Association between SARS-CoV-2 Infection and Adverse Perinatal Outcomes by Race/Ethnicity in a Large Integrated Health Care System.

OBJECTIVE: Recent studies have reported associations between severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection during pregnancy and adverse perinatal outcomes but the extent to which these associations vary by race/ethnicity remains uncertain. Therefore, we examined how the association between prenatal SARS-CoV-2 infection and adverse perinatal outcomes may be modified by race/ethnicity. STUDY DESIGN: A retrospective cohort study was performed using data on 67,986 pregnant women extracted from the Kaiser Permanente Southern California electronic health records between April 6, 2020, and December 31, 2021. Upon admission to labor and delivery, all women were routinely tested for coronavirus disease 2019 (COVID-19) using real-time reverse-transcriptase polymerase chain reaction test. Adjusted odds ratios (aORs) were used to estimate associations. RESULTS: During the study period, COVID-19 was diagnosed in 4,960 (7%) of singleton pregnancies, with the highest rates observed among Hispanics (9.4%) and non-Hispanic Blacks (6.2%). Compared with non-Hispanic Whites, Hispanics (aOR: 1.12, 95% CI: 1.03, 1.21) with SARS-CoV-2 infection had the highest odds of a pregnancy associated with nonreassuring fetal heart rate tracing. Neonates of all races/ethnicities, except for non-Hispanic Blacks, showed significantly increased odds of SARS-CoV-2 infection, with the highest risk observed among Asians/Pacific Islanders (aOR: 10.88, 95% CI: 1.33, 89.04). Non-Hispanic White mothers who tested positive were admitted to intensive care unit (ICU) at a higher rate at delivery and within 7 days of delivery (aOR: 34.77, 95% CI: 11.3, 107.04; aOR: 26.48, 95% CI: 9.55, 73.46, respectively). Hispanics were also at a significantly higher odds of admission to ICU (aOR: 4.62, 95% CI: 2.69, 7.94; aOR: 4.42, 95% CI: 2.58, 7.56, respectively). Non-Hispanic Black, Hispanic, and Asian/Pacific Islander mothers who tested positive for SARS-CoV-2 prenatally, were at increased risk for preeclampsia/eclampsia, and preterm birth as compared to non-Hispanic White mothers. CONCLUSION: The findings highlight racial/ethnic disparities in the association between SARS-CoV-2 infection and adverse perinatal outcomes. The risk of neonatal SARS-CoV-2 infection was highest for Asian/Pacific Islanders. We also observed a remarkably high risk of ICU admission for non-Hispanic White mothers infected with SARS-CoV-2. KEY POINTS: · Race/ethnicity influences perinatal outcomes in pregnancies impacted by SARS-CoV-2.. · The risk of neonatal SARS-CoV-2 infection was highest for Asian/Pacific Islanders.. · White mothers had a notably high risk of ICU admission at delivery following SARS-CoV-2 infection..

Rising Trends of Childhood Attention-Deficit/Hyperactivity Disorder in a Large Integrated Healthcare Delivery System in Southern California, 2010-2021.

OBJECTIVE: To evaluate trends of attention-deficit/hyperactivity disorder (ADHD) diagnosis rates among children aged 5-17 years over the past decade (2010-2021) and to investigate whether there have been differences in temporal changes based on race and ethnicity, sex, or income. STUDY DESIGN: Childhood ADHD diagnosis was ascertained from electronic health records using International Classification of Diseases ninth revision (314.xx) and International Classification of Diseases tenth revision (F90.x) codes. Data were stratified by child's sex, race and ethnicity, and household income, and rates of ADHD were estimated before and after adjustment for potential confounders. RESULTS: The overall ADHD diagnosis rates increased from 3.5% in 2010 to 4.0% in 2021. ADHD diagnosis was most prevalent among White children (6.1%), then Black (4.6%), Other/multiple (3.7%), Hispanic (3.1%), and Asian/Pacific Islander (PI) (1.7%). ADHD was also highly prevalent among boys (73.3%) or family income≥$70,000 (50.0%). ADHD diagnosis increased among Black (4.2% to 5.1%), Hispanic (2.8% to 3.6%), and Asian/PI children (1.5% to 2.0%) but remained stable for White (6.2% to 6.1%) and Other/multiple race/ethnic children (3.7% to 3.7%). Increases in the prevalence among girls were also observed. CONCLUSION: The prevalence of ADHD in children has risen with the largest increases observed for Black, Hispanic, and Asian/PI children. Rates among less affluent families and girls have also been increasing, narrowing the gaps in diagnosis rates previously observed. These increases may reflect improvements in screening and provision of care among demographics where ADHD has been historically underdiagnosed.

