Background: A history of unethical research and deficit-based paradigms have contributed to profound mistrust of research among Native Americans, serving as an important call to action. Lack of cultural safety in research with Native Americans limits integration of cultural and contextual knowledge that is valuable for understanding challenges and making progress toward sustainable change. Aim: To identify strategies for promoting cultural safety, accountability, and sustainability in research with Native American communities. Method: Using an integrative review approach, three distinct processes were carried out: (1) appraisal of peer-reviewed literature (Scopus, PubMed, and ProQuest), (2) review of grey literature (e.g. policy documents and guidelines), and (3) synthesis of recommendations for promoting cultural safety. Results: A total of 378 articles were screened for inclusion, with 55 peer-reviewed and grey literature articles extracted for full review. Recommendations from included articles were synthesised into strategies aligned with eight thematic areas for improving cultural safety in research with Native American communities. Conclusions: Research aiming to understand, respect, and acknowledge tribal sovereignty, address historical trauma, and endorse Indigenous methods is essential. Culturally appropriate, community-based and -engaged research collaborations with Native American communities can signal a reparative effort, re-establish trust, and inform pragmatic solutions. Rigorous research led by Native American people is critical to address common and complex health challenges faced by Native American communities. Impact statement: Respect and rigorous methods ensure cultural safety, accountability, and sustainability in research with Native Americans.

Background Trauma within Native American communities compromises parents’ parenting capacity; thus, increasing childrens’ risk for substance use and suicide over the lifespan. The objective of this manuscript is to describe the Wakȟáŋyeža (Little Holy One) intervention and evaluation protocol, that is designed to break cycles of intergenerational trauma, suicide, and substance use among Fort Peck Assiniboine and Sioux parents and their children. Methods A randomized controlled trial with an embedded single-case experimental design will be used to determine effectiveness of the modular prevention intervention on parent-child outcomes and the added impact of unique cultural lesson-components. Participants include 1) Fort Peck Assiniboine and Sioux parents who have had adverse childhood experiences, and 2) their children (3–5 years). Parent-child dyads are randomized (1:1) to Little Holy One or a control group that consists of 12 lessons taught by Indigenous community health workers. Lessons were developed from elements of 1) the Common Elements Treatment Approach and Family Spirit, both evidence-based interventions, and 2) newly created cultural (intervention) and nutrition (control group only) lessons. Primary outcomes are parent (primary caregiver) trauma symptoms and stress. Secondary outcomes include: Parent depression symptoms, parenting practices, parental control, family routines, substance use, historical loss, communal mastery, tribal identity, historical trauma. Child outcomes include, externalizing and internalizing behavior and school attendance. Primary analysis will follow an intent-to-treat approach, and secondary analysis will include examination of change trajectories to determine impact of cultural lessons and exploration of overall effect moderation by age and gender of child and type of caregiver (e.g., parent, grandparent). Discussion Many Native American parents have endured adverse childhood experiences and traumas that can negatively impact capacity for positive parenting. Study results will provide insights about the potential of a culturally-based intervention to reduce parental distress – an upstream approach to reducing risk for childrens’ later substance misuse and suicidality. Intervention design features, including use of community health workers, cultural grounding, and administration in Head Start settings lend potential for feasibility, acceptability, sustainability, and scalability. Trial registration ClinicalTrials.gov: NCT04201184. Registered 11 December 2019.

