Multilevel Interventions Targeting Obesity: State of the Science and Future Directions.

A seminal report, released in 2001 by the Institute of Medicine, spurred research on the design, implementation, and evaluation of multilevel interventions targeting obesity and related behaviors. By addressing social and environmental factors that support positive health behavior change, interventions that include multiple levels of influence (e.g., individual, social, structural) aim to bolster effectiveness and, ultimately, public health impact. With more than 20 years of multilevel obesity intervention research to draw from, this review was informed by published reviews (n = 51) and identified intervention trials (n = 103), inclusive of all ages and countries, to elucidate key learnings about the state of the science. This review provides a critical appraisal of the scientific literature related to multilevel obesity interventions and includes a description of their effectiveness on adiposity outcomes and prominent characteristics (e.g., population, setting, levels). Key objectives for future research are recommended to advance innovations to improve population health and reduce obesity.

A Hybrid Pragmatic and Factorial Cluster Randomized Controlled Trial for an Anti-racist, Multilevel Intervention to Improve Mental Health Equity in High Schools.

Systemic racism is pervasive in US society and disproportionately limits opportunities for education, work, and health for historically marginalized and minoritized racial and ethnic groups, making it an urgent issue of social justice. Because systemic racism is a social determinant of health prevalent across multiple social and institutional structures, it requires multilevel intervention approaches using effective designs and analytic methods to measure and evaluate outcomes. Racism is a fundamental cause of poor health outcomes, including mental health outcomes; thus, mental health services and programs that address racism and discrimination are key to promoting positive mental health of racial and ethnic minority youth. While multilevel interventions are well-suited for improving outcomes like youth mental health disparities, their evaluation poses unique methodological challenges, requiring specialized design and analytic approaches. There has been limited methodological guidance provided to researchers on how to test multilevel interventions using approaches that balance methodological rigor, practicality, and acceptability across stakeholder groups, especially within communities most affected by systemic racism. This paper addresses this gap by providing an example of how to rigorously evaluate a hypothetical, theoretically based, multilevel intervention promoting mental health equity in three US school systems using an anti-racist approach intervening at the macro- (i.e., school system), meso- (i.e., school), and micro- (i.e., family and student) levels to improve mental health in adolescents. We describe the design, sample size considerations, and analytic methods to comprehensively evaluate its effectiveness while exploring the extent to which the components interact synergistically to improve outcomes. The methodological approach proposed can be adapted to other multilevel interventions that include strategies addressing macro-, meso-, and micro-levels of influence.

Multilevel Intervention Stepped Wedge Designs (MLI-SWDs).

Multilevel interventions (MLIs) hold promise for reducing health inequities by intervening at multiple types of social determinants of health consistent with the socioecological model of health. In spite of their potential, methodological challenges related to study design compounded by a lack of tools for sample size calculation inhibit their development. We help address this gap by proposing the Multilevel Intervention Stepped Wedge Design (MLI-SWD), a hybrid experimental design which combines cluster-level (CL) randomization using a Stepped Wedge design (SWD) with independent individual-level (IL) randomization. The MLI-SWD is suitable for MLIs where the IL intervention has a low risk of interference between individuals in the same cluster, and it enables estimation of the component IL and CL treatment effects, their interaction, and the combined intervention effect. The MLI-SWD accommodates cross-sectional and cohort designs as well as both incomplete (clusters are not observed in every study period) and complete observation patterns. We adapt recent work using generalized estimating equations for SWD sample size calculation to the multilevel setting and provide an R package for power and sample size calculation. Furthermore, motivated by our experiences with the ongoing NC Works 4 Health study, we consider how to apply the MLI-SWD when individuals join clusters over the course of the study. This situation arises when unemployment MLIs include IL interventions that are delivered while the individual is unemployed. This extension requires carefully considering whether the study interventions will satisfy additional causal assumptions but could permit randomization in new settings.

