Pregnancy Outcomes among Pregnant Persons after COVID-19 Vaccination: Assessing Vaccine Safety in Retrospective Cohort Analysis of U.S. National COVID Cohort Collaborative (N3C).

COVID-19 vaccines have been shown to be effective in preventing severe illness, including among pregnant persons. The vaccines appear to be safe in pregnancy, supporting a continuously favorable overall risk/benefit profile, though supportive data for the U.S. over different periods of variant predominance are lacking. We sought to analyze the association of adverse pregnancy outcomes with COVID-19 vaccinations in the pre-Delta, Delta, and Omicron SARS-CoV-2 variants' dominant periods (constituting 50% or more of each pregnancy) for pregnant persons in a large, nationally sampled electronic health record repository in the U.S. Our overall analysis included 311,057 pregnant persons from December 2020 to October 2023 at a time when there were approximately 3.6 million births per year. We compared rates of preterm births and stillbirths among pregnant persons who were vaccinated before or during pregnancy to persons vaccinated after pregnancy or those who were not vaccinated. We performed a multivariable Poisson regression with generalized estimated equations to address data site heterogeneity for preterm births and unadjusted exact models for stillbirths, stratified by the dominant variant period. We found lower rates of preterm birth in the majority of modeled periods (adjusted incidence rate ratio [aIRR] range: 0.42 to 0.85; p-value range: <0.001 to 0.06) and lower rates of stillbirth (IRR range: 0.53 to 1.82; p-value range: <0.001 to 0.976) in most periods among those who were vaccinated before or during pregnancy compared to those who were vaccinated after pregnancy or not vaccinated. We largely found no adverse associations between COVID-19 vaccination and preterm birth or stillbirth; these findings reinforce the safety of COVID-19 vaccination during pregnancy and bolster confidence for pregnant persons, providers, and policymakers in the importance of COVID-19 vaccination for this group despite the end of the public health emergency.

Effect of Integrase Strand Transfer Inhibitor Use on Time to HIV Viral Suppression before Delivery.

OBJECTIVES: We sought to determine whether pregnant individuals with human immunodeficiency virus (HIV) prescribed integrase strand transfer inhibitor (INSTI) antiretrovirals (ARVs) achieve viral suppression faster than individuals taking non-INSTI regimens and to determine whether there were differences in viral suppression at delivery among INSTI ARVs. METHODS: This is a retrospective cohort study of pregnant individuals with HIV who delivered a live infant during the study period (January 1, 2009-December 31, 2020). Patients' ARV therapy (ART) was classified as including INSTI or non-INSTI. We compared the proportion of individuals with viral suppression at delivery by group and individual INSTI ARVs using χ2 and Fisher exact tests. A log rank test was used to compare time to viral suppression on ARVs. RESULTS: During the study period, 168 individuals delivered a live infant. Most of the patients were diagnosed as having HIV before pregnancy and had taken ARVs before conception (76%), but fewer than half had an undetectable viral load at the first antenatal visit (45%). During pregnancy, 46% were prescribed INSTI and 54% were prescribed non-INSTI ARVs. Most had an undetectable HIV RNA viral load at delivery (75% INSTI and 72% non-INSTI, P = 0.7). The time to viral suppression was similar between groups (log rank test P = 0.43). Viral suppression at delivery was similar among INSTI ARVs: raltegravir (53%), elvitegravir (88%), dolutegravir (73%), and bictegravir (88%) (P = 0.13). CONCLUSIONS: Despite recommendations to prescribe INSTI in pregnancy for rapid viral suppression, we did not find a significant difference in time to viral suppression when pregnant individuals were taking non-INSTI ARVs. We did not find that one INSTI ARV was superior for viral suppression.

Attitudes on breast feeding among persons with HIV who have given birth and their perceptions of coercion during counseling on safe infant feeding practices.

Persons with HIV can receive mixed messages about the safety of breastfeeding. We sought to assess if they felt coerced to formula feed when counseled about practices to reduce HIV transmission. Persons with HIV who had given birth were eligible to complete a survey to describe their experiences with infant feeding counseling and if they felt coerced to formula feed. An Iowa Infant Feeding Attitude Scale (IIFAS) assessed attitudes towards breastfeeding. Qualitative analyses were performed on narrative responses. One hundred surveys were collected from sites in Georgia, North Carolina, Pennsylvania, and South Carolina. The mean IIFAS score (n, 85) was 47 (SD 9.2), suggesting relatively favorable attitudes toward breastfeeding. Thirteen persons reported feeling coerced to formula feed. When controlling for choosing to give any breast milk, persons with any college education were more likely to report feeling coerced (aOR 9.8 [95% CI 1.8-52.5]). Qualitative analyses revealed three themes: perceiving breastfeeding as unsafe, engaging in shared decision-making, and resisting advice to formula feed. Persons with HIV desire to be counseled about safe infant feeding practices and have their questions answered without judgement. We highlight experiences of persons with HIV that reflect a need for a nuanced approach to infant feeding counseling.

Perception of coercion during contraceptive counseling among individuals with HIV.

