Coverage of maternal viral load monitoring during pregnancy in South Africa: Results from the 2019 national Antenatal HIV Sentinel Survey

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Study Justification:
The study aimed to assess the coverage of maternal viral load monitoring during pregnancy in South Africa. This is important because although the country has made progress in increasing antiretroviral therapy (ART) coverage among pregnant women, viral suppression among these women is reported to be low. Routine viral load testing is crucial to identify women with unsuppressed viral load early in pregnancy and provide timely intervention to improve viral suppression.
Highlights:
– Of the eligible participants, 81.7% received viral load testing during pregnancy.
– 94.1% of the viral load test results were documented in the medical records.
– Among those with documented viral load test results, 74.1% were virally suppressed.
– Women who initiated ART during pregnancy had lower coverage of viral load testing (73%) and viral suppression (56.8%) compared to women who initiated ART before pregnancy.
– Initiating ART during pregnancy was associated with a lower likelihood of receiving a viral load test during pregnancy.
Recommendations:
– Improve viral load testing coverage, especially among women initiating ART during pregnancy.
– Enhance adherence counseling during pregnancy to improve viral suppression among women who initiate ART during pregnancy.
– Consider Dolutegravir-containing regimens as the preferred regimen for women newly initiating ART during pregnancy for more rapid viral suppression.
Key Role Players:
– Ministry of Health: Responsible for policy development and implementation.
– Healthcare Facilities: Provide antenatal care services and viral load testing.
– Healthcare Workers: Conduct antenatal care services and provide adherence counseling.
– Laboratory Services: Perform viral load testing and provide test results.
– Research Institutions: Conduct studies and provide evidence-based recommendations.
Cost Items for Planning Recommendations:
– Training and capacity building for healthcare workers on viral load testing and adherence counseling.
– Procurement and maintenance of viral load testing equipment and supplies.
– Data management and reporting systems for tracking viral load testing coverage and outcomes.
– Monitoring and evaluation activities to assess the impact of interventions.
– Public awareness campaigns to promote the importance of viral load monitoring during pregnancy.

The strength of evidence for this abstract is 8 out of 10.
The evidence in the abstract is strong, but there are some areas for improvement. The study provides a clear objective and methodology, and the results are presented with specific percentages. The study also identifies factors associated with coverage of viral load testing. However, the abstract could be improved by providing more information on the sample size and demographics of the participants. Additionally, the abstract could include recommendations for improving viral load testing coverage, such as increasing access to testing or enhancing adherence counseling during pregnancy.

