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

Primary Purpose

Hypertension, HIV-1-infection

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hypertension control through education and monitoring

About this trial

This is an interventional health services research trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Duke UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Aim 3B

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility as measured by enrollment

Number of participants enrolled divided by total number of eligible patients in Duke Clinic 1K

Acceptability of nurse managed adherence strategy

Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)

Usefulness of contact with nurse

Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)

Subject's evaluation regarding ease of use of blood pressure machine

Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)

Subject's evaluation of ease of the completion of blood pressure logs

Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)

Secondary Outcome Measures

Total number of telephone contacts

Duration of time to reduce elevated BP to an under-control reading

Total number of specialty referrals

Number of anti-hypertensive medication changes

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)

Change in systolic blood pressure measurements

Comparison of baseline versus Week 24 visit measurements

Full Information

NCT ID

NCT05459077

First Posted

July 11, 2022

Last Updated

July 11, 2023

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT05459077

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2022 (Actual)

Primary Completion Date

May 2026 (Anticipated)

Study Completion Date

May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, HIV-1-infection

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Aim 3B group will participate in an adapted intervention related to blood pressure management.

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aim 3B

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Hypertension control through education and monitoring

Intervention Description

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..

Primary Outcome Measure Information:

Title

Feasibility as measured by enrollment

Description

Number of participants enrolled divided by total number of eligible patients in Duke Clinic 1K

Time Frame

1 year

Title

Acceptability of nurse managed adherence strategy

Description

Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)

Time Frame

Week 24

Title

Usefulness of contact with nurse

Description

Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)

Time Frame

Week 24

Title

Subject's evaluation regarding ease of use of blood pressure machine

Description

Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)

Time Frame

Week 24

Title

Subject's evaluation of ease of the completion of blood pressure logs

Description

Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Total number of telephone contacts

Time Frame

Week 24

Title

Duration of time to reduce elevated BP to an under-control reading

Time Frame

Week 24

Title

Total number of specialty referrals

Time Frame

Week 24

Title

Number of anti-hypertensive medication changes

Time Frame

Week 24

Title

Change in subject's self report of anti-hypertensive medication adherence

Description

Adherence to Hypertension and Medication Scales (Likert scale strongly disagree to strongly agree and not at all to very much)

Time Frame

Baseline and Week 24

Title

Change in systolic blood pressure measurements

Description

Comparison of baseline versus Week 24 visit measurements

Time Frame

Baseline and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stuart T Carr, BA

Phone

919 668-4849

stuart.carr@duke.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mersedes Brown, MPH

Phone

919 668-7364

mersedes.brown@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles Muiruri, PhD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mersedes Brown, MPH

Phone

919-668-7364

mersedes.brown@duke.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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