Background Globally, gender as a barrier or facilitator in achieving health outcomes is increasingly being documented. However, the role of gender in health programming and organization is frequently ignored. The Global Polio Eradication Initiative, one of the largest globally coordinated public health programs in history, has faced and worked to address gender-based challenges as they emerge. This paper seeks to describe the role of gender power relations in the polio program across global, national, subnational, and front-line levels to offer lessons learned for global programs. Methods We conducted qualitative key-informant interviews with individuals purposively selected from the polio universe globally and within seven country partners: Afghanistan, Bangladesh, the Democratic Republic of the Congo, Ethiopia, India, Indonesia, and Nigeria. The interview tool was designed to explore nuances of implementation challenges, strategies, and consequences within polio eradication. All interviews were conducted in the local or official language, audio-recorded, and transcribed. We employed a deductive coding approach and used four gender analysis domains to explore data at the household, community, workplace, and organizational levels. Results We completed 196 interviews globally and within each partner country; 74.5% of respondents were male and 25.5% were female. Male polio workers were not allowed to enter many households in conservative communities which created demand for female vaccinators. This changed the dynamics of front-line program teams and workplaces and empowered many women to enter the workplace for the first time. However, some faced challenges with safety and balancing obligations at home. Women were less likely to receive promotions to managerial or supervisory roles; this was also reflected at the global level. Some described how this lack of diverse management and leadership negatively affected the quality of program planning, delivery and limited accountability. Conclusions Gender power relations play an important role in determining the success of global health programs from global to local levels. Without consideration of gender, large-scale programs may fail to meet targets and/or reinforce gender inequities. Global disease programs should incorporate a gender lens in planning and implementation by engaging men and boys, supporting women in the workplace, and increasing diversity and representation among leadership.

Background Previous initiatives have aimed to document the history and legacy of the Smallpox Eradication Program (SEP) and the Global Polio Eradication Initiative (GPEI). In this multi-pronged scoping review, we explored the evolution and learning from SEP and GPEI implementation over time at global and country levels to inform other global health programs. Methods Three related reviews of literature were conducted; we searched for documents on 1) the SEP and 2) GPEI via online database searches and also conducted global and national-level grey literature searches for documents related to the GPEI in seven purposively selected countries under the Synthesis and Translation of Research and Innovations from Polio Eradication (STRIPE) project. We included documents relevant to GPEI implementation. We conducted full text data analysis and captured data on Expert Recommendations for Implementing Change (ERIC) implementation strategies and principles, tools, outcomes, target audiences, and relevance to global health knowledge areas. Results 200 articles were included in the SEP scoping review, 1885 articles in the GPEI scoping review, and 963 documents in the grey literature review. M&E and engagement strategies were consistently translated from the SEP to GPEI; these evolved into newer approaches under the GPEI. Management strategies including setting up robust record systems also carried forward from SEP to GPEI; however, lessons around the need for operational flexibility in applying these strategies at national and sub-national levels did not. Similarly, strategies and lessons around conducting health systems readiness assessments prior to implementation were not carried forward from SEP to GPEI. Differences in the planning and communication strategies between the two programs included fidelity to implementation blueprints appeared to be higher under SEP, and independent monitoring boards and communication and media strategies were more prominent under GPEI. Conclusions Linear learning did not always occur between SEP and GPEI; several lessons were lost and had to be re-learned. Implementation and adaptation of strategies in global health programs should be well codified, including information on the contextual, time and stakeholders’ issues that elicit adaptations. Such description can improve the systematic translation of knowledge, and gains in efficiency and effectiveness of future global health programs.

