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With new pre-exposure prophylaxis (PrEP) modalities for HIV prevention becoming available, understanding how adolescent girls and young women (AGYW) navigate through PrEP options is essential, including factors underlying their choice. Through 16 focus group discussions (FGDs) and 52 in-depth interviews (IDIs) from REACH, an open-label crossover study in which AGYW were allocated 1:1 (between 06 February 2019 and 18 March 2020) to receive oral PrEP for six months and the dapivirine ring for six months, in a randomized sequence, followed by a 6-month period where either product (or neither) could be chosen, we explored decision-making process and product choice, using a mixed inductive-deductive analytical approach. Key themes included the desire to remain HIV-negative and weighing product attributes through experiential learning. Product triability appeared important in informing product choice as individual circumstances changed or assuaging side effects with a given product. Approved biomedical prevention innovations may also benefit from hands-on experience to help with adoption and use during real-world implementation. Furthermore, support from trusted providers will remain critical as AGYW contemplate navigating through PrEP options and choice., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Atujuna et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Can a political party spend enough across electoral campaigns to garner a majority within the U.S. Congress? Prior research on campaign spending minimizes the importance of campaign heterogeneity and fails to aggregate effects across campaigns, rendering it unable to address this question. Instead, we tackle the question with a system-level analysis of campaign expenditures. First, using a flexible machine learning approach, we show that spending has substantial and nonlinear marginal effects on outcomes at the level of the campaign. Second, by aggregating these effects to the entire U.S. Congress, we show that large seat swings that change congressional control have, in the past, been possible for expenditure levels consonant with those presently observed after having removed the most extreme levels. However, this possibility appears to have faded over the past decade. Our approach also allows us to illustrate the often significant effects that eliminating campaign spending could have., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Minozzi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Purpose: To understand motivators, concerns, and factors associated with COVID-19 vaccine initiation for adults in five racial/ethnic communities across Colorado., Methods: Community-based data collectors surveyed participants from five Colorado communities (urban and rural Latina/o/x, urban Black, rural African American immigrant, and urban American Indian) about vaccine attitudes, intentions, and uptake from September to December 2021. Bivariate and multivariable logistic regression models were used to examine factors associated with the primary outcome of COVID-19 vaccine "initiation.", Results: Most participants (71.1%) reported having initiated COVID-19 vaccination; vaccine series completion was 65.1%. Both motivators and concerns about COVID-19 vaccines were prevalent. Vaccine hesitancy (OR: 0.41, 95% CI:0.32-0.53; p < .001) and low perceptions of COVID-19 vaccination social norms (OR: 0.48, 95% CI:0.27-0.84; p = .01) were associated with vaccine initiation., Conclusion: Despite the limitation of a moderate sample size, our findings support the need for further interventions to increase vaccination against COVID-19 by reducing vaccine hesitancy and improving perceived social norms of vaccination in underserved Colorado communities., Implications: To improve trust in vaccines and promote vaccine uptake, community messaging should be tailored to vaccination motivators and concerns and demonstrate COVID-19 vaccination as the community default., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Sarah Brewer served on an advisory board for Merck. The company did not play any role in this research, and we do not receive research funding from them. All other authors have no conflicts to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Brewer et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

This protocol presents a multilevel cluster randomized study in 24 communities in Cape Town, South Africa. The study comprises four specific aims. Aim 1, conducted during the formative phase, was to modify the original Couples Health CoOp (CHC) intervention to include antiretroviral therapy/pre-exposure prophylaxis (ART/PrEP), called the Couples Health CoOp Plus (CHC+), with review from our Community Collaborative Board and a Peer Advisory Board. Aim 1 has been completed for staging the trial. Aim 2 is to evaluate the impact of a stigma awareness and education workshop on community members' attitudes and behaviors toward young women and men who use AODs and people in their community seeking HIV services (testing/ART/PrEP) and other health services in their local clinics. Aim 3 is to test the efficacy of the CHC+ to increase both partners' PrEP/ART initiation and adherence (at 3 and 6 months) and to reduce alcohol and other drug use, sexual risk and gender-based violence, and to enhance positive gender norms and communication relative to HIV testing services (n = 480 couples). Aim 4 seeks to examine through mixed methods the interaction of the stigma awareness workshop and the CHC+ on increased PrEP and ART initiation, retention, and adherence among young women and their primary partners. Ongoing collaborations with community peer leaders and local outreach staff from these communities are essential for reaching the project's aims. Additionally, a manualized field protocol with regular training, fidelity checks, and quality assurance are critical components of this multilevel community trial for successful ongoing data collection. Trial registration. Clinicaltrials.gov Registration Number: NCT05310773. Pan African Trials: pactr.samrc.ac.za/ Registration Number: PACTR202205640398485., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Wechsberg et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Aim: To synthesize the impact of improvement interventions related to care coordination, discharge support and care transitions on patient experience measures., Method: Systematic review. Searches were completed in six scientific databases, five specialty journals, and through snowballing. Eligibility included studies published in English (2015-2023) focused on improving care coordination, discharge support, or transitional care assessed by standardized patient experience measures as a primary outcome. Two independent reviewers made eligibility decisions and performed quality appraisals., Results: Of 1240 papers initially screened, 16 were included. Seven studies focused on care coordination activities, including three randomized controlled trials [RCTs]. These studies used enhanced supports such as improvement coaching or tailoring for vulnerable populations within Patient-Centered Medical Homes or other primary care sites. Intervention effectiveness was mixed or neutral relative to standard or models of care or simpler supports (e.g., improvement tool). Eight studies, including three RCTs, focused on enhanced discharge support, including patient education (e.g., teach back) and telephone follow-up; mixed or neutral results on the patient experience were also found and with more substantive risks of bias. One pragmatic trial on a transitional care intervention, using a navigator support, found significant changes only for the subset of uninsured patients and in one patient experience outcome, and had challenges with implementation fidelity., Conclusion: Enhanced supports for improving care coordination, discharge education, and post-discharge follow-up had mixed or neutral effectiveness for improving the patient experience with care, compared to standard care or simpler improvement approaches. There is a need to advance the body of evidence on how to improve the patient experience with discharge support and transitional approaches., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Jesus et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Most health care providers in Lagos State, Nigeria are private and are not required to offer breastfeeding counseling to women. From May 2019-April 2020, Alive & Thrive implemented a multicomponent breastfeeding promotion intervention in private health facilities in Lagos that included training and support to implement the Baby-Friendly Hospital Initiative and provide breastfeeding counseling and support to pregnant women and lactating mothers in person and on WhatsApp. We conducted a mixed methods process evaluation in 10 intervention and 10 comparison private health facilities to examine the feasibility and acceptability of integrating the intervention into routine health services. We conducted in-depth interviews with 20 health facility owners/managers and providers, 179 structured observations of health providers during service provision to pregnant and lactating women and 179 exit interviews with pregnant and lactating women. The in-depth interviews were transcribed and analyzed thematically. The structured observations and exit interviews were summarized using descriptive and inferential statistics. The in-depth interviews indicated that almost all health facility owners/managers and providers at the intervention health facilities had generally positive experiences with the intervention. However, the health providers reported implementation barriers including increased workload, use of personal time for counseling on WhatsApp, and some mothers' lack of access to WhatsApp support groups. Observations suggested that more breastfeeding counseling occurred at intervention compared with comparison health facilities. Third trimester exit interviews showed that 86% of women in the intervention health facilities were very confident they could carry out the breastfeeding advice they received, compared to 47% in the comparison health facilities. Our research suggests that provision of breastfeeding counseling and support through private health facilities is feasible and acceptable, but service delivery challenges must be considered for successful scale-up., Competing Interests: i. “SB is employed by Alive & Thrive initiative. SB was involved in managing the evaluation of the intervention but was not involved in the design, data collection and analysis of the study. OA is employed by Equitable Health Access Initiative. OA was involved in the design and implementation of the intervention, but not in data collection or analysis for this study. OA’s affiliation with Equitable Health Access Initiative does not alter our adherence to PLOS ONE policies on sharing data and materials. All other authors have no conflicts of interest.”, (Copyright: © 2024 Allotey et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Experiencing drug cravings is an aspect of substance use disorders that frequently compromises the recovery efforts of people who use drugs. Most treatment approaches that address drug cravings either involve cognitive strategies or medication. Few interventions directly address the physiological aspects of craving, such as increased heart rate. Previous research has demonstrated that slow-paced breathing may be effective in managing drug cravings by manipulating an individual's heart rate. The purpose of this paper is to describe a study protocol for an intervention that offers resonance frequency breathing training for managing cravings via a smartphone application (app)., Methods: This trial is registered in ClinicalTrials.gov (Identifier: NCT05830773). The intervention focuses on persons in recovery from opioid use disorder who receive services from the Texas Health and Human Service Commission Recovery Support Services division. Participants will be trained to use Camera Heart Rate Variability (CHRV), a resonance frequency breathing app. The CHRV app measures heart rate and the volumetric variations of blood circulation. When experiencing stress, anxiety, or cravings, participants will use the app to practice breathing exercises. Participants (N = 60) will also complete surveys at baseline, 4 weeks, and 8 weeks; the survey questions, covers demographic characteristics, personal trauma history, substance use experience, and utilization of substance use treatment services. The surveys will also include psychosocial measures of craving, stress, and anxiety to allow the study team to assess changes between baseline and study completion. Participants who complete the full 8-week intervention will be invited to participate in a 30-minute interview about their experience with the app. Interviews will provide details on implementation outcomes, including acceptability, appropriateness, and feasibility., Conclusion: Many evidence-based interventions for opioid use require interpersonal communication with individuals in one's recovery network. However, individuals may be unable to engage others in their recovery network in the moments when they are experiencing cravings or stress- and anxiety-related triggers. Therefore, recovery support interventions that emphasize individual self-management of cravings, stress, and anxiety when they occur can empower individuals in recovery and enhance existing interventions., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Background: Young adults have a disproportionately high rate of HIV infection, high rates of attrition at all stages of the HIV care continuum, and an elevated probability of disease progression and transmission. Tracking and monitoring objective measures of antiretroviral therapy (ART) adherence in real time is critical to bolster the accuracy of research data, support adherence, and improve clinical outcomes. However, adherence monitoring often relies on self-reported and retrospective data or requires additional effort from providers to understand individual adherence patterns. In this study, we will monitor medication-taking using a real-time objective measure of adherence that does not rely on self-report or healthcare providers for measurement., Methods: The Youth Ending the HIV Epidemic (YEHE) study will pilot a novel automated directly observed therapy-conditional economic incentive (aDOT-CEI) intervention to improve ART adherence among youth with HIV (YWH) in California and Florida who have an unsuppressed HIV viral load. The aDOT app uses facial recognition to record adherence each day, and then economic incentives are given based on a participant's confirmed adherence. We will enroll participants in a 3-month pilot study to assess the feasibility and acceptability of the aDOT-CEI intervention using predefined metrics. During and after the trial, a subsample of the pilot participants and staff/providers from participating AIDS Healthcare Foundation (AHF) clinics will participate in individual in-depth interviews to explore intervention and implementation facilitators and barriers., Discussion: YEHE will provide data on the use of an aDOT-CEI intervention to improve adherence among YWH who are not virologically suppressed. The YEHE study will document the feasibility and acceptability and will explore preliminary data to inform a trial to test the efficacy of aDOT-CEI. This intervention has the potential to effectively improve ART adherence and virologic suppression among a key population experiencing health disparities., Trial Registration: The trial registration number is NCT05789875., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Stoner et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Effective use of oral HIV pre-exposure prophylaxis (PrEP) has been lower among African adolescent girls and young women (AGYW) than among older women, young men who have sex with men, and serodiscordant heterosexual couples in the region. Efforts to build PrEP support have centered around peers and male partners, but the family may also play an important role. This qualitative study aimed to describe family influence on PrEP use among AGYW in in three African cities., Methods: POWER (Prevention Options for Women Evaluation Research) was a PrEP demonstration project among 2550 AGYW (16-25 years old) in Johannesburg and Cape Town, South Africa and Kisumu, Kenya conducted from 2017 to 2020. In-depth interviews and focus group discussions were conducted with 136 AGYW participants to explore their PrEP views and experiences, including awareness and interest in PrEP; barriers and facilitators to uptake and use; the influence of family, peers, intimate partners, and community; and the key types of support for their PrEP use. Transcripts were coded and analysed thematically., Results: The decision to initiate PrEP was associated with fear and anxiety linked to anticipated stigma from family members, and with family's lived HIV experience. Family disclosure, especially to mothers, was important to participants, as most lived with their families and considered it essential for them to obtain their mother's approval to use PrEP. Most family members, particularly mothers, provided instrumental, emotional, informational and appraisal support to participants using PrEP, including reminders, encouragement, and problem-solving. Participants reported that family members with insufficient information about PrEP safety and efficacy and who voiced concerns were a substantial barrier to their use. However, they often became supportive after receiving more PrEP information., Conclusion: Families, particularly mothers, can play an important role in supporting PrEP use. PrEP programmes should leverage family support to help with PrEP persistence by providing basic information to families about PrEP safety and efficacy. AGYW using PrEP should be encouraged to selectively disclose PrEP use to build support and counseled on how to disclose and address family concerns., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Ndimande-Khoza et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: People who use drugs (PWUD) experience stigma from multiple sources due to their drug use. HIV seroprevalence for PWUD in Tanzania is estimated to range from 18 to 25%. So, many PWUD will also experience HIV stigma. Both HIV and drug use stigma have negative health and social outcomes, it is therefore important to measure their magnitude and impact. However, no contextually and linguistically adapted measures are available to assess either HIV or drug use stigma among PWUD in Tanzania. In response, we translated and culturally adapted HIV and drug use stigma measures among Tanzanian PWUD and described that process in this study., Methods: This was a cross-sectional study. We translated and adapted existing validated stigma measures by following a modified version of Wild's ten steps for translation and adaptation. We also added new items on stigmatizing actions that were not included in the original measures. Following translation and back translation, we conducted 40 cognitive debriefs among 19 PWUD living with and 21 PWUD not living with HIV in Dar es Salaam to assess comprehension of the original and new items. For challenging items, we made adaptations and repeated cognitive debriefs among ten new PWUD participants where half of them were living with HIV., Results: Most of the original items (42/54, 78%), response options and all items with new 12 stigmatizing actions were understood by participants. Challenges included response options for a few items; translation to Swahili; and differences in participants' interpretation of Swahili words. We made changes to these items and the final versions were understood by PWUD participants., Conclusion: Drug use and HIV stigma measures can successfully be translated and culturally adapted among Tanzanian PWUD living with and without HIV. We are currently conducting research to determine the stigma measures' psychometric properties and we will report the results separately., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Mlunde et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

