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Background: Few children in food insecure (FI) households meet dietary recommendations for fruit and vegetables ("produce"). Barriers include affordability, accessibility, and desirability. Home produce delivery may reduce FI, increase produce consumption, and decrease budget tradeoffs., Objective: Evaluate the acceptability and potential impact of delivering produce through home visiting programs on FI, diet, and budget tradeoffs., Methods: In this prospective pre/post mixed methods study, 51 parents engaged in home visiting programs were enrolled. Participants completed pre- and post-program surveys on FI (18-item Food Security Scale), produce consumption, and budget tradeoffs. Pre- and post-surveys were compared using McNemar's test and weighted kappas. Interview guides were based on Social Cognitive Theory and a previously published framework. Interviews were conducted in English or Spanish; thematic analysis was completed., Results: Twenty-nine (56.9%) participants completed both surveys. Most were female (96.3%) and Hispanic (79.3%) (Table 1). Food security improved in the post-period, with more participants reporting high food security (pre: 6.9%, post: 31.0%) and fewer reporting very low food security (pre: 20.7%, post: 6.9%, p<0.01) (Table 2). Budgetary tradeoffs decreased in the post-program period (pre: 71.4%, post: 48.1%, p=0.03). Fifteen participants were interviewed. Themes included 1) saved money, 2) increased fruit and vegetable consumption, and 3) interest in future participation., Conclusion: This pilot study found that an intervention for delivery of produce through home visiting programs was acceptable to participants and resulted in potential improvements in FI and household budgets. This supports future studies to further explore the impact of this novel intervention., What's New: In this prospective mixed-methods pilot, home delivered produce was acceptable and feasible with potentially improved food security and household budgets; evidence of potential change in produce consumption was mixed. Changes in budget tradeoffs is a novel outcome in food programs., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Laura Plencner, MD reports financial support was provided by No Kid Hungry. Laura Plencner, MD reports a relationship with No Kid Hungry that includes: consulting or advisory. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

Purpose: Research-based theater uses drama to communicate research findings to audiences beyond those that typically read peer-reviewed journals. We applied research-based theater to translate qualitative research findings on the impact of the COVID-19 pandemic on different segments of U.S. society., Approach: Theater artists and public health researchers collaborated to create a collection of eight monologues from systematically sourced, peer-reviewed publications. Following three virtual performances in Spring, 2021, audience members were invited to complete a survey., Setting/participants: Audience survey respondents (n = 120) were mostly U.S.-based and were diverse in terms of age, race/ethnicity, gender, profession, and experience attending theater., Method: We summarized closed-ended responses and explored patterns by demographic characteristics. We synthesized themes of open-ended responses with inductive coding., Results: Audience members somewhat/strongly agreed that COVID Monologues increased their knowledge (79.4%), represented the reality of the U.S. COVID-19 epidemic (95.7%), and offered new perspectives on what people had been experiencing (87.5%). Most also agreed research-based theater is an effective means of understanding health research (93.5%) and can promote community resilience in times of public health crisis (83.2%). Mann-Whitney U tests suggested less positive reactions from demographics that were not well-represented in monologue characters (cisgender men, Hispanics). Qualitative comments suggested audience members valued monologues that offered self-reflection and validation of their own COVID-19 experiences through relatable characters as well as those that offered insight into the experiences of people different from themselves., Conclusion: This work adds to evidence that research-based theater can help build knowledge and emotional insight around a public health issue. As these elements are foundational to pro-social, preventative health behaviors, research-based theater may have a useful role in promoting collective response to public health crises like COVID-19. Our method of systematically-sourcing research for theater-based dissemination could be extended to target more specific audiences with actionable behaviors., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants' locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant's real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas.

Background: Research priorities are best defined through engagement with communities who will be impacted by the research and have lived experience of the topics to be studied. We aimed to establish a pediatric rare disease community stakeholder group and empower them in (1) eliciting perspectives from affected families in the wider region and (2) synthesizing collective ideas into a research agenda focused on shared ethical, legal, and social implications (ELSI) across rare disease., Methods: This two-year project utilized a community-centered approach to engage rare disease community members as equal partners in developing a research agenda for ELSI in rare disease. We established "Rare Voices" (RV), a 22-member stakeholder group of patients, parents, clinicians and researchers. Following capacity-building trainings, RV designed and conducted listening sessions with teen patients and parents of children with rare diseases to explore challenges, positive experiences, and ethical concerns. Listening session findings were synthesized and contextualized into research topics, which RV members further refined and prioritized. We used established measures to assess RV member engagement and satisfaction., Results: From 14 listening sessions with parents (n = 52) and teen patients (n = 13), RV identified eight core research topics as most important for future rare disease research: coordinating care, communication, accessing resources and care, impact on family unit, community and support in society, mental health and identity, ethical aspects of care, and uncertainty. RV members were highly engaged throughout the two-year project and reported high levels of satisfaction with the experience and research agenda., Conclusions: Through capacity-building and authentic engagement, this project resulted in a community-led rare disease research agenda to guide future rare disease ELSI research that aligns with patients' and families' priorities. An environment of equal partnership and respect created a space for mutual learning where community members were empowered to shape the research agenda based on their collective experiences. The agenda recognizes the shared psychosocial and healthcare experiences of rare disease and offers practical areas of research to address patient and family needs., (© 2024. The Author(s).)

Background: Some studies indicate that pregnant Kenyan women were concerned about Coronavirus disease 2019 (COVID-19) exposure during maternity care. We assessed concern regarding COVID-19 exposure and any impact on antenatal care (ANC) enrollment and/or hospital delivery among pregnant women living with human immunodeficiency virus (HIV) in Kenya., Methods: Data were collected from 1,478 pregnant women living with HIV enrolled in prevention of mother to child transmission of HIV (PMTCT) care at 12 Kenyan hospitals from October 2020 to July 2022. Surveys were conducted when women first presented for PMTCT services at the study hospital and asked demographic questions as well as items related to concerns about COVID-19. A 5-point Likert scale (strongly disagree to strongly agree) assessed concerns about COVID-19 exposure and travel challenges. Gestational age at PMTCT enrollment, number of ANC appointments attended, and delivery location were compared among women who expressed COVID-19 concerns and those who did not., Results: Few women reported delaying antenatal care (4.7%), attending fewer antenatal care appointments (5.0%), or having concerns about a hospital-based delivery (7.7%) because of COVID-19. More (25.8%) reported travel challenges because of COVID-19. There were no significant differences in gestational age at enrollment, number of ANC appointments, or rates of hospital-based delivery between women with concerns about COVID-19 and those without, CONCLUSION: Few pregnant women living with HIV expressed concerns about COVID-19 exposure in the context of routine ANC or delivery care. Women with and without concerns had similar care seeking behaviors. The recognized importance of routine ANC care and facility-based deliveries may have contributed to these positive pregnancy indicators, even among women who worried about COVID-19 exposure., Trial Registration: www., Clinicaltrials: gov identifier NCT04571684., (© 2024. The Author(s).)

Antiretroviral therapy (ART) adherence during and after pregnancy is essential to reduce perinatal transmission of HIV. However, little is known about adherence during the intrapartum and early postpartum inpatient hospital stay. Using secondary data from a hospital-based cohort study focused on the relationship between birthweight and engagement in HIV care, we examined the magnitude of, reasons for, and factors associated with incomplete intrapartum and early postpartum ART adherence among adult women (18 years or older) living with HIV who delivered within the previous two weeks at one of five hospitals in Accra, Ghana. Of the 142 enrolled participants who had complete adherence data and reported being on ART at the time of hospital admission, 43% (61/142) reported missing at least one ART dose during labor, delivery, and postpartum, including almost 20% (28/142) missing 2 or more consecutive doses. Women who reported frequently missing ART doses during pregnancy had higher odds of reporting missed doses during their intrapartum and postpartum hospital stays. Among those with inpatient ART interruption, the most frequently cited reasons were: forgetting medication at home (42%) and challenges of being in or recovering from labor (29%). Maternal perception of infant health at birth, hospital level of care, and frequency of missing HIV medications during pregnancy were associated with incomplete ART adherence during the intrapartum and early postpartum inpatient stay. An enabling clinical environment to facilitate access to ART during inpatient stays may have positive implications for ART adherence.