CHECK - multilevel real-world pediatric asthma care coordination: results and lessons learned.

OBJECTIVE: Because asthma health disparities in children remain common, innovative approaches to obtain asthma health equity are essential. Comprehensive care coordination programs may address the social determinants of health that influence these disparities. This analysis aims to ascertain if receipt of Coordination of Healthcare for Complex Kids (CHECK) program services was associated with changes in school absence, cost, healthcare utilization, and controller prescription in children with asthma. METHODS: The CHECK program ran from December 1, 2014 through August 31, 2017. Engagement with community health workers was rolling and targeted based on risk level (low, medium, or high determined by healthcare utilization). This analysis included school-aged children with asthma (n = 2,629) and sufficient Chicago Public Schools attendance data (n = 430). RESULTS: Children engaged in CHECK were more likely to be female (p = .046) and to identify as Black and/or Hispanic/Latino than enrolled-only children. School absence was not different between the groups. Average total cost for engaged children was 21.3% more than enrolled-only children the first year (p = .027) but did not differ by the second year (p = .948). At baseline, 68.1% of the cohort had at least one ED visit 12 months prior to CHECK, this reduced to 49.5% post-1 and 41.9% post-2. Engaged children were 21% more likely to visit an ED (p = .010) and 40% more likely to have a controller. CONCLUSIONS: CHECK program receipt was associated with improved healthcare utilization and controller prescriptions. School attendance did not change. The CHECK model offers potential pathways to support low-income children with asthma.

Operationalizing Primary Outcomes to Achieve Reach, Effectiveness, and Equity in Multilevel Interventions.

When intervention scientists plan a clinical trial of an intervention, they select an outcome metric that operationalizes their definition of intervention success. The outcome metric that is selected has important implications for which interventions are eventually supported for implementation at scale and, therefore, what health benefits (including how much benefit and for whom) are experienced in a population. Particularly when an intervention is to be implemented in a population that experiences a health disparity, the outcome metric that is selected can also have implications for equity. Some outcome metrics risk exacerbating an existing health disparity, while others may decrease disparities for some but have less effect for the larger population. In this study, we use a computer to simulate implementation of a hypothetical multilevel, multicomponent intervention to highlight the tradeoffs that can occur between outcome metrics that reflect different operationalizations of intervention success. In particular, we highlight tradeoffs between overall mean population benefit and the distribution of health benefits in the population, which has direct implications for equity. We suggest that simulations like the one we present can be useful in the planning of a clinical trial for a multilevel and/or multicomponent intervention, since simulated implementation at scale can illustrate potential consequences of candidate operationalization of intervention success, such that unintended consequences for equity can be avoided.

African migrant women acquisition of clay for ingestion during pregnancy in London: a call for action.

OBJECTIVES: This study aimed to explore how African migrant women go about acquiring clay for ingestion during pregnancy in London against a backdrop of restrictions and warnings by the Food Standard Agency and Public Health England due to the potential health risks to expectant mothers and their unborn babies. STUDY DESIGN: This was a qualitative study using an interpretative phenomenological approach. METHODS: Individual in-depth interviews and a focus group discussion were used for data collection. Data collection took place between May and August 2020. RESULTS: Participants acquired clay from African shops and markets in London, countries of origin and online/social media platforms. Due to official restrictions and warnings, transactions were conducted under the counter based on trust between sellers and the women underpinned by shared community identities. However, clay was acquired, social networks emerged as crucial facilitators. The current top-down approach, which is also lacking a regulatory policy framework, has pushed clay transactions underground, thereby leaving pregnant women potentially ingesting toxic clay with little chances of dictation by authorities. CONCLUSION: We call on the UK Health Security Agency (UKHSA) and public health practitioners to collaborate with communities to design multilevel/multisectoral interventions as well as the Food Standards Agency (FSA) to consider an appropriate regulatory policy framework.

Walking through the valley of the shadow of death-The psychotherapy of the head and neck cancer patient expressing suicidal ideations and impulses.

