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Develop a 4-6 page plan that will allow your intervention to be implemented in your target population and setting. Target population VETERAN. 

TOPIC PREVENTING HOMELESSNESS FOR VETERAN POPULATION

Introduction

Note: Each assessment in this course builds on the work you completed in the previous assessment. Therefore, you must complete the assessments in this course in the order in which they are presented.

Even the best intervention plan will not be effective without a sound and reasonable approach to implementing it. The implementation of the same intervention plan can vary drastically between different care settings, based on the culture of the care setting, the resources available, and the stakeholders involved in the project, as well as the specific policies already in place. A successful implementation plan blends contemporary and emerging best practices and technology with an understanding of the on-the-ground realities of a specific care setting and the target population for an intervention. By synthesizing these various considerations it is possible to increase the likely success of the implementation and continued sustainability of an intervention plan.

Preparations

  • Read Guiding Questions: Implementation Plan Design [DOC]. This document is designed to give you questions to consider and additional guidance to help you successfully complete this assessment.
  • As you prepare to complete this assessment, you may want to think about other related issues to deepen your understanding or broaden your viewpoint. You are encouraged to consider the questions below and discuss them with a fellow learner, a work associate, an interested friend, or a member of your professional community. Note that these questions are for your own development and exploration and do not need to be completed or submitted as part of your assessment.
    • What are the needs of your stakeholders that are relevant to your target population and need?
    • What applicable health care policy and regulations are relevant to your target population and need?
    • How will these considerations impact the development of your Intervention Plan Design assessment?
    • How can you work these considerations into the development of your Implementation Plan Design assessment?

Instructions

Note: The assessments in this course are sequenced in such a way as to help you build specific skills that you will use throughout your program. Complete the assessments in the order in which they are presented.

Your implementation plan design will be the third section of your final project submission. The goal for this is to design a plan that will allow your intervention to be theoretically implemented in your target population and setting. You should be able to preserve the quality improvement outcomes that you designed for your target population and setting while also ensuring that the intervention does not put undue stress on the health care setting's resources or violate any policies or regulations. Provide enough detail so that the faculty member assessing your implementation plan design will be able to provide substantive feedback that you will be able to incorporate into the final draft of your project.

At minimum, be sure to address the bullet points below, as they correspond to the grading criteria. You may also want to read the scoring guide and the Guiding Questions: Implementation Plan Design document (linked above) to better understand how each criterion will be assessed. In addition to the bullet points below, provide a brief introduction that refreshes the reader's memory about your problem statement, as well as the setting and context for which this intervention plan was designed before launching into your implementation plan.

Reminder: these instructions are an outline. Your heading for this this section should be Management and Leadership and not Part 1: Management and Leadership.

Part 1: Management and Leadership
  • Propose strategies for leading, managing, and implementing professional nursing practices to ensure interprofessional collaboration during the implementation of an intervention plan.
  • Analyze the implications of change associated with proposed strategies for improving the quality and experience of care while controlling costs.
Part 2: Delivery and Technology
  • Propose appropriate delivery methods to implement an intervention which will improve the quality of the project.
  • Evaluate the current and emerging technological options related to the proposed delivery methods.
Part 3: Stakeholders, Policy, and Regulations
  • Analyze stakeholders, regulatory implications, and potential support that could impact the implementation of an intervention plan.
  • Propose existing or new policy considerations that would support the implementation of an intervention plan.
Part 4: Timeline
  • Propose a timeline to implement an intervention plan with reference to specific factors that influence the timing of implementation.
Address Generally Throughout
  • Integrate resources from diverse sources that illustrate support for all aspects of an implementation plan for a planned intervention.
  • Communicate implementation plan in a way that clearly illustrate the importance of interprofessional collaboration to create buy-in from the audience.

Implementation Plan Design Scoring Guide

CRITERIA NON-PERFORMANCE BASIC PROFICIENT DISTINGUISHED

Propose strategies for leading, managing, and implementing professional nursing practices to ensure interprofessional collaboration during the implementation of an intervention plan.

Does not propose strategies for leading, managing, and implementing professional nursing practices to ensure interprofessional collaboration during the implementation of an intervention plan.

Proposed strategies are not clearly relevant, or it is not clear how they will ensure interprofessional collaboration.

Proposes strategies for leading, managing, and implementing professional nursing practices to ensure interprofessional collaboration during the implementation of an intervention plan.

Proposes strategies for leading, managing, and implementing professional nursing practices to ensure interprofessional collaboration during the implementation of an intervention plan, and impartially considers conflicting data and other perspectives.

Analyze the implications of change associated with proposed strategies for improving the quality and experience of care while controlling costs.

Does not explain the implications of change associated with proposed strategies for improving the quality and experience of care while controlling costs.

Explains some of the implications of change, but fails to analyze how the proposed strategies will create change to improve quality, experience of care, and control costs.

Analyzes the implications of change associated with proposed strategies for improving the quality and experience of care while controlling costs.

Analyzes the implications of change associated with proposed strategies for improving the quality and experience of care while controlling costs; identifies knowledge gaps, unknowns, missing information, unanswered questions, or areas of uncertainty (where further information could improve the analysis).

Propose appropriate delivery methods to implement an intervention which will improve the quality of the project.

Does not propose delivery methods to implement an intervention which will improve the quality of the project.

Proposes delivery methods, but fails to clarify why the proposed methods are appropriate or how they will improve the quality of the project.

Proposes appropriate delivery methods to implement an intervention which will improve the quality of the project.

Proposes appropriate delivery methods to implement an intervention which will improve the quality of the project, and identifies assumptions on which the proposal of delivery methods is based.

Evaluate the current and emerging technological options related to the proposed delivery methods.

Does not describe the current and emerging technological options related to the proposed delivery methods.

Describes the current and emerging technological options related to the proposed delivery methods, but does not comparatively evaluate their impact on proposed delivery methods.

Evaluates the current and emerging technological options related to the proposed delivery methods.

Evaluates the current and emerging technological options related to the proposed delivery methods; identifies knowledge gaps, unknowns, missing information, unanswered questions, or areas of uncertainty (where further information could improve the analysis).

Analyze stakeholders, regulatory implications, and potential support

Does not consider stakeholders, regulatory implications, and potential support that

Gives partial but incomplete consideration to how the needs of stakeholders, health

Analyzes stakeholders, regulatory implications, and potential support that

Analyzes stakeholders, regulatory implications, and potential support that could impact the implementation of an

CRITERIA NON-PERFORMANCE BASIC PROFICIENT DISTINGUISHED that could impact the implementation of an intervention plan.

could impact the implementation of an intervention plan.

care regulations, and other support considerations could impact the implementation of an intervention plan.

could impact the implementation of an intervention plan.

intervention plan, and identifies assumptions on which the analysis is based.

Propose existing or new policy considerations that would support the implementation of an intervention plan.

Does not propose existing or new policy considerations.

Proposes existing or new policy considerations, but does not clarify how those policy considerations would support the implementation of an intervention plan.

Proposes existing or new policy considerations that would support the implementation of an intervention plan.

Proposes existing or new policy considerations that would support the implementation of an intervention plan, and considers how existing or new policy might impair the implementation of an intervention plan.

Propose a timeline to implement an intervention plan with reference to specific factors that influence the timing of implementation.

Does not propose a timeline to implement an intervention plan.

Proposes a timeline to implement an intervention plan, but fails to explain how specific factors will influence the timing of implementation, or timeline is not realistic.

Proposes a timeline to implement an intervention plan with reference to specific factors that influence the timing of implementation.

Proposes a timeline to implement an intervention plan with reference to specific factors that influence the timing of implementation, and considers factors that could force revision of the timeline.

Integrate resources from diverse sources that illustrate support for all aspects of an implementation plan for a planned intervention.

Does not integrate resources from diverse sources that illustrate support for all aspects of an implementation plan for a planned intervention.

Attempts to integrate resources, but resources lack diversity or do not clearly support all aspects of the implementation plan.

Integrates resources from diverse sources that illustrate support for all aspects of an implementation plan for a planned intervention.

Integrates resources from diverse sources that illustrate support for all aspects of an implementation plan for a planned intervention; impartially considers conflicting data and other perspectives.

Communicate implementation plan in a way that clearly illustrates the importance of interprofessional collaboration to create buy-in from the audience.

Does not communicate implementation plan in a way that clearly illustrates the importance of interprofessional collaboration, to create buy-in from the audience.

Inconsistently communicates implementation plan in a way that partially illustrates the importance of interprofessional collaboration; may create partial buy-in from the audience.

Communicates implementation plan in a way that clearly illustrates the importance of interprofessional collaboration to create buy-in from the audience.

Communicates implementation plan in a way that clearly illustrates the importance of interprofessional collaboration to create buy-in from the audience. Grammar, punctuation, spelling, and citations are error- free.

Demonstrate completion of hours toward the practicum experience.

Does not demonstrate completion of hours toward the practicum experience.

Demonstrates completion of hours toward the practicum experience, but provides no details about activities completed during those hours.

Demonstrates completion of hours toward the practicum experience.

Demonstrates completion of hours toward the practicum experience and provides a clear and concise description of the focus of the clinical hours and alignment to the capstone project.

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Intervention Plan Design

Student's Name

Institutional Affiliation

Course Title and Name

Professor

Date

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Intervention Plan Design: Addressing Nurse Burnout Problem in Healthcare Setting

Introduction

A holistic intervention plan focuses on providing support for individual wellbeing by

addressing the physical, emotional, social and spiritual needs. During the holistic intervention,

healthcare providers consider factors that affect the recovery process, such as age, gender,

cultural aspects and religious beliefs (Kozlovszky et al., 2016). Key problem nurses face burnout

which negatively affects delivering high-quality healthcare services. The intervention plan will

solve whether mindful techniques reduce staff burnout in hospital settings compared to the lack

of effective intervention plans. Therefore, healthcare facilities need to implement mindful

techniques using an intervention plan to reduce the negative impact of burnout on employees.

Intervention Plan Components

The primary purpose of an intervention plan is to outline and describe strategies that

prevent healthcare problems and tech new behaviors that replace the challenging behaviors

(Eldredge et al., 2016). The first component of the plan is to identify the problem. This entails

researching information behind the target audience, stakeholders and the setting in which the

plan is to be implemented. In this case, the problem identified is a high burnout rate among

nurses in the healthcare setting. The key stakeholders involved in the intervention plan include

nurses, healthcare managers and external nursing experts. Data collection during the intervention

plan is another critical component that enhances understanding of the cause and effects of the

problem. In this case, data on nurse burnout will be collected through interviews and

questionnaires on nurses. Besides, analytics of the strategies and action steps is an important

component in the intervention plan. The action plan is crucial in turning the vision of the

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intervention plan into a concrete plan. Intervention plan, in this case, will involve strategies such

as the use of mindfulness techniques.

Next, it is important to ensure that the implementation plan has an effective

communication strategy to achieve the desired results. Communication tools and technologies

facilitate interactive conversation among the stakeholders to ensure that the intervention plan is

timely, well defined, executed, and sustained to meet the specified objectives (Wang et al., 2018).

The timeline will outline the timeframe through which different activities of the intervention plan

will take. In this case, the intervention plan will take two months. Also, it is important to conduct

real-time monitoring, evaluation and program improvement. Throughout the project, this will be

done to ensure that the mindfulness techniques are in line with the intervention timeline and

expected results.

During the formulation of an intervention plan, cultural needs and characteristics play an

important role in determining the plan's success. Implementing a culturally sensitive

implementation plan involves understanding the client's background, ethnicity and belief system.

In the proposed plan, there will be effective communication of culturally sensitive issues to

enhance the success of the intervention plan. It will also include cultural values, attitudes and

expectancies to ensure inclusive participation by the nurses.

Theoretical Foundations

The theoretical nursing models consist of fundamental concepts of nursing which define

the nursing foundation. Key theoretical foundations in nursing focus on nursing, health,

environment and person (Smith, 2019). The intervention plan will incorporate the environmental

theory of nursing. The theory focuses on altering the healthcare environment to affect change of

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healthcare environment to deliver high-quality healthcare services. In the case presented, the

theory will create a conducive environment that will create a positive nurse experience, thus

limiting nurse burnouts. The interpersonal relations theory will also create strong partnerships

between nurses, patients and stakeholders to promote patient wellbeing and the overall

healthcare experience of nurses. Self-care theory will also be applied to nurses during healthcare

service delivery. The nurses will be expected to take care of themselves by maintaining healthy

lifestyles and managing overall wellbeing.

Next, the intervention plan will address the need to incorporate technological

advancement in nursing care. Technology plays an important role in reducing workload and

improving the quality of nursing care. Technology such as Nursing Observation and Virtual

Assistant (NOVA) will be implemented to reduce nurse burnouts. Tele-health will reduce nurse

workload and improve the quality of healthcare services without nurse burnout cases. Also,

during communication, virtual communication technology, electronic health records and

computerized provider order entry will reduce nurse burnouts.

Stakeholders, Policies and Regulations

Stakeholder identification and prioritization is an essential process that ensures successful

implementation plans. In the proposed plan, it will be important to identify stakeholder needs

because it helps in reducing risk and constraints during project implementation. The more

stakeholders are involved, the more likely the project will succeed. Assessing the needs will also

enhance project acceptance, improvement and sustainability (Leviton & Melichar, 2016). By

addressing stakeholder needs, healthcare facilities will gain a better understanding of the

intervention plan goals and objectives and review and adapt to stakeholder support in meeting

the goals. The stakeholders act as decision-makers who play a pivotal role in the success or

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failure of an intervention plan. Also, addressing stakeholders will build a better healthcare

organization because they will bring important issues to light and encourage the organization to

develop and implement better strategies in curbing nurse burnout.

The healthcare policies and regulations provide standardization in the daily operational

activities of healthcare facilities. The policies are important because they guide the desired

outcomes and help decision-making. In this case, policies and regulations such as HIPAA will be

followed when communicating the intervention plan with all stakeholders involved in the

intervention plan. The regulations will standardize the intervention plan and ensure that the plan

complies with the public health policies to enhance the safety of nurses in the healthcare

program. The plan will follow guidelines outlined in the National Council of State Boards of

Nursing (NCSBN) to improve the safety of nurses and limit cases of nurse burnouts.

Ethical and Legal Interventions

Healthcare interventions present distinct ethical issues because most plans focus on

prevention rather than the entire wellbeing of nurses and patients (Buchanan, 2019). The ethical

issues concerning the design of intervention plan design affect the success or failure of the plans.

The plan should also be within the legal frameworks and standards of nursing practice. During

communication of plan intervention, ethical issues regarding confidentiality and privacy of nurse

information might be faced (Doherty, 2020). It will be important for the intervention plan to

enhance the confidentiality of sensitive information during the plan's implementation. Nurse

safety is another ethical issue related to the intervention plan. For instance, nurses in the hospital

setting face burnouts, which results in stress and mental challenges, thus making it difficult to

perform their roles.

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Next, during the plan's implementation, it is important to ensure informed consent among

all stakeholders. Informed consent issues arise when stakeholders are not informed or do not

understand the components of the intervention plan. It is important to ensure that nurses and

other stakeholders feel comfortable asking questions and giving consent before implementing the

treatment plan. This will avoid resistance conflict of interest among nurses and enhance effective

implementation of the strategies.

Conclusion

In conclusion, the intervention plan provides key strategies and action plans that promote

nursing experience during healthcare service delivery. The proposed healthcare plan will include

key components such as problem identification, communication, action steps, monitoring and

evaluation. During the implementation of the intervention plan, theories such as environmental

and self-care theories will address the problem of nurse burnouts. The plan will also follow the

standards of nursing policies and regulations. The key ethical and legal interventions that will be

observed include informed consent, privacy and confidentiality and nurse safety. Therefore,

designing an effective implementation plan is critical in meeting the goals of quality healthcare

services because it addresses nurse issues such as burnouts.

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References

Doherty, R. F. (2020). Ethical Dimensions in the Health Professions-E-Book. Elsevier Health

Sciences.

Eldredge, L. K. B., Markham, C. M., Ruiter, R. A., Fernández, M. E., Kok, G., & Parcel, G. S.

(2016). Planning health promotion programs: an intervention mapping approach. John

Wiley & Sons.

Kozlovszky, M., Kovács, L., Batbayar, K., & Garaguly, Z. (2016, May). Automatic protocol

based intervention plan analysis in healthcare. In 2016 39th International Convention on

Information and Communication Technology, Electronics and Microelectronics

(MIPRO) (pp. 253-257). IEEE.

Leviton, L. C., & Melichar, L. (2016). Balancing stakeholder needs in the evaluation of

healthcare quality improvement. BMJ Quality & Safety, 25(10), 803-807.

Smith, M. C. (2019). Nursing theories and nursing practice. FA Davis.

