Table 1.

Theoretical and Model Underpinnings and Standardized Definitions.

Model/Theory	Description	Application
Social ecological model (SEM)	SEM constructs are used to explore individual and population health related to biobanking and stroke genomics including individual factors (e.g., genetics, individual knowledge, beliefs, behaviors, consent, privacy, confidentiality, return of results, and incidental findings), interpersonal factors (e.g., family, friends, peers, benefit sharing, and return of results), institutional processes (e.g., governance and regulatory framework, biobank networks, and social support systems), and community factors (e.g., relationships among networks, biobanking governance), and public policy (e.g., local, state, and national laws/policies on biobanking).	Provides overall framework for organizing our research. Each participant is viewed through the lens of the SEM. The SEM will guide the development of the focused ethnography (FE) within Aim 1, with in-depth interviews with stroke survivors and formal and informal caregivers, researchers, public health practitioners, community leaders, faith leaders, traditional healers, and lay public. The survey research methodology will incorporate information from the FE related to the SEM and will guide Aim 2.
Evidence-based community/partnership model (EBCPM)	The EBCPM process is designed to implement community-based participatory research and evidence-based practice “to support health improvement goals through evidence-based strategies while building community and practice capacity to implement those strategies in a manner consistent with community priorities, culture, and values.”	The EBCPM will be operationalized within Aims 1 and 2 in parts. Step 1 will include negotiation of goals among local community stakeholders, practices, and researchers (already done in planning grant proposal). Step 2 will include active involvement of the Biobanking Community Advisory Board (CAB) to guide researchers and actively participate in engaging the community in process. This will be done by matching community needs, resources, and values with evidence-based practice strategies to address unmet needs and tailor these to the community contexts (Aim 2).
Six Steps in Quality Intervention Development (SQuID)	The SQuID is a six-step process-based approach used to guide researchers in developing high-quality interventions. Steps: (1) Defining and understanding the problem and its causes, (2) clarifying which causal or contextual factors are malleable and have greatest scope for change, (3) identifying how to bring about change and change mechanism, (4) identifying how to deliver change mechanism, (5) testing and refining on small scale, and (6) collecting sufficient evidence of effectiveness to justify rigorous evaluation/implementation.	The six steps are used for capturing the process for development of the proposed interventions (in combination with the EBCPM). Given the scope of this work, pretesting/testing will be limited. FE and survey will incorporate Steps 1–4 (Aims 1 and 2), and Aim 2 will focus on Steps 2–5. Application of Step 6 will be tested in future grant.
Implementation cycle (IC)	The IC is a seven-step process that involves identification and exploration of evidence gaps and subsequent development, contextualization, communication of evidence-based consensus interventions to combat cardiovascular diseases in LMICs. It also entails the evaluation of the processes and outcomes involved. The cycle includes a Translatability Scale to grade the ease of implementation especially in resource-limited settings.	The seven steps of the IC are adaptable to the processes of African Neurobiobank Precision Stroke Medicine ELSI Project. Aim 1 of our project is in tandem with Steps A and B of the cycle, while Aim 2 aligns with Steps C–G of the IC. The training component (Aim 3) of the project will ensure an adequate supply of expertise for effective implementation, evaluation and scaling up the interventions tools, and platforms for wider population-based impact.
Reach, Effectiveness-Adoption, Implementation, Maintenance (RE-AIM) framework for Evaluation	RE-AIM provides a functional framework for assessing the public health impact of health promotion strategies. Evaluative criteria include: Reach assesses the percentage, and characteristics of individuals within population who participate in a program; effectiveness explores positive and negative programmatic outcomes; adoption encompasses the number, percentage, and representativeness of program participants in relation to the overall population of interest; implementation is an indicator of the extent of program delivery, adherence, and cost; and maintenance reflects sustained adoption/adherence of the primary outcomes (>6 months) at the individual level and sustainability of delivered programs at an organizational level.	We will use RE-AIM to evaluate the overall African Neurobiobank for Precision Stroke Medicine: Ethical Legal Social Implications (ELSI) Project. Specifically, REACH will be used to capture the numbers of investigator, trainee, and community participants in the project. Community participation will include CAB participation as well as community members participating in various aspects of the program. EFFECTIVENESS will be operationalized to capture both the negative and positive effects/outcomes for investigators and trainees, and the communities. Adoption process and outcome evaluation will include measurement of number of settings, organizations, trainees, and community members that actively participate in our ELSI project. Implementation will measure the overall and specific activities implemented as planned. Maintenance will examine the changes or outcomes that are potentially “lasting outcomes” or changes as a result of ELSI activities. We will specifically examine (1) new ELSI-related knowledge regarding stroke genomics and biobanking; (2) novel interventions to address the ELSI issues so identified; (3) processes, outcomes, and impact of the interventions; (4) training early career researchers in ELSI research and practice; and (5) enhanced capacity of ethics committees to deal with ELSI issues in new research projects being developed in biobanking, genomics, and precision stroke medicine according to the various levels of SEM and RE-AIM frameworks.

Note. LMIC = low- and middle-income countries.