|Step||Description and Methods|
|1. Identify community infrastructure & engage partners|
|A. Identify optimal community settings||Identify settings with infrastructure for delivering and sustaining intervention, experience providing similar services, and that are convenient for the target population.|
|B. Identify partners and form an academic-community coalition to address the health disparity||
Identify persons in the community with intimate knowledge of disparities and contributing factors and academic partners with relevant interest and experience; involve them in all phases of planning and execution.|
Develop an academic-community coalition based on CBPR principles (e.g., trust, shared decision-making, value scientific and community knowledge equally) that is responsible for all subsequent steps.
|2. Specify theory|
|A. Identify framework of social-ecological determinants of disparities||Identify, review, and select theoretical framework of determinants of disparities that fits the health priority and context. This involves using CBPR engagement principles.|
|B. Determine theoretical basis for behavioral changes||Working with the coalition identified in Step 1, identify, review and select one or more theories of behavior change relevant to the targeted health disparity population.|
|3. Identify multiple inputs for new program|
|A. Identify scientific evidence relevant to planned intervention to address targeted health disparity||
Review evidence-based interventions (EBIs), systematic reviews, evidence-based guidelines, and other evidence (e.g., optimal delivery modes) that can inform the intervention.|
For EBIs, identify core components that reflect mechanisms of action.
|B. Obtain input from community on locally developed programs, community resources, and target population (formative evaluation)||Review locally developed programs relevant to targeted disparity.|
|Identify cultural, practical, organizational, and contextual factors affecting intervention design, success, and sustainability through formative research including community resources, population characteristics and needs, and knowledge of determinants of disparity.|
|4. Design intervention prototype|
|A. Design intervention to incorporate scientific evidence and locally developed programs.||Examine commonalities of EBIs and other scientific evidence and locally developed programs and synthesize.|
|Build in intervention components and delivery methods that are supported by scientific evidence; include components that address hypothesized mechanisms of action.|
|B. Design intervention for fit to community setting and population||Build consensus on fit of potential intervention to community and potential to address targeted disparity. Assure that intervention is practical, accessible, and can be delivered within existing resources or with some capacity building.|
|Incorporate content to fit population including culture, language, and learning styles, and format to fit reading level and preferred communication channels.|
|C. Integrate 4A and B to develop intervention components; vet prototype for relevance and potential for success.||Design specific components and content by weighing tradeoffs between scientific evidence and fit to setting (community, population).|
|Specify delivery format (e.g., phone, in-person, group), location of in-person sessions, who delivers the program, session format/content, and dose.|
|Document components and rationale for each; have key stakeholders review prototype, modify as indicated.|
|D. Manualize intervention to assure standardization||
Develop detailed program manual for interventionists that specifies program delivery components, content, and procedures. Manual provides guidance to interventionists on methods to increase the fidelity of program delivery.|
Develop participant manual using principles for low-literacy participants.
|5. Design study, methods, & measures for community setting|
|A. Develop rigorous study design that is appropriate for intervention delivered in community setting||Randomized controlled trials, especially individual-level, may not be the most appropriate design. Identify alternatives that retain scientific rigor, e.g., cluster randomized trials, pragmatic trials, rigorous quasi-experimental designs.|
|B. Develop outreach, recruitment, and data collection strategies appropriate for population and setting||Design strategies based on evidence of effectiveness in disparity populations and perspective of community.|
|Utilize community members for outreach, recruitment, and data collection in community settings to the extent possible; develop training protocol.|
|C. Select measures of outcomes, mediators, and moderators that are relevant and appropriate for population||
Select outcomes based on conceptual framework linking components to outcomes. Identify measures that are responsive to similar interventions. Identify measures of moderators and mediators of effects.|
Assure that all measures are appropriate for the target population and meet stringent psychometric criteria in that population.
|6. Build community capacity for delivery|
|A. Enhance infrastructure and expertise||
Compensate community organizations and members for research involvement.|
Train community organization staff on skills that can be applied to fund, deliver, and evaluate programs in the future.
|B. Select/train community-based interventionists (an interim intervention)||
Establish qualifications for community-based interventionists (e.g., CHWs) including desired level of competence/knowledge after training.|
Hire and train community-based interventionists. Utilizing interventionist manual developed in step 4D, create training protocol including: 1) content, format, theory, and protocol of “transcreated” intervention, 2) delivery skills including communication skills, handling problems, and 3) importance of fidelity to the protocol.
|7. Deliver “transcreated” intervention & monitor implementation processes|
|A. Create and implement methods for monitoring delivery of intervention and providing ongoing technical assistance to interventionists||
Create ongoing technical assistance plans for interventionists as they deliver the intervention.|
Develop structured assessment for monitoring fidelity of interventionists to protocol.
Establish system for providing feedback and support to interventionists if needed to improve adherence or prevent burnout.
Establish system for modifying intervention if needed to address unanticipated situations.
|B. Create and implement methods for assessing other processes of delivering intervention (summative evaluation)||
Design specific procedures and data collection strategies to assess implementation processes.|
Interventionists: Suggested improvements, difficulties delivering program, acceptability of training and manual.
Participants: Real-time - Program receipt (attendance, how well they learned components) and enactment (can demonstrate skills). Retrospective - perceived benefits of program, suggested improvements, perceived usefulness and ease of use of program components and materials.
Stakeholders such as program managers, executive directors: issues in implementing program in that setting; successes and challenges of implementing program, suggestions for improvement.