The paper aims to show the multilevel and complex cooperation and the inclusion of the psychotherapist leading the psychotherapy in the medical team at the radiotherapy and clinical oncology clinic. We illustrate these interventions with the case of Stan. This 43-year-old firefighter was diagnosed with advanced head and neck cancer and pre-existing mental health problems meeting the criteria of ICD-10: obsessive-compulsive disorder, post-traumatic stress disorder and psychoactive substance abuse. During the treatment, suicidal thoughts and impulses emerged, triggered at the hospital by electronic noises and the feeling of entrapment without a way out. This situation put the patient at high risk and the whole healthcare team needed an urgent effective response. The patient agreed to stay in the secured room, where he was cared for by doctors, nurses, a dietitian, and a psychotherapist. He actively attended daily sessions with noticeable engagement. Psychotherapy sessions focused on alleviating posttraumatic stress disorder and OCD. Mindfulness and breathwork-based exercises were implemented to increase non-judgemental self-awareness and regulate the over-aroused nervous system. As a result, the patient's mental health has improved and the completion of the cancer treatment was possible. Psychotherapy, good therapeutic alliance, and attentive teamwork effectively managed his mental health and treatment-related symptoms.

'Menstruation means impurity': multilevel interventions are needed to break the menstrual taboo in Nepal.

BACKGROUND: During their menstrual period, women are generally considered impure in Nepal; in the rural areas of the western part of the country, they are even banished to stay in sheds (called chhaupadi) during this time, which increases their vulnerability to a variety of health consequences. There is lack of clarity regarding the effectiveness of interventions that have been implemented to address menstrual taboo and improve menstrual hygiene and practices in Nepal (e.g., public awareness, community sensitization and legislation). In this paper, we discuss why menstruation management interventions, particularly those implemented to change the menstrual taboo might not work, and the opinions and experiences regarding the implementation of such interventions. MAIN TEXT: Anecdotal reports from the field and empirical studies suggest that interventions to address menstrual taboos have only been effective for short durations of time due to several reasons. First, local community stakeholders have been reluctant to take actions to abandon retrogressive menstrual practices in rural areas. Second, women who have stopped practising chhaupadi have faced stigma (e.g., fear of exclusion) and discrimination (e.g., blaming, physical and verbal abuse). Third, contextual factors, such as poverty and illiteracy, limit the effectiveness of such interventions. Fourth, community sensitization activities against chhaupadi have faced resistance from community leaders and traditional healers. Fifth, the law prohibiting chhaupadi has also faced implementation problems, including poor filing of complaints. CONCLUSION: Multilevel, multisectoral interventions could be more effective than single-component interventions in breaking the prevailing menstrual taboo and in improving menstrual health and hygiene practices among young girls and women in the rural areas of Nepal. Moreover, interventions that have an active community mobilization component could be effective within local contexts and cultural groups.

Factors influencing health and safety practices among Vietnamese nail salon technicians and owners: A qualitative study.

OBJECTIVE: This qualitative study explored factors that influence health and safety practices among Vietnamese nail salon technicians and owners. METHODS: We conducted semi-structured focus group discussions and individual interviews with a sample of 17 Vietnamese nail salon technicians and owners in the Philadelphia metropolitan area, Pennsylvania. RESULTS: Analysis of transcripts revealed perceived health benefits/concerns, knowledge about work-related hazards, salon's management and policies attributed to owners, client influence, external policies/regulations, and protective equipment-specific challenges were among factors affecting workplace health promotion practices at the salons. CONCLUSIONS: The study highlighted a complex interplay among the various stakeholders including nail technicians, owners, clients, policy makers, and enforcers. Interventions addressing barriers at the personal and organizational levels, as well as public policy change and enforcement are needed to create sustainable behavioral and organizational change in nail salons.

Reducing HIV Risks in the Places Where People Drink: Prevention Interventions in Alcohol Venues.

Apart from individual alcohol drinking behavior, the context or places where people drink play a significant role in HIV transmission risk. In this paper, we review the research that has been conducted on alcohol venues to identify the social and structural factors (e.g., social norms, sexual behavior) that are associated with HIV risk in these places, to review HIV prevention interventions based in alcohol venues, and to discuss appropriate methodologies for alcohol venue research. Alcohol venues are defined here as places that sell or serve alcohol for onsite consumption, including bars, bottle stores, nightclubs, wine shops, and informal shebeens. Despite the many established HIV risk factors at play in alcohol venues, limited prevention strategies have been implemented in such places. A total of 11 HIV prevention interventions or programs were identified. HIV prevention interventions in alcohol venues may be conducted at the individual, social, or structural level. However, multilevel interventions that target more than one level appear to lead to the most sustainable behavior change. Strategies to incorporate alcohol venues in biomedical prevention strategies including antiretroviral therapy for alcohol users are also discussed.

Reducing high maternal mortality rates in western China: a novel approach.

Among the Millennium Development Goals, maternal mortality reduction has proven especially difficult to achieve. Unlike many countries, China is on track to meeting these goals on a national level, through a programme of institutionalizing deliveries. Nonetheless, in rural, disadvantaged, and ethnically diverse areas of western China, maternal mortality rates remain high. To reduce maternal mortality in western China, we developed and implemented a three-level approach as part of a collaboration between a regional university, a non-profit organization, and local health authorities. Through formative research, we identified seven barriers to hospital delivery in a rural Tibetan county of Qinghai Province: (1) difficulty in travel to hospitals; (2) hospitals lack accommodation for accompanying families; (3) the cost of hospital delivery; (4) language and cultural barriers; (5) little confidence in western medicine; (6) discrepancy in views of childbirth; and (7) few trained community birth attendants. We implemented a three-level intervention: (a) an innovative Tibetan birth centre, (b) a community midwife programme, and (c) peer education of women. The programme appears to be reaching a broad cross-section of rural women. Multilevel, locally-tailored approaches may be essential to reduce maternal mortality in rural areas of western China and other countries with substantial regional, socioeconomic, and ethnic diversity.

Alliance system and policy change: necessary ingredients for improvement in diabetes care and reduction of disparities.

Reducing diabetes inequities requires system and policy changes based on real-life experiences of vulnerable individuals living with the condition. While introducing innovative interventions for African American, Native American, and Latino low-income people, the five community-based sites of the Alliance to Reduce Disparities in Diabetes recognized that policy changes were essential to sustain their efforts. Data regarding change efforts were collected from site leaders and examined against documents provided routinely to the National Program Office at the University of Michigan. A policy expert refined the original lists to include only confirmed policy changes, scope of change (organizational to national), and stage of accomplishment (1, beginning; 2, adoption; 3, implementation; and 4, full maintenance). Changes were again verified through site visits and telephone interviews. In 3 years, Alliance teams achieved 53 system and policy change accomplishments. Efforts were implemented at the organizational (33), citywide (13), state (5), and national (2) levels, and forces helping and hindering success were identified. Three types of changes were deemed especially significant for diabetes control: data sharing across care-providing organizations, embedding community health workers into the clinical care team, and linking clinic services with community assets and resources in support of self-management.

Identifying Interventions to Improve Diagnostic Safety in Emergency Departments: Protocol for a Participatory Design Study.