In longitudinal surveys, repeated measurements are collected from the same sample units over time to measure gross change (i.e., change at the level of individual sample members). Longitudinal samples are sometimes supplemented by fresh sample to measure net change (i.e., change at the aggregate level). That is, in each measurement wave, while one part of the sample is newly recruited (fresh), another part overlaps with previously interviewed sample (repeated interviews). Many aspects of survey design of longitudinal surveys have been studied extensively, such as definition of target population, sample design, survey weighting, intervals between interviews, nonresponse, and panel attrition. Although the impact of the overlap between samples on the statistical power has been studied, sample size determination lacks a formulation that takes account of these factors in longitudinal surveys that aim to measure net and gross changes simultaneously. In this study, we propose a framework for sample size calculation to measure net and gross changes in estimated means or proportions concurrently in longitudinal surveys. We present a framework to compute panel and fresh sample sizes for varying levels of net and gross change. Finally, we illustrate the framework using nchange, an R package we developed to execute the algorithm of the proposed framework. The framework and the R package will support researchers to determine sample sizes targeting specific power of analysis with respect to measuring net and gross changes in rotating- or split-panel surveys., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Elkasabi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

The purpose of the study was to assess awareness of and receptivity to FDA's point-of-sale (POS) tobacco public education campaign for adult cigarette smokers called Every Try Counts; it was the first multi-county POS campaign in the U.S. The design was a county-level treatment-control three-wave longitudinal design. The setting was 15 treatment and 15 control counties. Subjects were smokers ages 25 to 54 (N = 3,628). 4,145 individuals screened in as eligible; 3,628 (87.5% response rate) completed the Wave 1 questionnaire (Wave 2: n = 2,812; Wave 3: n = 2,571; retention 70.9%). Measures were self-reported brand and ad awareness (saw any ad a few times or more) and receptivity (5-item perceived effectiveness scale). The analysis included descriptive analyses of receptivity; bivariate analyses of awareness by treatment group; and covariate- and time-adjusted logistic regression models to determine changes in awareness attributable to the campaign. Receptivity was moderate and differed significantly by race/ethnicity. As was the case for all waves, at wave 3, ad awareness was significantly higher in treatment (53.3%) than control counties (36.1%, p < .05). In regression models, brand (OR = 1.53, 95% CI: 1.26-1.86) and ad (OR = 1.74, 95% CI: 1.39-2.16) awareness were significantly higher in treatment than control counties. Every Try Counts generated a moderate level of receptivity and attention from cigarette smokers. Limitations include self-reports of campaign awareness and generalizability to a small number of U.S. counties., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Introduction: Adolescent girls and young women (AGYW) in sub-Saharan Africa are disproportionately affected by the HIV epidemic and face an array of challenges using proven behavioral and biomedical prevention methods. To address the urgent need for expanding prevention options, we evaluated the baseline preferences of HIV prevention methods among participants enrolled in the MTN-034/REACH crossover trial along with their stated product preference prior to product initiation., Methods: AGYW aged 16-21 years were enrolled at 4 study sites: Cape Town and Johannesburg, South Africa; Kampala, Uganda; and Harare, Zimbabwe and randomly assigned to the sequence of using oral PrEP and the dapivirine ring for 6 months each, followed by a choice period in which they could choose either product (or neither) for an additional six months. Eligible AGYW were HIV-negative, not pregnant and using effective contraception for at least two months prior to enrollment. Descriptive statistics were used to summarize demographic and behavioral data while multinomial analysis was used to determine predictors of stated product preference (ring or oral PrEP)., Results: Of the 247 AGYW enrolled in REACH, 34% were aged 16-17 and 89% had a primary partner.The median age of sexual debut was 16 years and 40% had ever been pregnant. At screening, 35% of participants were diagnosed with a sexually transmitted infection (STI), 39% had an AUDIT-C score associated with harmful drinking and 11% reported intimate partner violence in the past 6 months. Overall, 28% of participants, had CESD-10 scores suggestive of depressive symptoms (≥12) in the past week. At baseline, similar proportions stated a preference for the ring and oral PrEP (38.1% and 40.5% respectively), with 19% of participants stating they preferred both products equally. Only study site was significantly associated with product preference (P<0.05) with AGYW from Johannesburg having higher odds of preferring the ring and those from Kampala having higher odds of preferring both options equally., Conclusions: We successfully enrolled African AGYW with a clear unmet need for HIV prevention. The balanced preference between the two products suggests that multiple biomedical prevention options may be appealing to this age group and could address their prevention needs., Competing Interests: The authors have declared that no competing interests exist, (Copyright: © 2023 Ngure et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Importance: SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis., Methods: RECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms., Discussion: RECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options., Registration: NCT05172024., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Helen Chu reported consulting for Merck, GSK, Pfizer, Ellume, Janssen, Vindico CME, and the Bill and Melinda Gates Foundation, and receiving research support from Gates Ventures, Ellume, and Sanofi Pasteur. She also serves as a co-investigator on studies funded by Pfizer, Novavax, and GSK. Maged Costantine reported receiving grant support for work not related to RECOVER work/publications from Baxter International and Siemens Healthcare and personal consulting fees not related to this paper from Progenity, Quidel Ortho, and Siemens Healthcare. Kristine Erlandson reported research funding from Gilead Sciences and consulting payments from Gilead Sciences, Merck, and ViiV Pharmaceuticals, all paid to the University of Colorado. Emily Gallagher reported consulting for Novartis, Flare Therapeutics and Seagen. Edward Gardner reported research support (clinical trials) from Gilead Sciences, ViiV Healthcare, and Cepheid. Jason Goldman reported research support from Gilead, Eli Lilly and Regeneron; grants from Gilead, Merck (BARDA); personal fees for consulting from Gilead, Eli Lilly; and non-financial support from Adaptive Biotechnologies and Labcorp/Monogram Biosciences outside the submitted work. Timothy Heinrich reported grant support from Merck Inc. and consulting fees from Roche. Rachel Hess reported serving as Data Safety Monitoring Board member for Astellas Pharmaceuticals unrelated to the current work. Leora Horwitz reported being a member of the National Academy of Medicine Committee on the Long-Term Health Effects Stemming from COVID-19 and Implications for the Social Security Administration. Priscilla Hsue reported receiving honoraria from Gilead and Merck unrelated to study topic, receiving study drug from Regeneron unrelated to study topic, and receiving a research grant from Novartis. Judith James reported OMRF has licensed her IP to Progentec Biosciences, has received grant support from Progentec Biosciences, and serves on Advisory Committees to Glaxo Smith Klein, Merck and Novartis. Arthur Kim reports providing educational materials to Clinical Care Options and UpToDate and serving on a Data Safety Monitoring board for Kintor Pharmaceuticals, Ltd. Bruce Levy reported serving as a consultant for AstraZeneca, Entrinsic Biosciences, Gossamer Bio and Nocion Therapeutics and receiving research support from Amgen, Genentech, GlaxoSmithKline, Pieris Pharmaceuticals, SRA and Sanofi unrelated to the current work. Vincent Marconi reported receiving grants from NIH during the conduct of the study and grants from NIH, Veteran Affairs, and Centers for Disease Control and Prevention; grants, personal fees, nonfinancial support, and other from Lilly and Gilead; grants and personal fees from ViiV; and nonfinancial support from Bayer outside the submitted work. Grace McComsey reported serving as consultant for Merck, Gilead, ViiV, Janssen and have received research support from Pfizer, Vanda, Genentech, Roche, Redhill and Cognivue. Torri Metz reported being a site PI and a participant in the medical advisory board for the planning of a Pfizer clinical trial of SARS-CoV-2 vaccination in pregnancy. She also reported being a site PI for a Pfizer study evaluating the pharmacokinetics of Paxlovid in pregnant people with COVID-19. Janet Mullington reported support for investigator-initiated research by "Open Medicine Foundation and the Patient-Led Research Collaborative" Princess Ogbogu reported research support from Astrazeneca, GSK, Blueprint medical; advisory board for Astrazeneca, GSK, Sanofi, Kalvista; and consulting for Astrazeneca, GSK Sairam Parthasarathy reported research funding to Institution from Sergey Brin foundation of COVID and Long-COVID research. Michael Peluso reported consulting fees from Gilead Sciences and AstraZeneca, and service on data safety monitoring board for American Gene Technologies. Sean Quigley reported service on speaker Board for Servier, Alnylam, Agios; service on advisory board for Recordati, Alexion. Franz Rischard reported research support from NIH/NHLBI, United Therapeutics, Acceleron/Merck, Janssen, Insmed, Aerovate, and Bayer; and consulting/advisory compensation from Acceleron and Bayer. Nadine Rouphael reported being a consultant for ICON and EMMES as a safety consultant for clinical trials; service on the advisory boards for Moderna; funds to institution from Sanofi, Lilly, Merck, Quidel and Pfizer. PJ Utz reported stock ownership of Gilead and PI of biomarker studies for Pfizer STOP-PASC paxlovid trial Juan Wisnivesky received receiving consulting honorarium from Sanofi, Banook, Prospero, PPD and Atea and research grants from Sanofi, Regeneron, Axella, and Arnold Consultants., (Copyright: © 2023 Horwitz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Given the high rates of both HIV and unintended pregnancies in sub-Saharan Africa, the SCHIELD program aims to develop a multipurpose technology implant for HIV and pregnancy prevention. An end-user evaluation was undertaken with young women and health care providers to assess preferences for modifiable implant attributes to improve future adoption and rollout., Methods: Focus group discussions were conducted with potential women end users, and health care providers experienced in implant insertion or removal participated in in-depth interviews. All participants were recruited from Harare, Zimbabwe, or Soshanguve, South Africa. The purposively stratified sampled women were either implant experienced or implant naïve and were categorized into three groups: nulliparous, postpartum, or engaged in transactional sex. Topics covered included duration (six months to three years), biodegradability, removability, and independent rod retrievability (per indication). Data were analyzed using Dedoose software and summarized into emerging themes., Results: Participants identified three key areas that could facilitate rollout, uptake, and adherence of an implant for HIV and pregnancy prevention. First, discreetness was the most salient topic and was associated with implant characteristics such as anatomical location, flexibility, and biodegradability. Second, the ability to independently retrieve the HIV or pregnancy prevention component was preferred, as life circumstances may change and was favored by all participants, except for young women in Soshanguve. Third, there is a need for proper counseling, sensitization, provider training, and health campaigns to facilitate rollout of a 2-in-1 implant., Conclusions: A 2-in-1 implant was seen as highly desirable by most young women and health care providers. Participants discussed potential concerns and barriers to uptake of a biodegradable implant with dual HIV prevention and contraceptive properties, identifying key implant attributes that product developers can modify while still in preclinical stages., Competing Interests: The technology disclosed in this manuscript is protected by pending US Patent application US 20210346661 A1 (and corresponding international applications) and PCT application WO/2021/207329 (and corresponding international applications) with LMJ and AVS as named inventors., (Copyright: © 2023 Nkomo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