Objectives: South Africa has made remarkable progress in increasing the coverage of antiretroviral therapy (ART) among pregnant women; however, viral suppression among pregnant women receiving ART is reported to be low. Access to routine viral load testing is crucial to identify women with unsuppressed viral load early in pregnancy and to provide timely intervention to improve viral suppression. This study aimed to determine the coverage of maternal viral load monitoring nationally, focusing on viral load testing, documentation of viral load test results, and viral suppression (viral load  4000) primary healthcare facilities in South Africa provide antenatal care services. Prevention of vertical HIV transmission services, including viral load testing, are provided in all antenatal care facilities. At the time of this survey (October to November 2019), the South African viral load monitoring guidelines recommended that all women on ART should have viral load testing at their first antenatal care visit or upon confirmation of pregnancy [11]. For newly diagnosed women initiating ART during pregnancy, viral load testing was recommended at 3 months after ART initiation. For all HIV‐positive pregnant women, repeat viral load testing was recommended at delivery and 6 months after delivery. For women who were not virally suppressed, depending on their viral load level, viral load testing was to be repeated in 8–10 weeks (for viral load 50–999 copies/mL) or 4–6 weeks (for viral load ≥ 1000 copies/mL) after the initial unsuppressed viral load result. Although viral load testing services have been available in South Africa since 2004 [7], the coverage of viral load testing increased in recent years following WHO’s endorsement of viral load monitoring as the primary method for monitoring response to ART [6]. At the time of this survey, viral load testing for public health facilities in South Africa was provided at 17 laboratories using both the Roche and Abbott assays [12]. Results are returned via hard copy, short message system (SMS) printers or accessed through web portals [13]. At the time of this study, the first‐line regimen for women initiating ART during pregnancy was a non‐nucleoside reverse transcriptase (NNRTI)‐based ‐ most often efavirenz (EFV) ‐based ‐ regimen. The antenatal survey is a cross‐sectional survey conducted biennially in South Africa to primarily monitor HIV prevalence among pregnant women but also to evaluate the performance of the prevention of vertical HIV transmission programme. The survey aimed to enrol 36 015 pregnant women (regardless of HIV status) from 1589 public health facilities selected from each of the 52 districts in South Africa, biennially. For this sub‐analysis, only HIV‐positive pregnant women who either initiated ART before pregnancy or were taking ART for ≥ 3 months at enrolment were included in the analysis. Health facilities that took part in the 2019 antenatal survey were selected using a stratified probability proportional to size (PPS) sampling method from each district. The 2019 survey was conducted between 1 October and 15 November 2019. During this period, consenting pregnant women aged 15–49 years, attending the antenatal clinic for the first time or for follow‐up visits during their current pregnancy were consecutively enrolled (regardless of HIV or ART status) until either the required sample size or the end of the study was reached. Health workers providing antenatal care services in the selected facilities collected demographic and clinical data (including maternal education, relationship with the father of the child, and gravidity) through interviews. Data were extracted from medical records, which included: age of the woman, gestational age at booking, gestational age today, HIV status (per rapid test performed at the clinic at the time of first antenatal care visit, during follow‐up visit, or test done before pregnancy if participants were already on ART at the time of pregnancy), the timing of ART initiation as a categorical response (i.e. initiated before pregnancy, at the first, second or third trimester), viral load test done during pregnancy, whether viral load test result was documented, and latest viral load test result as a categorical response (i.e.  1000 copies/mL). If more than one viral load test was done during the pregnancy, only information on the most recent viral load test was extracted. On the day of the survey, blood specimens were collected from each participant, regardless of prior knowledge of HIV status, and tested for HIV at regional laboratories using two serial imunoassays (IAs) following the standard guideline [14]. Detailed descriptions of the methodology of the survey have been published previously [15, 16 The coverage of the following three viral load cascade indicators was estimated: viral load testing; viral load test result documentation; and viral suppression (defined as viral load < 50 copies/mL). This indicator measured the proportion of HIV‐positive women eligible for viral load testing who received a viral load test in their current pregnancy (if there was more than one viral load test, the most recent viral load test was assessed). Participants were considered as ‘eligible for viral load testing’, according to the national guideline, if they initiated ART before pregnancy, or if they were newly initiated on ART during pregnancy but had received ART for at least 3 months. For the latter group, as the timing of ART initiation was reported by trimester (i.e. as first, second or third trimester), duration on ART was calculated by subtracting the mid‐week of the trimester that ART was initiated from the participants’ gestational age at survey enrolment. For participants initiated on ART in the first trimester, the gestational age/week of their first antenatal care visit was considered as the time of ART initiation, as almost all participants started antenatal care after the mid‐week of the first trimester; and where gestational age at the first visit is not reported, time of ART initiation was set at 10 weeks as most women do not attend antenatal care before 10 weeks. Participants whose ART status was not reported, those who reported not initiating ART, and those whose rapid test or IA test was HIV‐negative were excluded from this analysis, regardless of their response to the viral load monitoring questions. This study also excluded participants whose reported timing of ART initiation was less than 3 months from their gestational age at enrolment in the survey. This indicator measured the percentage of participants who had undergone a viral load test with a result (from a test provided during pregnancy) that was documented on the medical record – if there was more than one viral load test, documentation of the most recent viral load test result was assessed (the denominator for this indicator was the number of HIV‐positive women with viral load test done). This indicator measured the percentage of participants with a documented viral load test result of < 50 copies/mL (using participants with documented viral load test result as a denominator). In the case where participants had more than one viral load test result during pregnancy, the most recent result was extracted from the medical record. The three viral load cascade indicators were analysed at the national level and in stratified groups. χ2 test was used to assess significant associations. A sensitivity analysis was conducted to validate the viral load data extracted from the medical record using laboratory data (these data are presented under Supplementary Box 1). We fitted a multivariable survey logistic regression model to assess factors associated with not receiving a viral load test. All variables significant at a P‐value cut‐off point of 0.2 in a bivariable analysis were included in multivariable analysis. Variables significant at a P‐value cut‐off point of 0.05 and other variables that have ≥ 10% effect on other significant variables were kept in the final model. Adjusted odds ratios (AORs) and 95% confidence intervals (CIs) were reported. All analyses took into account the survey design (i.e. all analyses adjusted for the different sampling stages: stratification and clustering within primary sampling units, and for the finite number of primary sampling units). All analyses were also weighted for sample size realization and the Statistics South Africa 2019 midyear population size of women of reproductive age (15–49 years) to adjust for differential population size across provinces and for different sample size achievement at district level [17] Participation in the survey was voluntary, requiring written informed consent. Ethical approval was obtained from the University of the Witwatersrand Human Research Ethics Committee (Medical) (ethics clearance number: M170556), and the nine provincial health research ethics committees. The study protocol was reviewed following the Centers for Disease Control and Prevention, United States (CDC‐US) human research protection procedures.

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

1. Mobile Health (mHealth) Solutions: Implementing mobile health technologies, such as SMS reminders and mobile applications, to provide pregnant women with information about antenatal care, reminders for appointments, and educational resources on maternal health.

2. Telemedicine: Introducing telemedicine services to allow pregnant women in remote or underserved areas to access prenatal care through virtual consultations with healthcare providers. This can help overcome geographical barriers and improve access to specialized care.

3. Point-of-Care Testing: Utilizing portable and rapid diagnostic tests for viral load monitoring during pregnancy. This would enable healthcare providers to obtain immediate results and make timely interventions to improve viral suppression.

4. Community Health Workers: Training and deploying community health workers to provide maternal health services, including viral load testing, in areas with limited healthcare infrastructure. These workers can conduct home visits, educate women about the importance of viral load monitoring, and facilitate access to testing facilities.

5. Integration of Services: Integrating maternal health services with other existing healthcare programs, such as HIV/AIDS treatment and prevention programs, to ensure comprehensive care for pregnant women. This can streamline service delivery and improve coordination between different healthcare providers.

6. Public-Private Partnerships: Collaborating with private healthcare providers and organizations to expand access to maternal health services. This can involve leveraging existing private sector infrastructure and resources to reach more pregnant women and improve the availability of viral load testing.

7. Health Information Systems: Strengthening health information systems to ensure accurate and timely documentation of viral load test results. This can involve implementing electronic medical records and data management systems to improve data collection, analysis, and reporting.

8. Health Education and Counseling: Enhancing adherence counseling and health education for pregnant women on antiretroviral therapy. This can help improve medication adherence, viral suppression rates, and overall maternal health outcomes.

9. Task Shifting: Training and empowering non-specialist healthcare providers, such as nurses and midwives, to perform viral load testing and provide basic antenatal care services. This can help alleviate the burden on specialized healthcare providers and improve access to essential maternal health services.

10. Quality Improvement Initiatives: Implementing quality improvement initiatives to address gaps in viral load testing coverage and documentation. This can involve regular monitoring and evaluation of service delivery, feedback mechanisms, and continuous training and capacity building for healthcare providers.

It is important to note that the specific implementation of these innovations would require careful planning, stakeholder engagement, and consideration of local context and resources.
AI Innovations Description
Based on the information provided, the following recommendation can be developed into an innovation to improve access to maternal health:

1. Implement a comprehensive and integrated digital health system: Develop a digital platform that integrates antenatal care services, viral load monitoring, and medical records. This platform should allow for real-time data collection, analysis, and reporting, ensuring that viral load test results are accurately documented and accessible to healthcare providers. It should also provide reminders and alerts for follow-up viral load testing and adherence counseling.

2. Strengthen healthcare provider training and capacity building: Develop training programs for healthcare providers on the importance of viral load monitoring during pregnancy and the management of unsuppressed viral load. This should include training on counseling techniques to enhance adherence to antiretroviral therapy (ART) during pregnancy. Continuous professional development programs should be implemented to ensure healthcare providers stay updated on the latest guidelines and best practices.

3. Improve accessibility and availability of viral load testing: Expand the coverage of viral load testing by increasing the number of laboratories equipped to perform viral load testing. This can be achieved by investing in laboratory infrastructure, equipment, and personnel. Additionally, explore the use of point-of-care viral load testing technologies that can be easily deployed in remote or resource-limited settings.

4. Strengthen community engagement and support: Develop community-based programs that raise awareness about the importance of viral load monitoring during pregnancy and encourage women to access antenatal care services. Engage community health workers and peer educators to provide counseling and support to pregnant women living with HIV, emphasizing the benefits of viral suppression for maternal and child health.

5. Foster collaboration and partnerships: Establish partnerships between government agencies, healthcare providers, non-governmental organizations, and community-based organizations to coordinate efforts and resources towards improving access to maternal health services. This can include joint advocacy campaigns, sharing of best practices, and resource pooling to address gaps in service delivery.

By implementing these recommendations, it is possible to develop innovative solutions that improve access to maternal health, particularly in the context of viral load monitoring during pregnancy. These interventions can contribute to better maternal and child health outcomes by ensuring timely identification of unsuppressed viral load and appropriate interventions to achieve viral suppression.
AI Innovations Methodology
To improve access to maternal health, here are some potential recommendations:

1. Strengthening Antenatal Care Services: Enhance the quality and availability of antenatal care services by ensuring that all primary healthcare facilities in South Africa have the necessary resources, equipment, and trained healthcare professionals to provide comprehensive maternal health services.

2. Increasing Awareness and Education: Implement community-based education programs to raise awareness about the importance of maternal health and encourage women to seek antenatal care early in their pregnancy. This can be done through community health workers, mobile clinics, and public awareness campaigns.

3. Improving Viral Load Testing: Enhance the coverage and accessibility of viral load testing for pregnant women by expanding the number of laboratories providing testing services, improving transportation and logistics for sample collection and result delivery, and implementing innovative technologies such as point-of-care testing.

4. Adherence Counseling and Support: Strengthen adherence counseling and support services for pregnant women on antiretroviral therapy (ART) to ensure optimal viral suppression. This can include individual counseling sessions, peer support groups, and the use of mobile health technologies for remote monitoring and support.

5. Integration of Services: Integrate maternal health services with other healthcare services, such as family planning, HIV testing and treatment, and mental health support, to provide comprehensive care for pregnant women and improve overall health outcomes.

Methodology to simulate the impact of these recommendations on improving access to maternal health:

1. Define the Objectives: Clearly define the objectives of the simulation study, such as assessing the potential impact of the recommendations on increasing the coverage of viral load testing and improving viral suppression among pregnant women.

2. Data Collection: Gather relevant data on the current state of maternal health access, including the coverage of viral load testing, documentation of test results, and viral suppression rates. This can be obtained from national health surveys, medical records, and other relevant sources.

3. Model Development: Develop a simulation model that represents the maternal health system, taking into account factors such as the number of healthcare facilities, healthcare workforce, patient flow, and resource allocation. The model should also incorporate the potential impact of the recommendations on improving access to maternal health.

4. Parameter Estimation: Estimate the parameters of the simulation model based on available data and expert knowledge. This may involve conducting surveys, interviews, or literature reviews to gather information on key variables and their relationships.

5. Scenario Testing: Simulate different scenarios to assess the impact of the recommendations on improving access to maternal health. This can include varying factors such as the availability of antenatal care services, coverage of viral load testing, and adherence counseling support.

6. Analysis and Interpretation: Analyze the simulation results to evaluate the potential impact of the recommendations on improving access to maternal health. This can involve comparing different scenarios, identifying key drivers of change, and assessing the cost-effectiveness of the proposed interventions.

7. Sensitivity Analysis: Conduct sensitivity analysis to assess the robustness of the simulation results and identify the key uncertainties or assumptions that may affect the outcomes.

8. Communication and Policy Recommendations: Summarize the findings of the simulation study and communicate them to relevant stakeholders, such as policymakers, healthcare providers, and community organizations. Use the results to inform evidence-based decision-making and develop policy recommendations for improving access to maternal health.

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