OBJECTIVE: Historically, individuals with HIV have reported feeling coerced during contraceptive counseling or experienced forced sterilization. The purpose of this study was to assess perceptions of coercion related to counseling and influence on postpartum contraceptive choice among individuals with HIV. METHODS: This is a mixed methods study conducted in Georgia, North Carolina, Pennsylvania, and South Carolina between March 2020 and June 2021. Participants completed a survey to assess their experiences with contraception counseling and perceived coercion. An Interpersonal Quality of Family Planning (IQFP) care score was calculated to assess quality of counseling. Qualitative analyses were performed on narrative responses. Bivariate and regression analyses were used to evaluate factors associated with perceived coercion and IQFP scores. RESULTS: 100 surveys were collected. The median age of respondents was 29 (IQR 24-35). The median IQFP score was 53 (IQR 44-55) and 45 % of individuals had a maximum IQFP score of 55. Most individuals (96 %) report that a provider "did a good job" explaining contraceptive options and 26 % report their provider's preference affected their contraceptive choice to some degree. Few (11 %) respondents felt pressured to use long-acting reversible contraception postpartum. This perceived coercion was more likely when a provider suggested a specific contraceptive method, aOR 6.1 [95 % CI 1.1-33.1] and such specific provider suggestions were reported by one-third of respondents. CONCLUSION: While perceived coercion was reported by few individuals with HIV, it was strongly associated with the provider making a specific method suggestion. Disproportionate provider influence in the final contraceptive decision occurred in one-quarter of individuals. More research is needed to discern to what extent provider preference compromises patient autonomy in shared decision-making.

Impact of Integrase Strand Transfer Inhibitor Use During Pregnancy on Viral Suppression at Delivery and Infant Outcomes: A Statewide Retrospective Cohort Study.

BACKGROUND: We sought to determine whether pregnant women with HIV prescribed integrase strand transfer inhibitor (INSTI) were more likely to have viral suppression at delivery and any increased risk of adverse infant outcomes. METHODS: This was a retrospective, statewide cohort study of women with HIV and their HIV-exposed infants who delivered in South Carolina from 2008 to 2019. Women's antenatal AVRs were classified as INSTI or non-INSTI. We compared the percentage of women with undetectable HIV RNA viral load (<40 copies/mL) at delivery between groups. We compared the percentage of HIV-exposed singleton infants who were born preterm delivery, low birth weight, and small for gestational age and had confirmed perinatal HIV infection. Categorical outcomes were compared using the χ2 test or Fischer exact test. RESULTS: A total of 832 infants, including 11 sets of twins, were exposed to maternal HIV. Detailed antiretroviral regimens were available for analysis in a third of mother-infant pairs (n = 315). Half of the infants were exposed to INSTI (159) and half to non-INSTI antiretrovirals (156). Most women had an undetectable viral load at delivery (80% INSTI and 73% non-INSTI, P= 0.11). The percentage of singleton infants with adverse outcomes was similar between INSTI and non-INSTI groups: preterm delivery (21% and 16%, P = 0.3), low birth weight (19% and 21%, P = 0.7), small for gestational age (11% vs 9%, P = 0.5), and perinatal HIV infection (2.5% and 1.3%, P = 0.7). CONCLUSIONS: We observed that viral suppression before delivery was similar between pregnant women prescribed INSTI and non-INSTI antiretroviral therapy. The percentage of infants with adverse outcomes was similar when exposed to INSTI and non-INSTI antiretroviral therapy.

Quality improvement to evaluate and provide treatment for chronic hepatitis C postpartum.

BACKGROUND: Chronic hepatitis C virus (HCV) infections are increasing among reproductive age individuals. Direct acting antivirals (DAAs) can cure HCV, but the use of DAAs is not currently recommended during pregnancy and breastfeeding. Individuals with HCV commonly have inadequate prenatal and postnatal care. OBJECTIVES: The purpose of our study was to demonstrate the success of a quality improvement program to increase evaluation during pregnancy and ensuring access to DAA treatment medication during the postpartum period for individuals with chronic HCV to achieve cure 12 weeks after completing therapy. The primary outcome was documented HCV cure rate compared among individuals who received immediate treatment with DAA after delivery or after weaning or a traditional approach of referral to an infectious diseases specialist or hepatologist. The secondary outcome was the proportion of infants exposed to HCV evaluated. METHODS: An interdisciplinary team developed a program to increase evaluation and HCV treatment for postpartum individuals. Individuals who received prenatal care from March 2017 to May 2021 were eligible. Individuals with chronic HCV had a laboratory evaluation before delivery, and appropriate DAAs were selected for postpartum treatment. The health system specialty pharmacy dispensed DAA prescriptions immediately after delivery to those who were not breastfeeding. Individuals who did breastfeed had the option to begin treatment after weaning. Cure was defined as a sustained viral response or undetectable HCV RNA collected 12 weeks after completing DAA treatment. RESULTS: We demonstrate the success of an interdisciplinary team to ensure access to therapy for the treatment of postpartum chronic HCV. Only 3 infants (25%) with mothers referred were evaluated at our institution compared with 44% of infants (n = 10) whose mothers were treated after delivery. CONCLUSION: An interdisciplinary team for HCV treatment improves access to treatment therapy with DAAs leading to the cure of chronic HCV after delivery.

Cognitive effects of diarrhea, malnutrition, and Entamoeba histolytica infection on school age children in Dhaka, Bangladesh.

Cognitive function was assessed in 191 Bangladeshi children 6-9 years of age using verbal and nonverbal tests. These scores were added to a health surveillance database that was compiled over the four previous years that includes incidence of diarrhea and Entamoeba histolytica infection and nutritional status. The associations of diarrhea, malnutrition, and social factors with cognitive scores were analyzed statistically, and associations between diarrhea and test scores were controlled for the influence of social factors. Cognitive scores were negatively associated with stunting during school age, as well as the height-for-age and weight-for-age scores at study enrollment. Incidence of diarrhea was associated with nonverbal test scores before, but not after, controlling for socioeconomic factors. Generally E. histolytica infection was not found to independently influence scores, except that E. histolytica-associated dysentery was associated with lower test scores while dysentery of any etiology was not. Thus, malnutrition during the school age years, but not diarrhea or E. histolytica infection, was associated with a lower level of cognitive functioning. This suggested that intervention during school age years may be able to mitigate the cognitive deficiencies associated with malnutrition.