This paper provides the detailed protocol for a pilot study testing the feasibility, acceptability, and initial efficacy of a targeted two-phase, remotely delivered early intervention program for infants with neurogenetic conditions (NGC) and their caregivers. The Parent and Infant Inter(X)action Intervention (PIXI) is designed to support parents and infants with a NGC diagnosed in the first year of life. PIXI is implemented in two phases, with the first phase focusing on psychoeducation, parent support, and how to establish routines for supporting infant development. Phase II helps parents learn targeted skills to support their infant's development as symptoms may begin to emerge. The proposed non-randomized feasibility pilot study will establish the feasibility of a year-long virtually implemented intervention program to support new parents of an infant diagnosed with an NGC., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Wheeler et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Variation in genes involved in ethanol metabolism has been shown to influence risk for alcohol dependence (AD) including protective loss of function alleles in ethanol metabolizing genes. We therefore hypothesized that people with severe AD would exhibit different patterns of rare functional variation in genes with strong prior evidence for influencing ethanol metabolism and response when compared to genes not meeting these criteria., Objective: Leverage a novel case only design and Whole Exome Sequencing (WES) of severe AD cases from the island of Ireland to quantify differences in functional variation between genes associated with ethanol metabolism and/or response and their matched control genes., Methods: First, three sets of ethanol related genes were identified including those a) involved in alcohol metabolism in humans b) showing altered expression in mouse brain after alcohol exposure, and altering ethanol behavioral responses in invertebrate models. These genes of interest (GOI) sets were matched to control gene sets using multivariate hierarchical clustering of gene-level summary features from gnomAD. Using WES data from 190 individuals with severe AD, GOI were compared to matched control genes using logistic regression to detect aggregate differences in abundance of loss of function, missense, and synonymous variants, respectively., Results: Three non-independent sets of 10, 117, and 359 genes were queried against control gene sets of 139, 1522, and 3360 matched genes, respectively. Significant differences were not detected in the number of functional variants in the primary set of ethanol-metabolizing genes. In both the mouse expression and invertebrate sets, we observed an increased number of synonymous variants in GOI over matched control genes. Post-hoc simulations showed the estimated effects sizes observed are unlikely to be under-estimated., Conclusion: The proposed method demonstrates a computationally viable and statistically appropriate approach for genetic analysis of case-only data for hypothesized gene sets supported by empirical evidence., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Gentry et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Decisions about prevention of and response to Ebola outbreaks require an understanding of the macroeconomic implications of these interventions. Prophylactic vaccines hold promise to mitigate the negative economic impacts of infectious disease outbreaks. The objective of this study was to evaluate the relationship between outbreak size and economic impact among countries with recorded Ebola outbreaks and to quantify the hypothetical benefits of prophylactic Ebola vaccination interventions in these outbreaks., Methods: The synthetic control method was used to estimate the causal impacts of Ebola outbreaks on per capita gross domestic product (GDP) of five countries in sub-Saharan Africa that have previously experienced Ebola outbreaks between 2000 and 2016, where no vaccines were deployed. Using illustrative assumptions about vaccine coverage, efficacy, and protective immunity, the potential economic benefits of prophylactic Ebola vaccination were estimated using the number of cases in an outbreak as a key indicator., Results: The impact of Ebola outbreaks on the macroeconomy of the selected countries led to a decline in GDP of up to 36%, which was greatest in the third year after the onset of each outbreak and increased exponentially with the size of outbreak (i.e., number of reported cases). Over three years, the aggregate loss estimated for Sierra Leone from its 2014-2016 outbreak is estimated at 16.1 billion International$. Prophylactic vaccination could have prevented up to 89% of an outbreak's negative impact on GDP, reducing the outbreak's impact to as little as 1.6% of GDP lost., Conclusion: This study supports the case that macroeconomic returns are associated with prophylactic Ebola vaccination. Our findings support recommendations for prophylactic Ebola vaccination as a core component of prevention and response measures for global health security., Competing Interests: This research was sponsored by Johnson and Johnson Services, Inc., and is related to the development of products licensed to Johnson and Johnson Services, Inc. LTRM, BA, AB, SET, NB, PDMM, and AAH are employees of RTI International which is an independent research organization that received funding from Johnson and Johnson Services, Inc. for the conduct of this study. LM and MG are employees of Johnson & Johnson Global Public Health, and VOM is an employee of Janssen Vaccines & Prevention B.V., which are companies of Johnson & Johnson Services, Inc. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2023 Morrison et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Although social support from fathers is associated with improved child feeding practices, evidence on feasible, acceptable, and effective ways to involve fathers in supporting child nutrition, including animal source food (ASF) consumption, is limited. This study was a follow-on to a trial that tested the effects of social and behavior change communication (SBCC) targeted mainly at mothers to promote ASF consumption by children in households that received an exotic or crossbred cow through the government of Rwanda's Girinka "One Cow Per Poor Family" program (NCT0345567). A delayed SBCC intervention was provided to mothers in the non-intervention arms prior to the present pre/post study, which targeted fathers in households across the trial study arms. Baseline and endline surveys with a cohort of 149 fathers with a child <5 years were used to evaluate the effects of a SBCC intervention for fathers on their children's ASF consumption and on fathers' knowledge, awareness, and support for children's ASF consumption. Qualitative data collected from fathers, mothers, and program implementers were used to assess feasibility and acceptability of the intervention for fathers. The SBCC intervention comprised group meetings led by model fathers, text messages, print materials, and megaphone blasts. The odds of children consuming any type of ASF ≥2 times in the last week increased from baseline to endline (OR 4.9, 95% CI 1.9, 12.3), as did the odds consuming milk, eggs, and beef, but not fish. Fathers' mean ASF knowledge and awareness scores increased from baseline to endline (knowledge: 2.3 to 3.5 out of 4 items, P<0.001; awareness: 2.5 to 3.0 out of 3 items, P<0.001), with the largest changes observed in knowledge of timing of introduction of milk and other ASFs. The percentage of fathers who offered two or more supportive actions for their children's milk and other ASF consumption increased from baseline to endline (milk: 19.5% to 31.5%, P = 0.017; other ASFs: 18.8% to 37.6%, P<0.001). Fathers appreciated gaining knowledge on child nutrition in a setting specifically for men and liked the print materials that offered clear actions they could take to support their children's ASF consumption. This study shows that an SBCC intervention for fathers can improve children's ASF consumption and increase fathers' knowledge, awareness, and support for children's nutrition., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Flax et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Prior research has found that experiences with violence in the U.S. differ across individual demographic characteristics, including race, gender, and sexual orientation. However, peer reviewed studies have yet to examine the relationship between the intersections of race, gender, and sexual orientation, victimization risk, and characteristics of victimization., Methods: We use data from three years (2017-2019) of the National Crime Victimization Survey, the primary source of information on criminal victimization in the United States, to examine victimization at the intersection of sexual orientation, gender, and race/ethnicity. We test whether non-Hispanic Black, Hispanic, and non-Hispanic White sexual and gender minority (SGM) persons aged 16 or over are victimized at greater rates than their non-SGM counterparts and assess whether there are differences between sexual minority females and males of each racial group. We further document characteristics of victimization such as reporting to the police by SGM status and race or ethnicity., Results: We find that SGMs are disproportionately more likely to be victims of violent crime than non-SGM people, and these disparities are present across the assessed racial and ethnic groups (non-Hispanic Black odds ratio [OR] = 3.3, 90% CI [CI] = 1.36, 5.16; Hispanic OR = 4.5, CI = 2.25, 6.71; non-Hispanic White OR = 4.8, CI = 2.25, 6.71). However, sexual orientation disparities are statistically distinguishable for lesbian or bisexual (LB) non-Hispanic White and Hispanic females but not for non-Hispanic Black LB females. Among LB females, the overall differences in victimization were primarily driven by bisexual respondents. We further find racial and ethnic differences among SGM victims in the likelihood of having the victimization reported to the police, in the utilization of community (non-police) resources, and in other aspects of victimization experiences, such as whether arrests occurred or in the suspicion that the violent incident was a hate crime., Conclusions: Our findings raise indicate a complex picture of how sexual orientation, gender identity, sex, and race and ethnicity interact in victimizations and their characteristics that should be further explored., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Flores et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

We estimate the prevalence and characteristics of violent hate crime victimization of lesbian, gay, bisexual, and transgender (LGBT) people in the United States, and we compare them to non-LGBT hate crime victims and to LGBT victims of violent non-hate crime. We analyze pooled 2017-2019 data from the National Crime Victimization Survey (n persons = 553, 925;n incidents = 32, 470), the first nationally representative and comprehensive survey on crime that allows identification of LGBT persons aged 16 or older. Descriptive and bivariate analysis show that LGBT people experienced 6.6 violent hate crime victimizations per 1,000 persons compared with non-LGBT people's 0.6 per 1,000 persons (odds ratio = 8.30, 95% confidence interval = 1.94, 14.65). LGBT people were more likely to be hate crime victims of sexual orientation or gender bias crime and less likely to be victims of race or ethnicity bias crimes compared to non-LGBT hate crime victims. Compared to non-LGBT victims, LGBT victims of hate crime were more likely to be younger, have a relationship with their assailant, and have an assailant who is white. Compared to LGBT victims of non-hate violence, more LGBT hate crime victims reported experiencing problems in their social lives, negative emotional responses, and physical symptoms of distress. Our findings affirm claims that hate crimes have adverse physical and psychological effects on victims and highlight the need to ensure that LGBT persons who experience hate crime get necessary support and services in the aftermath of the crime., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Flores et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objectives: To adopt the FAIR principles (Findable, Accessible, Interoperable, Reusable) to enhance data sharing, the Cure Sickle Cell Initiative (CureSCi) MetaData Catalog (MDC) was developed to make Sickle Cell Disease (SCD) study datasets more Findable by curating study metadata and making them available through an open-access web portal., Methods: Study metadata, including study protocol, data collection forms, and data dictionaries, describe information about study patient-level data. We curated key metadata of 16 SCD studies in a three-tiered conceptual framework of category, subcategory, and data element using ontologies and controlled vocabularies to organize the study variables. We developed the CureSCi MDC by indexing study metadata to enable effective browse and search capabilities at three levels: study, Patient-Reported Outcome (PRO) Measures, and data element levels., Results: The CureSCi MDC offers several browse and search tools to discover studies by study level, PRO Measures, and data elements. The "Browse Studies," "Browse Studies by PRO Measures," and "Browse Studies by Data Elements" tools allow users to identify studies through pre-defined conceptual categories. "Search by Keyword" and "Search Data Element by Concept Category" can be used separately or in combination to provide more granularity to refine the search results. This resource helps investigators find information about specific data elements across studies using public browsing/search tools, before going through data request procedures to access controlled datasets. The MDC makes SCD studies more Findable through browsing/searching study information, PRO Measures, and data elements, aiding in the reuse of existing SCD data., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Pan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Infant and young child feeding (IYCF) practices are important for child survival and healthy growth, but IYCF practices remain suboptimal in Nigeria. The objective of this study was to measure the impact of Alive & Thrive's IYCF social and behavior change communication intervention on early initiation of breastfeeding, exclusive breastfeeding, and minimum dietary diversity in Kaduna and Lagos States., Methods: Local government areas were randomly allocated to intervention or comparison. Cross-sectional surveys of households with children aged 0-23 months were conducted [N = 6,266 baseline (2017), N = 7,320 endline (2020)]. Logistic regression was used to calculate difference-in-differences estimates (DDEs) of impact on IYCF practices and to assess within group changes from baseline to endline. Associations between intervention exposures and IYCF practices were tested in both study groups combined., Results: In Kaduna, a positive differential effect of the intervention was found for exclusive breastfeeding (adjusted DDE 8.9 pp, P<0.099). Increases in both study groups from baseline to endline were observed in Kaduna for early initiation of breastfeeding (intervention 12.2 pp, P = 0.010; comparison 6.4 pp, P = 0.118) and minimum dietary diversity (intervention 20.0 pp, P<0.001; comparison 19.7 pp, P<0.001), which eliminated differential effects. In Lagos, no differential intervention impacts were found on IYCF practices because changes in early initiation of breastfeeding from baseline to endline were small in both study groups and increases in both study groups from baseline to endline were observed for exclusive breastfeeding (intervention 8.9 pp, P = 0.05; comparison 6.6 pp, P<0.001) and minimum dietary diversity (intervention 18.9 pp, P<0.001; comparison 24.3 pp, P<0.001). Odds of all three IYCF practices increased with exposure to facility-based interpersonal communication in both states and with community mobilization or mass media exposure in Kaduna., Conclusions: This evaluation found weak impacts of the Alive & Thrive intervention on IYCF practices in the difference-in-differences analysis because of suspected intervention spillover to the comparison group. Substantial within group increases in IYCF practices from baseline to endline are likely attributable to the intervention, which was the major IYCF promotion activity in both states. This is supported by the association between intervention exposures and IYCF practices., Trial Registration: The study was registered with clinicaltrials.gov (NCT02975063)., Competing Interests: VLF, MF, CHS, JU, SE have no competing interests. AAK and SB have read the journal’s policy and have the following competing interests: they are employed by Alive & Thrive and were involved in the design, implementation, and monitoring of the intervention, but not in data collection or analysis for this study. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2022 Flax et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: COVID-19 has resulted in over 1 million deaths in the U.S. as of June 2022, with continued surges after vaccine availability. Information on related attitudes and behaviors are needed to inform public health strategies. We aimed to estimate the prevalence of COVID-19, risk factors of infection, and related attitudes and behaviors in a racially, ethnically, and socioeconomically diverse urban population., Methods: The DFW COVID-19 Prevalence Study Protocol 1 was conducted from July 2020 to March 2021 on a randomly selected sample of adults aged 18-89 years, living in Dallas or Tarrant Counties, Texas. Participants were asked to complete a 15-minute questionnaire and COVID-19 PCR and antibody testing. COVID-19 prevalence estimates were calculated with survey-weighted data., Results: Of 2969 adults who completed the questionnaire (7.4% weighted response), 1772 (53.9% weighted) completed COVID-19 testing. Overall, 11.5% of adults had evidence of COVID-19 infection, with a higher prevalence among Hispanic and non-Hispanic Black persons, essential workers, those in low-income neighborhoods, and those with lower education attainment compared to their counterparts. We observed differences in attitudes and behaviors by race and ethnicity, with non-Hispanic White persons being less likely to believe in the importance of mask wearing, and racial and ethnic minorities more likely to attend social gatherings., Conclusion: Over 10% of an urban population was infected with COVID-19 early during the pandemic. Differences in attitudes and behaviors likely contribute to sociodemographic disparities in COVID-19 prevalence., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Singal et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

This scoping review identified observational studies of adults that utilized accelerometry to assess physical activity and sedentary behavior. Key elements on accelerometry data collection were abstracted to describe current practices and completeness of reporting. We searched three databases (PubMed, Web of Science, and SPORTDiscus) on June 1, 2021 for articles published up to that date. We included studies of non-institutionalized adults with an analytic sample size of at least 500. The search returned 5686 unique records. After reviewing 1027 full-text publications, we identified and abstracted accelerometry characteristics on 155 unique observational studies (154 cross-sectional/cohort studies and 1 case control study). The countries with the highest number of studies included the United States, the United Kingdom, and Japan. Fewer studies were identified from the continent of Africa. Five of these studies were distributed donor studies, where participants connected their devices to an application and voluntarily shared data with researchers. Data collection occurred between 1999 to 2019. Most studies used one accelerometer (94.2%), but 8 studies (5.2%) used 2 accelerometers and 1 study (0.6%) used 4 accelerometers. Accelerometers were more commonly worn on the hip (48.4%) as compared to the wrist (22.3%), thigh (5.4%), other locations (14.9%), or not reported (9.0%). Overall, 12.7% of the accelerometers collected raw accelerations and 44.6% were worn for 24 hours/day throughout the collection period. The review identified 155 observational studies of adults that collected accelerometry, utilizing a wide range of accelerometer data processing methods. Researchers inconsistently reported key aspects of the process from collection to analysis, which needs addressing to support accurate comparisons across studies., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Evenson et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Accruing evidence reveals best practices for how to help individuals living with Sickle Cell Disease (SCD); yet, the implementation of these evidence-based practices in healthcare settings is lacking. The Sickle Cell Disease Implementation Consortium (SCDIC) is a national consortium that uses implementation science to identify and address barriers to care in SCD. The SCDIC seeks to understand how and why patients become unaffiliated from care and determine strategies to identify and connect patients to care. A challenge, however, is the lack of agreed-upon definition for what it means to be unaffiliated and what it means to be a "SCD expert provider". In this study, we conducted a Delphi process to obtain expert consensus on what it means to be an "unaffiliated patient" with SCD and to define an "SCD specialist," as no standard definition is available. Twenty-eight SCD experts participated in three rounds of questions. Consensus was defined as 80% or more of respondents agreeing. Experts reached consensus that an individual with SCD who is unaffiliated from care is "someone who has not been seen by a sickle cell specialist in at least a year." A sickle cell specialist was defined as someone with knowledge and experience in SCD. Having "knowledge" means: being knowledgeable of the 2014 NIH Guidelines, "Evidence-Based Management of SCD", trained in hydroxyurea management and transfusions, trained on screening for organ damage in SCD, trained in pain management and on SCD emergencies, and is aware of psychosocial and cognitive issues in SCD. Experiences that are expected of a SCD specialist include experience working with SCD patients, mentored by a SCD specialist, regular attendance at SCD conferences, and obtains continuing medical education on SCD every 2 years." The results have strong implications for future research, practice, and policy related to SCD by helping to lay a foundation for an new area of research (e.g., to identify subpopulations of unaffiliation and targeted interventions) and policies that support reaffiliation and increase accessibility to quality care., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

In 2017, Kenya became one of the first African countries to provide pre-exposure prophylaxis (PrEP) in its national HIV prevention plan. We sought to characterize factors associated with PrEP uptake and persistence among a cohort of women at risk of HIV infection during the early stages of PrEP scale-up in Kenya. HIV-negative women ≥18 years with ≥2 sexual partners in the past 4 weeks were recruited as part of an ongoing cluster randomized trial of an HIV self-testing intervention. PrEP use was assessed at baseline and at 6- and 12-month follow-up visits. Between June 2017 and August 2018, 2,086 were enrolled and had complete baseline data. 138 (6.6%) reported PrEP use during the first year of the study. Although PrEP use increased, persistence on PrEP was low, and less than half of individuals reported continuing PrEP at follow-up visits. In multivariate analyses, PrEP use was associated with recent STIs, having an HIV-positive primary partner, having regular transactional sex in the past 12 months, and being a female sex worker. In the early stages of PrEP scale-up in Kenya, uptake increased modestly among women with risk factors for HIV infection, but overall uptake and persistence was low., Competing Interests: The authors have declared that no competing interests exist.

HIV acquisition among pregnant and breastfeeding women in sub-Saharan Africa and vertical transmission rates remain high despite established strategies for HIV prevention. During the MTN-041/MAMMA study, we explored the influence of grandmothers (mothers and mothers-in-law of pregnant and breastfeeding women) in eastern and southern Africa on the health-related decisions of pregnant and breastfeeding women and their potential to support use of HIV prevention products. To do this we used structured questionnaires and focus group discussions with three stakeholder groups: 1) grandmothers, 2) HIV-uninfected currently or recently pregnant or breastfeeding women and 3) male partners of currently or recently pregnant or breastfeeding women. A total of 23 focus group discussions comprising 68 grandmothers, 65 pregnant or breastfeeding women and 63 male partners were completed across four study sites. Grandmothers were described as important sources of information during pregnancy and breastfeeding playing both supportive and influencer roles due to personal maternal experience and generational knowledge. While pregnant and breastfeeding women were not keen to involve grandmothers in HIV prevention decision making, they were accepting of grandmothers' involvement in a supportive role. Grandmothers expressed willingness to support pre-exposure prophylaxis use and agreed with the other two stakeholder groups that this decision should be made by women themselves or together with partners. These novel data indicate potential for grandmothers' health related supportive roles to be extended to support decision-making and adherence to biomedical HIV prevention options, and possibly contribute to the decline in HIV acquisition among pregnant and breastfeeding women in these communities., Competing Interests: The authors have declared that no competing interests exist.

Background: Haiti has been experiencing a resurgence of diphtheria since December 2014. Little is known about the factors contributing to the spread and persistence of the disease in the country. Geographic information systems (GIS) and spatial analysis were used to characterize the epidemiology of diphtheria in Haiti between December 2014 and June 2021., Methods: Data for the study were collected from official and open-source databases. Choropleth maps were developed to understand spatial trends of diphtheria incidence in Haiti at the commune level, the third administrative division of the country. Spatial autocorrelation was assessed using the global Moran's I. Local indicators of spatial association (LISA) were employed to detect areas with spatial dependence. Ordinary least squares (OLS) and geographically weighted regression (GWR) models were built to identify factors associated with diphtheria incidence. The performance and fit of the models were compared using the adjusted r-squared (R2) and the corrected Akaike information criterion (AICc)., Results: From December 2014 to June 2021, the average annual incidence of confirmed diphtheria was 0.39 cases per 100,000 (range of annual incidence = 0.04-0.74 per 100,000). During the study period, diphtheria incidence presented weak but significant spatial autocorrelation (I = 0.18, p<0.001). Although diphtheria cases occurred throughout Haiti, nine communes were classified as disease hotspots. In the regression analyses, diphtheria incidence was positively associated with health facility density (number of facilities per 100,000 population) and degree of urbanization (proportion of urban population). Incidence was negatively associated with female literacy. The GWR model considerably improved model performance and fit compared to the OLS model, as indicated by the higher adjusted R2 value (0.28 v 0.15) and lower AICc score (261.97 v 267.13)., Conclusion: This study demonstrates that GIS and spatial analysis can support the investigation of epidemiological patterns. Furthermore, it shows that diphtheria incidence exhibited spatial variability in Haiti. The disease hotspots and potential risk factors identified in this analysis could provide a basis for future public health interventions aimed at preventing and controlling diphtheria transmission., Competing Interests: The authors have declared that no competing interests exist.

Background: Globally, socioeconomic status (SES) is an important health determinant across a range of health conditions and diseases. However, measuring SES within low- and middle-income countries (LMICs) can be particularly challenging given the variation and diversity of LMIC populations., Objective: The current study investigates whether maternal SES as assessed by the newly developed Global Network-SES Index is associated with pregnancy outcomes (stillbirths, perinatal mortality, and neonatal mortality) in six LMICs: Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan, and Zambia., Methods: The analysis included data from 87,923 women enrolled in the Maternal and Newborn Health Registry of the NICHD-funded Global Network for Women's and Children's Health Research. Generalized estimating equations models were computed for each outcome by SES level (high, moderate, or low) and controlling for site, maternal age, parity, years of schooling, body mass index, and facility birth, including sampling cluster as a random effect., Results: Women with low SES had significantly higher risks for stillbirth (p < 0.001), perinatal mortality (p = 0.001), and neonatal mortality (p = 0.005) than women with high SES. In addition, those with moderate SES had significantly higher risks of stillbirth (p = 0.003) and perinatal mortality (p = 0.008) in comparison to those with high SES., Conclusion: The SES categories were associated with pregnancy outcomes, supporting the validity of the index as a non-income-based measure of SES for use in studies of pregnancy outcomes in LMICs., Competing Interests: The authors have declared that no competing interests exist.

Introduction: Young female sex workers (FSW) are disproportionately vulnerable to HIV. Zimbabwe data show higher HIV incidence and lower engagement in services compared to older FSW. Utilizing data from a combination HIV prevention and treatment intervention, we describe engagement in the HIV services over time among FSW 18-24 years, compared to those ≥25 years of age., Materials and Methods: Data were collected via respondent-driven sampling (RDS) surveys in 14 communities in 2013 and 2016, with >2500 FSW per survey. They included blood samples for HIV and viral load testing. As the intervention had no significant impact on HIV care cascade outcomes, data were aggregated across study arms. Analyses used RDS-II estimation., Results: Mean age in 2013 and 2016 was 31 and 33 years, with 27% and 17% aged 18-24 years. Overall HIV prevalence was 59% at each timepoint, and 35% and 36% among younger FSW. From 2013 to 2016 there was an increase in young HIV-positive FSW knowing their status (38% vs 60%, OR = 2.51, p<0.01). Outcomes for all FSW improved significantly over time at all steps of the cascade, and the relative change over time was similar among older versus younger FSW for most cascade variables., Discussion: Young FSW had improvements in care cascade outcomes, and proportionate improvements similar to older FSW, yet they remain less engaged in services overall. This implies that the dedicated FSW services in Zimbabwe are having a comparably positive impact across age groups, however more is likely required to address young FSW's unique vulnerabilities and needs., Competing Interests: The authors have declared that no competing interests exist.

We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis., Competing Interests: Clare Whitehead declares a a relationship with the following entities, Ferring Pharmaceuticals COVID19 Investigational, Grant, NHMRC Fellowship (salary support). Edward Mullins declares a relationship with the following entities National Institute for Health Research (Project grant for PAN COVID study). Deborah Money declares a relationship with the following entities, Canadian Institutes of Health Research (payments to my institution only), Public Health Agency of Canada (payments to institution only), BC Women’s Foundation (payments to institution only) and is a Member of the COVID-19 Immunity Task Force sponsored by the Canadian government. Torri D. Metz declares a relationship with the following entities, Pfizer (site Principal Investigator for SARS-CoV-2 vaccination in pregnancy study, money paid to institution and member of Medical Advisory Board for SARS-CoV-2 vaccination in pregnancy study, money paid to me), NICHD (subcommittee Chair for the NICHD Maternal-Fetal Medicine Units Network Gestational Research Assessments of COVID-19 (GRAVID) study), and Society for Maternal-Fetal Medicine (board member). Erica Lokken declares a relationship with the following entity, US NIH (paid institution). Karen L. Kotloff declares a relationship with the following entity, Bill and Melinda Gates Foundation. Siran He declares a relationship with the following entity, Bill and Melinda Gates Foundtion (payments made to institution). Valerie Flaherman declares a relationship with the following entities, Bill and Melinda Gates Foundation (payments to institution), Yellow Chair Foundation (payments to institution), Robert Woods Johnson Foundation (payments to institution), CDC Foundation, California Health Care Foundation (payments to institution), Tara Health Foundation (payments to institution), UCSF Women’s Health Center of Excellence (payments to institution) and California Department of Health Care Services (payments made to institution). Jose Sanin-Blair declares a relationship with the following entity, Ferring Pharmaceuticals which gave a grant ($10,000) for the expenses of RECOGEST trial and is a part of the Columbian Federation of Perinatology. Yalda Afshar declares a relationship with the following entities, Bill and Melinda Gates Foundation (payments made to institution), CDC Foundation (payments made to my institution), Robert Woods Johnson Foundation (payments made to institution), and UCLA Dean’s Office COVID-19 research (payments made to institution). Rebecca Clifton declares a relationship with the following entity, NIH HD36801 (MFMU Network DCC). Alice Panchaud declared a relationship with the European Medicines Agency (research grant to institution) and the Federal Office of Public Health Switzerland (research grant to institution).

Background: Male partner awareness and acceptance of microbicide and family planning product use has been shown to increase women's own acceptance and adherence of a product. However, little is known about preferences regarding potential Multipurpose Prevention Technology (MPT) product delivery forms. As part of the TRIO study, men's reactions to their female partner's TRIO product use and comparisons of men's and women's views of TRIO product attributes and use acceptability were explored to better understand product preferences., Methods: Women in TRIO used three placebo products that represented potential MPTs: daily oral tablets, monthly vaginal rings, and monthly dual injections. Male partners (N = 39) and women (N = 88) completed in-depth interviews on their own and their partner's experiences with these products. Qualitative coding and analyses followed a conceptual model of HIV prevention product acceptability, and here, we explored themes of disclosure, trust and infidelity as they informed barriers and facilitators to product use., Results: Men expressed a desire to know of their partner's product use decisions and be informed and educated on the products to better support their partners, in some cases, expressing a high level of concern regarding maximizing the ease of product adherence for their partner. They also wanted to understand the effects of products on sexual encounters with their partner, but in some cases, wanted more knowledge in order to control their partner's product use decisions. Similarly to women, men found long-acting, discreet products that have little to no effect on sexual encounters or libido the most acceptable for their female partners' use. Product use was most acceptable to men if they were informed of use without inadvertent discovery., Conclusions: Men's product attribute preferences often aligned with women's opinions of the same products. To support women's correct use of MPTs, further research is needed to determine the best strategy for achieving male partner acceptance and support of product use, particularly for less familiar delivery forms, such as the vaginal ring., Competing Interests: No conflicts of interest are declared.

Introduction: Sickle cell disease (SCD) is an inherited hemoglobinopathy that predominantly affects African Americans in the United States. The disease is associated with complications leading to high healthcare utilization rates, including emergency department (ED) visits and hospitalizations. Optimal SCD care requires a multidisciplinary approach involving SCD specialists to ensure preventive care, minimize complications and prevent unnecessary ED visits and hospitalizations. However, most individuals with SCD receive sub-optimal care or are unaffiliated with care (have not seen an SCD specialist). We aimed to identify barriers to care from the perspective of individuals with SCD in a multi-state sample., Methods: We performed a multiple methods study consisting of surveys and interviews in three comprehensive SCD centers from March to June 2018. Interviews were transcribed and coded, exploring themes around barriers to care. Survey questions on the specific themes identified in the interviews were analyzed using summary statistics., Results: We administered surveys to 208 individuals and conducted 44 in-depth interviews. Barriers to care were identified and classified according to ecological level (i.e., individual, family/interpersonal, provider, and socio-environmental/organizational level). Individual-level barriers included lack of knowledge in self-management and disease severity. Family/interpersonal level barriers were inadequate caregiver support and competing life demands. Provider level barriers were limited provider knowledge, provider inexperience, poor provider-patient relationship, being treated differently, and the provider's lack of appreciation of the patient's SCD knowledge. Socio-environmental/organizational level barriers included limited transportation, lack of insurance, administrative barriers, poor care coordination, and reduced access to care due to limited clinic availability, services provided or clinic refusal to provide SCD care., Conclusion: Participants reported several multilevel barriers to SCD care. Strategies tailored towards reducing these barriers are warranted. Our findings may also inform interventions aiming to locate and link unaffiliated individuals to care., Competing Interests: The authors have declared that no competing interests exist.

Agent-based models (ABMs) have become a common tool for estimating demand for hospital beds during the COVID-19 pandemic. A key parameter in these ABMs is the probability of hospitalization for agents with COVID-19. Many published COVID-19 ABMs use either single point or age-specific estimates of the probability of hospitalization for agents with COVID-19, omitting key factors: comorbidities and testing status (i.e., received vs. did not receive COVID-19 test). These omissions can inhibit interpretability, particularly by stakeholders seeking to use an ABM for transparent decision-making. We introduce a straightforward yet novel application of Bayes' theorem with inputs from aggregated hospital data to better incorporate these factors in an ABM. We update input parameters for a North Carolina COVID-19 ABM using this approach, demonstrate sensitivity to input data selections, and highlight the enhanced interpretability and accuracy of the method and the predictions. We propose that even in tumultuous scenarios with limited information like the early months of the COVID-19 pandemic, straightforward approaches like this one with discrete, attainable inputs can improve ABMs to better support stakeholders., Competing Interests: The authors have declared the no competing interests exist.

Given challenges with adherence to existing HIV prevention products, the development of an extended duration vaginal ring could improve adherence while reducing patient and provider burden. Additionally, women have other interlinked sexual health concerns such as unintended pregnancy. We evaluated acceptability of a 90-day ring to prevent HIV and hypothetical preferences for a dual (HIV and contraceptive) indication. This was a secondary analysis of a Phase 1, two-arm, multi-site, placebo-controlled randomized trial evaluating safety and pharmacokinetics of a 90-day vaginal ring containing tenofovir for HIV prevention (N = 49). We used a mixed methods approach to assess quantitative data on acceptability (n = 49) and used qualitative data from a random subset to explain the quantitative findings (N = 25). The 3-month extended duration tenofovir ring was highly acceptable. Participants perceived the ring to be easy to use, comfortable and reported liking it more over time. About half felt the ring during sex but most of those participants said it bothered them only a little. Concerns about hygiene increased over the study period but were often outweighed by the benefits of an extended duration ring. Interest in a multi-purpose ring was high (77%) and even higher among those who were sexually active and had male partners. The 3-month extended duration tenofovir ring for HIV prevention was highly acceptable among women and interest in an MPT was high., Competing Interests: Dr. Chen receives research grants from Medicines360 and Sebela, which are all managed by Magee-Womens Research Institute. All other authors declare no conflict of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

This study is a randomized, placebo-controlled, double-blinded trial performed to investigate the effects of a dietary supplement containing a mixture of Boswellia serrata Roxb., chlorophyll, green tea extract, glucosamine, chondroitin sulfate, hyaluronic acid, and further in the manuscript: non-hydrolised type II collagen in dogs with osteoarthritis (OA). A total of 40 dogs were enrolled in the study, they were randomly divided in control (CTR) and treatment (TRT) groups. The TRT group received the dietary supplement for 60 days. The CTR group received a placebo for the same number of days. All the subjects had veterinary evaluations during the trial and owners were requested to fill in questionnaires on chronic pain using the Helsinki Chronic Pain Index. The product was easy to administer and no side effects were reported. Combining results from veterinarian and owner evaluations, the tested product proved to be significantly beneficial in alleviating pain and in reducing the clinical signs in dogs with OA., Competing Interests: EM and MB were paid as consultants of Candioli Pharma Srl, and RA and NB as employees of the Candioli Pharma Srl. There are no patents, products in development or marketed products to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

We conducted a scoping systematic review with respect to how consumer engagement with interactive advertising is evaluated and if interactive features influence consumer recall, awareness, or comprehension of product claims and risk disclosures for informing regulatory science. MEDLINE, PsycINFO, Business Source Corporate, and SCOPUS were searched for original research published from 1997 through February 2021. Two reviewers independently screened titles/abstracts and full-text articles for inclusion. Outcomes were abstracted into a structured abstraction form. We included 32 studies overall. The types of interactive ads evaluated included website banner and pop up ads, search engine ads, interactive TV ads, advergames, product websites, digital magazine ads, and ads on social network sites. Twenty-three studies reported objective measures of engagement using observational analyses or laboratory-based experiments. In nine studies evaluating the association between different interactivity features and outcomes, the evidence was mixed on whether more interactivity improves or worsens recall and comprehension. Studies vary with respect to populations, designs, ads evaluated, and outcomes assessed., Competing Interests: HS and AO are employees of the study sponsor. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Objective: Little is known about the association between maternal depressive symptoms and attendance at safety promotion interventions. This study used latent class analysis (LCA) to identify the profile of attendance within a toddler safety intervention and assessed its relation with maternal depressive symptoms at baseline and reduction of home safety problems over time, separately., Methods: The analytic sample included 91 mothers of toddlers (mean maternal age 28.16 years) who were assigned to the safety promotion intervention group as part of a randomized trial and assessed at baseline, 6-month and 12-month follow-ups. Using LCA, we classified mothers into low and high attendance classes based on their attendance at 8 intervention sessions. We assessed maternal depressive symptoms with the Beck Depression Inventory (BDI) and home safety problems with a 9-item home safety problem observation., Results: The mothers were classified into low attendance (45%) and high attendance classes (55%). The posterior probability of attending each session ranged from 0-0.29 for the low attendance class and 0.68-0.92 for the high attendance class. Each one unit increase of BDI sum score at baseline was associated with an 8% reduced odds of being in the high attendance class (aOR = 0.92, 95% CI: 0.86, 1.00, p = 0.037). The home safety problem score reduction was greater among high attendance class participants than low attendance class participants at the 6-month follow-up (b = -1.15, 95% CI:-2.09, -0.20, p = 0.018)., Conclusion: Maternal depressive symptoms were associated with the reduced probability of maternal attendance at toddler safety promotion sessions; high session attendance was related to greater reduction of toddler home safety problems. Identifying risk factors for maternal low attendance to interventions and developing strategies to promote attendance should lead to reductions in home safety problems and reductions in unintentional injuries among young children., Competing Interests: The authors have declared that no competing interests exist.

Background: Men with have sex with men (MSM) in Africa face high levels of stigma due to elevated HIV exposure (actual or perceived), same-sex practices, and gender non-conformity. These stigmas are documented barriers to HIV prevention and treatment. Most stigma-reduction interventions have focused on single-level targets (e.g., health care facility level [HCF]) and addressed one type of stigma (e.g., HIV), without engaging the multiple intersecting stigmas that MSM encounter. Determining the feasibility and acceptability of multi-level intervention of reducing intersectional stigma and estimating its efficacy on increasing HIV testing are needed., Methods: We proposed a mixed method study among MSM in Ghana. First, we will develop the intervention protocol using the Convergence Framework, which combines three interventions that were previously implemented separately in Ghana for reducing stigma at the HCF-level, increasing HIV testing at the peer group-level, and increasing peer social support at the individual-level. Then, we will conduct a cluster randomized controlled trial with four pairs of HCFs matched on staff size. HCFs within each pair are randomized to the HCF-level stigma-reduction intervention or control arm. MSM (n = 216) will be randomized to receive the group-level and individual-level interventions or standard of care control arm. MSM will be assigned to receive HIV testing at one of the HCFs that match their study assignment (intervention or control facility). The frequency of HIV testing between MSM in the study arms at 3 and 6 months will be compared, and the predictors of HIV testing uptake at the HCF, peer group and individual-levels will be assessed using multi-level regression models., Discussion: These findings from this study will provide important evidence to inform a hybrid implementation-effectiveness trial of a public health intervention strategy for increasing HIV case detection among key populations in sub-Saharan African communities. Accurate information on HIV prevalence can facilitate epidemic control through more precise deployment of public health measures aimed at HIV treatment and viral load suppression, which eliminates risk of transmission., Trial Registration: This study was prospectively registered on ClinicalTrials.gov, Identifier: NCT04108078, on September 27, 2019., Competing Interests: This study is supported by the National Institute of Nursing Research in the form of a grant to LEN and LN [R01NR019009]. This study also receives core services and support from the Center for Interdisciplinary Research on AIDS (CIRA)—a National Institute of Mental Health AIDS Research Center—in the form of a grant [P30MH062294] (PI: Trace Kershaw). The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

The first case of COVID-19 was detected in North Carolina (NC) on March 3, 2020. By the end of April, the number of confirmed cases had soared to over 10,000. NC health systems faced intense strain to support surging intensive care unit admissions and avert hospital capacity and resource saturation. Forecasting techniques can be used to provide public health decision makers with reliable data needed to better prepare for and respond to public health crises. Hospitalization forecasts in particular play an important role in informing pandemic planning and resource allocation. These forecasts are only relevant, however, when they are accurate, made available quickly, and updated frequently. To support the pressing need for reliable COVID-19 data, RTI adapted a previously developed geospatially explicit healthcare facility network model to predict COVID-19's impact on healthcare resources and capacity in NC. The model adaptation was an iterative process requiring constant evolution to meet stakeholder needs and inform epidemic progression in NC. Here we describe key steps taken, challenges faced, and lessons learned from adapting and implementing our COVID-19 model and coordinating with university, state, and federal partners to combat the COVID-19 epidemic in NC., Competing Interests: The authors have declared that no competing interests exist.

HIV infection during pregnancy and breastfeeding has implications for maternal health. Between May- November 2018, we explored prospective acceptability of two novel HIV Pre-exposure Prophylaxis (PrEP) products, oral pills and vaginal rings, through focus group discussions with 65 pregnant and breastfeeding women in Malawi, South Africa, Uganda, Zimbabwe. Qualitative analysis was completed, guided by the Theoretical Framework of Acceptability (TFA). First, a deductive thematic analysis was applied to relevant coded data, into the seven TFA constructs (Affective Attitude; Burden; Ethicality, Intervention Coherence; Opportunity Costs; Perceived Effectiveness; Self-efficacy). Next, an iterative analysis was completed to generate themes within each of the TFA constructs. Women's positive attitudes towards daily oral PrEP highlighted the familiarity of taking pills, understanding the purpose of taking pills, and the perception that it is an effective method to protect mothers and babies from HIV during pregnancy and breastfeeding. Women emphasized the ease of using the ring given its monthly duration that lowers burden on the user, its discreetness and invisibility once in place. The TFA analysis highlighted how acceptability of both methods could be enhanced by focusing on perceptions of the end users (i.e. the women) and not just the products themselves. This approach provided insights into how to refine the intervention materials and plans for implementation., Competing Interests: The authors have read the journal’s policy and have the following competing interests: Dr van der Straten is currently an independent consultant and sole proprietor of ASTRA consulting. There are no patents, products in development or marketed products associated with this research to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Introduction: Sex-based clinical outcome differences in sickle cell disease (SCD) remain largely unknown despite evidence that female sex is associated with an increased lifespan. To better characterize sex-based differences in SCD, we assessed pain, treatment characteristics, laboratory measures and complications among males and females currently enrolled in the Sickle Cell Disease Implementation Consortium (SCDIC) registry., Methods: The SCDIC consists of eight comprehensive SCD centers and one data coordinating center that received funding from the National Heart Lung and Blood Institute to improve outcomes for individuals with SCD. Eligibility criteria included: 15 to 45 years of age and a confirmed diagnosis of SCD. Self-report surveys were completed and data were also abstracted from the participants' medical records., Results: A total of 2,124 participants were included (mean age: 27.8 years; 56% female). The majority had hemoglobin SS SCD genotype. Females had worse reports of pain severity (mean (SD) T-score 51.6 (9.6) vs 49.3 (10), p<0.001), more vaso-occlusive episodes (p = 0.01) and a higher occurrence of 3 or more hospital admissions in the past year (30.9% vs. 25.5, p = 0.03). On multivariable analysis, males had higher odds of acute chest syndrome (odds ratio (OR) 1.4, p = 0.002), cardiovascular (OR 1.70, p<0.001) and musculoskeletal (OR 1.33, p = 0.0034) complications and lower odds of depression (OR 0.77, p = 0.0381). Females had higher fetal hemoglobin levels with and without hydroxyurea use (9.6% vs 8.5%, p = 0.03 and 3% vs 2.2%, p = 0.0005, respectively)., Conclusion: Our data suggests that sex differences in clinical outcomes do occur among individuals with SCD. Future research needs to explore the mechanisms underlying these differences., Competing Interests: Jane S. Hankins receives consultancy fees from Forma Therapeutics, Global Blood Therapeutics and bluebird bio. All other authors have declared that no competing interests exist.

Successful scale-up of PrEP for HIV prevention in African adolescent girls and young women (AGYW) requires integration of PrEP into young women's everyday lives. We conducted interviews and focus group discussions with 137 AGYW PrEP users aged 16-25 from South Africa and Kenya. Individual and relational enablers and disablers were explored at key moments during their PrEP-user journey from awareness, initiation and early use through persistence, including PrEP pauses, restarts, and discontinuation. PrEP uptake was facilitated when offered as part of an integrated sexual reproductive health service, but hampered by low awareness, stigma and misconceptions about PrEP in the community. Daily pill-taking was challenging for AGYW due to individual, relational and structural factors and PrEP interruptions (intended or unintended) were described as part of AGYW's PrEP-user journey. Disclosure, social support, adolescent-friendly health counseling, and convenient access to PrEP were reported as key enablers for PrEP persistence., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests:JMB, LGB, CC, SD and ER received personal fees for advisory board participation from Gilead Sciences outside of this current scope of work. JMB is employed by Gilead Sciences, Inc.