Placental abruption: Incidence and risk of recurrence in subsequent pregnancies.

AIM: To estimate the incidence of abruption in first births and recurrence in the subsequent birth in patients of a large US-based integrated health care system. METHODS: Retrospective population-based cohort study of patients with first two consecutive singleton births using data from the Kaiser-Permanente South California health care system who delivered over a period of 30 years (1991-2021), using longitudinally linked electronic health records. ICD-9/ICD-10 codes "641.20" and "O45.x" identified placental abruption. We calculated the incidence and rates of abruption in first and second pregnancies. We used logistic regression to estimate the adjusted odds ratios (aOR) for abruption in second pregnancies in patients with and without abruptions in their first pregnancies. RESULTS: Of the 126 264 patients with first two consecutive singleton births over the period, 805 had abruptions in their first births, and 861 in their second births. Rates of abruption in first and second births were 0.63% and 0.68%, respectively. Twenty-seven patients had abruptions in both first and second births. Rates of abruption in the second birth among individuals with and without previous placental abruption were 3.35% and 0.66%, respectively, giving an approximately five-fold increased odds of abruption in a second pregnancy in individuals who had abruption in their first birth when compared with those who did not have placental abruption in their first birth (aOR: 4.95, 95% confidence interval: 3.35-7.31, p < 0.00001). Interpregnancy interval had no statistically significant association with recurrence. CONCLUSION: Abruption in a first birth is associated with an approximately five-fold increased odds of abruption in a second birth.

Maternal-child consumption of ultra-processed foods and sugar-sweetened beverages in informal settlements in Mumbai, India.

BACKGROUND: The global nutrition transition is associated with increased consumption of ultra-processed snack foods and sugar-sweetened beverages (UPF/SSB), contributing to the double burden of child obesity and undernutrition. METHODS: This cross-sectional study describes the prevalence of maternal and child UPF/SSB consumption and the factors associated with frequent consumption in a convenience sample of 749 children ages 6 months through 6 years and their mothers participating in a community-based child oral health program in five informal settlement communities in Mumbai, India. Mothers were interviewed regarding maternal and child oral health and nutrition characteristics, including consumption of beverages and foods associated with tooth decay-milk, soda, tea with sugar, sweets, and chips/biscuits-using standardized questionnaires. Spearman correlations were used to assess for associations between various social factors and the frequency of maternal and child consumption of the five food categories. Chi-square tests were used to assess differences in child consumption patterns by age groups. RESULTS: Though reported soda consumption was low among both mothers and children, nearly 60% of children consumed sweets and chips/biscuits daily, four to five times the rate of mothers. Factors associated with children's frequent consumption of UPF/SSB included lower maternal education level, frequent maternal consumption of UPF/SSB, greater number of household members, greater amount of money given to the child, and closer proximity to a store. CONCLUSION: Our findings demonstrate social factors that may promote UPF/SSB consumption. The nutritional dangers of sugary drinks and non-nutritious snacks for mothers and young children should be addressed across maternal-child health, education, and social service programs. Early childhood nutrition interventions should involve the entire family and community and emphasize the need to limit children's consumption of unhealthy foods and beverages from an early age.

Evaluating the use of oral pre-exposure prophylaxis among pregnant and postpartum adolescent girls and young women in Cape Town, South Africa.