BACKGROUND: Emergency departments (EDs) are complex and fast-paced clinical settings where a diagnosis is made in a time-, information-, and resource-constrained context. Thus, it is predisposed to suboptimal diagnostic outcomes, leading to errors and subsequent patient harm. Arriving at a timely and accurate diagnosis is an activity that occurs after an effective collaboration between the patient or caregiver and the clinical team within the ED. Interventions such as novel sociotechnical solutions are needed to mitigate errors and risks. OBJECTIVE: This study aims to identify challenges that frontline ED health care providers and patients face in the ED diagnostic process and involve them in co-designing technological interventions to enhance diagnostic excellence. METHODS: We will conduct separate sessions with ED health care providers and patients, respectively, to assess various design ideas and use a participatory design (PD) approach for technological interventions to improve ED diagnostic safety. In the sessions, various intervention ideas will be presented to participants through storyboards. Based on a preliminary interview study with ED patients and health care providers, we created intervention storyboards that illustrate different care contexts in which ED health care providers or patients experience challenges and show how each intervention would address the specific challenge. By facilitating participant group discussion, we will reveal the overlap between the needs of the design research team observed during fieldwork and the needs perceived by target users (ie, participants) in their own experience to gain their perspectives and assessment on each idea. After the group discussions, participants will rank the ideas and co-design to improve our interventions. Data sources will include audio and video recordings, design sketches, and ratings of intervention design ideas from PD sessions. The University of Michigan Institutional Review Board approved this study. This foundational work will help identify the needs and challenges of key stakeholders in the ED diagnostic process and develop initial design ideas, specifically focusing on sociotechnological ideas for patient-, health care provider-, and system-level interventions for improving patient safety in EDs. RESULTS: The recruitment of participants for ED health care providers and patients is complete. We are currently preparing for PD sessions. The first results from design sessions with health care providers will be reported in fall 2024. CONCLUSIONS: The study findings will provide unique insights for designing sociotechnological interventions to support ED diagnostic processes. By inviting frontline health care providers and patients into the design process, we anticipate obtaining unique insights into the ED diagnostic process and designing novel sociotechnical interventions to enhance patient safety. Based on this study's collected data and intervention ideas, we will develop prototypes of multilevel interventions that can be tested and subsequently implemented for patients, health care providers, or hospitals as a system. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55357.

Breaking down silos: the multifaceted nature of obesity and the future of weight management.

The continued global increase in the prevalence of obesity prompted a meeting at the Royal Society of London investigating causal mechanisms of the disease, 'Causes of obesity: theories, conjectures, and evidence' in October 2022. Evidence presented indicates areas of obesity science where there have been advancements, including an increased understanding of biological and physiological processes of weight gain and maintenance, yet it is clear there is still debate on the relative contribution of plausible causes of the modern obesity epidemic. Consensus was reached that obesity is not a reflection of diminished willpower, but rather the confluence of multiple, complex factors. As such, addressing obesity requires multifactorial prevention and treatment strategies. The accumulated evidence suggests that a continued focus primarily on individual-level contributors will be suboptimal in promoting weight management at the population level. Here, we consider individual biological and physiological processes within the broader context of sociodemographic and sociocultural exposures as well as environmental changes to optimize research priorities and public health efforts. This requires a consideration of a systems-level approach that efficiently addresses both systemic and group-specific environmental determinants, including psychosocial factors, that often serve as a barrier to otherwise efficacious prevention and treatment options. This article is part of a discussion meeting issue 'Causes of obesity: theories, conjectures and evidence (Part I)'.

All systems are interrelated: Multilevel interventions with indigenous communities.

Colonial historical trauma and ongoing structural racism have impacted Indigenous peoples for generations and explain the ongoing health disparities. However, Indigenous peoples have been engaging in multilevel, clinical trial interventions with Indigenous and allied research scientists resulting in promising success. In this paper, National Institutes of Health funded scientists in the field of Indigenous health have sought to describe the utility and need for multilevel interventions across Indigenous communities (Jernigan et al., 2020). We posit limitations to the existing socioecological, multilevel frameworks and propose a dynamic, interrelated heuristic framework, which focuses on the inter-relationships of the collective within the environment and de-centers the individual. We conclude with identified calls for action within multilevel clinical trial research.

Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) in Appalachia: protocol for a group randomized, delayed intervention trial.

Appalachian regions of Kentucky and Ohio are hotspots for colorectal cancer (CRC) mortality in the USA. Screening reduces CRC incidence and mortality; however, screening uptake is needed, especially in these underserved geographic areas. Implementation science offers strategies to address this challenge. The aim of the current study was to conduct multi-site, transdisciplinary research to evaluate and improve CRC screening processes using implementation science strategies. The study consists of two phases (Planning and Implementation). In the Planning Phase, a multilevel assessment of 12 health centers (HC) (one HC from each of the 12 Appalachian counties) was conducted by interviewing key informants, creating community profiles, identifying HC and community champions, and performing HC data inventories. Two designated pilot HCs chose CRC evidence-based interventions to adapt and implement at each level (i.e., patient, provider, HC, and community) with evaluation relative to two matched control HCs. During the Implementation Phase, study staff will repeat the rollout process in HC and community settings in a randomized, staggered fashion in the remaining eight counties/HCs. Evaluation will include analyses of electronic health record data and provider and county surveys. Rural HCs have been reluctant to participate in research because of concerns about capacity; however, this project should demonstrate that research does not need to be burdensome and can adapt to local needs and HC abilities. If effective, this approach could be disseminated to HC and community partners throughout Appalachia to encourage the uptake of effective interventions to reduce the burden of CRC.

We conducted a multi-site study to evaluate and improve CRC screening processes using implementation science strategies at multiple levels including the patient, provider, health center, and community. Our goals were to increase rates of guideline-recommended CRC screening, follow-up, and referral-to-care in an Appalachian, medically underserved population.

The Baltimore Urban Food Distribution (BUD) App: Study Protocol to Assess the Feasibility of a Food Systems Intervention.

Low-income urban communities in the United States commonly lack ready access to healthy foods. This is due in part to a food distribution system that favors the provision of high-fat, high-sugar, high-sodium processed foods to small retail food stores, and impedes their healthier alternatives, such as fresh produce. The Baltimore Urban food Distribution (BUD) study is a multilevel, multicomponent systems intervention that aims to improve healthy food access in low-income neighborhoods of Baltimore, Maryland. The primary intervention is the BUD application (app), which uses the power of collective purchasing and delivery to affordably move foods from local producers and wholesalers to the city's many corner stores. We will implement the BUD app in a sample of 38 corner stores, randomized to intervention and comparison. Extensive evaluation will be conducted at each level of the intervention to assess overall feasibility and effectiveness via mixed methods, including app usage data, and process and impact measures on suppliers, corner stores, and consumers. BUD represents one of the first attempts to implement an intervention that engages multiple levels of a local food system. We anticipate that the app will provide a financially viable alternative for Baltimore corner stores to increase their stocking and sales of healthier foods, subsequently increasing healthy food access and improving diet-related health outcomes for under-resourced consumers. The design of the intervention and the evaluation plan of the BUD project are documented here, including future steps for scale-up. Trial registration #: NCT05010018.

Antisocial Behavior and Attitudes Towards Antisocial Behavior after a Five-Year Municipal Youth and Family Master Plan in Pomona, California, USA.

Within an integrated conceptual framework made up of social cognitive theory, theory of fundamental causes, and the risk and protective factor approach, we assess reported antisocial behavior and favorable attitudes toward antisocial behavior among youths and parents in a high-school sample after the implementation of a Youth and Family Master Plan in Pomona, California, USA from 2005 to 2009. We perform z tests for same students (8th grade 2005 and 12th grade 2009), same grade (8th,10th, and 12th grade), inter-grade, same year, and overall, 2005 to 2009 comparisons for Pomona, Los Angeles, and US national samples. It was hypothesized that after five years of implementation, Pomona Youth and Family Master Plan (PYFMP) activities will reduce antisocial behavior and favorable parental and youth attitudes toward antisocial behavior. Within a p-value of 05, z-test results show a decline in youth antisocial behavior among youths in the Pomona sample. Patterns in youth antisocial behavior were not consistent with youth favorable attitudes toward antisocial behavior but were consistent with perceived parental favorable attitudes toward antisocial behavior. Though youth favorable attitudes toward antisocial behavior were generally rising within the Pomona data, when compared to the rates of change in Los Angeles and US, Pomona rates of change were lower. Intra and inter jurisdictional patterns above could be attributed to the community multicomponent interventions of the PYFMP. They also align with assumptions and explanations offered in the integrated conceptual framework, which suggest a mediating role for environmental factors.

