Addressing Barriers to Anti-hypertensive Medication Adherence Among PLWH Who Have Achieved Viral Suppression

Study Overview
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Brief Summary
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Among those with hypertension, persons living with HIV (PWH) have a 50% higher risk of incident myocardial infarction compared to the general population, and they often fail to meet evidence-based treatment goals for hypertension. An important contributing factor for insufficient blood pressure control is non-adherence to antihypertensive medications. Research on medication adherence for PWH has largely focused on antiretroviral therapy adherence with limited focus on adherence to other non-AIDS condition medications. With a large proportion of PWH in the U.S. achieving viral suppression, providers may now have an opportunity to focus on the management of non-AIDS conditions like hypertension. However, because PWH who have achieved suppression have reduced clinic encounters (once or twice a year) there is potential loss of opportunity to effectively monitor and intensify hypertension treatment as needed an important opportunity to focus on preventing cardiovascular disease. CVD and other non-AIDS comorbidities. The study's overarching goal is to improve the hypertension outcomes for PWH on suppressive ART to reduce cardiovascular disease risk. In this study, we will identify and evaluate healthcare and patient-level factors that must be addressed in an intervention to increase hypertension medication adherence for PWH who have achieved viral suppression. We will use these factors to tailor an intervention and assess the feasibility and acceptability at the Duke ID clinic.

Detailed Description
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The study is divided into 5 separate groups, Aim 1A, Aim 1B, Aim 2, Aim 3A and Aim 3B. Aims 1A and 1B will identify and evaluate patient-level factors that must be addressed in an intervention to increase hypertension medication adherence for (persons living with HIV) PWH who have achieved viral suppression. Aim 2 will identify HIV providers' practice norms after their patients achieve viral suppression and explore barriers faced in monitoring and managing patient adherence to antihypertensive medications to inform an intervention aimed at increasing antihypertensive medication adherence. Aim 3A will adapt the health care delivery intervention components to the Duke ID clinic context with key stakeholder input and data from Aims 1 and 2. Aim 3B will evaluate the feasibility and acceptability of the adapted health care delivery intervention to improve anti-hypertensive medication adherence and BP control in PWH at 24 weeks.

Official Title
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Addressing Barriers to Anti-hypertensive Medication Adherence Among Persons Living With HIV Who Have Achieved Viral Suppression

Conditions
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Hypertension, HIV-1-infection

Intervention / Treatment
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* Behavioral: Hypertension control through education and monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aims 1A and 1B Age ≥18 years Confirmed HIV+ diagnosis Undetectable HIV viral load: defined as the most recent HIV viral load <200 copies/mL checked within the past year (assessed via chart abstraction) Hypertension diagnosis in medical records Taking an antihypertensive medication Receiving care at the Duke HIV clinic Aim 2 HIV providers including infectious disease physicians, internists or advance practice practitioners who have a patient pool of PLWH under their care in the last 6 months. Aim 3A Stakeholders composed of willing participants recruited from the Duke ID clinic and may include, HIV providers, clinic directors, nurses, pharmacists, social workers, people living with HIV who have hypertension and take antihypertensive medications, and representatives of the community advisory boards, and any other key stakeholders. Aim 3 B Age ≥18 years Confirmed HIV+ diagnosis Receiving care at the Duke ID clinic Achievement of HIV suppression defined as having HIV-1 RNA <200 copies/ml Take antihypertensive medications Uncontrolled BP over a 12 months period defined by participants with systolic BP>130mmHg on ≥ 2 occasions in the past 12 months as indicated in the individual patient's electronic medical records Exclusion Criteria: Aims 1A, 1B and 3B Severely hearing or speech impaired, or other disability that would limit participation in the intervention components In a nursing home and/or receiving in-patient psychiatric care Terminal illness with life expectancy < 4 months No reliable access to a telephone Pregnant, breast-feeding, or planning a pregnancy during the study period Planning to move out of the area in the next 6 months Non-English speaking.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Aim 3B group will participate in an adapted intervention related to blood pressure management.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Aim 3B<br>This aim will evaluate the feasibility and acceptability of the adapted health care delivery intervention to improve anti-hypertensive medication adherence and blood pressure control in persons living with HIV at 24 weeks. | Behavioral: Hypertension control through education and monitoring<br>* Enrollment of 60 PLWH ≥18 years old receiving care at the Duke ID clinic who have achieved HIV viral suppression who take antihypertensive medication and have uncontrolled blood pressure. Subjects will have be given educational materials, blood pressure monitors to use and report findings, follow up with study coordinator and communication with subject's HIV provider in order to maximize blood pressure control..<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by enrollment | Number of participants enrolled divided by total number of eligible patients in Duke Clinic 1K | 1 year | 
| Acceptability of nurse managed adherence strategy | Intervention Measure (Likert scale 1 completely disagree to 5 completely agree) | Week 24 | 
| Usefulness of contact with nurse | Intervention Measure (Likert scale 1 completely disagree to 5 completely agree) | Week 24 | 
| Subject's evaluation regarding ease of use of blood pressure machine | Intervention Measure (Likert scale 1 completely disagree to 5 completely agree) | Week 24 | 
| Subject's evaluation of ease of the completion of blood pressure logs | Intervention Measure (Likert scale 1 completely disagree to 5 completely agree) | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of telephone contacts |  | Week 24 | 
| Duration of time to reduce elevated BP to an under-control reading |  | Week 24 | 
| Total number of specialty referrals |  | Week 24 | 
| Number of anti-hypertensive medication changes |  | Week 24 | 
| Change in subject's self report of anti-hypertensive medication adherence | Adherence to Hypertension and Medication Scales (Likert scale strongly disagree to strongly agree and not at all to very much) | Baseline and Week 24 | 
| Change in systolic blood pressure measurements | Comparison of baseline versus Week 24 visit measurements | Baseline and Week 24 |