Clinical trial NCT05459077: 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
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
HIV-1-infection
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Aim 3B group will participate in an adapted intervention related to blood pressure management.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Feasibility as measured by enrollment
timeFrame: 1 year
measure: Acceptability of nurse managed adherence strategy
timeFrame: Week 24
measure: Usefulness of contact with nurse
timeFrame: Week 24
measure: Subject's evaluation regarding ease of use of blood pressure machine
timeFrame: Week 24
measure: Subject's evaluation of ease of the completion of blood pressure logs
timeFrame: Week 24
Secondary outcomes:
measure: Total number of telephone contacts
timeFrame: Week 24
measure: Duration of time to reduce elevated BP to an under-control reading
timeFrame: Week 24
measure: Total number of specialty referrals
timeFrame: Week 24
measure: Number of anti-hypertensive medication changes
timeFrame: Week 24
measure: Change in subject's self report of anti-hypertensive medication adherence
timeFrame: Baseline and Week 24
measure: Change in systolic blood pressure measurements
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Charles Muiruri, PhD
role: PRINCIPAL_INVESTIGATOR
References: