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

NCT05459077 | Not Yet Recruiting

• 1 other identifier: Pro00108808
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; HIV-1-infection

Outcome Measures

Primary Outcomes (5)

• Feasibility as measured by enrollment

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

  1 year

• Acceptability of nurse managed adherence strategy

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

  Week 24

• Usefulness of contact with nurse

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

  Week 24

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

  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

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

  Week 24

Secondary Outcomes (6)

• Total number of telephone contacts

  Week 24

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

  Week 24

• Total number of specialty referrals

  Week 24

• Number of anti-hypertensive medication changes

  Week 24

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

  Baseline and Week 24

Study Arms (1)

Aim 3B

OTHER

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.

Behavioral: Hypertension control through education and monitoring

Interventions

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..

Aim 3B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Charles Muiruri, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stuart T Carr, BA

CONTACT

919 668-4849; stuart.carr@duke.edu

Mersedes Brown, MPH

CONTACT

919 668-7364; mersedes.brown@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: April 20, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)