Background: Lifestyle Africa is an adapted version of the Diabetes Prevention Program designed for delivery by community health workers to socioeconomically disadvantaged populations in low- and middle-income countries (LMICs). Results from the Lifestyle Africa trial conducted in an under-resourced community in South Africa indicated that the programme had a significant effect on reducing haemoglobin A1c (HbA1c)., Objective: To estimate the cost of implementation and the cost-effectiveness (in cost per point reduction in HbA1c) of the Lifestyle Africa programme to inform decision-makers of the resources required and the value of this intervention., Methods: Interviews were held with project administrators to identify the activities and resources required to implement the intervention. A direct-measure micro-costing approach was used to determine the number of units and unit cost for each resource. The incremental cost per one point improvement in HbA1c was calculated., Results: The intervention equated to 71 United States dollars (USD) in implementation costs per participant and a 0.26 improvement in HbA1c per participant., Conclusions: Lifestyle Africa reduced HbA1c for relatively little cost and holds promise for addressing chronic disease in LMIC. Decision-makers should consider the comparative clinical effectiveness and cost-effectiveness of this intervention when making resource allocation decisions., Trial Registration: Trial registration is at ClinicalTrials.gov (NCT03342274).

Fears of relationship dissolution and the inability to bear healthy children remain barriers to HIV testing in sub-Saharan Africa. Pre-exposure prophylaxis (PrEP) carries both clinical and symbolic benefits that counter these fears. We conducted a pilot messaging intervention through Uganda's assisted partner notification (APN) program, where providers assist HIV-positive index clients in notifying sexual partners and encourage testing. We randomized providers at three clinics to implement phone scripts over two months with (1) gain-framed or (2) loss-framed information about PrEP and childbearing; or (3) usual care. In 23 in-depth interviews with providers, index clients, and partners, five major themes emerged on intervention acceptability and feasibility: (1) value of PrEP and childbearing messaging in APN; (2) value of this messaging coming earlier in APN; (3) overall preference for gain-framed messages; (4) need to tailor timing of messaging; and (5) need for messaging outside of APN. Register data (109 index clients, 145 partners) indicated most index clients (95%) wanted their potential conception partners informed about PrEP. Preliminary trends suggest the intervention sites outperformed usual care in testing rates among potential conception partners. Messaging that highlights PrEP and safe childbearing may be a promising new communication strategy to promote HIV testing.

A. Wade Boykin's scholarship has provided key insights into the psychological realities of racially minoritized people and catalyzed revolutionary changes in psychology and education. Combining insights from personal and research experiences, Boykin authored the foundational triple quandary (TQ), a framework describing how Black Americans must navigate the often conflicting values and priorities of dominant mainstream society, the heritage culture of Black communities, and dynamics associated with being racially minoritized. TQ describes the unique developmental challenges faced by Black children, for whom misalignment between home cultural socialization and U.S. schooling often leads to pathologizing mischaracterizations of their attitudes and behaviors, resulting in chronic academic opportunity gaps. Boykin used his training as an experimental psychologist to empirically test the validity and explanatory utility of the TQ framework and to determine whether Black cultural values could be leveraged to improve student learning. Focusing on cultural values such as expressive movement, verve, and communalism, studies with his collaborators consistently supported Boykin's framework and predictions for improving Black student achievement-related outcomes. Beginning in the early 2000s, Boykin and his colleagues began to scale the lessons of decades of empirical work into the talent quest model for school reform. The TQ and talent quest continue to evolve in their application, as scholars and practitioners have found them relevant to a diverse range of minoritized populations in American society and beyond. Boykin's work continues to bear on the scholarship, career outcomes, and day-to-day lives of many scholars, administrators, practitioners and students across disciplines and institutions. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Background: Adolescents and young adults (AYAs) in Haiti experience a high unintended pregnancy rate, in part due to unmet contraception needs. Little is known about AYA opinions of and experiences with contraception that may explain remaining gaps in coverage. We aimed to describe barriers and facilitators to contraception use among AYAs in Haiti., Methods: We conducted a cross-sectional survey and semi-structured qualitative interviews with a convenience sample of AYA females aged 14-24 in two rural communities in Haiti. The survey and semi-structured interviews assessed demographics, sexual health and pregnancy prevention behaviors and explored contraception opinions and experiences according to Theory of Planned Behavior constructs: attitudes, subjective norms, and perceived behavioral control. We used descriptive statistics to report means and responses to Likert scale and multiple-choice questions. Guided by content analysis, we analyzed interview transcripts through inductive coding and team debriefing., Results: Among 200 survey respondents, 94% reported any past vaginal sexual activity, and 43% reported ever being pregnant. A large majority were trying to avoid pregnancy (75%). At last sexual activity, 127 (64%) reported use of any contraceptive method; Among them, condoms were the most common method (80%). Among those with previous condom use, most reported use less than half the time (55%). AYAs were concerned about parental approval of birth control use (42%) and that their friends might think they are looking for sex (29%). About one-third felt uncomfortable going to a clinic to ask for birth control. In interviews, AYAs desired pregnancy prevention but frequently noted concerns about privacy and parental, community and healthcare provider judgement for seeking care for reproductive health needs. AYAs also noted a lack of contraception knowledge, evident by frequent misconceptions and associated fears., Conclusion: Among AYAs in rural Haiti, a large majority were sexually active and desire pregnancy avoidance, but few were using effective contraception due to numerous concerns, including privacy and fear of judgement. Future efforts should address these identified concerns to prevent unintended pregnancy and improve maternal and reproductive health outcomes in this population., (© 2023. The Author(s).)

Background: Individuals with substance use disorders (SUD) have disproportionately high rates of unintended pregnancy. Reducing harm associated with this risk and its biopsychosocial consequences requires evidence-based, non-coercive interventions that ensure access to contraception for individuals who choose to prevent pregnancy. We examined feasibility and impact of SexHealth Mobile, a mobile unit-based intervention that aimed to increase access to patient-centered contraceptive care for individuals in SUD recovery programs., Methods: We conducted a quasi-experimental study (enhanced usual care [EUC] followed by intervention) at three recovery centers with participants (n = 98) at risk for unintended pregnancy. EUC participants were offered printed information on community locations where they could access contraception care. SexHealth Mobile participants were offered same-day, onsite clinical consultation on a medical mobile unit and contraception if desired. The primary outcome was use of contraception (hormonal or intrauterine device) at one-month post-enrollment. Secondary outcomes were at two-weeks and three-months. Confidence in preventing unintended pregnancy, reasons for non-use of contraception at follow-up, and intervention feasibility were also assessed., Results: Participants (median age = 31, range 19-40) enrolled in the intervention period were almost 10 times more likely to be using contraception at one-month (51.5%) versus the those enrolled in the EUC period (5.4%) (unadjusted relative risk [URR] = 9.3 [95%CI: 2.3-37.1]; adjusted relative risk [ARR] = 9.8 [95%CI: 2.4-39.2]). Intervention participants were also more likely to be using contraception at 2-weeks (38.7% vs. 2.6%; URR = 14.3 [95%CI: 2.0-104.1]) and three-months (40.9% vs. 13.9%; URR = 2.9 [95% CI: 1.1-7.4]). EUC participants reported more barriers (cost, time) and less confidence in preventing unintended pregnancies. Mixed-methods feasibility data indicated high acceptability and feasible integration into recovery settings., Conclusions: Mobile contraceptive care based on principles of reproductive justice and harm reduction reduces access barriers, is feasible to implement in SUD recovery settings, and increases contraception use. Expanding interventions like SexHealth Mobile may help reduce harm from unintended pregnancies among individuals in SUD recovery. Trial Registration NCT04227145., (© 2023. The Author(s).)

Background: Adolescent and young adult (AYA) females in low- and middle-income countries often face disparities in menstrual health (MH). Poor MH and lack of sexual and reproductive health education leads to school absenteeism, increasing risk for adverse psychosocial and educational outcomes. Further, disasters (e.g., earthquakes) are linked with unsafe living environments and sanitation facilities for women. We sought to describe MH perspectives and practices among AYAs in rural Haiti., Methods: We conducted a cross-sectional survey in two rural communities in Haiti. AYA females aged 14-24 years completed questions on demographics, the Menstrual Practice Needs Scale (36 items; MPNS-36) and the Menstrual Practices Questionnaire (4 items). We performed descriptive statistics and Chi square or Fisher's Exact tests to compare responses among sub-groups., Results: Among 200 respondents, the median age was 20 years (IQR 17-22). 51% (95% CI 44%, 58%; 102/200) were currently attending school at least 3 days/week and 97% (94%, 99%; 193/200) were not married. According to the MPNS-36, 68% (62%, 74%; 136/200) of participants had unmet MH needs. Seventy-one (77%) reused some of their menstrual materials during their last menstruation. During their last menstruation, 44% (37%, 50%; 87/200) reported they often or always skipped school because they had their menses, and 31% (25%, 37%; 62/200) sometimes skipped. Many felt always or often worried that someone or something would harm them while they were changing their menstrual materials at home and at school., Conclusions: Among AYAs in rural Haiti, three-quarters reported menses-related school absenteeism and two-thirds had unmet MH needs. AYA females often lacked a safe environment to change their menstrual materials. Given recent disasters in Haiti, (August 2021 earthquake), safe environments for MH are critically needed to offset risk for poor psychosocial and health outcomes. Future efforts to improve MH among AYAs in Haiti are needed to ensure access to MH resources and school attendance., (© 2022. The Author(s).)

