Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review.

INTRODUCTION: Pharmacovigilance (PV), or the ongoing safety monitoring after a medication has been licensed, plays a crucial role in pregnancy, as clinical trials often exclude pregnant people. It is important to understand how pregnancy PV projects operate in low- and middle-income countries (LMICs), where there is a disproportionate lack of PV data yet a high burden of adverse pregnancy outcomes. We conducted a scoping review to assess how exposures and outcomes were measured in recently published pregnancy PV projects in LMICs. METHODS: We utilized a search string, secondary review, and team knowledge to review publications focusing on therapeutic or vaccine exposures among pregnant people in LMICs. We screened abstracts for relevance before conducting a full text review, and documented measurements of exposures and outcomes (categorized as maternal, birth, or neonatal/infant) among other factors, including study topic, setting, and design, comparator groups, and funding sources. RESULTS: We identified 31 PV publications spanning at least 24 LMICs, all focusing on therapeutics or vaccines for infectious diseases, including HIV (n = 17), tuberculosis (TB; n = 9), malaria (n = 7), pertussis, tetanus, and diphtheria (n = 1), and influenza (n = 3). As for outcomes, n = 15, n = 31, and n = 20 of the publications covered maternal, birth, and neonatal/infant outcomes, respectively. Among HIV-specific publications, the primary exposure-outcome relationship of focus was exposure to maternal antiretroviral therapy and adverse outcomes. For TB-specific publications, the main exposures of interest were second-line drug-resistant TB and isoniazid-based prevention therapeutics for pregnant people living with HIV. For malaria-specific publications, the primary exposure-outcome relationship of interest was antimalarial medication exposure during pregnancy and adverse outcomes. Among vaccine-focused publications, the exposure was assessed during a specific time during pregnancy, with an overall interest in vaccine safety and/or efficacy. The study settings were frequently from Africa, designs varied from cohort or cross-sectional studies to clinical trials, and funding sources were largely from high-income countries. CONCLUSION: The published pregnancy PV projects were largely centered in Africa and concerned with infectious diseases. This may reflect the disease burden in LMICs but also funding priorities from high-income countries. As the prevalence of non-communicable diseases increases in LMICs, PV projects will have to broaden their scope. Birth and neonatal/infant outcomes were most reported, with fewer reporting on maternal outcomes and none on longer-term child outcomes; additionally, heterogeneity existed in definitions and ascertainment of specific measures. Notably, almost all projects covered a single therapeutic exposure, missing an opportunity to leverage their projects to cover additional exposures, add scientific rigor, create uniformity across health services, and bolster existing health systems. For many publications, the timing of exposure, specifically by trimester, was crucial to maternal and neonatal safety. While currently published pregnancy PV literature offer insights into the PV landscape in LMICs, further work is needed to standardize definitions and measurements, integrate PV projects across health services, and establish longer-term monitoring.

Abortion Care After the Dobbs Decision: An Academic Health System's Response to a Statewide Ban.

ABSTRACT: Indiana was the first state to pass legislation severely restricting access to abortion care following the Dobbs v. Jackson Women's Health Organization decision. Indiana Senate Enrolled Act 1 (SEA 1) outlaws all abortions with few exceptions. Indiana University Health (IU Health), the largest and only academic health system in the state, has a unique relationship with the Indiana University School of Medicine and a vision to improve the health of Indiana residents. IU Health employed the Hospital Incident Command System model to create a plan to ensure its patients continue to have access to safe, high-quality family planning, maternal, and neonatal care services and that clinicians are protected against criminal penalties and threats to personal safety. This article provides an overview of the Incident Command structure used to rapidly work across many disciplines, tackle complex issues, respond to concerns, and design and implement changes. The article also outlines the key considerations and decisions made by Incident Command leaders, such as where abortions that met the new law's criteria should be performed, changes to clinical workflows and protocols, and the creation of a rapid response team. The article then examines the operational, legal, and clinical challenges encountered by clinicians and health care team members, including a lack of peer support or idea sharing with other health systems in the state; accurate estimation of abortion, live birth, and neonatal intensive care unit volumes; and ambiguity in the law and lack of guidance from the state government. Recommendations regarding communication with clinicians and other health care team members and engaging information technology early are offered for health systems and medical schools that may face legislative barriers to health care delivery in the future. Finally, IU Health's commitment to tracking the impact of SEA 1 on patients, clinicians, employees, and the state is outlined.

