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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459077
• Other study ID #: Pro00108808
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: May 2026

Study information

• Verified date: July 2023
• Source: Duke University
• Contact: Stuart T Carr, BA
• Phone: 919 668-4849
• Email: stuart.carr[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1-infection
• Hypertension

Intervention

Behavioral:
• Hypertension control through education and monitoring
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..

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as measured by enrollment	Number of participants enrolled divided by total number of eligible patients in Duke Clinic 1K	1 year
Primary	Acceptability of nurse managed adherence strategy	Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)	Week 24
Primary	Usefulness of contact with nurse	Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)	Week 24
Primary	Subject's evaluation regarding ease of use of blood pressure machine	Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)	Week 24
Primary	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	Total number of telephone contacts		Week 24
Secondary	Duration of time to reduce elevated BP to an under-control reading		Week 24
Secondary	Total number of specialty referrals		Week 24
Secondary	Number of anti-hypertensive medication changes		Week 24
Secondary	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
Secondary	Change in systolic blood pressure measurements	Comparison of baseline versus Week 24 visit measurements	Baseline and Week 24