Background: Children with acute respiratory tract infections (ARTIs) receive ≈11.4 million unnecessary antibiotic prescriptions annually. A noted contributor is inadequate parent-clinician communication, however, efforts to reduce overprescribing have only indirectly targeted communication or been impractical., Objectives: Compare two feasible (higher vs lower intensity) interventions for enhancing parent-clinician communication on the rate of inappropriate antibiotic prescribing., Design: Multisite, parallel group, cluster randomised comparative effectiveness trial. Data collected between March 2017 and March 2019., Setting: Academic and private practice outpatient clinics., Participants: Clinicians (n=41, 85% of eligible approached) and 1599 parent-child dyads (ages 1-5 years with ARTI symptoms, 71% of eligible approached)., Interventions: All clinicians received 20 min ARTI diagnosis and treatment education. Higher intensity clinicians received an additional 50 min communication skills training. All parents viewed a 90 second antibiotic education video., Main Outcomes and Measures: Inappropriate antibiotic treatment was assessed via blinded medical record review by study clinicians and a priori defined as prescriptions for the wrong diagnosis or use of the wrong agent. Secondary outcomes were revisits, adverse drug reactions (both assessed 2 weeks after the visit) and parent ratings of provider communication, shared decision-making and visit satisfaction (assessed at end of the visit on Likert-type scales)., Results: Most clinicians completed the study (n=38, 93%), were doctors (n=25, 66%), female (n=30, 78%) and averaged 8 years in practice. All parent-child dyad provided data for the main outcome (n=855 (54%) male, n=1043 (53%) < 2 years). Inappropriate antibiotic prescribing was similar among patients who consulted with a higher intensity (54/696, 7.8%) versus a lower intensity (85/904, 9.4%) clinician. A generalised linear mixed effect regression model (adjusted for the two-stage nested design, clinician type, clinic setting and clinician experience) revealed that the odds of receiving inappropriate antibiotic treatment did not significantly vary by group (AOR 0.99, 95% CI: 0.52 to 1.89, p=0.98). Secondary outcomes of revisits and adverse reactions did not vary between arms, and parent ratings of satisfaction with quality of parent-provider communication (5/5), shared decision making (9/10) and visit satisfaction (5/5) were similarly high in both arms., Conclusions and Relevance: Rate of inappropriate prescribing was low in both arms. Clinician education coupled with parent education may be sufficient to yield low inappropriate antibiotic prescribing rates. The absence of a significant difference between groups indicates that communication principles previously thought to drive inappropriate prescribing may need to be re-examined or may not have as much of an impact in practices where prescribing has improved in recent years., Trial Registration Number: NCT03037112., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human-nonhuman chimeric research. Led by bioethics researchers working closely with an interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human-nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics' previous focus on human-centered questions about the ethics of "humanization" and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less-siloed governance and oversight and more-comprehensive public communication., (© 2022 The Hastings Center.)

Uptake of pre-exposure prophylaxis (PrEP) fell short of targets for Sub-Saharan Africa's initial rollout, revealing the need for more effective promotion strategies. In Uganda, we explored potential benefits and challenges of integrating safer conception messaging to promote PrEP among serodiscordant couples. In-depth interviews were conducted with clients and personnel at three clinics and analyzed thematically. Participants (n = 58) valued PrEP as a safer conception method (SCM) but described lack of integration of safer conception and PrEP services as well as inconsistent practices in prescribing PrEP to couples pursuing conception. Participants reported that the wider population remains largely unaware of PrEP and SCM or harbors misconceptions that PrEP is primarily for highly stigmatized groups like sex workers. Participants further described how heterosexual couples can still be reluctant to test for HIV, unaware of tools like PrEP and SCM that would allow them to continue their relationship and/or pursuit of childbearing. Overall, findings suggest that integrating PrEP and SCM in messaging and services targeting serodiscordant couples holds untapped benefits throughout the HIV prevention cascade., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Low- and middle-income countries (LMICs) are experiencing major increases in diabetes and cardiovascular conditions linked to overweight and obesity. Lifestyle interventions such as the United States National Diabetes Prevention Program (DPP) developed in high-income countries require adaptation and cultural tailoring for LMICs. The objective of this study was to evaluate the efficacy of "Lifestyle Africa," an adapted version of the DPP tailored for an underresourced community in South Africa compared to usual care., Methods and Findings: Participants were residents of a predominantly Xhosa-speaking urban township of Cape Town, South Africa characterized by high rates of poverty. Participants with body mass index (BMI) ≥ 25 kg/m2 who were members of existing social support groups or "clubs" receiving health services from local nongovernmental organizations (NGOs) were enrolled in a cluster randomized controlled trial that compared Lifestyle Africa (the intervention condition) to usual care (the control condition). The Lifestyle Africa intervention consisted of 17 video-based group sessions delivered by trained community health workers (CHWs). Clusters were randomized using a numbered list of the CHWs and their assigned clubs based on a computer-based random allocation scheme. CHWs, participants, and research team members could not be blinded to condition. Percentage weight loss (primary outcome), hemoglobin A1c (HbA1c), blood pressure, triglycerides, and low-density lipoprotein (LDL) cholesterol were assessed 7 to 9 months after enrollment. An individual-level intention-to-treat analysis was conducted adjusting for clustering within clubs and baseline values. Trial registration is at ClinicalTrials.gov (NCT03342274). Between February 2018 and May 2019, 782 individuals were screened, and 494 were enrolled. Participants were predominantly retired (57% were receiving a pension) and female (89%) with a mean age of 68 years. Participants from 28 clusters were allocated to Lifestyle Africa (15, n = 240) or usual care (13, n = 254). Fidelity assessments indicated that the intervention was generally delivered as intended. The modal number of sessions held across all clubs was 17, and the mean attendance of participants across all sessions was 61%. Outcome assessment was completed by 215 (90%) intervention and 223 (88%) control participants. Intent-to-treat analyses utilizing multilevel modeling included all randomized participants. Mean weight change (primary outcome) was -0.61% (95% confidence interval (CI) = -1.22, -0.01) in Lifestyle Africa and -0.44% (95% CI = -1.06, 0.18) in control with no significant difference (group difference = -0.17%; 95% CI = -1.04, 0.71; p = 0.71). However, HbA1c was significantly lower at follow-up in Lifestyle Africa compared to the usual care group (mean difference = -0.24, 95% CI = -0.39, -0.09, p = 0.001). None of the other secondary outcomes differed at follow-up: systolic blood pressure (group difference = -1.36; 95% CI = -6.92, 4.21; p = 0.63), diastolic blood pressure (group difference = -0.39; 95% CI = -3.25, 2.30; p = 0.78), LDL (group difference = -0.07; 95% CI = -0.19, 0.05; p = 0.26), triglycerides (group difference = -0.02; 95% CI = -0.20, 0.16; p = 0.80). There were no unanticipated problems and serious adverse events were rare, unrelated to the intervention, and similar across groups (11 in Lifestyle Africa versus 13 in usual care). Limitations of the study include the lack of a rigorous dietary intake measure and the high representation of older women., Conclusions: In this study, we found that Lifestyle Africa was feasible for CHWs to deliver and, although it had no effect on the primary outcome of weight loss or secondary outcomes of blood pressure or triglycerides, it had an apparent small significant effect on HbA1c. The study demonstrates the potential feasibility of CHWs to deliver a program without expert involvement by utilizing video-based sessions. The intervention may hold promise for addressing cardiovascular disease (CVD) and diabetes at scale in LMICs., Trial Registration: ClinicalTrials.gov NCT03342274., Competing Interests: The authors have declared that no competing interests exist.

Background: With rates of childhood obesity continually increasing, effective physical activity and nutrition interventions are needed. Formative research is used to tailor interventions to different cultural and geographic contexts and can be vital in adapting intervention strategies in the face of significant disruptive circumstances (like COVID-19)., Objective: We conducted formative research via in-person and web-based focus groups among middle schoolers and parents to better understand the facilitators and barriers to physical activity and fruit and vegetable consumption and to inform the design of a large intervention for a low-income, urban setting in the US Midwest., Methods: We conducted 2 phases of qualitative focus groups with parents (n=20) and 6th-9th grade middle schoolers (n=23). Phase 1 was conducted prior to the COVID-19 pandemic in late 2019, and phase 2 was conducted during the COVID-19 pandemic in the summer of 2020. Focus groups were transcribed and thematically coded using the Dedoose software., Results: The main facilitators of physical activity prior to the pandemic included the opportunity to have fun, peer influence, competition (for some), and incentives, while the main barriers to physical activity were time constraints and social discomfort. The main facilitators of eating fruits and vegetables included parental influence, preparation technique, and convenience, while barriers included dislike of vegetables, time constraints, and preparation or freshness. During the pandemic, facilitators of physical activity remained the same, while additional barriers to physical activity such as lack of motivation and limited time spent outside of the home were reported. For fruit and vegetable consumption, both facilitators and barriers remained the same for both time periods. Additionally, for some participants, the pandemic offered an opportunity to offer more fruits and vegetables to middle schoolers throughout the day., Conclusions: Some themes identified were common to those reported in previous studies, such as peer influence on physical activity and parental influence on fruit and vegetable consumption. Novel themes such as lack of motivation to be active and limited time outside the home helped improve intervention adaptation, specifically during the COVID-19 pandemic. The continuity of formative research after a major unexpected change in the intervention context can be essential in targeting areas of an intervention that can be retained and those that need to be adjusted., (©Amanda Grimes, Joseph S Lightner, Kimberly Pina, Evelyn S Donis de Miranda, Emily Meissen-Sebelius, Robin P Shook, Emily A Hurley. Originally published in JMIR Formative Research (https://formative.jmir.org), 21.01.2022.)

Purpose: Efforts have been made to standardize laboratory variant interpretation, but clinicians are ultimately tasked with clinical correlation and application of genetic test results in patient care. This study aimed to explore processes clinicians utilize when reviewing and returning genetic test results, and how they impact patient care., Methods: Medical geneticists, genetic counselors, and nongenetics clinicians from two Midwestern states completed surveys (n = 98) and in-depth interviews (n = 29) on practices of reviewing and returning genetic test results. Retrospective chart review (n = 130) examined discordant interpretations and the impact on care., Results: Participants reported variable behaviors in both reviewing and returning results based on factors such as confidence, view of role, practice setting, and relationship with the lab. Providers did not report requesting changes to variant classifications from laboratories, but indicated relaying conflicting classifications to patients in some cases. Chart reviews revealed medically impactful differences in interpretation between laboratories and clinicians in 18 (13.8%) records., Conclusion: Clinician practices for reviewing and integrating genetic test results into patient care vary within and between specialties and impact patient care. Strategies to better incorporate both laboratory and clinician expertise into interpretation of genetic results could result in improved care across providers and settings., (© 2021. The Author(s), under exclusive licence to the American College of Medical Genetics and Genomics.)

Aims: During the early months of the U.S. COVID-19 outbreak, women suffered disproportionate burdens of pandemic-related psychological and economic distress. We aimed to describe the experiences of women in substance use disorder (SUD) recovery programs by (1) exploring the pandemic's impact on their lives, sobriety, and recovery capital and (2) tracking COVID-19 perceptions and preventative behaviors., Methods: We conducted monthly semistructured interviews with women in residential and outpatient SUD recovery programs in Kansas City in April, May, and June 2020. Participants described the pandemic's impact on their life and sobriety and completed survey items on factors related to COVID-19 preventative behaviors. We interpreted qualitative themes longitudinally alongside quantitative data., Results: In 64 interviews, participants (n = 24) described reduced access to recovery capital, or resources that support sobriety, such as social relationships, housing, employment, and health care. Most experienced negative impacts on their lives and feelings of stability in March and April but maintained sobriety. Four women described relapse, all attributed to pandemic stressors. Participants described relief related to societal re-opening in May and June, and increased engagement with their communities, despite rising infection rates., Conclusions: For women recovering from SUDs during COVID-19, securing recovery capital often meant assuming greater COVID-19 risk. As substance use appeared to have increased during the pandemic and COVID-19 transmission continues, public health planning must prioritize adequate and safe access to recovery capital and timely distribution of vaccines to people struggling with SUDs., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: The sharp rise in opioid use disorder (OUD) among women coupled with disproportionally high rates of unintended pregnancy have led to a four-fold increase in the number of pregnant women with OUD in the United States over the past decade. Supporting intentional family planning can have multiple health benefits and reduce harms related to OUD but requires a comprehensive understanding of women's perspectives of preventing unintended pregnancies. The purpose of this study was to comprehensively evaluate the knowledge, attitudes and experiences as they relate to seeking contraception, particularly LARCs, among women with active or recovered opioid misuse., Methods: In-depth interviews and focus group discussions with 36 women with current or past opioid misuse were recorded and transcribed. Transcripts were coded by ≥ 2 investigators. Themes related to contraceptive care seeking were identified and contextualized within the Health Belief Model., Results: Our analysis revealed seven interwoven themes that describe individual level factors associated with contraceptive care seeking in women with current or past opioid misuse: relationship with drugs, reproductive experiences and self-perceptions, sexual partner dynamics, access, awareness of options, healthcare attitudes/experiences, and perceptions of contraception efficacy/ side effects. Overall, perceived susceptibility and severity to unintended pregnancy varied, but most women perceived high benefits of contraception, particularly LARC. However, perceived barriers were too high for most to obtain desired contraception to support family planning intentions., Conclusions: The individual-level factors identified should inform the design of integrated services to promote patient-centered contraceptive counseling as a form of harm reduction. Interventions should reduce barriers to contraceptive access, particularly LARCs, and establish counseling strategies that use open, non-judgmental communication, acknowledge the continuum of reproductive needs, explore perceived susceptibility to pregnancy, and utilize peer educators., (© 2021. The Author(s).)

Much of the scholarship concerning African American culture is premised on the notion that it is a legacy of African origins but there has been essentially no attempt to document that relationship empirically. This paper briefly reviews existing evidence for cultural continuity in the Diaspora and then compares the responses of Black and Coloured South African and African Americans on measures of culture emic to African American populations. The observed patterns of psychometric performance, participants' responses, and the predictive utility of the measures employed were consistent with the thesis that despite inevitable variation, these three groups of the African Diaspora share similar orientations on the cultural themes assessed. This research hopes to initiate empirical work on the continuity thesis as it applies to connecting African American culture with a legacy of Africa and as related more broadly to the study of global Diasporas., (© 2020 International Union of Psychological Science.)

Context: Among people living with HIV in Uganda, desires to have a child and unplanned pregnancies are both common, while utilization of safer conception methods (SCM) and modern contraceptives are low., Methods: Three hundred eighty-nine HIV clients who reported considering childbearing with their uninfected partner enrolled in a safer conception counseling intervention trial in Uganda. Multiple regression analysis and baseline data were used to examine correlates of reproductive intentions and behaviors, including use of safer conception methods and contraception., Results: Most (n = 313; 80.5%) reported that both they and their partner wanted to have a child now, which was associated with being married, in a longer relationship, not having a child with partner, greater SCM knowledge, lower internalized childbearing stigma, and higher perceived community stigma of childbearing. However, just 117 reported trying to conceive in the prior 6 months, which was associated with being female, not having a child with their partner, less decision-making control within the relationship, and greater perceived cultural acceptability of SCM. Among those who had tried to conceive in the past 6 months, 14 (11.9%) used SCM, which was associated with greater control in decision making. Of the 268 who were not trying to conceive, 69 (25.7%) were using a modern contraceptive, which was associated with being in a shorter relationship, less control over decision-making, more positive attitudes towards contraception and lower depression., Conclusion: Methods to promote reproductive goals are underused by HIV serodiscordant couples, and relationships characteristics and childbearing-related stigma appear to be most influential and thus targets for intervention., Trial Registration: Clinicaltrials.gov, NCT03167879 ; date registered May 23, 2017.

A research participant's right to withdraw from all research procedures is widely accepted, but there can be justifiable limits to a participant's exercise of autonomy to withdraw from some procedures. Clinical outcomes trials depend on complete subject follow-up for accurate assessment of the safety and efficacy of investigational therapies. Subjects' refusal to complete follow-up, even through passive medical record review, can cause failure to detect safety signals, inaccurate estimation of efficacy, or lack of acceptance of trial results, which alters the study's benefit-risk ratio. Allowing participant refusal of follow-up data collection therefore creates tension between respect for persons and beneficence. With minimal risk study procedures that can help preserve trial benefit, such as passive data collection, we argue that the importance of upholding the principle of beneficence outweighs individual autonomy concerns. Furthermore, a consent process that prospectively informs participants of mandatory passive follow-up is ethically justified and optimizes the balance between autonomy and beneficence., (© 2021 by The Hastings Center. All rights reserved.)

Purpose: As almost nine in ten pregnancies among women with opioid use disorder (OUD) are unintended, expanding access to contraception is an underutilized but potentially effective strategy in increasing reproductive agency and reducing the overall burden of neonatal abstinence syndrome. We aimed to identify where and how contraceptive services could be integrated into existing points-of-contact for women with OUD., Approach: In-depth qualitative interviews., Setting: Three diverse catchment areas in Missouri., Participants: Women with OUD (n = 15) and professional stakeholders (n = 16) representing five types of existing OUD service points: syringe exchange programs, recovery support programs, substance use treatment programs, emergency departments, and Federally Qualified Health Centers., Method: Interviews were audio-recorded, transcribed, and thematically coded using Dedoose software., Results: Six themes emerged as essential components for integrating contraceptive services into existing points-of-contact for women with OUD: (1) reach women with unmet need; (2) provide free or affordable contraception; (3) maximize service accessibility; (4) provide patient-centered care; (5) employ willing, qualified contraceptive providers; and (6) utilize peer educators. Participants affirmed the overall potential benefit of contraceptive service integration and illuminated various opportunities and challenges relevant to each type of existing service point., Conclusion: As health promotion initiatives look to increase access to contraception among women with OUD, these six' participant-identified components offer essential guidance in selecting advantageous points-of-contact and addressing remaining gaps in services.

Infants born to HIV-infected mothers are more likely to be low birthweight (LBW) than other infants, a condition that is stigmatized in many settings worldwide, including sub-Saharan Africa. Few studies have characterized the social-cultural context and response to LBW stigma among mothers in sub-Saharan Africa or explored the views of women living with HIV (WLHIV) on the causes of LBW. We purposively sampled thirty postpartum WLHIV, who had given birth to either LBW or normal birthweight infants, from two tertiary hospitals in Accra, Ghana. Using semi-structured interviews, we explored women's understanding of the etiology of LBW, and their experiences of caring for a LBW infant. Interviews were analyzed using interpretive phenomenology. Mothers assessed their babies' smallness based on the baby's size, not hospital-recorded birthweight. Several participants explained that severe depression and a loss of appetite, linked to stigma following an HIV diagnosis during pregnancy, contributed to infants being born LBW. Women with small babies also experienced stigma due to the newborns' "undesirable" physical features and other people's unfamiliarity with their size. Consequently, mothers experienced blame, reluctance showing the baby to others, and social gossip. As a result of this stigma, women reported self-isolation and depressive symptoms. These experiences were layered on the burden of healthcare and infant feeding costs for LBW infants. LBW stigma appeared to attenuate with increased infant weight gain. A few of the women also did not breastfeed because they thought their baby's small size indicated pediatric HIV infection. Among WLHIV in urban areas in Ghana, mother and LBW infants may experience LBW-related stigma. A multi-component intervention that includes reducing LBW incidence, treating antenatal depression, providing psychosocial support after a LBW birth, and increasing LBW infants' weight gain are critically needed., Competing Interests: The authors have declared no competing interests exist.

Objectives: To assess the impact of a 90-second animated video on parents' interest in receiving an antibiotic for their child., Study Design: This pre-post test study enrolled English and Spanish speaking parents (n = 1051) of children ages 1-5 years presenting with acute respiratory tract infection symptoms. Before meeting with their provider, parents rated their interest in receiving an antibiotic for their child, answered 6 true/false antibiotic knowledge questions, viewed the video, and then rated their antibiotic interest again. Parents rated their interest in receiving an antibiotic using a visual analogue scale ranging from 0 to 100, with 0 being "I definitely do not want an antibiotic," 50 "Neutral," and 100 "I absolutely want an antibiotic.", Results: Parents were 84% female, with a mean age of 32 ± 6.0, 26.0% had a high school education or less, 15% were black, and 19% were Hispanic. After watching the video, parents' average antibiotic interest ratings decreased by 10 points (mean, 57.0 ± 20 to M ± 21; P < .0001). Among parents with the highest initial antibiotic interest ratings (≥60), even greater decreases were observed (83.0 ± 12.0 to 63.4 ± 22; P < .0001) with more than one-half (52%) rating their interest in the low or neutral ranges after watching the video., Conclusions: A 90-second video can decrease parents' interest in receiving antibiotics, especially among those with higher baseline interest. This scalable intervention could be used in a variety of settings to reduce parents' interest in receiving antibiotics., Trial Registration: ClinicalTrials.gov: NCT03037112., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Children in food-insecure families face increased barriers to meeting recommendations for fruit and vegetable consumption. Hospitals and pediatric healthcare institutions have attempted to alleviate food-insecurity through various internal programs like food prescriptions, yet little evidence for these programs exist. Consistent with a patient-centered perspective, we sought to develop a comprehensive understanding of barriers to fruit and vegetable consumption and a parent-driven agenda for healthcare system action., Methods: We conducted six qualitative focus group discussions (four in English, two in Spanish) with 29 parents and caregivers of patients who had screened positive for food-insecurity during visits to a large pediatric healthcare system in a midwestern U.S. city. Our iterative analysis process consisted of audio-recording, transcribing and coding discussions, aiming to produce a) a conceptual framework of barriers to fruit and vegetable consumption and b) a synthesis of participant programmatic suggestions for their healthcare system., Results: Participants were 90% female, 38% Black/African American and 41% Hispanic/Latino. Barriers to fruit and vegetable consumption in their families fell into three intersecting themes: affordability, accessibility and desirability. Participant-generated intervention recommendations were multilevel, suggesting healthcare systems focus not only on clinic and community-based action, but also advocacy for broader policies that alleviate barriers to acquiring healthy foods., Conclusion: Parents envision an expanded role for healthcare systems in ensuring their children benefit from a healthy diet. Findings offer critical insight on why clinic-driven programs aimed to address healthy eating may have failed and healthcare organizations may more effectively intervene by adopting a multilevel strategy.

Background: Maternal retention in HIV care is lower for women in the postpartum period than during pregnancy, but the reasons are poorly understood. We examined key differences in barriers to retention in HIV care during and after pregnancy., Methods: We conducted semi-structured, in-depth interviews with 30 postpartum women living with HIV. Participants were recruited from two tertiary facilities implementing Option B+ for prevention of mother-to-child HIV transmission in Accra, Ghana. We collected data from mothers who had disengaged from HIV care and those who were still engaged in care. The interviews were analyzed using principles adapted from grounded theory., Results: Participants' experiences and narratives showed that retention in HIV care was more challenging during the postpartum period than during pregnancy. Poor maternal physical health (from birth complications and cesarean section), socio-cultural factors (norms about newborn health and pregnancy), and economic difficulties linked to childbirth (such as unemployment, under-employment, and debt) made the costs of retention in HIV care more economically and socially expensive in the postpartum period than during pregnancy. Some participants also shared that transportation costs and resulting dependence on a partner to pay increased during the postpartum period because of a strong shift in maternal preference for private modes of transportation due to HIV stigma and the desire to protect the newborn. These factors played a larger role in the postpartum period than during pregnancy and created a significant barrier to retention. A conceptual model of how these factors interrelate, the synergy between them, and how they affect retention in the postpartum period is presented., Conclusions: In Ghana, lower retention in HIV care in the postpartum period compared to in pregnancy may be primarily driven by social, economic, and newborn health factors. Multifaceted economic-based and stigma-reduction interventions are needed to increase retention in maternal HIV care after childbirth.

Rationale: Early Infant Diagnosis (EID) is critical to timely identification of HIV and rapid treatment initiation for infants found to be infected. Completing the EID cascade involves a series of age-specific tests between birth and 18 months and can be challenging for mother- infant pairs in low-resource settings. Even prior to recent increases in Kenya's testing recommendations, approximately 22% of mother-infant pairs enrolled in EID were lost to follow-up. As EID cascades become increasingly complex, identifying strategies to maximize retention becomes even more essential. Despite ongoing health system improvements, we still lack a framework for understanding the individual-level, psychosocial processes underlying EID completion-insight that could be essential for shaping strategies to support patients and close gaps in retention., Objective: Our objective was to explain individual-level processes that lead to EID completion among mothers who successfully completed the EID cascade., Methods: Using qualitative methods informed by grounded theory, we conducted 65 interviews with Kenyan mothers who completed EID., Results: We identified three themes related to completion: (1) Negative motivation, from the consequences of infant infection, fear of postnatal transmission, and burden of maternal failure; (2) Positive motivation, from achieving a final goal, responding to provider support, and maximizing infant health; and (3) Overcoming challenges, through resolve/resiliency, planning/privatizing and rejecting stigma/leveraging support., Conclusion: Overall, the EID cascade served as a framing process for women to secure an identity as a good mother. Successful EID completion was the product of a strong motivational foundation channeled into strategies to surmount persistent challenges. Participant accounts of overcoming challenges highlight their resiliency as well as the outstanding need to address financial, logistical, and social barriers to care. Future EID programs may capitalize on these findings by affirming patients' quest for identity control, leveraging positive motivators, and expanding peer support structures to help mothers feel connected throughout the cascade., (Copyright © 2020. Published by Elsevier Ltd.)

Rates of cardiovascular disease and diabetes are rising in low- and middle-income countries (LMIC), but there is a dearth of research devoted to developing and evaluating chronic disease interventions in these settings, particularly in Africa. Lifestyle Africa is a novel, culturally adapted version of the Diabetes Prevention Program (DPP) being evaluated in an ongoing community-based cluster-randomized trial in an underresourced urban community in South Africa. The purpose of this study is to describe the adaptations and adaptation process used to develop the program and to report preliminary implementation findings from the first wave of groups (n = 11; 200 individuals) who participated in the intervention. The RE-AIM model and community advisory boards guided the adaptation process. The program was designed to be delivered by community health workers (CHWs) through video-assisted sessions and supplemented with text messages. Participants in the trial were overweight and obese members of existing chronic disease "support groups" served via CHWs. Implementation outcomes included completion of sessions, session attendance, fidelity of session delivery, and participant satisfaction. Results indicated that 10/11 intervention groups completed all 17 core sessions. Average attendance across all sessions and groups was 54% and the percentage who attended at least 75% of sessions across all groups was 35%. Fidelity monitoring indicated a mean of 84% of all required procedures were completed while overall communication skills were rated as "good" to "excellent". These preliminary results support the feasibility of culturally adapting the DPP for delivery by CHWs in underresourced settings in LMIC., (© Society of Behavioral Medicine 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: New international guidelines for antenatal care (ANC) will likely result in an increase in nutritional supplements and preventative medications for pregnant women in low and middle-income countries. Our objective was to understand how pregnant women in Mali perceive and experience multi-drug regimens in ANC in order to reveal factors that may influence uptake and adherence., Methods: We conducted 29 semi-structured interviews and three focus groups with 21 pregnant women in two urban ANC sites in Bamako, Mali. Interviews focused on perception of purpose of ANC pharmaceuticals (particularly iron supplements, sulfadoxine-pyrimethamine as intermittent prevention of malaria and antiretroviral therapy for HIV), beliefs regarding efficacy and risk, and understanding of dosage and regimen. Transcripts were inductively coded and analyzed using the 'Framework' method., Results: Participant descriptions of medication purpose, understanding of dosing, and beliefs about risks and efficacy varied widely, revealing that many pregnant women lack complete information about their medications. While some were burdened by side effects or complex regimens, women generally held favorable attitudes toward ANC medications. Responses suggest major barriers to adherence lie in the health system, namely insufficient patient-provider communication and inconsistent prescribing practices., Conclusions for Practice: National health programs looking to improve maternal and child health with ANC pharmaceuticals need to place greater attention on patient counseling and consistent implementation of administration guidelines. Communication that positions pharmaceuticals as beneficial to mother and child, while presenting understandable information about purpose, dosing and potential side effects can promote uptake of multi-drug regimens and ANC services in general.

Introduction: Low and middle-income countries like South Africa are experiencing major increases in burden of non-communicable diseases such as diabetes and cardiovascular conditions. However, evidence-based interventions to address behavioural factors related to these diseases are lacking. Our study aims to adapt the CDC's National Diabetes Prevention Program (DPP) within the context of an under-resourced urban community in Cape Town, South Africa., Methods/analysis: The new intervention ( Lifestyle Africa ) consists of 17 weekly sessions delivered by trained community health workers (CHWs). In addition to educational and cultural adaptations of DPP content, the programme adds novel components of text messaging and CHW training in Motivational Interviewing. We will recruit overweight and obese participants (body mass index ≥25 kg/m 2 ) who are members of 28 existing community health clubs served by CHWs. In a 2-year cluster randomised control trial, clubs will be randomly allocated to receive the intervention or usual care. After year 1, usual care participants will also receive the intervention and both groups will be followed for another year. The primary outcome analysis will compare percentage of baseline weight loss at year 1. Secondary outcomes will include diabetes and cardiovascular risk indicators (blood pressure, haemoglobin A1C, lipids), changes in self-reported medication use, diet (fat and fruit and vegetable intake), physical activity and health-related quality of life. We will also assess potential psychosocial mediators/moderators as well as cost-effectiveness of the programme., Ethics/dissemination: Ethical approval was obtained from the University of Cape Town and Children's Mercy. Results will be submitted for publication in peer-reviewed journals and training curricula will be disseminated to local stakeholders., Trial Registration Number: NCT03342274., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The HIV Infant Tracking System (HITSystem) is an eHealth intervention to improve early infant diagnosis (EID) through alerts to providers and text messages to mothers. This study explored mothers' experiences receiving standard and HITSystem-enhanced EID services to assess perceived intervention benefits, acceptability, and opportunities for improvement. This qualitative study was embedded within a cluster-randomized control trial to evaluate the HITSystem at six Kenyan government hospitals (3 intervention, 3 control). We conducted semi-structured interviews with 137 mothers attending EID follow-up visits. Compared to control sites, participants at HITSystem sites described enhanced EID quality; HITSystem-generated texts informed them of result availability and retesting needs, provided cues-to-action for clinic attendance, and engendered opportunities for patient support. They described improved EID efficiency through shorter waiting periods for results and fewer hospital visits. Participants reported high satisfaction with EID and acceptability of text messages; however, modifications to ensure text delivery, increase repeat testing reminders, include low literacy content options, and provide encouraging messages were suggested. These user experience data suggest improvements in EID at HITSystem sites when compared with control sites.

Early infant diagnosis (EID) involves age-specific tracking and testing of HIV-exposed infants during the first 18 months of life and rapid initiation of life-saving treatment for those infected. In Kenya, pre-2013 data estimate EID lost to follow-up (LTFU) at 39-65%, yet no study has documented LTFU rates and predictors throughout the EID cascade since Option B+ fundamentally changed services by placing all HIV-positive expectant mothers on lifelong treatment. Using an explanatory mixed-method design, we assessed LTFU rates and predictors among 870 mother-infant dyads enrolled in EID in six urban/peri-urban Kenyan government hospitals. Mothers completed baseline surveys, and dyads were tracked through EID. We selected 12 baseline variables and modeled odds of LTFU at 9 and 18 months using mixed logistic regression. Qualitative interviews were conducted with 61 mothers to assess barriers and facilitators to completing EID. Thematically coded transcripts were used to interpret quantitative predictors of LTFU. By the 18-month test, 145 dyads (22%) were LTFU, with three-quarters of LTFU occurring between 9- and 18-month tests. Odds of LTFU at 18 months decreased by 10% for each additional year of maternal age and by 66% with HIV status disclosure. Qualitative data revealed how disclosure facilitated essential social support for EID completion and how older mothers attributed maturity and life experience to successful engagement in care. Findings suggest LTFU rates in Kenya have declined, but gaps remain in ensuring universal coverage. Efforts to improve retention should focus on increasing support for younger mothers and those who have not disclosed their HIV status.

Objective: Shared decision-making (SDM) measures have never been assessed for validity and feasibility in pediatric outpatient settings. We compared psychometric performance of parent adaptations of a well-established measure (SDM-Q-9) to a newer measure focusing on provider effort in facilitating SDM (CollaboRATE) in two clinics., Methods: English (n = 955) and Spanish (n = 58) speaking parents of children ages 1-5 years with symptoms of acute respiratory tract infections (ARTI) completed post-visit SDM-Q-9, CollaboRATE, satisfaction items (visit, provider communication, and study participation), and qualitative feedback., Results: Parents felt CollaboRATE was more comprehensible and relevant than SDM-Q-9, which refers to decision-making actions difficult to define in ARTI visits. Among English-speakers, both measures showed high internal consistency (α = 0.91, α = 0.97). SDM-Q-9 reliability was strong (split-half, r = 0.83) and CollaboRATE weak-to-moderate (two-week test-retest, ρ = 0.41-0.66). Convergent validity with communication and visit satisfaction was poor for SDM-Q-9 (r=0.38, r=0.34) but higher for CollaboRATE (r=0.59, r = 0.52). Both showed divergent validity with study participation satisfaction (r=0.08, r=0.13). Spanish versions demonstrated similar results., Conclusions: Parent preference and correlations with satisfaction support CollaboRATE over SDM-Q-9, however psychometrics were borderline acceptable., Practice Implications: Tools like CollaboRATE that focus on provider effort appear more appropriate for routine pediatric visits where SDM outcomes may be difficult to identify, yet additional validation research is needed., (Copyright © 2018 Elsevier B.V. All rights reserved.)

High rates of fertility desires, childbearing and serodiscordant partnerships among people living with HIV (PLHIV) in Uganda underscore the need to promote use of safer conception methods (SCM). Effective SCM exist but few PLHIV benefit from provider-led safer conception counseling (SCC) and comprehensive national SCC guidelines are still lacking. Providers' self-efficacy, intentions and attitudes for SCC impact provision and should inform development of services, but there are no longitudinal studies that assess these important constructs. This study reports on changes in providers' knowledge, attitudes, motivation and confidence to provide SCC among a 24-month observational cohort of Ugandan HIV providers. Compared to baseline, providers evidenced increased awareness of SCM, perceived greater value in providing SCC, saw all SCM but sperm washing as likely to be acceptable to clients, reported consistently high interest in and peer support for providing SCC, and perceived fewer barriers at the 24-month follow-up. Providers' intentions for providing SCC stayed consistently high for all SCM except manual self-insemination which decreased at 24 months. Self-efficacy for providing SCC increased from baseline with the greatest improvement in providers' confidence in advising serodiscordant couples where the man is HIV-infected. Providers consistently cite the lack of established guidelines, training, and their own reluctance to broach the issue with clients as significant barriers to providing SCC. Despite providers being more interested and open to providing SCC than ever, integration of SCC into standard HIV services has not happened. Concerted efforts are needed to address remaining barriers by establishing national SCC guidelines and implementing quality provider training.

Background: Literature suggests that electronic health (eHealth) interventions can improve the efficiency and accuracy of health service delivery and improve health outcomes and are generally well received by patients; however, there are limited data on provider experiences using eHealth interventions in resource-limited settings. The HIV Infant Tracking System (HITSystem) is an eHealth intervention designed to improve early infant diagnosis (EID) outcomes among HIV-exposed infants., Objective: We aimed to compare provider experiences with standard EID and HITSystem implementation at 6 Kenyan hospitals and 3 laboratories. The objective of this study was to better understand provider experiences implementing and using the HITSystem in order to assess facilitators and barriers that may impact adoption and sustainability of this eHealth intervention., Methods: As part of a randomized controlled trial to evaluate the HITSystem, we conducted semistructured interviews with 17 EID providers at participating intervention and control hospitals and laboratories., Results: Providers emphasized the perceived usefulness of the HITSystem, including improved efficiency in sample tracking and patient follow-up, strengthened communication networks among key stakeholders, and improved capacity to meet patient needs compared to standard EID. These advantages were realized from an intervention that providers saw as easy to use and largely compatible with workflow. However, supply stock outs and patient psychosocial factors (including fear of HIV status disclosure and poverty) provided ongoing challenges to EID service provision. Furthermore, slow or sporadic internet access and heavy workload prevented real-time HITSystem data entry for some clinicians., Conclusions: Provider experiences with the HITSystem indicate that the usefulness of the HITSystem, along with the ease with which it is able to be incorporated into hospital workflows, contributes to its sustained adoption and use in Kenyan hospitals. To maximize implementation success, care should be taken in intervention design and implementation to ensure that end users see clear advantages to using the technology and to account for variations in workflows, patient populations, and resource levels by allowing flexibility to suit user needs., Trial Registration: ClinicalTrials.gov NCT02072603; https://clinicaltrials.gov/ct2/show/NCT02072603 (Archived by WebCite at http://www.webcitation.org/71NgMCrAm)., (©Catherine Wexler, Melinda Brown, Emily A Hurley, Martin Ochieng, Kathy Goggin, Brad Gautney, May Maloba, Raphael Lwembe, Samoel Khamadi, Sarah Finocchario-Kessler. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 22.08.2018.)

Background: About 40% of HIV-positive women in sub-Saharan Africa become pregnant post-diagnosis. Despite about half of their pregnancies being planned, safer conception methods (SCM) are underutilized among serodiscordant couples, partially due to the fact that safer conception counseling (SCC) has not been integrated into routine HIV family planning (FP) services., Methods: Our Choice is a comprehensive FP intervention that promotes unbiased childbearing consultations to ensure clients receive SCC or contraception services to achieve their desired reproductive goals. The intervention is theoretically grounded and has demonstrated preliminarily feasibility and acceptance through pilot testing. This three-arm cluster randomized controlled trial compares two implementation strategies for integrating Our Choice into routine FP services vs. usual care. Six sites in Uganda will be randomized to receive either (1) Our Choice intervention with enhanced training and supervision provided by study staff (SCC1), (2) Our Choice intervention implemented by the Ministry of Health's standard approach to disseminating new services (SCC2), or (3) existing FP services (usual care). Our Choice and usual care FP services will be implemented simultaneously over a 30-month period. Sixty clients in serodiscordant relationships who express childbearing desires will be enrolled by a study coordinator at each site (n = 360) and followed for 12 months or post-pregnancy (once, if applicable). Analysis will compare intervention arms (SCC1 and SCC2) to usual care and then to each other (SCC1 vs. SCC2) on the primary outcome of correct use of either SCM (if trying to conceive) or dual contraception (if pregnancy is not desired). Secondary outcomes (i.e., pregnancy, use of prevention of mother-to-child transmission services, condom use, and partner seroconversion) and cost-effectiveness will also be examined., Discussion: Findings will provide critical information about the success of implementation models of varying intensity for integrating SCC into FP, thereby informing policy and resource allocation within and beyond Uganda., Trial Registration: NCT03167879 ClinicalTrials.gov, Registered 30 May, 2017.

Introduction: Children with acute respiratory tract infections (ARTIs) are prescribed up to 11.4 million unnecessary antibiotic prescriptions annually. Inadequate parent-provider communication is a chief contributor, yet efforts to reduce overprescribing have only indirectly targeted communication or been impractical. This paper describes our multisite, parallel group, cluster randomised trial comparing two feasible interventions for enhancing parent-provider communication on the rate of inappropriate antibiotic prescribing (primary outcome) and revisits, adverse drug reactions and parent-rated quality of shared decision-making, parent-provider communication and visit satisfaction (secondary outcomes)., Methods/analysis: We will attempt to recruit all eligible paediatricians and nurse practitioners (currently 47) at an academic children's hospital and a private practice. Using a 1:1 randomisation, providers will be assigned to a higher intensity education and communication skills or lower intensity education-only intervention and trained accordingly. We will recruit 1600 eligible parent-child dyads. Parents of children ages 1-5 years who present with ARTI symptoms will be managed by providers trained in either the higher or lower intensity intervention. Before their consultation, all parents will complete a baseline survey and view a 90 s gain-framed antibiotic educational video. Parent-child dyads consulting with providers trained in the higher intensity intervention will, in addition, receive a gain-framed antibiotic educational brochure promoting cautious use of antibiotics and rate their interest in receiving an antibiotic which will be shared with their provider before the visit. All parents will complete a postconsultation survey and a 2-week follow-up phone survey. Due to the two-stage nested design (parents nested within providers and clinics), we will employ generalised linear mixed-effect regression models., Ethics/dissemination: Ethical approval was obtained from the Children's Mercy Hospital Pediatric Institutional Review Board (#16060466). Results will be submitted for publication in peer-reviewed journals., Trial Registration Number: NCT03037112; Pre-results., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background/objective: Patient-centred attitudes have been shown to decline during medical training in high-income countries, yet little is known about attitudes among West African medical students. We sought to measure student attitudes towards patient-centredness and examine validity of the 18-item Patient-Practitioner Orientation Scale (PPOS) in this context., Participants/setting: 430 medical students in years 1, 3, 5 and 6 of a 6-year medical training programme in Bamako, Mali., Design: We conducted a cross-sectional survey, compared the proportion of students who agreed with each PPOS item by gender and academic year, and calculated composite PPOS scores. To examine psychometrics of the PPOS and its two subscales ('sharing' and 'caring'), we calculated internal consistency (Cronbach's alpha) and performed confirmatory and exploratory factor analyses (CFA and EFA)., Results: In seven of the nine 'sharing' items, the majority of students held attitudes favouring a provider-dominant style. For five of the nine 'caring' items, the majority of student responded consistently with patient-centred attitudes, while in the other four, responses indicated a disease-centred orientation. In eight items, a greater proportion of fifth/sixth year students held patient-centred attitudes as compared with first year students; there were few gender differences. Average PPOS scores indicated students were moderately patient-centred, with more favourable attitudes towards the 'caring' aspect than 'sharing'. Internal consistency of the PPOS was inadequate for the full scale (α=0.58) and subscales ('sharing' α=0.37; 'caring' α=0.48). CFA did not support the original PPOS factors and EFA did not identify an improved structure., Conclusions: West African medical students training in Bamako are moderately patient-centred and do not show the same declines in patient-centred attitudes in higher academic years as seen in other settings. Medical students may benefit from training in shared power skills and in attending to patient lifestyle factors. Locally validated tools are needed to guide West African medical schools in fostering patient-centredness among students., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Mounting evidence in sub-Saharan Africa suggests poor patient-provider communication (PPC) negatively impacts patient engagement (retention in care and adherence to medication) in antiretroviral therapy (ART) programs. In Bamako, Mali, where 36% of ART patients are lost to follow-up within 12 months of initiating treatment, we aimed to define features of positive PPC according to patient values and explore the mechanisms by which these features may sustain engagement and re-engagement according to patient and provider experiences. We conducted 33 in-depth interviews and 7 focus groups with 69 patients and 17 providers in five ART clinics. Regarding sustaining engagement, participants highlighted "establishing rapport" as a foundational feature of effective PPC, but also described how "responding to emotional needs", "eliciting patient conflicts and perspective" and "partnering to mitigate conflicts" functioned to address barriers to engagement and increase connectedness to care. Patients who had disengaged felt that "communicating reacceptance" may have prompted them re-engage sooner and that tailored "partnering to mitigate conflicts" would be more effective in sustaining re-engagement than the standard adherence education providers typically offer. Optimizing provider skills related to these key PPC features may help maximize ART patient engagement, ultimately improving health outcomes and decreasing HIV transmission in sub-Saharan Africa.

