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Stakeholders, Policy, and Regulations ● Analyze the impact of stakeholder needs, health care policy, regulations, and governing bodies relevant to health care practice and specific components of an intervention plan

PICOT Statement (APA format, Times New Roman, 12 pt, 1″ margins):

PICOT Question:

 In adults living with HIV who are virally suppressed (P), how does monthly long-acting injectable Cabenuva (I) compared to daily oral antiretroviral therapy (C) affect medication adherence and viral suppression rates (O) over a 6-month period (T)?

 Assignment 1: PICOT Breakdown

Population and Setting

The target population includes adults diagnosed with HIV who have achieved viral suppression on oral antiretroviral therapy (ART). The setting is an urban outpatient infectious disease clinic (AHF) that provides continuity of care and medication management for people living with HIV. This population often struggles with adherence to daily oral medications due to stigma, pill fatigue, or unstable living situations.

Intervention Overview

The proposed intervention is the administration of long-acting injectable Cabenuva, which combines cabotegravir and rilpivirine, given as an intramuscular injection once every month or every two months. This therapy removes the need for daily pill intake, potentially improving long-term adherence and quality of life. Nursing roles would include medication education, administering injections, and monitoring for side effects.

Comparison of Approaches

 The comparison group will continue with standard daily oral ART. While effective, oral ART can be associated with adherence challenges that impact viral suppression. Alternative or complementary interventions could include nurse-led adherence counseling, mobile health reminders, or pharmacy-based support programs. These strategies may help improve outcomes in both treatment modalities.

Outcome

The outcome is to measure the differences in adherence and sustained viral suppression between patients receiving injectable therapy versus those on daily oral ART. Improved outcomes would support the clinical value of expanding access to injectable treatment, especially for patients struggling with daily adherence.

Time Estimate

A proposed timeline for the intervention and evaluation is six months. Month 1 would involve participant selection, education, and initial assessment. Months 2 through 5 would include ongoing treatment and data tracking. Month 6 would be dedicated to outcome evaluation, comparing adherence rates and viral load measurements.  

This my References 

During this Capstone project we find sources that highly and thoroughly explain the point with valid sources, sources that have been acquired within the last 5 years. My PICOT Question:  In adults living with HIV who are virally suppressed (P), how does monthly long-acting injectable Cabenuva (I) compared to daily oral antiretroviral therapy (C) affect medication adherence and viral suppression rates (O) over a 6-month period (T)?

Analysis of Current Evidence

Recent studies have demonstrated that long-acting injectable antiretroviral therapy (LAI-ART), such as Cabenuva, is effective in maintaining viral suppression among individuals with HIV who have previously achieved viral suppression on oral ART. A study published in 2024 reviewed clinical trial and real-world data, highlighting that LAI-ART is associated with excellent virologic outcomes, even among individuals with adherence challenges . This evidence supports the potential of LAI-ART to improve medication adherence and viral suppression rates in the target population.

However, the implementation of LAI-ART faces several barriers. Clinics have reported challenges related to the high cost of the medication, complexity in procurement, and the need for refrigerated storage . Additionally, state-level variations in access to LAI-ART have been observed, with some Medicaid programs and AIDS Drug Assistance Programs (ADAPs) not covering the medication or requiring prior authorization . These policy-related barriers could impact the feasibility and scalability of implementing LAI-ART in the proposed setting.

 

Evaluation of Existing Health Policy

Health policies play a crucial role in determining the accessibility and implementation of LAI-ART. The Ryan White HIV/AIDS Program (RWHAP) provides funding for medication assistance, but the coverage of LAI-ART varies across states. A report from the ACE TA Center indicates that procurement and distribution requirements for LAI-ART often differ by payer, and providers must navigate various billing and payment processes . These disparities in policy could affect the consistent availability of LAI-ART for individuals in need.

Furthermore, the Centers for Medicare & Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA) have roles in overseeing and providing guidance to improve access to LAI-ART. Policies that increase access are needed to ensure the equitable distribution of LAI-ART . Advocacy for policy changes at both the state and federal levels is essential to address these barriers and facilitate the broader implementation of LAI-ART.

Now I will write the five references in which I will extract my Data to support my PICOT thesis. 

 

References

●       Centers for Disease Control and Prevention. (2022). HIV prevention: Pre-exposure prophylaxis (PrEP). https://www.cdc.gov/hiv/risk/prep/index.html

 

●       National Institutes of Health. (2023). Long-acting injectable antiretroviral therapy for HIV.

https://www.nih.gov/news-events/nih-research-matters/long-acting-injectable-antiretrovir al-therapy-hiv

 

●       U.S. Department of Health and Human Services. (2024). Ryan White HIV/AIDS Program services report. https://hab.hrsa.gov/data/data-reports

 

●       U.S. Department of Health and Human Services. (2025). State Medicaid and AIDS Drug Assistance Program formularies.

https://www.medicaid.gov/medicaid/prescription-drugs/formularies/index.html

 

●       U.S. Department of Health and Human Services. (2025). Health Resources and Services Administration: HIV/AIDS Bureau. https://hab.hrsa.gov/

Below is what they are asking for: 

 

APA FORMAT REQUIRED FOR ALL ASSIGNMENTS

●       Written communication is free of errors that detract from the overall message.

●       Font and font size: Times New Roman, 12 point.

●       Use 1” margins and in text citations

(minimum of 3 to 4 pages)

Intervention Plan Components

●      Define the major components of an intervention plan for a health promotion, quality improvement, prevention, education, or management need 

●      Explain the impact of cultural needs and characteristics of a target population and setting on the development of intervention plan components 

Theoretical Foundations

●      Evaluate theoretical nursing models, strategies from other disciplines, and health care technologies relevant to an intervention plan 

●      Justify the major components of an intervention by referencing relevant and contemporary evidence from the literature and best practices 

Stakeholders, Policy, and Regulations

● Analyze the impact of stakeholder needs, health care policy, regulations, and governing bodies relevant to health care practice and specific components of an intervention plan 

Ethical and Legal Implications

● Analyze relevant ethical and legal issues related to health care practice, organizational change, and specific components of an intervention plan 

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 

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 

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 

Timeline

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

Stakeholders, Policy, and Regulations ● Analyze the impact of stakeholder needs, health care policy, regulations, and governing bodies relevant to health care practice and specific components of an intervention plan
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