COHESION: a core outcome set for the treatment of neonatal encephalopathy.

BACKGROUND: Heterogeneity in outcomes reported in trials of interventions for the treatment of neonatal encephalopathy (NE) makes evaluating the effectiveness of treatments difficult. Developing a core outcome set for NE treatment would enable researchers to measure and report the same outcomes in future trials. This would minimise waste, ensure relevant outcomes are measured and enable evidence synthesis. Therefore, we aimed to develop a core outcome set for treating NE. METHODS: Outcomes identified from a systematic review of the literature and interviews with parents were prioritised by stakeholders (n = 99 parents/caregivers, n = 101 healthcare providers, and n = 22 researchers/ academics) in online Delphi surveys. Agreement on the outcomes was achieved at online consensus meetings attended by n = 10 parents, n = 18 healthcare providers, and n = 13 researchers/ academics. RESULTS: Seven outcomes were included in the final core outcome set: survival; brain injury on imaging; neurological status at discharge; cerebral palsy; general cognitive ability; quality of life of the child, and adverse events related to treatment. CONCLUSION: We developed a core outcome set for the treatment of NE. This will allow future trials to measure and report the same outcomes and ensure results can be compared. Future work should identify how best to measure the COS. IMPACT: We have identified seven outcomes that should be measured and reported in all studies for the treatment of neonatal encephalopathy. Previously, a core outcome set for neonatal encephalopathy treatments did not exist. This will help to reduce heterogeneity in outcomes reported in clinical trials and other studies, and help researchers identify the best treatments for neonatal encephalopathy.

Multi-Round versus Real-Time Delphi survey approach for achieving consensus in the COHESION core outcome set: a randomised trial.

BACKGROUND: Delphi surveys are commonly used to prioritise critical outcomes in core outcome set (COS) development. This trial aims to compare a three-round (Multi-Round) Delphi (MRD) with a Real-Time Delphi (RTD) in the prioritisation of outcomes for inclusion in a COS for neonatal encephalopathy treatments and explore whether 'feedback', 'iteration', and 'initial condition' effects may occur in the two survey methods. METHODS: We recruited 269 participants (parents/caregivers, healthcare providers and researchers/academics) of which 222 were randomised to either the MRD or the RTD. We investigated the outcomes prioritised in each survey and the 'feedback', 'iteration', and 'initial condition' effects to identify differences between the two survey methods. RESULTS: In the RTD, n = 92 participants (83%) fully completed the survey. In the MRD, n = 60 participants (54%) completed all three rounds. Of the 92 outcomes presented, 26 (28%) were prioritised differently between the RTD and MRD. Significantly fewer participants amended their scores when shown stakeholder responses in the RTD compared to the MRD ('feedback effect'). The 'iteration effect' analysis found most experts appeared satisfied with their initial ratings in the RTD and did not amend their scores following stakeholder response feedback. Where they did amend their scores, ratings were amended substantially, suggesting greater convergence. Variance in scores reduced with subsequent rounds of the MRD ('iteration effect'). Whilst most participants did not change their initial scores in the RTD, of those that did, later recruits tended to align their final score more closely to the group mean final score than earlier recruits (an 'initial condition' effect). CONCLUSION: The feedback effect differed between the two Delphi methods but the magnitude of this difference was small and likely due to the large number of observations rather than because of a meaningfully large difference. It did not appear to be advantageous to require participants to engage in three rounds of a survey due to the low change in scores. Larger drop-out through successive rounds in the MRD, together with a lesser convergence of scores and longer time to completion, indicate considerable benefits of the RTD approach. TRIAL REGISTRATION: NCT04471103. Registered on 14 July 2020.

Impact of free maternity services on outcomes related to hypertensive disorders of pregnancy at Moi Teaching and Referral Hospital in Kenya: a retrospective analysis.