Wang, Y. Y., Wan, Q. Q., Lin, F., Zhou, W. J., & Shang, S. M. (2018). Interventions to improve

communication between nurses and physicians in the intensive care unit: An integrative

literature review. International journal of nursing sciences, 5(1), 81-88.

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INTERVENTION PLAN DESIGN 1

Intervention Plan Design

Student

Instructor

Institution

Course

Date

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INTERVENTION PLAN DESIGN 2

HIV Intervention Plan Design amongst the African-American Women

Part 1: Intervention Plan Components

The purpose of this healthcare action plan is to inform healthcare providers about the

recent increase in HIV infection rates among African-American women aged 18-24 in the United

States. With the assistance of this intervention, patients and nurses will learn how to deal with

situations in a way that promotes better healthcare outcomes. The plan also addresses clinical

concerns such as how to perform quickly and accurately, meet a specific need, recognize and

address dysfunctions as they occur, and analyze behavioral and social issues, among other things.

Given the critical importance of reducing HIV incidence and its impact on society, the program

will work to increase community awareness of sexual risks as well as the use of antiretroviral

medication by HIV-infected people.

In the course of this project, the community will be exposed to various cultural influences

from around the world. Upon encountering a diverse range of cultural practices and beliefs,

many communities may find themselves with contradictory understandings. Educational

opportunities will, on the other hand, be viewed as a source of interference in the daily cultural

activities of caregivers (Williams, et al., 2010). African-American women will be the target

audience for this project, which will take place in a community social hall where they will

receive HIV counseling and guidance from the project's coordinator. It is anticipated that the

community film hall will be utilized as a result. It is planned to hold a two-day educational

conference in the community as well as at the film studio on the first and second days of the

festival, which will be open to any and all neighborhood workers who are interested in learning

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INTERVENTION PLAN DESIGN 3

more about filmmaking. However, it is possible to predict the emergence of these cultural beliefs

or stereotypes in children.

Part 2: Theoretical Foundations

Using Lewin's theory of change, a person can go through three stages of change in which

they transition from a rigid to a fluid state, and then back to rigidity again. It is necessary to

remove restraints from the vehicle and increase driving force in order for it to be unfrozen. The

use of open communication encourages all stakeholders to communicate with one another and to

participate in the change process, which in turn encourages a group to adopt a different

perspective. It is referred to as freezing when someone is forced to adopt a new point of view by

other people (Xiao, et al., 2020). In order to better understand and control HIV/AIDS in the

population, Lewin's change theory will be applied from the perspectives of both individuals and

medical professionals.

The community group is considering a theory that is different from the TRA (Theory of

Reasoned Action). People, according to TRA, are rational, and they must feel good about

themselves when they take actions that contribute to the desired change. As a result, Stroubouki

asserts that if people want to make positive changes in their society, they must take responsibility

for their own actions (2013). According to the majority of experts, social beliefs, attitudes, and

intentions are influenced by the theory over time, which in turn influences national and

international behavioral performance in the long run. This theory, if properly implemented, has

the potential to significantly improve overall performance by reducing errors.

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INTERVENTION PLAN DESIGN 4

These individuals' beliefs and motivations have a significant impact on their actions and

behavior. Furthermore, nursing and population health professionals can use TRA frameworks to

improve the health of HIV-infected people and reduce the risk of HIV transmission to vulnerable

people in their communities (Cummings, et al., 2016). It is anticipated that, as a result of this

theoretical framework, the target population will be better prepared to recognize and understand

HIV, as well as its potential complications, which may include exposure to other infectious

diseases. In order for antiretroviral drugs to be recognized and accepted for educational purposes,

this tool must be used to the fullest extent possible. During the course of the project, this

hypothesis will be tested to determine whether or not teenagers and young people have strong

anti-vaccination beliefs and a desire to spread these beliefs to others.