Background: Thoughtful and equitable engagement with international partners is key to successful research. STRIPE, a consortium of 8 academic and research institutions across the globe whose objective is to map, synthesize, and disseminate lessons learned from polio eradication, conducted a process evaluation of this partnership during the project's first year which focused on knowledge mapping activities. Methods: The STRIPE consortium is led by Johns Hopkins University (JHU) in partnership with 6 universities and 1 research consultancy organization in polio free, at-risk, and endemic countries. In December 2018 JHU team members submitted written reflections on their experiences (n = 9). We held calls with each consortium member to solicit additional feedback (n = 7). To establish the partnership evaluation criteria we conducted preliminary analyses based on Blackstock's framework evaluating participatory research. In April 2019, an in-person consortium meeting was held; one member from each institution was asked to join a process evaluation working group. This group reviewed the preliminary criteria, adding, subtracting, and combining as needed; the final evaluation criteria were applied to STRIPE's research process and partnership and illustrative examples were provided. Results: Twelve evaluation criteria were defined and applied by each member of the consortium to their experience in the project. These included access to resources, expectation setting, organizational context, external context, quality of information, relationship building, transparency, motivation, scheduling, adaptation, communication and engagement, and capacity building. For each criteria members of the working group reflected on general and context-specific challenges and potential strategies to overcome them. Teams suggested providing more time for recruitment, training, reflection, pre-testing. and financing to alleviate resource constraints. Given the large scope of the project, competing priorities, and shifting demands the working group also suggested a minimum of one fulltime project coordinator in each setting to manage resources. Conclusion: Successful management of multi-country, multicentered implementation research requires comprehensive communication tools (which to our knowledge do not exist yet or are not readily available), expectation setting, and institutional support. Capacity building activities that address human resource needs for both individuals and their institutions should be incorporated into early project planning.

ObjectiveTo describe and evaluate recruitment approaches for a randomized controlled trial (RCT) of community gardening in Denver, Colorado. (ClinicalTrials.gov: NCT03089177).MethodsWe used community and staff feedback to adapt our recruitment approach from year 1 to year 2 of a multi-year RCT to address health behaviors related to cancer prevention. In year 2, we added a full-time recruitment coordinator, designed and implemented a tracking spreadsheet, and engaged advisory committee members, local garden leaders, and health partners in planning and outreach. Screening and consent rates, staff time and costs for years 1 and 2 are compared.ResultsIn year 1, recruitment methods yielded 136 initial contacts, 106 screenings and 64 consented participants. In year 2, enhanced staffing and outreach yielded 257 initial contacts, 193 screenings, and 123 consented participants. Personal referrals, health fairs, NextDoor, and fliers yielded the highest percentage of consented participants. School and community meetings yielded the lowest yield for potential participants. Spanish-speaking participants were mostly recruited by direct methods. Compared to year 1 recruitment, which required 707 h of staff time and cost $14,446, year 2 recruitment required 1224 h of staff time and cost $22,992. Average cost for retained participants was $226 (year 1) and $186 (year 2).DiscussionThose planning pragmatic clinical trials with recruitment in multi-ethnic communities can use the results from this study to understand the efficacy of techniques, and to budget costs for recruitment. While our culturally-tailored recruitment methods cost more, they provided more effective and efficient ways to reach recruitment goals.

Background Native American youth, primarily living on reservations, suffer the highest burden of suicide of any racial group in the USA. Implementation and sustainability of culturally grounded, evidence-based interventions are needed to address suicide in Native American populations. For nearly 40 years, Montana has ranked at or near the top nationwide for suicide. Fort Peck Tribal leadership declared a state of emergency in 2010 after six suicides and 20 attempts that occurred over a 5-month period. Methods We used a community-based participatory research approach for adapting the Celebrating Life (CL) program with a specific focus on long-term sustainability, which has demonstrated efficacy in addressing suicide with the White Mountain Apache. The aims were to (1) adapt the CL program intake forms through roundtable discussions, (2) conduct asset and resource mapping to identify community and cultural resources to leverage for the CL program within the Fort Peck context, and (3) develop a sustainability plan for CL in Fort Peck through qualitative approaches informed by the Program Sustainability Assessment Tool. Results Roundtable discussions resulted in adapted intake forms that capture variables relevant to the Fort Peck context. Asset mapping identified 13 community assets and 10 cultural resources to incorporate within the CL implementation process. Focus group discussions yielded four key themes that were incorporated into a plan for sustainability: (1) strategic partnerships, (2) long-term funding, (3) communication planning, and (4) workforce planning and engagement. Conclusions This paper outlines an avenue for using culturally adapted tools to design an implementation system driven by community and cultural assets within tribal communities and for integrating program planning for sustainability early in the implementation process.