BACKGROUND: Preeclampsia is a major contributor to maternal and neonatal mortality worldwide. Ninety-nine percent of these deaths occur in resource limited settings. One of the greatest barriers to women seeking medical attention remains the cost of care. Kenya implemented a nation-wide policy change in 2013, offering free inpatient maternity services to all women to address this concern. Here, we explore the impact of this policy change on maternal and neonatal outcomes specific to the hypertensive disorders of pregnancy. METHODS: We conducted a retrospective cross-sectional chart review of patients discharged or deceased with a diagnosis of gestational hypertension, preeclampsia, eclampsia or HELLP syndrome at a tertiary referral center in western Kenya one year before (June 1, 2012-May 31, 2013) and one year after (June 1, 2013-May 31, 2014) free maternity services were introduced at public facilities across the country. Demographic information, obstetric history, medical history, details of the current pregnancy, diagnosis on admission and at discharge, antepartum treatment, maternal outcomes, and neonatal outcomes were collected and comparisons were made between the time points. RESULTS: There were more in hospital births after policy change was introduced. The proportion of women diagnosed with a hypertensive disorder of pregnancy was higher in the year before free maternity care although there was a statistically significant increase in the proportion of women diagnosed with gestational hypertension after policy change. Among those diagnosed with hypertensive disorders, there was no difference in the proportion who developed obstetric or medical complications. Of concern, there was a statistically significant increase in the proportion of women dying as a result of their condition. There was a statistically significant increase in the use of magnesium sulfate for seizure prophylaxis. There was no overall difference in the use of anti-hypertensives between groups and no overall difference in the proportion of women who received dexamethasone for fetal lung maturity. CONCLUSIONS: Free maternity services, however necessary, are insufficient to improve maternal and neonatal outcomes related to the hypertensive disorders of pregnancy at a tertiary referral center in western Kenya. Multiple complementary strategies acting in unison are urgently needed.

Impacts of the COVID-19 pandemic on access to HIV and reproductive health care among women living with HIV (WLHIV) in Western Kenya: A mixed methods analysis.

Introduction: The COVID-19 pandemic has impacted access to health services. Our objective was to understand the pandemic's impact on access to HIV, pregnancy, and family planning (FP) care among women living with HIV (WLHIV). Methods: Data were collected after June 2020, when questions about the pandemic were added to two ongoing mixed methods studies using telephone surveys and in-depth interviews among WLHIV in western Kenya. The Chaguo Langu (CL) study includes primarily non-pregnant WLHIV receiving HIV care at 55 facilities supported by AMPATH and the Opt4Mamas study includes pregnant WLHIV receiving antenatal care at five facilities supported by FACES. Our outcomes were self-reported increased difficulty refilling medication, accessing care, and managing FP during the pandemic. We summarized descriptive data and utilized multivariable logistic regression to evaluate predictors of difficulty refilling medication and accessing care. We qualitatively analyzed the interviews using inductive coding with thematic analysis. Results: We analyzed 1,402 surveys and 15 in-depth interviews. Many (32%) CL participants reported greater difficulty refilling medications and a minority (14%) reported greater difficulty accessing HIV care during the pandemic. Most (99%) Opt4Mamas participants reported no difficulty refilling medications or accessing HIV/pregnancy care. Among the CL participants, older women were less likely (aOR = 0.95, 95% CI: 0.92-0.98) and women with more children were more likely (aOR = 1.13, 95% CI: 1.00-1.28) to report difficulty refilling medications. Only 2% of CL participants reported greater difficulty managing FP and most (95%) reported no change in likelihood of using FP or desire to get pregnant. Qualitative analysis revealed three major themes: (1) adverse organizational/economic implications of the pandemic, (2) increased importance of pregnancy prevention during the pandemic, and (3) fear of contracting COVID-19. Discussion: The two unique participant groups included in our study encountered overlapping problems during the COVID-19 epidemic. Access to HIV services and antiretrovirals was interrupted for a large proportion of non-pregnant WLHIV in western Kenya, but access to pregnancy/family planning care was less affected in our cohort. Innovative solutions are needed to ensure HIV and reproductive health outcomes do not worsen during the ongoing pandemic.

Contraception use and HIV outcomes among women initiating dolutegravir-containing antiretroviral therapy in Kenya: a retrospective cohort study.

INTRODUCTION: The rollout of dolutegravir (DTG) in low- and middle-income countries was disrupted by a potential association reported with periconceptional DTG exposure among women living with HIV (WLHIV) and infant neural tube defects. This prompted countries to issue interim guidance limiting DTG use among women of reproductive potential to those on effective contraception. Data to understand the potential impact of such guidance on WLHIV are limited. METHODS: We conducted a retrospective cohort analysis of WLHIV 15-49 years initiating DTG-containing antiretroviral treatment (ART) in Kenya from 2017 to 2020. We determined baseline effective (oral, injectable or lactational amenorrhea) and very effective (implant, intrauterine device or female sterilization) contraception use among women who initiated DTG before (Group 1) or during (Group 2) the interim guideline period. We defined incident contraception use in each group as the number of contraceptive methods initiated ≤180 days post-guideline (Group 1) or post-DTG initiation (Group 2). We determined the proportions of all women who switched from DTG- to non-nucleoside reverse transcriptase inhibitor (NNRTI)- (efavirenz or nevirapine) containing ART ≤12 months post-DTG initiation, compared their viral suppression (<1000 copies/ml) and conducted multivariable logistic regression to determine factors associated with switching from DTG to NNRTI-containing ART. RESULTS: Among 5155 WLHIV in the analysis (median age 43 years), 89% initiated DTG after transitioning from an NNRTI. Baseline effective and very effective contraception use, respectively, by the group were: Group 1 (12% and 13%) and Group 2 (41% and 35%). Incident contraception use in each group was <5%. Overall, 498 (10%) women switched from DTG to an NNRTI. Viral suppression among those remaining on DTG versus switched to NNRTI was 95% and 96%, respectively (p = 0.63). In multivariable analysis, incident effective and very effective contraception use was not associated with switching. CONCLUSIONS: Baseline, but not incident, effective contraception use was higher during the interim guideline period compared to before it, suggesting women already using effective contraception were preferentially selected to initiate DTG after the guideline was released. These findings reveal challenges in the implementation of policy which ties antiretroviral access to contraceptive use. Future guidance should capture nuances of contraception decision-making and support women's agency to make informed decisions.

Acceptability and feasibility of community-based provision of urine pregnancy tests to support linkages to reproductive health services in Western Kenya: a qualitative analysis.

BACKGROUND: The majority of women living in rural Kenya access antenatal care (ANC) late in pregnancy, and approximately 20% have an unmet need for family planning (FP). This study aimed to determine whether training community health volunteers (CHVs) to deliver urine pregnancy testing (UPT), post-test counselling, and referral to care was an acceptable and feasible intervention to support timely initiation of ANC and uptake of FP. METHODS: We applied community-based participatory methods to design and implement the pilot intervention between July 2018 and May 2019. We conducted qualitative content analysis of 12 pre-intervention focus group discussions (FGDs) with women, men, and CHVs, and of 4 post-intervention FGDs with CHVs, each with 7-9 participants per FGD group. Using a pragmatic approach, we conducted inductive line-by-line coding to generate themes and subthemes describing factors that positively or negatively contributed to the intervention's acceptability and feasibility, in terms of participants' views and the intervention aims. RESULTS: We found that CHV-delivered point of care UPT, post-test counselling, and referral to care was an acceptable and feasible intervention to increase uptake of ANC, FP, and other reproductive healthcare services. Factors that contributed to acceptability were: (1) CHV-delivery made UPT more accessible; (2) UPT and counselling supported women and men to build knowledge and make informed choices, although not necessarily for women with unwanted pregnancies interested in abortion; (3) CHVs were generally trusted to provide counselling, and alternative counselling providers were available according to participant preference. A factor that enhanced the feasibility of CHV delivering UPT and counselling was CHV's access to appropriate supplies (e.g. carrying bags). However, factors that detracted from the feasibility of women actually accessing referral services after UPT and counselling included (1) downstream barriers like cost of travel, and (2) some male community members' negative attitudes toward FP. Finally, improved financial, educational, and professional supports for CHVs would be needed to make the intervention acceptable and feasible in the long-term. CONCLUSION: Training CHVs in rural western Kenya to deliver UPT, post-test counselling, and referral to care was acceptable and feasible to men, women, and CHVs in this context, and may promote early initiation of ANC and uptake of FP. Additional qualitative work is needed to explore implementation challenges, including issues related to unwanted pregnancies and abortion, the financial burden of volunteerism on CHVs, and educational and professional supports for CHVs.

Contraceptive implant use duration is not associated with breakthrough pregnancy among women living with HIV and using efavirenz: a retrospective, longitudinal analysis.

INTRODUCTION: Contraceptive implants containing etonogestrel and levonorgestrel have emerged as popular contraceptive options among women in areas of high HIV burden in sub-Saharan Africa. However, recent pharmacokinetic data have shown drug-drug interactions between implants and efavirenz-containing antiretroviral therapy (ART), reducing the effectiveness of the implants. Here, we evaluated pregnancy incidence in 6-month intervals following implant initiation among women using efavirenz and contraceptive implants to assess whether the risk of breakthrough pregnancy is higher after specific periods of implant use. METHODS: We used data from a retrospective longitudinal analysis of women living with HIV ages 18-45 years in western Kenya who attended HIV-care facilities between 2011 and 2015. We used Cox proportional hazard models to compute hazard ratios (HRs) for breakthrough pregnancy by implant type and ART regimen. Depending on the model, we adjusted for socio-demographic and clinical factors, programme, site and interaction between calendar time and ART regimen. We utilized inverse probability weights (IPWs) to account for three sampling phases (electronic medical record [EMR], chart review and phone interview) and calculated overall parameter estimates. RESULTS: Women contributed 14,768 woman-years from the largest sampling phase (EMR). The median age was 31 years. Women used etonogestrel implants for 26-69% of the time and levonorgestrel implants for 7-31% of the time, depending on the sampling phase. Women used efavirenz, nevirapine or no ART for 27-33%, 40-46% and 15-26% of follow-ups, respectively. When combining sampling phases, there was little evidence to suggest that the relative hazard of pregnancy among efavirenz-containing ART users relative to nevirapine-containing ART changed with length of time on implants: IPW-adjusted HR of 3.1 (CI: [1.5; 6.4]) at 12 months, 3.4 (CI: [1.8; 6.3]) at 24 months, 3.8 (CI: [1.9; 7.7]) at 36 months and 4.2 (CI: [1.6; 11.1]) at 48 months (interaction p-value = 0.88). Similarly, no significant change in HRs over time was found when comparing women not using ART to nevirapine-containing ART users (interaction p-value = 0.49). CONCLUSIONS: We did not find evidence to suggest implants being more fallible from drug-drug interactions with efavirenz at later time intervals of implant use. Thus, we would not recommend shortening the duration of implant use or replacing implants sooner when concomitantly used with efavirenz.

Core outcomes in neonatal encephalopathy: a qualitative study with parents.

OBJECTIVE: To identify the outcomes considered important to parents or caregivers of infants diagnosed with neonatal encephalopathy, hypoxic ischaemic encephalopathy or birth asphyxia in high-income and low- to middle-income countries (LMiCs), as part of the outcome-identification process in developing a core outcome set (COS) for the treatment of neonatal encephalopathy. DESIGN: A qualitative study involving 25 semistructured interviews with parents or other family members (caregivers) of infants who were diagnosed with, and treated for, neonatal encephalopathy, hypoxic ischaemic encephalopathy or birth asphyxia. SETTING: Interviews were conducted in high-income countries (HiCs) (n=11) by Zoom video conferencing software and in LMiCs (n=14) by phone or face to face. FINDINGS: Parents identified 54 outcomes overall, which mapped to 16 outcome domains. The domains identified were neurological outcomes, respiratory outcomes, gastrointestinal outcomes, cardiovascular outcomes, motor development, cognitive development, development (psychosocial), development (special senses), cognitive development, development (speech and social), other organ outcomes, survival/living outcomes, long-term disability, hospitalisation, parent-reported outcomes and adverse events. CONCLUSIONS: This study provides insight into the outcomes that parents of infants diagnosed with neonatal encephalopathy have identified as the most important, to be considered in the process of developing a COS for the treatment of neonatal encephalopathy. We also provide description of the processes employed to ensure the inclusion of participants from LMiCs as well as HiCs.

Evaluation of family planning and abortion education in preclinical curriculum at a large midwestern medical school.

Objective: Evaluate a Midwestern medical school's current pregnancy termination and family planning undergraduate medical curriculum (UMC) in accordance with Association of Professors of Gynecology and Obstetrics (APGO) guidelines. Assess 1) student interest 2) preparedness to counsel patients, and 3) preferred modality of instruction. Study design: A survey assessed students about UMC. Course syllabus learning objectives and APGO educational guidelines were compared. Results: There were 309 responses total; six did not complete all survey questions and were excluded. Participants (n = 303) were primarily female (62%) and White (74%). Across all class levels, many (61%) students expected to learn about family planning and contraception in UMC. While most (84-88%) participants who completed the preclinical course with or without the clerkship felt prepared to counsel about common, non-controversial pharmacotherapies, only 20% of students felt prepared to counsel on abortion options, and 75% of students who had completed both the preclinical and OBGYN clerkship felt unprepared for abortion counseling Overall, 86% of all students surveyed believed that the medical school should enhance its reproductive health coverage in UMC. Traditional lectures, panels, and direct clinical exposure were the most popular instructional modalities. Conclusion: We identified potential gaps in UMC where students expressed high level of interest with low level of preparedness regarding abortion options counseling, even among senior students. Considering the high percentage of students expecting to learn about pregnancy termination and family planning in their UMC, this expectation is not being met. Students were open to a variety of modalities of instruction, indicating that several possible options exist for curricular integration. Implications: Despite evidence of need for training in family planning and abortion, few medical institutions have a standardized curriculum. Little available literature exists on curricula covering pregnancy options and contraception counseling, signifying a gap of knowledge and an opportunity to study how to integrate these important topics into UMC.

Preferences for Multipurpose Technology and Non-oral Methods of Antiretroviral Therapy Among Women Living With HIV in Western Kenya: A Survey Study.

Introduction: Understanding interests in and preferences for multipurpose technology (MPT) for the co-administration of contraception and antiretroviral therapy (ART) and alternative, non-oral ART methods among women living with HIV (WLHIV) is vital to successful implementation of future treatment options, such as long-acting injectable ART. Methods: Between May 2016 and March 2017 we conducted a cross-sectional telephone survey of 1,132 WLHIV of reproductive potential with prior experience using intermediate- or long-acting contraceptive methods in western Kenya. We present descriptive statistics and multinomial logistic regression to evaluate predictors of interest in specific MPT and non-oral ART methods. Results: Two-thirds (67%) reported interest in MPT, with the most common reason for interest being ease of using a single medication for both purposes of HIV treatment and pregnancy prevention (26%). Main reasons for lack of interest in MPT were need to stop/not use contraception while continuing ART (21%) and risk of side effects (16%). Important characteristics of MPT were effectiveness for pregnancy prevention (26%) and HIV treatment (24%) and less than daily dosing (19%). Important characteristics of non-oral ART methods were less than daily dosing (47%), saving time accessing ART (16%), and effectiveness of HIV treatment (15%). The leading preferred methods for both MPT and non-oral ART were injectables (50 and 54%) and implants (32 and 31%). Prior use of a contraceptive implant or injectable predicted interest in similar methods for both MPT and non-oral ART methods, while this relationship did not appear to vary between younger vs. older WLHIV. Discussion: Most WLHIV in western Kenya are interested in MPT for HIV treatment and contraception. Prior exposure to contraceptive implants or injectables appears to predict interest in similar methods of MPT and non-oral ART. Developers of MPT and non-oral ART methods should strongly consider WLHIV's preferences, including their changing reproductive desires.

Disparities in Dolutegravir Uptake Affecting Females of Reproductive Age With HIV in Low- and Middle-Income Countries After Initial Concerns About Teratogenicity : An Observational Study.

BACKGROUND: The transition to dolutegravir-containing antiretroviral therapy (ART) in low- and middle-income countries (LMICs) was complicated by an initial safety signal in May 2018 suggesting that exposure to dolutegravir at conception was possibly associated with infant neural tube defects. On the basis of additional evidence, in July 2019, the World Health Organization recommended dolutegravir for all adults and adolescents living with HIV. OBJECTIVE: To describe dolutegravir uptake and disparities by sex and age group in LMICs. DESIGN: Observational cohort study. SETTING: 87 sites that began using dolutegravir in 11 LMICs in the Asia-Pacific; Caribbean, Central and South America network for HIV epidemiology (CCASAnet); and sub-Saharan African regions of the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium. PATIENTS: 134 672 patients aged 16 years or older who received HIV care from January 2017 through March 2020. MEASUREMENTS: Sex, age group, and dolutegravir uptake (that is, newly initiating ART with dolutegravir or switching to dolutegravir from another regimen). RESULTS: Differences in dolutegravir uptake among females of reproductive age (16 to 49 years) emerged after the safety signal. By the end of follow-up, the cumulative incidence of dolutegravir uptake among females 16 to 49 years old was 29.4% (95% CI, 29.0% to 29.7%) compared with 57.7% (CI, 57.2% to 58.3%) among males 16 to 49 years old. This disparity was greater in countries that began implementing dolutegravir before the safety signal and initially had highly restrictive policies versus countries with a later rollout. Dolutegravir uptake was similar among females and males aged 50 years or older. LIMITATION: Follow-up was limited to 6 to 8 months after international guidelines recommended expanding access to dolutegravir. CONCLUSION: Substantial disparities in dolutegravir uptake affecting females of reproductive age through early 2020 are documented. Although this disparity was anticipated because of country-level restrictions on access, the results highlight its extent and initial persistence. PRIMARY FUNDING SOURCE: National Institutes of Health.

A laparoscopic approach to cesarean scar ectopic pregnancy.

Cesarean scar pregnancies confer serious risk and severe morbidity. Appropriate management is the key to preventing complications. Although expectant management is usually contraindicated, the ideal combination of medical or surgical treatments is unclear and must be tailored to the patient's preferences and stability, provider skill, and the available resources. In this article, we present a combined medical and surgical approach that was successfully employed for the termination and excision of a cesarean scar pregnancy at 12 weeks' gestation in a patient desiring uterine preservation. A video is included, demonstrating the surgical steps of a laparoscopic approach used to safely resect the pregnancy and cesarean delivery scar with minimal blood loss. The management technique described can be utilized to effectively resolve cesarean scar pregnancy, to possibly decrease the risk of recurrence, and preserve future fertility with a minimally invasive outpatient surgery.

Allies Welcomed to Advance Racial Equity (AWARE) Faculty Seminar Series: Program Design and Implementation.

INTRODUCTION: In the wake of George Floyd's murder, White faculty in our department began to express the desire to gain a greater understanding of structural racism and racial inequity. To facilitate this learning, support allyship, and mitigate the emotional labor and taxation that frequently falls on faculty of color to respond to these appeals, we developed AWARE (Allies Welcomed to Advance Racial Equity), a faculty seminar series primarily designed for and led by a majority White faculty to tackle the topics of structural racism, Whiteness, and Anti-racist action. METHODS: We developed a 6-session seminar series, identifying 5 White faculty as lecturers and a cadre of Black and White volunteer facilitators, to lead 60-minute sessions comprised of lecture, facilitated small group reflection, and large group sharing, that reviewed key topics/texts on structural racism, Whiteness, and Anti-racism. RESULTS: Attendance ranged from 26 to 37 participants at each session. About 80% of faculty participated in at least 1 session of the program. The majority of participants (85%) felt "more empowered to influence their current environment to be more inclusive of others" and were "better equipped to advocate for themselves or others." Most (81%) felt "more connected to their colleagues following completion of the program." Ultimately, faculty thought highly of the program upon completion with 26/27 (96%) stating they would recommend the program to a colleague. DISCUSSION: We offer a reproducible model to improve departmental climate by engaging in the shared labor of educating our colleagues and communities about structural racism, Whiteness, and Anti-racism to create a point of entry into reflection, dialogue, and deliberate actions for change.

Pregnancies among women living with HIV using contraceptives and antiretroviral therapy in western Kenya: a retrospective, cohort study.

BACKGROUND: Preventing unintended pregnancies is paramount for women living with HIV (WLHIV). Previous studies have suggested that efavirenz-containing antiretroviral therapy (ART) reduces contraceptive effectiveness of implants, but there are uncertainties regarding the quality of the electronic medical record (EMR) data used in these prior studies. METHODS: We conducted a retrospective, cohort study of EMR data from 2011 to 2015 among WLHIV of reproductive age accessing HIV care in public facilities in western Kenya. We validated a large subsample of records with manual chart review and telephone interviews. We estimated adjusted incidence rate ratios (aIRRs) with Poisson regression accounting for the validation sampling using inverse probability weighting and generalized raking. RESULTS: A total of 85,324 women contributed a total of 170,845 women-years (w-y) of observation time; a subset of 5080 women had their charts reviewed, and 1285 underwent interviews. Among implant users, the aIRR of pregnancy for efavirenz- vs. nevirapine-containing ART was 1.9 (95% CI 1.6, 2.4) using EMR data only and 3.2 (95% CI 1.8, 5.7) when additionally using both chart review and interview validated data. Among efavirenz users, the aIRR of pregnancy for depomedroxyprogesterone acetate (DMPA) vs. implant use was 1.8 (95% CI 1.5, 2.1) in EMR only and 2.4 (95% CI 1.0, 6.1) using validated data. CONCLUSION: Pregnancy rates are higher when contraceptive implants are concomitantly used with efavirenz-containing ART, though rates were similar to leading alternative contraceptive methods such as DMPA. Our data provides policymakers, program staff, and WLHIV greater confidence in guiding their decision-making around contraceptive and ART options. Our novel, 3-phase validation sampling provides an innovative tool for using routine EMR data to improve the robustness of data quality.

Acceptability of Contraceptive Services in the Emergency Department: A Cross-sectional Survey.

INTRODUCTION: Unintended pregnancy disproportionately affects marginalized populations and has significant negative health and financial impacts on women, their families, and society. The emergency department (ED) is a promising alternative setting to increase access to sexual and reproductive health (SRH) services including contraception, especially among marginalized populations. The primary objective of this study was to determine the extent to which adult women of childbearing age who present to the ED would be receptive to receiving contraception and/or information about contraception in the ED. As a secondary objective, we sought to identify the barriers faced in attempting to obtain SRH care in the past. METHODS: We conducted a quantitative, cross-sectional, assisted, in-person survey of women aged 18-50 in the ED setting at two large, urban, academic EDs between June 2018-September 2019. The survey was approved by the institutional review board. Survey items included demographics, interest in contraception initiation and/or receiving information about contraception in the ED, desire to conceive, prior SRH care utilization, and barriers to SRH. RESULTS: A total of 505 patients participated in the survey. Participants were predominantly single and Black, with a mean age of 31 years, and reporting not wanting to become pregnant in the next year. Of those participants, 55.2% (n = 279) stated they would be interested in receiving information about birth control AND receiving birth control in the ED if it were available. Of those who reported the ability to get pregnant, and not desiring pregnancy in the next year (n = 279, 55.2%), 32.6% were not currently using anything to prevent pregnancy (n = 91). Only 10.5% of participants stated they had experienced barriers to SRH care in the past (n = 53). Participants who experienced barriers to SRH reported higher interest in receiving information and birth control in the ED (74%, n = 39) compared to those who had not experienced barriers (53%, n = 240); (P = 0.004, 95% confidence interval, 1.30-4.66). CONCLUSION: The majority of women of childbearing age indicated the desire to access contraception services in the ED setting. This finding suggests favorable patient acceptability for an implementation study of contraception services in emergency care.