People can better understand why they are pursuing a particular course of action if they

use the TPB framework, which was developed by Askelson (2011). While the doctor was

bragging about a variety of treatments, including ACIP (Advisory Committee on Immunization

Practices) and CDC (Centers for Disease Control and Prevention) guidelines, because they were

recommended by the doctor and endorsed by professional organizations, most notably the ACIP

and the CDC, the situation changed. Because of this, it will make an effort to answer the question

of whether the doctor has administered HIV medication to any of his or her patients (Center for

Disease Control and Prevention, 2018). The communication of sexual concerns about HIV

transmission and containment to African-American women between the ages of 18 and 24 may

be made easier for providers who are aware of, prepared for, and confident in their ability to

control the HIV infection. The research used in this HIV awareness program indicates that if you

intend to discuss a sexually related subject with a female, you are more likely to be HIV positive,

according to the findings. Perceptions of behavioral regulation are only one of many factors that

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INTERVENTION PLAN DESIGN 5

contribute to the formation of an attitude, and there are many others as well. His interventions

were associated with an increase in HIV transmission, which he observed. Before, clinicians

found it difficult to bring up the subject of sexual intercourse with their young patients because

they were embarrassed to do so. As a result of increased funding for global HIV awareness

campaigns, health-care providers have recently expressed an increased interest in educating their

patients about the disease.

Part 3: Stakeholders, Regulations, and Policy

For a long time, HIV/AIDS researchers and activists believed that a cross-sectional study

of the target population was the most effective method for developing an educational prevention

program. A targeted intervention strategy that focuses on a specific demographic will be used,

and a variety of activities will be implemented to assist the program in meeting its objectives

(Baird, et al., 2017). “ACIP’s Health Economics Report includes several approaches to

identifying and describing intervention techniques, each of which is explained in detail

(Advisory Committee on Immunization Practices). The costs as well as the asset values will be

included in the total package price. The direct and indirect costs of HIV treatment and prevention

will be presented to the AIDS Coordinating Committee for International Policy. By utilizing the

cost-effectiveness model, ACIP was able to comprehend the complexities of the awareness

program.

Part 4: Legal and Ethical Implications

Due to the fact that the process is focused on improving the quality of life of the target

population and does not include data analysis, the IRB (Internal Review Board) review process is

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INTERVENTION PLAN DESIGN 6

avoided. Obtaining permission from the appropriate authorities will be sought in order to ensure

that all research participants have given their consent and that the research is in compliance with

HIPAA regulations (Health Insurance Portability and Accountability Act). It is also possible to

protect the privacy of patients by ensuring the security of their personal data and medical

conditions (Adimora, et al., 2009). In general, they are between the ages of 18 and 24 and come

from a diverse range of ethnic and socioeconomic backgrounds, but they are all African-

Americans in some way or another. It is planned that the intervention will last twenty one days

and will consist of 4 hours of activity per day during that time period.

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INTERVENTION PLAN DESIGN 7

References

Adimora, A. A., Schoenbach, V. J., & Floris-Moore, M. A. (2009). Ending the epidemic of

heterosexual HIV transmission among African Americans. American journal of preventive

medicine, 37(5), 468-471.

Askelson, N. M., Campo, S., Smith, S., Lowe, J. B., Dennis, L. K., & Andsager, J. (2011). The

birds, the bees, and the HPVs: what drives mothers’ intentions to use the HPV vaccination as a

chance to talk about sex?. Journal of Pediatric Health Care, 25(3), 162- 170.

Baird, J., Jacob, C., Barker, M., Fall, C. H., Hanson, M., Harvey, N. C., … & Cooper, C. (2017,

March). Developmental origins of health and disease: a life-course approach to the prevention of

non-communicable diseases. In Healthcare (Vol. 5, No. 1, p. 14). Multidisciplinary Digital

Publishing Institute.

Center for Disease Control and Prevention. (2018). HIV and African Americans. Retrieved from

Center for Disease Control and Prevention:

Cummings, S., Bridgman, T., & Brown, K. G. (2016). Unfreezing change as three steps:

Rethinking Kurt Lewin’s legacy for change management. Human Relations, 69(1), 33-60.

Stroubouki, T. G. (2013). Translation of evidence into nursing and health care practice.

Williams, J. K., Wyatt, G. E., & Wingood, G. (2010). The four Cs of HIV prevention with

African Americans: crisis, condoms, culture, and community. Current HIV/aids Reports, 7(4),

185-193.

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INTERVENTION PLAN DESIGN 8

Xiao, X., Reynolds, N. R., Saligan, L., Lei, Y., Wang, M., & Wang, H. (2020). Protocol:

Effectiveness of non-pharmacological interventions to decrease fatigue in people living with

HIV/AIDS: a systematic review and meta-analysis protocol. BMJ Open, 10(9).

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