HIV-1-infection, Hypertension
Conditions
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.
Interventions
BEHAVIORALHypertension 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..
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Aim 3B group will participate in an adapted intervention related to blood pressure management.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as measured by enrollment | 1 year | Number of participants enrolled divided by total number of eligible patients in Duke Clinic 1K |
| Acceptability of nurse managed adherence strategy | Week 24 | Intervention Measure (Likert scale 1 completely disagree to 5 completely agree) |
| Usefulness of contact with nurse | Week 24 | Intervention Measure (Likert scale 1 completely disagree to 5 completely agree) |
| Subject's evaluation regarding ease of use of blood pressure machine | Week 24 | Intervention Measure (Likert scale 1 completely disagree to 5 completely agree) |
| Subject's evaluation of ease of the completion of blood pressure logs | Week 24 | Intervention Measure (Likert scale 1 completely disagree to 5 completely agree) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of telephone contacts | Week 24 | \# of times participant was engaged via phone calls including successful and unsuccessful contacts |
| Duration of time to reduce elevated BP to an under-control reading | Week 24 | time frame it took for participant to self-report a reduced bp reading within a normal range |
| Total number of specialty referrals | Week 24 | \# of specialty referrals that the participant experienced during the duration of study enrollment |
| Number of anti-hypertensive medication changes | Week 24 | \# of times medication changes (including switch to a different antihypertensive medication or the addition of another anti-hypertensive medication) |
| Change in subject's self report of anti-hypertensive medication adherence | Baseline and Week 24 | Adherence to Hypertension and Medication Scales (Likert scale strongly disagree to strongly agree and not at all to very much) |
| Change in systolic blood pressure measurements | Baseline and Week 24 | Comparison of baseline versus Week 24 visit measurements |
Countries
United States
Contacts
CONTACTStuart T Carr, BA
CONTACTMersedes Brown, MPH
PRINCIPAL_INVESTIGATORCharles Muiruri, PhD
Duke University
Outcome results
None listed