Effective patient-provider communication (PPC) promotes patient adherence and retention in long-term care. Sub-Saharan Africa faces unprecedented demand for chronic care for HIV patients on antiretroviral therapy (ART), yet adherence and retention remain challenging. In high-income countries, research describing patient preferences for different PPC styles has guided interventions to improve PPC and patient outcomes. However, research on PPC preferences in sub-Saharan Africa is limited. We sought to define PPC dimensions relevant to ART programs in Bamako, Mali through recordings of clinical interactions, in-depth interviews and focus-group discussions with 69 patients and 17 providers. Qualitative analysis revealed two PPC dimensions similar to those described in the literature on patient-centered communication (level of psychosocial regard, balance of power), and one unique dimension that emerged from the data (guiding patient behavior: easy/tough/sharp). To assess preferences toward contrasting PPC styles within dimensions, we conducted a vignette-based survey with 141 patients across five ART facilities. Significantly more participants chose the vignette demonstrating high psychosocial regard (52.2%) compared to a biomedical style (22.5%) (p<0.001). Within balance of power, a statistically similar proportion of participants chose the vignette demonstrating shared power (40.2%) compared to a provider-dominated style (35.8%). In guiding patient behavior, a similar proportion of participants preferred the vignette depicting the "easy" (38.4%) and/or "tough" style (40.6%), but significantly fewer preferred the "sharp" style (14.5%) (p<0.001). Highly educated participants chose biomedical and shared power styles more frequently, while less educated participants more frequently indicated "no preference". Working to understand, develop, and tailor PPC styles to patients in chronic care may help support patient retention and ultimately, clinical outcomes. Emphasis on developing skills in psychosocial regard and on adapting styles of power balance and behavioral guidance to individual patients is likely to yield positive results and should be considered a high priority for ART providers in Mali., Competing Interests: Conflicts of Interest The authors declare no conflicts of interest.

Purpose: Considering the increased risk of HIV among alcohol users, we explored the role of individual alcohol expectancies in risk behaviors among youth in the Democratic Republic of the Congo., Methods: We surveyed 1,396 adolescents (ages 15-19) and young adults (ages 20-24) on alcohol and sexual behaviors in May, 2010. We assessed expectancies of alcohol use (1) leading to sex or positive sexual experiences; (2) diminishing one's ability to resist unwanted sex; and (3) diminishing one's ability to use or negotiate use of condoms. Adjusted logistic regression models assessed the association between alcohol use and alcohol expectancies with unprotected sex and multiple sex partners (MSP)., Results: Participants reporting alcohol use (36.8%) were more likely to have engaged in unprotected sex and MSP than nondrinkers (adjusted odds ratio [AOR]: 2.87, 95% confidence interval [CI]: 2.29-3.60; AOR: 3.73 95% CI: 2.94-4.72, respectively). Among alcohol users, after adjusting for drinking quantity, moderate expectancies of alcohol leading to positive sexual experiences were significantly associated with MSP among adolescent boys (AOR: 4.20, 95% CI: 1.49-11.86) and girls (AOR: 3.97, 95% CI: 1.36-11.60), whereas high expectancies were significant among young adult men (AOR: 2.70, 95% CI: 1.19-6.10). Among adolescent girls who used alcohol, adjusted odds of unprotected sex were elevated among those with expectancies of diminished ability to refuse unwanted sex (AOR: 5.13, 95% CI: 1.41-16.64) or to negotiate condom use (AOR: 16.22; 2.08-126.8)., Conclusions: HIV prevention efforts for youth should acknowledge the role of alcohol expectancies in sexual risk behaviors and tailor programs to address different roles of expectancies in males and females., (Copyright © 2016 Society for Adolescent Health and Medicine. All rights reserved.)

Objectives: To identify factors contributing to low uptake of intermittent preventive treatment of malaria in pregnancy with sulfadoxine-pyrimethamine (IPTp-SP) in rural Mali., Methods: We conducted secondary data analysis on Mali's 2012-2013 Demographic and Health Survey (DHS) to determine the proportion of women who failed to take IPTp-SP due to ineligibility or non-attendance at antenatal care (ANC). We also identified the proportion who reported taking other or unknown medications to prevent malaria in pregnancy and those who did not know if they took any medication to prevent malaria in pregnancy. We conducted qualitative interviews, focus groups and ANC observations in six rural sites in Mali's Sikasso and Koulikoro regions to identify reasons for missed opportunities., Results: Our secondary data analysis found that reported IPTp-SP coverage estimates are misleading due to their dependence on a variable ("source of IPTp") that is missing 62% of its data points. Among all women who gave birth in the two years prior to the survey, 56.2% reported taking at least one dose of IPTp-SP. Another 5.2% reported taking chloroquine, 1.9% taking another drug to prevent malaria in pregnancy, 4.4% not knowing what drug they took to prevent malaria, and 1.1% not knowing if they took any drug to prevent malaria. The majority of women who did not receive IPTp-SP were women who also did not attend ANC. Our qualitative data revealed that many health centers neither administer IPTp-SP by directly observed therapy, nor give IPTp-SP at one month intervals through the second and third trimesters, nor provide IPTp-SP free of charge. Women generally reported IPTp-SP as available and tolerable, but frequently could not identify its name or purpose, potentially affecting accuracy of responses in household surveys., Conclusion: We estimate IPTp-SP uptake to be significantly higher than stated in Mali's 2012-13 DHS report. Increasing ANC attendance should be the first priority for increasing IPTp-SP coverage. Reducing cost and access barriers, ensuring that providers follow up-to-date guidelines, and improving patient counseling on IPTp-SP would also facilitate optimal uptake.

Objectives: Past research has established that the Multigroup Ethnic Identity Measure (MEIM) exhibits measurement invariance across diverse ethnic groups. However, relatively little research has evaluated whether this measure is invariant across generational status. Thus, the present study evaluates the invariance of the MEIM across foreign-born, second-generation, and later-generation respondents., Method: A large, ethnically diverse sample of college students completed the MEIM as part of an online survey (N = 9,107; 72.8% women; mean age = 20.31 years; SD = 3.38)., Results: There is evidence of configural and metric invariance, but there is little evidence of scalar invariance across generational status groups., Conclusions: This study suggests that the MEIM has an equivalent factor structure across generation groups, indicating it is appropriate to compare the magnitude of associations between the MEIM and other variables across foreign-born, second-generation, and later-generation individuals. However, the lack of scalar invariance suggests that mean-level differences across generational status should be interpreted with caution. (PsycINFO Database Record, ((c) 2016 APA, all rights reserved).)