- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05459077
Addressing Barriers to Anti-hypertensive Medication Adherence Among PLWH Who Have Achieved Viral Suppression
Addressing Barriers to Anti-hypertensive Medication Adherence Among Persons Living With HIV Who Have Achieved Viral Suppression
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stuart T Carr, BA
- Phone Number: 919 668-4849
- Email: stuart.carr@duke.edu
Study Contact Backup
- Name: Mersedes Brown, MPH
- Phone Number: 919 668-7364
- Email: mersedes.brown@duke.edu
Study Locations
-
-
North Carolina
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Durham, North Carolina, United States, 27710
- Recruiting
- Duke University
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Contact:
- Mersedes Brown, MPH
- Phone Number: 919-668-7364
- Email: mersedes.brown@duke.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Aim 3B
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.
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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..
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility as measured by enrollment
Time Frame: 1 year
|
Number of participants enrolled divided by total number of eligible patients in Duke Clinic 1K
|
1 year
|
Acceptability of nurse managed adherence strategy
Time Frame: Week 24
|
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
|
Week 24
|
Usefulness of contact with nurse
Time Frame: Week 24
|
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
|
Week 24
|
Subject's evaluation regarding ease of use of blood pressure machine
Time Frame: Week 24
|
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
Time Frame: Week 24
|
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
|
Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total number of telephone contacts
Time Frame: Week 24
|
Week 24
|
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Duration of time to reduce elevated BP to an under-control reading
Time Frame: Week 24
|
Week 24
|
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Total number of specialty referrals
Time Frame: Week 24
|
Week 24
|
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Number of anti-hypertensive medication changes
Time Frame: Week 24
|
Week 24
|
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Change in subject's self report of anti-hypertensive medication adherence
Time Frame: Baseline and Week 24
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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
Time Frame: Baseline and Week 24
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Comparison of baseline versus Week 24 visit measurements
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Baseline and Week 24
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charles Muiruri, PhD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00108808
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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