Food insecurity, drug resistance and nondisclosure are associated with virologic nonsuppression among HIV pregnant women on antiretroviral treatment

  • PLoS ONE, Volume 16, No. 8 August, Year 2021

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Study Justification:
This study aimed to identify social and behavioral factors associated with virologic non-suppression among pregnant women receiving antiretroviral treatment (ART) for HIV. Understanding these factors is crucial for improving virologic suppression in pregnancy and reducing the risk of drug resistance.
Highlights:
– The study found that 12.1% of pregnant women on ART had virologic non-suppression, indicating a significant proportion of women are not achieving optimal viral suppression.
– Among those with virologic non-suppression, 65% had HIV drug resistance mutations, highlighting the importance of monitoring resistance.
– Moderate-to-severe food insecurity was associated with a higher risk of virologic non-suppression, emphasizing the need to address food security as part of HIV care for pregnant women.
– Disclosure of HIV status and higher adherence skills were associated with a lower risk of virologic non-suppression, suggesting the importance of tailored counseling and support.
– Other factors such as age, side-effects, social support, abuse, and distance were not found to be associated with virologic non-suppression.
Recommendations:
– Implement regular monitoring of HIV viral load and resistance to detect and address virologic non-suppression and drug resistance early.
– Provide tailored counseling and support to pregnant women on ART, focusing on disclosure of HIV status and improving adherence skills.
– Integrate interventions to address food insecurity into HIV care for pregnant women, as it is associated with virologic non-suppression.
Key Role Players:
– Healthcare providers: Responsible for monitoring viral load, resistance testing, and providing counseling and support to pregnant women on ART.
– Counselors: Provide tailored counseling to address disclosure and adherence skills.
– Nutritionists: Assist in addressing food insecurity and providing nutritional support.
– Researchers: Conduct further studies to explore additional factors contributing to virologic non-suppression and evaluate the effectiveness of interventions.
Cost Items for Planning Recommendations:
– Viral load testing kits and equipment
– Resistance testing kits and equipment
– Training for healthcare providers and counselors
– Counseling materials and resources
– Nutritional support programs
– Research funding for further studies and evaluation of interventions

The strength of evidence for this abstract is 7 out of 10.
The evidence in the abstract is moderately strong. The study used baseline data from a randomized controlled trial (RCT) and performed statistical analysis using Poisson regression. The study also included a large sample size of 470 pregnant women on antiretroviral treatment. However, the study design is observational and cross-sectional, which limits the ability to establish causality. To improve the strength of the evidence, future research could consider using a longitudinal design to assess the impact of interventions on virologic suppression among pregnant women on antiretroviral treatment.

We determined social and behavioral factors associated with virologic non-suppression among pregnant women receiving Option B+ antiretroviral treatment (ART). Baseline data was used from women in Mobile WAChX trial from 6 public maternal child health (MCH) clinics in Kenya. Virologic non-suppression was defined as HIV viral load (VL) ≥1000 copies/ml. Antiretroviral resistance testing was performed using oligonucleotide ligation (OLA) assay. ART adherence information, motivation and behavioral skills were assessed using Lifewindows IMB tool, depression using PHQ-9, and food insecurity with the Household Food Insecurity Access Scale. Correlates of virologic non-suppression were assessed using Poisson regression. Among 470 pregnant women on ART ≥4 months, 57 (12.1%) had virologic nonsuppression, of whom 65% had HIV drug resistance mutations. In univariate analyses, risk of virologic non-suppression was associated with moderate-to-severe food insecurity (RR 1.80 [95% CI 1.06-3.05]), and varied significantly by clinic site (range 2%-22%, p <0.001). In contrast, disclosure (RR 0.36 [95% CI 0.17-0.78]) and having higher adherence skills (RR 0.70 [95% CI 0.58-0.85]) were associated with lower risk of virologic non-suppression. In multivariate analysis adjusting for clinic site, disclosure, depression symptoms, adherence behavior skills and food insecurity, disclosure and food insecurity remained associated with virologic non-suppression. Age, side-effects, social support, physical or emotional abuse, and distance were not associated with virologic non-suppression. Prevalence of virologic non-suppression among pregnant women on ART was appreciable and associated with food insecurity, disclosure and frequent drug resistance. HIV VL and resistance monitoring, and tailored counseling addressing food security and disclosure, may improve virologic suppression in pregnancy.

This post-hoc analysis used enrollment data from a 3-arm randomized controlled trial (RCT) of short message service (SMS) in PMTCT (Mobile WAChX, {"type":"clinical-trial","attrs":{"text":"NCT02400671","term_id":"NCT02400671"}}NCT02400671), conducted at 6 public, Ministry of Health MCH clinics in Kenya. Women were eligible if they were ≥14 years old, attending antenatal care (ANC), HIV-infected, and had daily access to a mobile phone. The design and methods of the Mobile WAChX study have been described [18]. In brief, pregnant WLWH were enrolled between November 2015 and May 2017, and randomized to 1-way SMS, 2-way SMS, or control (no SMS). A questionnaire was administered to ascertain ART adherence information, motivation and behavioral skills (IMB) using an abbreviated LifeWindows instrument [19], social support using the Medical Outcomes Study (MOS) survey [20], partner abuse using the Abuse Assessment Screen [21], and depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) [22]. Stigma was assessed using the 4-question version of the Stigma Scale for Chronic Illness (SSCI) [23]. Food security was assessed using the Household Food Insecurity Access Scale (HFIAS) [16, 24]. ART initiation date and regimen were abstracted from clinic records. Participant blood samples were collected to perform ARV resistance analyses and HIV VL test if required. A survey was conducted to assess facility PMTCT services to examine if any services or clinic characteristics were associated with virologic non-suppression among the women. Follow-up of Mobile WAChX participants lasted 24 months, with the final study visit conducted in January 2020. This manuscript presents analysis of enrollment data only. At enrolment, consent was obtained and participant VL was abstracted from program data. If program VL was unavailable, VL testing of study samples was conducted at the Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) in Kisumu or Nairobi, Kenya using the Roche COBAS® TaqMan® Analyzer or COBAS® TaqMan® Version 2.0 (CAP/CTMv2.0) platform with a lower limit of quantification of 40 copies/ml. ARV drug resistance mutations were identified in cryopreserved plasma samples from women with HIV RNA levels ≥ 1000 copies/mL using an oligonucleotide ligation assay (OLA) [25]. The OLA assay detects mutations at HIV-1 pol reverse transcriptase codons 65, 103, 181, 184, and 190 that can confer resistance to non-nucleoside reverse transcriptase inhibitors (NNRTI) and nucleoside/tide reverse transcriptase inhibitors (NRTI). OLA probes have been optimized for HIV subtypes A, D, and C, common in Kenya [25]. Viral RNA extracted from plasma was reverse-transcribed and resultant cDNA was analyzed using OLA and consensus sequencing when OLA testing failed at any of the codons analyzed [25]. The study classified resistance mutations as detected if they were at an abundance of 10% or more. Statistical analysis was performed using Stata version 13 [26]. PHQ-9 scores were dichotomized with score ≥ 5 indicating at least mild depressive symptoms. HFIAS scores classified food insecurity into four levels per instrument guidelines: food secure, mildly, moderately, or severely food insecure and dichotomized into secure/mildly insecure vs. moderate/severely insecure [24]. Virologic non-suppression was defined as VL ≥ 1000 copies/ml. Analysis was restricted to women on ART for ≥ 4 months at enrollment, to allow sufficient time to achieve virologic suppression. Correlates of virologic non-suppression were determined by Poisson regression with robust standard errors. Multivariate analysis was conducted including all variables that were associated with virologic non-suppression in univariate analysis at a significance level of p<0.1. Ethical approval was obtained from the University of Washington and Kenyatta National Hospital/University of Nairobi institutional review boards. The study was performed in accordance with ethical standards in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Participants provided written informed consent prior to enrollment.

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

1. Mobile phone-based interventions: The study mentioned the use of short message service (SMS) in PMTCT. Expanding on this, mobile phone-based interventions can be further developed to provide pregnant women with important health information, reminders for medication adherence, appointment reminders, and access to counseling services.

2. Tailored counseling addressing food security: The study found that food insecurity was associated with virologic non-suppression among pregnant women on ART. Innovations can be developed to provide tailored counseling and support services specifically addressing food security, such as providing nutritional education, connecting women with local food resources, or implementing programs that provide food assistance to pregnant women.

3. HIV viral load and resistance monitoring: The study highlighted the importance of monitoring HIV viral load and drug resistance mutations among pregnant women on ART. Innovations can focus on improving access to regular viral load testing and resistance testing, such as developing point-of-care testing devices that can be used in resource-limited settings or implementing mobile clinics to reach women in remote areas.

4. Integration of mental health support: The study mentioned the assessment of depressive symptoms among pregnant women. Innovations can focus on integrating mental health support into maternal health services, such as providing counseling services, training healthcare providers in mental health screening and support, or implementing telemedicine platforms for remote mental health consultations.

5. Strengthening partner involvement and disclosure support: The study found that disclosure and having higher adherence skills were associated with lower risk of virologic non-suppression. Innovations can focus on developing interventions that promote partner involvement in maternal health, support women in disclosing their HIV status to their partners, and provide counseling and support for couples navigating HIV treatment and prevention.

It’s important to note that these recommendations are based on the information provided and may need to be further tailored and evaluated in specific contexts.
AI Innovations Description
Based on the information provided, the recommendation to improve access to maternal health would be to implement tailored counseling and interventions that address food security and disclosure among pregnant women receiving antiretroviral treatment (ART) for HIV. This recommendation is based on the findings that virologic non-suppression among pregnant women on ART was associated with moderate-to-severe food insecurity and lack of disclosure.

Specifically, the following actions can be taken:

1. HIV VL and resistance monitoring: Regular monitoring of HIV viral load (VL) and resistance testing should be conducted to identify women who are not achieving virologic suppression. This will help healthcare providers to adjust treatment regimens and provide appropriate interventions.

2. Tailored counseling: Healthcare providers should offer counseling sessions that specifically address food security and disclosure. This can include providing information on available resources for accessing nutritious food, addressing barriers to food security, and promoting open communication about HIV status with partners and healthcare providers.

3. Collaboration with support services: Collaborate with local organizations and support services that focus on food security and social support for pregnant women. This can help provide additional resources and assistance to women experiencing food insecurity.

4. Integration of mental health support: Given the association between virologic non-suppression and depression symptoms, it is important to integrate mental health support into maternal health services. Screening for depression using tools like the Patient Health Questionnaire-9 (PHQ-9) can help identify women who may need additional support and referral to mental health services.

5. Mobile health interventions: Utilize mobile health interventions, such as short message service (SMS), to provide reminders, educational information, and support to pregnant women on ART. This can help improve adherence to treatment and provide ongoing support for food security and disclosure.

By implementing these recommendations, access to maternal health can be improved by addressing the social and behavioral factors that contribute to virologic non-suppression among pregnant women on ART.
AI Innovations Methodology
Based on the information provided, here are some potential recommendations to improve access to maternal health:

1. Strengthening Antiretroviral Therapy (ART) Adherence: Develop interventions that focus on improving adherence to ART among pregnant women. This could include providing counseling and support services, implementing reminder systems (such as SMS reminders), and addressing barriers to adherence.

2. Addressing Food Insecurity: Implement strategies to address food insecurity among pregnant women on ART. This could involve providing nutritional support, linking women to food assistance programs, and integrating food security assessments and interventions into maternal health services.

3. Enhancing Disclosure Support: Develop interventions to support pregnant women in disclosing their HIV status to their partners, family members, and healthcare providers. This could include counseling services, peer support groups, and educational materials on the importance of disclosure.

4. Monitoring HIV Viral Load and Resistance: Strengthen monitoring systems to ensure regular HIV viral load testing for pregnant women on ART. Additionally, implement routine resistance testing to identify drug resistance mutations early and guide appropriate treatment adjustments.

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 of pregnant women on ART who would benefit from the recommendations. This could include factors such as age, HIV status, and access to healthcare services.

2. Collect baseline data: Gather data on the current status of access to maternal health services, including ART adherence rates, food insecurity levels, disclosure rates, and virologic suppression rates. This data can be obtained through surveys, medical records, and program data.

3. Develop a simulation model: Create a mathematical model that incorporates the various factors influencing access to maternal health, such as ART adherence, food insecurity, disclosure, and virologic suppression. This model should consider the interplay between these factors and their impact on maternal health outcomes.

4. Input intervention scenarios: Input the potential recommendations into the simulation model as intervention scenarios. This could involve adjusting parameters related to ART adherence, food insecurity, disclosure rates, and virologic suppression based on the expected impact of the interventions.

5. Simulate outcomes: Run the simulation model with the intervention scenarios to simulate the impact on improving access to maternal health. This could include measuring changes in ART adherence rates, food insecurity levels, disclosure rates, and virologic suppression rates.

6. Analyze results: Analyze the simulation results to determine the potential impact of the recommendations on improving access to maternal health. This could involve comparing the outcomes of the intervention scenarios with the baseline data to assess the effectiveness of the recommendations.

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

It’s important to note that the methodology described above is a general framework and may need to be adapted based on the specific context and available data. Additionally, the simulation results should be interpreted with caution and validated with real-world data and implementation studies.


Statistics:
Citations: 2
Identifiers:
DOI: 10.1371/journal.pone.0256249
Research Areas:
Community Interventions, Disparities, Food Security, Genetics and Genomics, Health System and Policy, Infectious Diseases, Maternal Access, Maternal and Child Health, Mental Health, Quality of Care, Sexual and Reproductive Health, Social Determinants
Study Countries:
Kenya
Study Design:
Cohort Study, Cross Sectional Study, randomised-control-trial
Study Approach:
Quantitative
Participants Gender:
Female
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