors such as population size, healthcare infrastructure, and resource availability.

4. Run simulations: Use the simulation model to run multiple scenarios that reflect the implementation of the recommendations. Adjust the parameters and assumptions in the model to simulate different levels of intervention coverage and effectiveness.

5. Analyze results: Analyze the simulation results to assess the potential impact of the recommendations on improving access to maternal health. Compare the outcomes of different scenarios to identify the most effective interventions.

6. Validate the model: Validate the simulation model by comparing the simulated results with real-world data, if available. This step helps ensure the accuracy and reliability of the model’s predictions.

7. Refine and iterate: Based on the simulation results and validation, refine the recommendations and the simulation model if necessary. Iterate the process to further optimize the interventions and improve access to maternal health.

By following this methodology, policymakers and healthcare providers can gain insights into the potential impact of different interventions on improving access to maternal health in the PMTCT program in Papua New Guinea. This information can guide decision-making and resource allocation to achieve better outcomes for HIV-positive pregnant women and their infants.

Autor

Dima Health

Statistics:

Citations: 4

Identifiers:

DOI: 10.1136/bmjopen-2020-038311

Research Areas:

Community Interventions, Environmental, Genetics and Genomics, Health System and Policy, Infectious Diseases, Maternal Access, Maternal and Child Health, Quality of Care, Sexual and Reproductive Health, Workforce

Study Countries:

Guinea

Study Design:

Cohort Study, Cross Sectional Study

Study Approach:

Quantitative

Participants Gender:

Female

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