Development of a multilevel intervention to increase colorectal cancer screening in Appalachia.

BACKGROUND: Colorectal cancer (CRC) screening rates are lower in Appalachian regions of the United States than in non-Appalachian regions. Given the availability of various screening modalities, there is critical need for culturally relevant interventions addressing multiple socioecological levels to reduce the regional CRC burden. In this report, we describe the development and baseline findings from year 1 of "Accelerating Colorectal Cancer Screening through Implementation Science (ACCSIS) in Appalachia," a 5-year, National Cancer Institute Cancer MoonshotSM-funded multilevel intervention (MLI) project to increase screening in Appalachian Kentucky and Ohio primary care clinics. METHODS: Project development was theory-driven and included the establishment of both an external Scientific Advisory Board and a Community Advisory Board to provide guidance in conducting formative activities in two Appalachian counties: one in Kentucky and one in Ohio. Activities included identifying and describing the study communities and primary care clinics, selecting appropriate evidence-based interventions (EBIs), and conducting a pilot test of MLI strategies addressing patient, provider, clinic, and community needs. RESULTS: Key informant interviews identified multiple barriers to CRC screening, including fear of screening, test results, and financial concerns (patient level); lack of time and competing priorities (provider level); lack of reminder or tracking systems and staff burden (clinic level); and cultural issues, societal norms, and transportation (community level). With this information, investigators then offered clinics a menu of EBIs and strategies to address barriers at each level. Clinics selected individually tailored MLIs, including improvement of patient education materials, provision of provider education (resulting in increased knowledge, p = .003), enhancement of electronic health record (EHR) systems and development of clinic screening protocols, and implementation of community CRC awareness events, all of which promoted stool-based screening (i.e., FIT or FIT-DNA). Variability among clinics, including differences in EHR systems, was the most salient barrier to EBI implementation, particularly in terms of tracking follow-up of positive screening results, whereas the development of clinic-wide screening protocols was found to promote fidelity to EBI components. CONCLUSIONS: Lessons learned from year 1 included increased recognition of variability among the clinics and how they function, appreciation for clinic staff and provider workload, and development of strategies to utilize EHR systems. These findings necessitated a modification of study design for subsequent years. TRIAL REGISTRATION: Trial NCT04427527 is registered at https://clinicaltrials.gov and was registered on June 11, 2020.

Tu'Washindi na PrEP: Working With Young Women and Service Providers to Design an Intervention for PrEP Uptake and Adherence in the Context of Gender-Based Violence.

HIV pre-exposure prophylaxis (PrEP) reduces HIV acquisition among adolescent girls and young women (AGYW). Existing evidence suggests that uptake and adherence are low among AGYW and that relationship factors such as gender-based violence (GBV) are important barriers. Through a community-based participatory research (CBPR) process, a youth advisory board (YAB), service providers (SP), and a study team developed the Tu'Washindi na PrEP intervention to support AGYW PrEP use in the context of GBV. The YAB also guided the formative research and interpretation of results. The authors pretested the intervention with SP, AGYW and their partners, and community change agents, and then developed guides for AGYW support clubs, community-based male sensitization sessions, and couples-based events that included formulation of story lines for dramatized PrEP negotiation and information dissemination skills. Stakeholder engagement led to an intervention responsive to AGYW's needs for PrEP support in the context of their relationships, which was evaluated through a 6-month pilot community randomized controlled trial.