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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Hypertension control through education and monitoring

    Behavioral

    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..

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Aim 3BOther 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility as measured by enrollment

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

Time frame
1 year
2

Acceptability of nurse managed adherence strategy

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

Time frame
Week 24
3

Usefulness of contact with nurse

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

Time frame
Week 24
4

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

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

Time frame
Week 24

Secondary outcomes

1

Total number of telephone contacts

\# of times participant was engaged via phone calls including successful and unsuccessful contacts

Time frame
Week 24
2

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

time frame it took for participant to self-report a reduced bp reading within a normal range

Time frame
Week 24
3

Total number of specialty referrals

\# of specialty referrals that the participant experienced during the duration of study enrollment

Time frame
Week 24
4

Number of anti-hypertensive medication changes

\# of times medication changes (including switch to a different antihypertensive medication or the addition of another anti-hypertensive medication)

Time frame
Week 24

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: