Correlates of HIV detection among breastfeeding postpartum Kenyan women eligible under Option B+

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Study Justification:
– The study aims to assess the effectiveness of the Option B+ strategy in delivering HIV antiretroviral therapy (ART) to breastfeeding postpartum women in Nairobi, Kenya.
– It investigates the rates of virologic failure (HIV RNA detection) in plasma, breast milk, and endocervical secretions at two postpartum timepoints.
– The study also examines the correlates of virologic failure, such as maternal age, breastfeeding intentions, and timing of ART initiation.
Study Highlights:
– 21.4% of women at 6-14 weeks postpartum had HIV RNA detected in plasma, 14.3% in breast milk, and 23.7% in endocervical secretions.
– At 18-24 weeks postpartum, the percentages were 21.1%, 7.1%, and 14.3%, respectively.
– Younger maternal age, intent to breastfeed for longer, and later ART start in pregnancy were significantly associated with plasma virologic failure.
– Earlier ART initiation in pregnancy was significantly associated with plasma suppression after adjusting for time on ART.
– Only 3 women had resistance mutations to their ART regimen.
Recommendations for Lay Reader and Policy Maker:
– Postpartum HIV RNA monitoring should be implemented in Option B+ programs to achieve elimination of mother-to-child transmission (MTCT) of HIV.
– Emphasis should be placed on timely ART initiation during pregnancy to improve virologic suppression in the postpartum period.
– Support and education should be provided to younger mothers and those intending to breastfeed for longer to improve adherence to ART.
Key Role Players:
– Public health officials and policymakers
– Healthcare providers and clinics
– HIV/AIDS advocacy organizations
– Community health workers
– Researchers and scientists
Cost Items for Planning Recommendations:
– Training and capacity building for healthcare providers on Option B+ implementation and postpartum HIV RNA monitoring
– Development and dissemination of educational materials for younger mothers and those intending to breastfeed for longer
– HIV RNA testing kits and laboratory equipment
– Support for community health workers to provide counseling and support to postpartum women
– Research funding for further studies on the effectiveness of Option B+ and strategies to improve virologic suppression in the postpartum period

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 a cohort, which provides valuable data. The sample size is relatively small, with only 42 women included. The study identifies significant correlates of virologic failure, such as younger maternal age, intent to breastfeed for longer, and later ART start in pregnancy. However, the abstract does not provide information on the statistical significance of these associations. Additionally, the abstract mentions that only 3 women had resistance mutations to their regimen, but it does not provide any further details or implications of this finding. To improve the evidence, the abstract could include the p-values for the significant correlates and provide more context and implications for the resistance mutations.

Background The Option B+ strategy streamlines delivery of HIV antiretroviral therapy (ART) to pregnant women, but concerns remain about ART treatment adherence and long term outcomes. Methods We conducted a retrospective analysis of a cohort of HIV-positive, postpartum breastfeeding women receiving ART via Option B+ in Nairobi, Kenya. The primary outcome was virologic failure in plasma (HIV RNA >1000 copies/mL), and detection in breast milk (>150 copies/mL) and endocervical secretions (>100 copies/mL) at 2 postpartum timepoints. Correlates of virologic failure were assessed using univariate tests and multivariate logistic regression. Results Of 42 women at 6–14 weeks postpartum, 21.4% of women had HIV RNA detected in plasma; 14.3% in breast milk, and 23.7% in endocervical secretions. At 18–24 weeks postpartum, the percentages were 21.1%, 7.1%, and 14.3%, respectively. Younger maternal age, intent to breastfeed for longer, and later ART start in pregnancy were significantly associated with plasma virologic failure (p 1000 copies/mL; for breast milk >150 copies/mL, and for endocervical secretions, >100 copies/mL. For both breast milk and endocervical secretions, the threshold was also the lower limit of RNA detection of the assay. For subjects with >1000 copies/mL of HIV RNA in plasma at any visit, plasma was evaluated for HIV genotypic resistance via the oligonucleotide ligation assay (OLA), using probes optimized for subtypes A, D and C prevalent in Kenya [20, 21]. Data was entered into RedCap and analyses were performed using STATA/SE 14.2. Our primary outcome was plasma virologic failure. Participant characteristics at 6–14 weeks postpartum were evaluated using descriptive statistics. Participants with plasma virologic failure were compared against those with virologic suppression at the same time point to elicit sociodemographic and clinical correlates of virologic failure. Comparisons were made for both enrollment (6–14 week) and follow-up (18–24 week) timepoints, as women’s adherence to ART may differ in the early and late postpartum periods. Univariate analyses were performed using Fisher’s exact test for categorical variables and the Mann Whitney U test for continuous variables; two-sided p-values were calculated. Cohen’s Kappa was calculated to examine concurrency in virologic failure among multiple compartments [22]. Missing values for variables with over 10% of data missing were treated as additional categories in analyses. Viral load measurements below the limit of detection were recoded to midway between zero and the assay’s lower limit of detection, which was 100 copies/mL for plasma and endocervical secretions, and 150 copies/mL for breast milk [23]. For women for whom weeks of gestation at ART initiation were missing, this value was calculated using infant’s birth date. Weeks of gestation under 0 were recoded as 0 and over 45 were recoded as 45. Variables determined through univariate analysis to be associated with plasma virologic failure at p-values of 0.20 and under, and biologically plausible for association, were considered for multivariate models constructed using both stepwise and backwards elimination methods. Separate analyses were performed for the 6–14 week and 18–24 week postpartum periods using logistic regression and a 2-sided significance threshold of 0.05. The clinic started Option B+ in August 2014. We excluded subjects who enrolled before Dec. 1, 2014 to ensure that all subjects were offered ART under Option B+. We did not have access to infant HIV test results, although all infants in the study were tested for HIV at age 6 weeks. HIV viral load testing was technically offered to mothers at the clinic, but in practice, very few women were tested, due to a variety of technical barriers.

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

1. Mobile Health (mHealth) Solutions: Develop mobile applications or text messaging services to provide reminders and educational information about maternal health, including ART adherence and HIV viral load monitoring.

2. Telemedicine: Implement telemedicine platforms to enable remote consultations and follow-up care for postpartum women, reducing the need for in-person visits and improving access to healthcare services.

3. Community Health Workers: Train and deploy community health workers to provide education, counseling, and support to postpartum women, particularly in remote or underserved areas where access to healthcare facilities may be limited.

4. Point-of-Care Testing: Introduce point-of-care HIV viral load testing devices that can be used in primary care clinics or community settings, allowing for real-time monitoring of viral suppression and timely adjustments to treatment regimens.

5. Integrated Care Models: Establish integrated care models that combine maternal health services with family planning, HIV care, and other essential healthcare services, ensuring comprehensive and coordinated care for postpartum women.

6. Health Information Systems: Strengthen health information systems to improve data collection, analysis, and reporting on maternal health outcomes, enabling better monitoring and evaluation of Option B+ programs and identification of areas for improvement.

7. Peer Support Programs: Develop peer support programs where women who have successfully navigated the Option B+ program can provide guidance, encouragement, and practical tips to newly enrolled women, fostering a sense of community and empowerment.

8. Supply Chain Management: Optimize supply chain management systems to ensure consistent availability of ART medications, contraceptives, and other essential maternal health commodities, reducing stockouts and improving treatment adherence.

9. Policy and Advocacy: Advocate for policy changes and increased funding to support maternal health programs, including Option B+ implementation, and address systemic barriers that hinder access to care for postpartum women.

10. Research and Innovation: Invest in research and innovation to continuously improve the effectiveness and efficiency of Option B+ programs, identify new strategies for preventing mother-to-child transmission of HIV, and address the unique needs and challenges faced by postpartum women in different settings.
AI Innovations Description
Based on the information provided, here is a recommendation that can be developed into an innovation to improve access to maternal health:

1. Implement routine postpartum HIV RNA monitoring: The study found that nearly one-quarter of the women in the cohort did not achieve plasma virologic suppression in the postpartum period, despite months of antiretroviral therapy (ART). To address this, it is recommended to introduce routine postpartum HIV RNA monitoring in Option B+ programs. This would involve regularly testing the plasma, breast milk, and endocervical secretions of postpartum women to detect HIV RNA levels. By monitoring viral load levels, healthcare providers can identify women who are not achieving viral suppression and provide appropriate interventions to improve treatment adherence and outcomes.