Background: Adolescent girls and young women (AGYW) in South Africa are at a higher risk of acquiring HIV. Despite the increasing availability of daily oral pre-exposure prophylaxis (PrEP) for HIV prevention, knowledge on PrEP use during pregnancy and postpartum periods at antenatal care (ANC) facilities remains inadequate. Methods: Data from HIV-uninfected pregnant women in Cape Town, South Africa, were used in this study. These women aged 16-24 years were enrolled in the PrEP in pregnancy and postpartum (PrEP-PP) cohort study during their first ANC visit. Using the PrEP cascade framework, the outcomes of the study were PrEP initiation (prescribed tenofovir disoproxil fumarate and emtricitabine at baseline), continuation (returned for prescription), and persistence [quantifiable tenofovir diphosphate (TFV-DP) in dried blood samples]. The two primary exposures of this study were risk perception for HIV and baseline HIV risk score (0-5), which comprised condomless sex, more than one sexual partner, partner living with HIV or with unknown serostatus, laboratory-confirmed sexually transmitted infections (STIs), and hazardous alcohol use before pregnancy (Alcohol Use Disorders Identification Test for Consumption score ≥ 3). Logistic regression was used to examine the association between HIV risk and PrEP, adjusting for a priori confounders. Results: A total of 486 pregnant women were included in the study, of which 16% were "adolescents" (aged 16-18 years) and 84% were "young women" (aged 19-24 years). The adolescents initiated ANC later than the young women [median = 28 weeks (20-34) vs. 23 weeks (16-34), p = 0.04]. Approximately 41% of the AGYW were diagnosed with sexually transmitted infection at baseline. Overall, 83% of the AGYW initiated PrEP use during their first ANC. The percentage of PrEP continuation was 63% at 1 month, 54% at 3 months, and 39% at 6 months. Approximately 27% consistently continued PrEP use through 6 months, while 6% stopped and restarted on PrEP use at 6 months. With a higher risk score of HIV (≥2 vs. ≤1), the AGYW showed higher odds of PrEP continuation [adjusted odds ratio: 1.85 (95% CI: 1.12-3.03)] through 6 months, adjusting for potential confounders. Undergoing the postpartum period (vs. pregnant) and having lower sexual risk factors were found to be the barriers to PrEP continuation. TFV-DP concentration levels were detected among 49% of the AGYW, and 6% of these women had daily adherence to PrEP at 3 months. Conclusions: AGYW were found to have high oral PrEP initiation, but just over one-third of these women continued PrEP use through 6 months. Pregnant AGYW who had a higher risk of acquiring HIV (due to condomless sex, frequent sex, and STIs) were more likely to continue on PrEP use through the postpartum period. Pregnant and postpartum AGYW require counseling and other types of support, such as community delivery and peer support to improve their effective PrEP use through the postpartum period. Clinical Trial Number: ClinicalTrials.gov, NCT03826199.

Psychosocial determinants of pre-exposure prophylaxis use among pregnant adolescent girls and young women in Cape Town, South Africa: A qualitative study.

BACKGROUND: In South Africa, at least 7.5 million people (age ≥15 years) are living with Human Immunodeficiency Virus (HIV). In 2020, 220,000 new infections occurred, approximately one-third of which were among cisgender adolescent girls and women (age ≥15 years). The perspectives of pregnant adolescent girls and young women (AGYW) as key, targeted end-users of pre-exposure prophylaxis (PrEP) in this setting are not well known. METHODS: We purposively recruited participants enrolled in an ongoing cohort study at an urban antenatal clinic in Cape Town, South Africa for in-depth interviews between July-September 2020. We restricted our analysis to pregnant AGYW (age: 16-25 years) who initiated daily oral PrEP (Tenofovir/Emtricitabine) antenatally and self-reported either high PrEP persistence (≥25 days in the past 30 days and no missed PrEP collection), or low PrEP persistence and/or discontinuation (missing >5 days in the last 30 days or missed PrEP collection). The findings were organized thematically, per the adapted Health Behavior Model (2000), using Nvivo-v.1.5. RESULTS: We interviewed 18 AGYW (mean age = 22 years), at a mean of 14 weeks postpartum. Higher self-esteem and high-quality study provider-client relationships, including empathic psychosocial support, facilitated PrEP continuation. Reported barriers included unstable social structure characteristics (i.e., financial hardship) and individual factors (i.e., unintended pregnancy, parental rejection, and inadequate peer- and [non-cohabiting] partner support). Participants self-perceived a need for PrEP, feeling susceptible to non-consensual, forced sex, or considering partners' (presumed) sexual risk-taking. Limited community awareness regarding PrEP availability and/or perceived complexity in navigating health system access to PrEP, impede continuation. CONCLUSIONS: PrEP-focused healthcare access pathways for pregnant and postpartum AGYW need to be simplified. Further research is needed on health system determinants (i.e., structural barriers, provider-client interactions, and related outcomes) of oral PrEP utilization. In 2022, South Africa announced regulatory approval of long-acting PrEP options (i.e., the dapivirine ring for non-pregnant women and injectable cabotegravir, respectively); these may mitigate implementation barriers reported in this study. However, the safety and efficacy of long-acting PrEP (e.g., injectables, implants) among pregnant or breastfeeding women, specifically, remains to be confirmed in this setting.