Background: Although people living with HIV in Côte d'Ivoire receive antiretroviral therapy (ART) at no cost, other out-of-pocket (OOP) spending related to health can still create a barrier to care., Methods: A convenience sample of 400 adults living with HIV for at least 1 year in Côte d'Ivoire completed a survey on their health spending for HIV and chronic non-communicable diseases (NCDs). In addition to descriptive statistics, we performed simple linear regression analyses with bootstrapped 95% confidence intervals., Findings: 365 participants (91%) reported OOP spending for HIV care, with a median of $16/year (IQR 5-48). 34% of participants reported direct costs with a median of $2/year (IQR 1-41). No participants reported user fees for HIV services. 87% of participants reported indirect costs, with a median of $17/year (IQR 7-41). 102 participants (26%) reported at least 1 NCD. Of these, 80 (78%) reported OOP spending for NCD care, with a median of $50/year (IQR 6-107). 76 participants (95%) with both HIV and NCDs reported direct costs, and 48% reported paying user fees for NCD services. Participants had missed a median of 2 HIV appointments in the past year (IQR 2-3). Higher OOP costs were not associated with the number of HIV appointments missed. 21% of participants reported spending over 10% of household income on HIV and/or NCD care., Discussion and Conclusions: Despite the availability of free ART, most participants reported OOP spending. OOP costs were much higher for participants with co-morbid NCDs., Competing Interests: The authors have declared that no competing interests exist.

Background: Malawi has halved the neonatal mortality rate between 1990-2018, however, is not on track to achieve the Sustainable Development Goal 12 per 1,000 live births. Despite a high facility birth rate (91%), mother-newborn dyads may not remain in facilities long enough to receive recommended care and quality of care improvements are needed to reach global targets. Physical access and distance to health facilities remain barriers to quality postnatal care., Methods: Using data We used individual data from the 2015-16 Malawi Demographic and Health Survey and facility data from the 2013-14 Malawi Service Provision Assessment, linking households to all health facilities within specified distances and travel times. We calculated service readiness scores for facilities to measure their capacity to provide birth/newborn care services. We fitted multi-level regression models to evaluate the association between the service readiness and appropriate newborn care (receiving at least five of six interventions)., Results: Households with recent births (n = 6010) linked to a median of two birth facilities within 5-10 km and one facility within a two-hour walk. The maximum service environment scores for linked facilities median was 77.5 for facilities within 5-10 km and 75.5 for facilities within a two-hour walk. While linking to one or more facilities within 5-10km or a two-hour walk was not associated with appropriate newborn care, higher levels of service readiness in nearby facilities was associated with an increased risk of appropriate newborn care., Conclusions: Women's choice of nearby facilities and quality facilities is limited. High quality newborn care is sub-optimal despite high coverage of facility birth and some newborn care interventions. While we did not find proximity to more facilities was associated with increased risk of appropriate care, high levels of service readiness was, showing facility birth and improved access to well-prepared facilities are important for improving newborn care., Competing Interests: The authors have declared that no competing interests exist.

Acute gastrointestinal infection (AGI) represents a significant public health concern. To control and treat AGI, it is critical to quickly and accurately identify its causes. The use of novel multiplex molecular assays for pathogen detection and identification provides a unique opportunity to improve pathogen detection, and better understand risk factors and burden associated with AGI in the community. In this study, de-identified results from BioFire® FilmArray® Gastrointestinal (GI) Panel were obtained from January 01, 2016 to October 31, 2018 through BioFire® Syndromic Trends (Trend), a cloud database. Data was analyzed to describe the occurrence of pathogens causing AGI across United States sites and the relative rankings of pathogens monitored by FoodNet, a CDC surveillance system were compared. During the period of the study, the number of tests performed increased 10-fold and overall, 42.6% were positive for one or more pathogens. Seventy percent of the detections were bacteria, 25% viruses, and 4% parasites. Clostridium difficile, enteropathogenic Escherichia coli (EPEC) and norovirus were the most frequently detected pathogens. Seasonality was observed for several pathogens including astrovirus, rotavirus, and norovirus, EPEC, and Campylobacter. The co-detection rate was 10.2%. Enterotoxigenic E. coli (ETEC), Plesiomonas shigelloides, enteroaggregative E. coli (EAEC), and Entamoeba histolytica were detected with another pathogen over 60% of the time, while less than 30% of C. difficile and Cyclospora cayetanensis were detected with another pathogen. Positive correlations among co-detections were found between Shigella/Enteroinvasive E. coli with E. histolytica, and ETEC with EAEC. Overall, the relative ranking of detections for the eight GI pathogens monitored by FoodNet and BioFire Trend were similar for five of them. AGI data from BioFire Trend is available in near real-time and represents a rich data source for the study of disease burden and GI pathogen circulation in the community, especially for those pathogens not often targeted by surveillance., Competing Interests: The authors have read the journal’s policy, and the authors of the manuscript have the following competing interests to declare: At the time that the study was conducted, KO, JN, and LM were all paid employees of BioFire. KO, JN, and LM hold stocks and shares of BioMérieux (owner of BioFire). RS is also on BioFire’s Scientific Advisory Board, and has received funding for research, unrelated to the present study, from: BioFire Diagnostics; Cepheid; Abbott; Becton and Dickinson; Hologic; Diasorin; Luminex; Merck; and Bacterioscan. This does not alter our adherence to PLOS ONE policies on sharing data and materials. There are no patents, products in development or marketed products associated with this research to declare.

Background: An integrated collaborative care intervention was used to treat primary care patients with comorbid obesity and depression in a randomized clinical trial. To increase wider uptake and dissemination, information is needed on translational potential., Methods: The trial collected longitudinal, qualitative data at baseline, 6 months (end of intensive treatment), 12 months (end of maintenance treatment), and 24 months (end of follow-up). Semi-structured interviews (n = 142) were conducted with 54 out of 409 randomly selected trial participants and 37 other stakeholders, such as recruitment staff, intervention staff, and clinicians. Using a Framework Analysis approach, we examined themes across time and stakeholder groups according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework., Results: At baseline, participants and other stakeholders reported being skeptical of the collaborative care approach related to some RE-AIM dimensions. However, over time they indicated greater confidence regarding the potential for future public health impact. They also provided information on barriers and actionable information to enhance program reach, effectiveness, adoption, implementation, and maintenance., Conclusions: RE-AIM provided a useful framework for understanding how to increase the impact of a collaborative and integrative approach for treating comorbid obesity and depression. It also demonstrates the utility of using the framework as a planning tool early in the evidence-generation pipeline., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Dr. Ma is a paid scientific consultant for Health Mentors, Inc., San Jose, CA. All other authors have no conflicts of interest to declare. This declaration does not alter adherence to any PLOS ONE policies on sharing data and materials according to your author guidelines.

Introduction: There is limited understanding of how social dynamics impact pre-exposure prophylaxis (PrEP) adherence among adolescent girls and young women (AGYW) in generalized HIV-epidemic settings. We examined experiences of oral PrEP use disclosure to various social groups with the goal of identifying supportive relationships that can be leveraged to promote adherence., Methods: We used qualitative methods to explore experiences disclosing PrEP use and the perceived impact of disclosure on adherence among 22 South African AGYW (16-25 years) taking daily oral PrEP. Serial in-depth-interviews (IDIs) were conducted 1-, 3-, and 12-months post-PrEP initiation. Respondents also self-reported their disclosures separately for various social groups and adherence was assessed using intracellular tenofovir-diphosphate levels., Results: Qualitative respondents had a median age of 20.5 years and reported disclosing their PrEP use to friends (n = 36 total disclosures), partners, siblings, other family members (n = 24 disclosures each), and parents (n = 19 disclosures). IDI data revealed that parents and partners provided the most support to respondents and a lack of support from these groups was most often perceived as negatively affecting PrEP use. AGYW described difficulties explaining PrEP to their mothers, who believed PrEP was HIV treatment or would lead to HIV infection. Disclosure to household members was notably meaningful for AGYW (both positively and negatively). Respondents reported leveraging supportive relationships for pill reminders. For respondents who perceived a household member would be unsupportive, however, non-disclosure was less feasible and PrEP use was often stigmatized. To avoid stigma, several respondents hid or discontinued PrEP., Conclusions: While supportive relationships may facilitate PrEP use, disclosure can also lead to stigma. Counselors should support AGYW in disclosing to key people in their social networks and provide AGYW with materials that lend credibility to explanations of PrEP. Community education is necessary to alleviate PrEP-related stigma and facilitate disclosure., Competing Interests: The authors have declared that no competing interests exist.

Cigarette smoking patterns vary within the population, with some individuals remaining never smokers, some remaining occasional users, and others progressing to daily use or quitting. There is little research on how population-level tobacco control policy interventions affect individuals within different smoking trajectories. We identified associations between tobacco control policy interventions and changes across different smoking trajectories among adolescents and young adults. Using 15 annual waves of data drawn from the National Longitudinal Survey of Youth 1997 (NLSY97), we applied a group-based trajectory model to identify associations between days smoked per month, comprehensive smoke-free laws, cigarette tax rates, and known socio-demographic risk factors for membership in different smoking trajectories. Comprehensive smoke-free laws were associated with reduced risk of initiation and reductions in days smoked per month for all trajectories other than occasional users. Higher tax rates were associated with reduced risk of initiation and days smoked for all trajectories other than established users. Overall, population-based tobacco control policies, particularly comprehensive smoke-free laws, were associated with reduced smoking. Tobacco taxes primarily reduced risk of initiation and use among never smokers, experimenters, and quitters, consistent with previous research suggesting that tobacco manufacturers lower prices after tax increases to reduce the cost of continued smoking for established users. These results provide support for expanding smoke-free laws and establishing a minimum tobacco floor price, which could improve public health by reducing the risk of initiation as well as use among occasional and established smokers., Competing Interests: The authors have declared that no competing interests exist.