2. Early initiation of ART in pregnancy: The study also found that earlier initiation of ART in pregnancy was significantly associated with plasma virologic suppression. To improve access to maternal health, it is recommended to promote early initiation of ART in pregnant women who are HIV-positive. This can be achieved through increased awareness and education among healthcare providers and pregnant women about the benefits of early initiation of ART in preventing mother-to-child transmission of HIV.

3. Strengthen adherence support: Adherence to ART is crucial for achieving viral suppression and improving maternal health outcomes. To enhance adherence, it is recommended to strengthen adherence support for postpartum women on ART. This can include providing counseling and education on the importance of adherence, addressing barriers to adherence such as stigma and side effects, and offering practical support such as reminder systems and peer support groups.

4. Improve access to viral load testing: The study mentioned that access to viral load testing for mothers was limited due to technical barriers. To address this, it is recommended to improve access to viral load testing for postpartum women. This can be done by ensuring that healthcare facilities have the necessary equipment and trained personnel to perform viral load testing. Additionally, efforts should be made to address any logistical or financial barriers that may prevent women from accessing viral load testing.

By implementing these recommendations, it is expected that access to maternal health will be improved, leading to better outcomes for HIV-positive postpartum women and their infants.
AI Innovations Methodology
In order to improve access to maternal health, there are several potential recommendations that can be considered:

1. Strengthening healthcare infrastructure: Investing in healthcare facilities, equipment, and trained healthcare professionals can help improve access to maternal health services. This includes ensuring that healthcare facilities are adequately equipped to provide antenatal care, skilled birth attendance, emergency obstetric care, and postnatal care.

2. Increasing community awareness and education: Conducting awareness campaigns and providing education on maternal health can help increase knowledge and understanding among women and their families. This can include information on the importance of antenatal care, skilled birth attendance, postnatal care, and family planning.

3. Improving transportation and logistics: Addressing transportation challenges can help ensure that pregnant women can access healthcare facilities in a timely manner. This can involve improving road infrastructure, providing transportation subsidies or vouchers, and establishing referral systems for emergency obstetric care.

4. Promoting maternal health insurance: Introducing or expanding maternal health insurance schemes can help reduce financial barriers to accessing maternal health services. This can include providing subsidized or free health insurance coverage for pregnant women and their families.

5. Integrating technology: Leveraging technology, such as telemedicine and mobile health applications, can help improve access to maternal health services, especially in remote or underserved areas. This can include providing remote consultations, health information, and reminders for antenatal and postnatal care.

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

1. Define the target population: Identify the specific population that will be impacted by the recommendations, such as pregnant women in a particular region or country.

2. Collect baseline data: Gather data on the current state of access to maternal health services in the target population. This can include information on healthcare infrastructure, transportation availability, community awareness, insurance coverage, and technology usage.

3. Define indicators: Determine the key indicators that will be used to measure the impact of the recommendations. This can include indicators such as the number of antenatal care visits, skilled birth attendance rates, postnatal care utilization, and maternal health outcomes.

4. Develop a simulation model: Create a simulation model that incorporates the various recommendations and their potential impact on the defined indicators. This can involve using mathematical equations, statistical models, or simulation software to estimate the changes in access to maternal health services.

5. Input data and run simulations: Input the baseline data into the simulation model and run multiple simulations to estimate the impact of the recommendations. This can involve varying the parameters of the recommendations, such as the level of investment in healthcare infrastructure or the coverage of maternal health insurance.

6. Analyze results: Analyze the results of the simulations to determine the potential impact of the recommendations on improving access to maternal health. This can include comparing the baseline data with the simulated data to identify the changes in the defined indicators.

7. Validate and refine the model: Validate the simulation model by comparing the simulated results with real-world data, if available. Refine the model based on feedback and additional data to improve its accuracy and reliability.

By following this methodology, policymakers and healthcare stakeholders can gain insights into the potential impact of different recommendations on improving access to maternal health and make informed decisions on implementing the most effective strategies.

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