Identification of Postpartum Depression in Electronic Health Records: Validation in a Large Integrated Health Care System.

BACKGROUND: The accuracy of electronic health records (EHRs) for identifying postpartum depression (PPD) is not well studied. OBJECTIVE: This study aims to evaluate the accuracy of PPD reporting in EHRs and compare the quality of PPD data collected before and after the implementation of the International Classification of Diseases, Tenth Revision (ICD-10) coding in the health care system. METHODS: Information on PPD was extracted from a random sample of 400 eligible Kaiser Permanente Southern California patients' EHRs. Clinical diagnosis codes and pharmacy records were abstracted for two time periods: January 1, 2012, through December 31, 2014 (International Classification of Diseases, Ninth Revision [ICD-9] period), and January 1, 2017, through December 31, 2019 (ICD-10 period). Manual chart reviews of clinical records for PPD were considered the gold standard and were compared with corresponding electronically coded diagnosis and pharmacy records using sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Kappa statistic was calculated to measure agreement. RESULTS: Overall agreement between the identification of depression using combined diagnosis codes and pharmacy records with that of medical record review was strong (κ=0.85, sensitivity 98.3%, specificity 83.3%, PPV 93.7%, NPV 95.0%). Using only diagnosis codes resulted in much lower sensitivity (65.4%) and NPV (50.5%) but good specificity (88.6%) and PPV (93.5%). Separately, examining agreement between chart review and electronic coding among diagnosis codes and pharmacy records showed sensitivity, specificity, and NPV higher with prescription use records than with clinical diagnosis coding for PPD, 96.5% versus 72.0%, 96.5% versus 65.0%, and 96.5% versus 65.0%, respectively. There was no notable difference in agreement between ICD-9 (overall κ=0.86) and ICD-10 (overall κ=0.83) coding periods. CONCLUSIONS: PPD is not reliably captured in the clinical diagnosis coding of EHRs. The accuracy of PPD identification can be improved by supplementing clinical diagnosis with pharmacy use records. The completeness of PPD data remained unchanged after the implementation of the ICD-10 diagnosis coding.

Examining recent trends in spontaneous and iatrogenic preterm birth across race and ethnicity in a large managed care population.

BACKGROUND: For the past several decades, epidemiological studies originating from the United States have consistently reported increasing rates of preterm birth (PTB). Despite the implementation of several clinical and public health interventions to reduce PTB rates, it remains the leading cause of infant morbidity and mortality in the United States and around the world. OBJECTIVE: This study aimed to examine recent trends in preterm birth and its clinical subtypes by maternal race and ethnicity among singleton births. STUDY DESIGN: Kaiser Permanente Southern California electronic health records for all singleton births between 2009 and 2020 (n=427,698) were used to examine preterm birth trends and their subtypes (spontaneous and iatrogenic preterm births). Data on preterm labor triage extracted from electronic health records using natural language processing were used to define preterm birth subtypes. Maternal race and ethnicity are categorized as non-Hispanic White, non-Hispanic Black, Hispanic, and non-Hispanic Asian or Pacific Islander. Multiple logistic regression was used to quantify the linear trend for preterm birth and its subtypes. Racial and ethnic trends were further examined by considering statistical interactions and stratifications. RESULTS: From 2009 to 2020, the overall preterm birth rate decreased by 9.12% (from 8.04% to 7.31%; P<.001). The rates decreased by 19.29% among non-Hispanic Whites (from 7.23% to 5.83%; P<.001), 6.15% among Hispanics (from 7.82% to 7.34%; P=.036), and 12.60% among non-Hispanic Asian or Pacific Islanders (from 8.90% to 7.78%; P<.001), whereas a nonsignificantly increased preterm birth rate (8.45%) was observed among non-Hispanic Blacks (from 9.91% to 10.75%; P=.103). Between 2009 and 2020, overall spontaneous preterm birth rates decreased by 28.85% (from 5.75% to 4.09%; P<.001). However, overall iatrogenic preterm birth rates increased by 40.45% (from 2.29% to 3.22%; p<.001). Spontaneous preterm birth rates decreased by 34.73% among non-Hispanic Whites (from 5.44% to 3.55%; P<.001), 19.75% among non-Hispanic Blacks (from 6.82% to 5.47%; P<.001), 22.96% among Hispanics (from 5.55% to 4.28%; P<.001), and 28.19% among non-Hispanic Asian or Pacific Islanders (from 6.50% to 4.67%; P<.001). Iatrogenic preterm birth rates increased by 52.42% among non-Hispanic Whites (from 1.88% to 2.61%; P<.001), 107.89% among non-Hispanic Blacks (from 3.18% to 6.13%; P<.001), 46.88% among Hispanics (from 2.29% to 3.26%; P<.001), and 42.21% among non-Hispanic Asian or Pacific Islanders (from 2.45% to 3.44%; P<.001). CONCLUSION: The overall preterm birth rate decreased over time and was driven by a decrease in the spontaneous preterm birth rate. There is racial and ethnic variability in the rates of spontaneous preterm birth and iatrogenic preterm birth. The observed increase in iatrogenic preterm birth among all racial and ethnic groups, especially non-Hispanic Blacks, is disconcerting and needs further investigation.

Postpartum Migraine Headache Coding in Electronic Health Records of a Large Integrated Health Care System: Validation Study.

BACKGROUND: Migraine is a common neurological disorder characterized by repeated headaches of varying intensity. The prevalence and severity of migraine headaches disproportionally affects women, particularly during the postpartum period. Moreover, migraines during pregnancy have been associated with adverse maternal outcomes, including preeclampsia and postpartum stroke. However, due to the lack of a validated instrument for uniform case ascertainment on postpartum migraine headache, there is uncertainty in the reported prevalence in the literature. OBJECTIVE: The aim of this study was to evaluate the completeness and accuracy of reporting postpartum migraine headache coding in a large integrated health care system's electronic health records (EHRs) and to compare the coding quality before and after the implementation of the International Classification of Diseases, 10th revision, Clinical Modification (ICD-10-CM) codes and pharmacy records in EHRs. METHODS: Medical records of 200 deliveries in all 15 Kaiser Permanente Southern California hospitals during 2 time periods, that is, January 1, 2012 through December 31, 2014 (International Classification of Diseases, 9th revision, Clinical Modification [ICD-9-CM] coding period) and January 1, 2017 through December 31, 2019 (ICD-10-CM coding period), were randomly selected from EHRs for chart review. Two trained research associates reviewed the EHRs for all 200 women for postpartum migraine headache cases documented within 1 year after delivery. Women were considered to have postpartum migraine headache if either a mention of migraine headache (yes for diagnosis) or a prescription for treatment of migraine headache (yes for pharmacy records) was noted in the electronic chart. Results from the chart abstraction served as the gold standard and were compared with corresponding diagnosis and pharmacy prescription utilization records for both ICD-9-CM and ICD-10-CM coding periods through comparisons of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), as well as the summary statistics of F-score and Youden J statistic (J). The kappa statistic (κ) for interrater reliability was calculated. RESULTS: The overall agreement between the identification of migraine headache using diagnosis codes and pharmacy records compared to the medical record review was strong. Diagnosis coding (F-score=87.8%; J=82.5%) did better than pharmacy records (F-score=72.7%; J=57.5%) when identifying cases, but combining both of these sources of data produced much greater accuracy in the identification of postpartum migraine cases (F-score=96.9%; J=99.7%) with sensitivity, specificity, PPV, and NPV of 100%, 99.7%, 93.9%, and 100%, respectively. Results were similar across the ICD-9-CM (F-score=98.7%, J=99.9%) and ICD-10-CM coding periods (F-score=94.9%; J=99.6%). The interrater reliability between the 2 research associates for postpartum migraine headache was 100%. CONCLUSIONS: Neither diagnostic codes nor pharmacy records alone are sufficient for identifying postpartum migraine cases reliably, but when used together, they are quite reliable. The completeness of the data remained similar after the implementation of the ICD-10-CM coding in the EHR system.

Identification of Preterm Labor Evaluation Visits and Extraction of Cervical Length Measures from Electronic Health Records Within a Large Integrated Health Care System: Algorithm Development and Validation.

BACKGROUND: Preterm birth (PTB) represents a significant public health problem in the United States and throughout the world. Accurate identification of preterm labor (PTL) evaluation visits is the first step in conducting PTB-related research. OBJECTIVE: We aimed to develop a validated computerized algorithm to identify PTL evaluation visits and extract cervical length (CL) measures from electronic health records (EHRs) within a large integrated health care system. METHODS: We used data extracted from the EHRs at Kaiser Permanente Southern California between 2009 and 2020. First, we identified triage and hospital encounters with fetal fibronectin (fFN) tests, transvaginal ultrasound (TVUS) procedures, PTL medications, or PTL diagnosis codes within 240/7-346/7 gestational weeks. Second, clinical notes associated with triage and hospital encounters within 240/7-346/7 gestational weeks were extracted from EHRs. A computerized algorithm and an automated process were developed and refined by multiple iterations of chart review and adjudication to search the following PTL indicators: fFN tests, TVUS procedures, abdominal pain, uterine contractions, PTL medications, and descriptions of PTL evaluations. An additional process was constructed to extract the CLs from the corresponding clinical notes of these identified PTL evaluation visits. RESULTS: A total of 441,673 live birth pregnancies were identified between 2009 and 2020. Of these, 103,139 pregnancies (23.35%) had documented PTL evaluation visits identified by the computerized algorithm. The trend of pregnancies with PTL evaluation visits slightly decreased from 24.41% (2009) to 17.42% (2020). Of the first 103,139 PTL visits, 19,439 (18.85%) and 44,423 (43.97%) had an fFN test and a TVUS, respectively. The percentage of first PTL visits with an fFN test decreased from 18.06% at 240/7 gestational weeks to 2.32% at 346/7 gestational weeks, and TVUS from 54.67% at 240/7 gestational weeks to 12.05% in 346/7 gestational weeks. The mean (SD) of the CL was 3.66 (0.99) cm with a mean range of 3.61-3.69 cm that remained stable across the study period. Of the pregnancies with PTL evaluation visits, the rate of PTB remained stable over time (20,399, 19.78%). Validation of the computerized algorithms against 100 randomly selected records from these potential PTL visits showed positive predictive values of 97%, 94.44%, 100%, and 96.43% for the PTL evaluation visits, fFN tests, TVUS, and CL, respectively, along with sensitivity values of 100%, 90%, and 90%, and specificity values of 98.8%, 100%, and 98.6% for the fFN test, TVUS, and CL, respectively. CONCLUSIONS: The developed computerized algorithm effectively identified PTL evaluation visits and extracted the corresponding CL measures from the EHRs. Validation against this algorithm achieved a high level of accuracy. This computerized algorithm can be used for conducting PTL- or PTB-related pharmacoepidemiologic studies and patient care reviews.

Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial.

BACKGROUND: HIV incidence among pregnant and postpartum women remains high in South Africa. Pre-exposure prophylaxis (PrEP) use remains suboptimal in this population, particularly during the postpartum period when women's engagement with routine clinic visits outside PrEP decreases. Key barriers to sustained PrEP use include the need for ongoing contact with the health facility and suboptimal counseling around effective PrEP use. METHODS: Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP), is a two-stepped unblinded, individually randomized controlled trial (RCT) that aims to optimize peripartum and postpartum PrEP use by providing a stepped package of evidence-based interventions. We will enroll 650 pregnant women (> 25 weeks pregnant) who access PrEP at a busy antenatal clinic in Cape Town at the time of recruitment and follow them for 15 months. We will enroll and individually randomize pregnant women > 16 years who are not living with HIV who are either on PrEP or interested in starting PrEP during pregnancy. In step 1, we will evaluate the impact of enhanced adherence counselling and biofeedback (using urine tenofovir tests for biofeedback) and rapid PrEP collection (to reduce time required) on PrEP use in early peripartum compared to standard of care (SOC) (n = 325 per arm). The primary outcome is PrEP persistence per urine tenofovir levels and dried blood spots of tenofovir diphosphate (TFV-DP) after 6-months. The second step will enroll and individually randomize participants from Step 1 who discontinue taking PrEP or have poor persistence in Step 1 but want to continue PrEP. Step 2 will test the impact of enhanced counseling and biofeedback plus rapid PrEP collection compared to community PrEP delivery with HIV self-testing on PrEP use (n = up to 325 postpartum women). The primary outcome is PrEP continuation and persistence 6-months following second randomization (~ 9-months postpartum). Finally, we will estimate the cost effectiveness of SCOPE-PP vs. SOC per primary outcomes and disability-adjusted life-years (DALYs) averted in both Step 1 and 2 using micro-costing with trial- and model-based economic evaluation. DISCUSSION: This study will provide novel insights into optimal strategies for delivering PrEP to peripartum and postpartum women in this high-incidence setting. TRIAL REGISTRATION: NCT05322629 : Date of registration: April 12, 2022.

Early pre-exposure prophylaxis (PrEP) initiation and continuation among pregnant and postpartum women in antenatal care in Cape Town, South Africa.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) is a safe and effective prevention strategy to reduce women's risk of HIV in pregnancy and postpartum. Effective PrEP protection requires daily PrEP adherence, but little is known about maternal PrEP continuation and factors that influence PrEP use. METHODS: The PrEP in pregnancy and postpartum (PrEP-PP) study enrolled consenting pregnant, HIV-negative women at first antenatal care (ANC) visit with follow-up through 12 months postpartum. Eligible and consenting women and girls ≥16 years received HIV prevention counselling and were offered PrEP. Interviewers collected socio-demographic and behavioural data from participants at each visit. We analysed the proportion of women who initiated PrEP and the proportion who continued PrEP after 3 months with associated correlates by estimating the prevalence ratio adjusting for a priori confounders. RESULTS: Between August 2019 and October 2021, we enrolled 1201 pregnant women (median gestation 21 weeks; age 26 years); 84% of women initiated PrEP at their first ANC visit (n = 1014); 55% were married or cohabiting. Overall, 66% of women on PrEP returned for a repeat prescription at 1 month; 58% returned at 3 months (n = 493 of 844). Almost one-half of women on PrEP reported a side effect at 1 month, mostly nausea/vomiting. Women on PrEP in the first and second trimesters had higher odds of reporting side effects (aOR 2.61; 95% CI 1.17-5.84) versus postpartum women. Women who reported side effects continued with PrEP less than those who did not report side effects (aPR = 0.87; 95% CI 0.77-0.97). Women with ≥1 previous pregnancy (aPR = 0.76; 95% CI 0.57-1.01) or were postpartum (aPR 0.85; 95% CI 0.75-0.97) were less likely to continue PrEP compared to women who were primigravid or pregnant. Women who reported having an HIV+ partner (aPR = 1.45; 95% CI 1.13-1.85) or high HIV risk perception (aPR = 1.20, 95% CI = 1.01-1.41) were more likely to continue on PrEP than those who had HIV-negative partners or low risk perception. CONCLUSIONS: PrEP initiation and early continuation were high in this setting, compared to other studies in women. Being postpartum and experiencing side effects were associated with lower PrEP continuation, presenting opportunities for counselling on early transient side effects. Interventions for postpartum women on PrEP are needed.

Early Childhood Junk Food Consumption, Severe Dental Caries, and Undernutrition: A Mixed-Methods Study from Mumbai, India.

In India, globalization has caused a nutrition transition from home-cooked foods to processed sugary snacks and drinks, contributing to increased early childhood caries (ECC). This mixed-methods study describes risk factors for ECC and associations with undernutrition in low-income communities in Mumbai. Interviews with mothers of 959 children, ages six-months through six-years, addressed maternal-child nutrition and oral health, and children received dental exams and anthropometric assessments. Focus groups with community health workers and mothers explored experiences and perceptions of oral health, nutrition, and ECC. Descriptive and logistic regression analyses of quantitative data, and content analysis of qualitative data were performed. Eighty percent of children lived 5 min from a junk-food store, over 50% consumed junk-food and sugary tea daily, 50% experienced ECC, 19% had severe deep tooth decay, 27% experienced mouth pain, and 56% experienced chronic and/or acute malnutrition. In children ages 3-6, each additional tooth with deep decay was associated with increased odds of undernutrition (Odds Ratio [OR] 1.10, Confidence Interval [CI] 1.02-1.21). Focus groups identified the junk-food environment, busy family life, and limited dental care as contributors to ECC. Policy interventions include limits on junk-food marketing and incorporating oral health services and counseling on junk-food/sugary drinks into maternal-child health programs.

Associations between Child Snack and Beverage Consumption, Severe Dental Caries, and Malnutrition in Nepal.

The global nutrition transition and increased consumption of sugar-sweetened beverages and ultra-processed snacks have contributed to increasing rates of child obesity and dental caries in developing countries. In Nepal, where child malnutrition rates are high, the relationship between malnutrition and dental caries is poorly understood. This cross-sectional study aims to assess this relationship among a convenience sample of 273 children age six months to less than 12 years in three communities in Nepal, using parent/caregiver interviews, child dental exams, and anthropometric measurements. Fisher's exact test and independent t-tests examined associations between dietary practices and severe caries and between severe caries and malnutrition, respectively. Children consumed sugar-sweetened beverages and processed snacks frequently: 80% consumed tea with sugar, 60% consumed sweet snacks, and 65% consumed processed savory snacks daily. Overall, 74% of children had untreated tooth decay, and 21% exhibited stunting malnutrition, 14% were underweight, and 6% presented wasting. Significant associations were found between daily consumption of sweets and processed snacks with severe caries and between severe caries and poorer nutritional status. These findings underscore the need to incorporate nutrition and oral health promotion and dental treatment into maternal-child health services and schools and to strengthen policies to reduce children's access to junk food.

Early Childhood Oral Health and Nutrition in Urban and Rural Nepal.

Globalization and urbanization in Nepal have driven a nutritional transition from an agricultural-based diet to an ultra-processed, sugary diet. This study assessed the nutrition and oral health of 836 children age 6 months to 6 years and their families in rural and urban Nepal. Mothers were interviewed about maternal-child oral health and nutrition, and children received dental exams and height and weight measurements. Analyses utilized SPSS statistical software. Most families lived within a 5-minute walk to a store selling ultra-processed snacks and sugary drinks. While most mothers knew sweets caused tooth decay, half of the children were given sweets daily, and 58.2% of children had dental caries. Caries began in the first 2 years and increased in prevalence and severity to age 6, when 74.3% had caries and 20% experienced mouth pain. Despite greater health knowledge and resources among urban mothers, urban children's increased access to junk food and frequency of consumption was associated with higher prevalence and severity of caries compared to rural children. Severe caries was associated with malnutrition, especially in rural children. Preventive strategies are needed in early childhood to incorporate nutrition and oral health education and dental care into maternal-child health services, and develop policies to prohibit the sale of junk food around schools.