Education and Monitoring for High Blood Pressure Control in HIV Patients

Overseen By Mersedes Brown, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Antihypertensives

Disqualifiers: Severe disability, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

60 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since the study focuses on improving adherence to hypertension medications, it seems likely that you will continue taking them.

What data supports the effectiveness of the treatment for high blood pressure control in HIV patients?

Research shows that among HIV patients who started antihypertensive treatment, 63% achieved blood pressure control within one year, indicating that treatments like Cozaar (Losartan Potassium) can be effective in managing high blood pressure in this group. ^{1 2 3 4 5}

Is Losartan (Cozaar) safe for humans?

Losartan, used to manage high blood pressure, has been evaluated in over 4,000 patients and is generally considered safe. It has been used for more than a year in some patients without significant issues, and it causes fewer side effects like cough compared to some other blood pressure medications. ^{4 5 6 7 8}

How does the drug Cozaar (Losartan Potassium) differ in treating high blood pressure in HIV patients?

Cozaar (Losartan Potassium) is unique for treating high blood pressure in HIV patients because it is an angiotensin receptor blocker (ARB) that helps manage hypertension without significant interactions with antiretroviral drugs, which is crucial for HIV patients who are often on complex medication regimens. ^{1 9 10 11 12}

Research Team

Charles Muiruri, PhD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for adults over 18 with HIV who have achieved viral suppression and are being treated at the Duke ID clinic. They must have high blood pressure despite taking medication, as shown by their medical records. People can't join if they're severely hearing or speech impaired, in a nursing home, terminally ill, without phone access, pregnant or planning to be so soon, non-English speaking, or moving away within six months.

Inclusion Criteria

This criterion involves recruiting people from the Duke ID clinic, including HIV providers, clinic directors, nurses, pharmacists, social workers, people with HIV and hypertension, and community advisory board members, as well as other important individuals.

I am over 18, HIV positive with undetectable viral load, have hypertension, take blood pressure medicine, and receive care at the Duke HIV clinic.

Criterion: We are looking for healthcare providers who have been taking care of people living with HIV in the past 6 months.

Exclusion Criteria

You have severe hearing or speech impairment, are living in a nursing home or receiving in-patient psychiatric care, have a terminal illness with less than 4 months to live, lack reliable access to a telephone, are pregnant, breastfeeding, planning a pregnancy during the study, planning to move within the next 6 months, or do not speak English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Aim 1A and 1B

Identify and evaluate patient-level factors to increase hypertension medication adherence for PWH who have achieved viral suppression

8 weeks

Aim 2

Identify HIV providers' practice norms and explore barriers in monitoring and managing patient adherence to antihypertensive medications

8 weeks

Aim 3A

Adapt the health care delivery intervention components to the Duke ID clinic context with stakeholder input

4 weeks

Aim 3B

Evaluate the feasibility and acceptability of the adapted health care delivery intervention to improve anti-hypertensive medication adherence and BP control

24 weeks

Baseline and Week 24 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Hypertension control through education and monitoring

Trial Overview The study aims to improve blood pressure control among people living with HIV (PWH) on antiretroviral therapy (ART) to reduce heart disease risk. It will identify factors affecting hypertension medication adherence and test an educational and monitoring intervention tailored for PWH who've achieved viral suppression.

Participant Groups

Group I: Aim 3B Experimental Treatment 1 Intervention

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.

Hypertension control through education and monitoring is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cozaar for:

• Hypertension
• Diabetic nephropathy
• Risk of stroke

Approved in European Union as Losartan for:

• Hypertension
• Diabetic nephropathy
• Heart failure

Approved in Canada as Losartan for:

• Hypertension
• Diabetic nephropathy

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

In a study of 2,595 HIV-infected patients with hypertension, those who received treatment experienced a significant decrease in both systolic and diastolic blood pressure over time, highlighting the efficacy of antihypertensive therapy in this population.

Poorly controlled hypertension was linked to a higher risk of cardiovascular events, emphasizing the importance of better management strategies for hypertension in individuals living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of cardiovascular events and blood pressure control in hypertensive HIV-infected patients: Swiss HIV Cohort Study (SHCS). Nüesch, R., Wang, Q., Elzi, L., et al.[2022]

In a study of 5,428 adults in South Africa, HIV-infected individuals showed significantly lower blood pressure before testing compared to HIV-negative individuals, but experienced a notable increase in blood pressure after receiving their HIV test results.

The findings suggest that blood pressure measurements taken before HIV testing may be more reliable, and it is recommended to monitor blood pressure again after starting antiretroviral therapy (ART) to accurately diagnose hypertension in HIV-infected adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating hypertension screening at the time of voluntary HIV testing among adults in South Africa. Drain, PK., Hong, T., Hajat, A., et al.[2022]

In a study of 1061 hypertensive individuals living with HIV in Uganda, blood pressure control significantly improved from 14.4% at baseline to 66.1% after 6 months of treatment, highlighting the efficacy of integrated HIV and hypertension care.

Comorbid diabetes mellitus and the disclosure of HIV status were linked to poorer blood pressure control, suggesting that these factors may require more intensive management strategies for effective treatment in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with blood pressure control in patients with hypertension and HIV at a large urban HIV clinic in Uganda. Musimbaggo, DJ., Kimera, ID., Namugenyi, C., et al.[2022]

In a study of 310 HIV-infected patients, the prevalence of confirmed hypertension was found to be 15%, highlighting the importance of monitoring blood pressure in this population.

Isolated office hypertension was present in 39% of patients with office hypertension, suggesting that ambulatory blood pressure monitoring could be beneficial for accurate diagnosis, especially since factors like age, family history of hypertension, and the number of antiretroviral regimens were significantly associated with hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension and isolated office hypertension in HIV-infected patients determined by ambulatory blood pressure monitoring: prevalence and risk factors. Bernardino, JI., Mora, M., Zamora, FX., et al.[2020]

Among 2274 patients with HIV, 39% had prevalent hypertension, and the incidence rate of new hypertension cases was 6.3 per 100 person-years, indicating a significant burden of hypertension in this population.

Only 16% of patients with newly diagnosed hypertension initiated antihypertensive treatment within a year, and among those who did, 63% achieved blood pressure control, highlighting the need for improved management strategies to address delays in treatment and control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension burden, treatment, and control among people with HIV at a clinical care center in the Southeastern US, 2014-2019. Remch, M., Franceschini, N., Davy-Mendez, T., et al.[2023]

In a 12-week study involving 366 hypertensive patients, losartan significantly reduced both systolic and diastolic blood pressure compared to placebo, demonstrating its efficacy as an antihypertensive medication.

Losartan was well tolerated with a safety profile similar to placebo, and there was no evidence of rebound hypertension after stopping the medication, indicating it is a safe option for managing mild-to-moderate hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative antihypertensive effects of losartan 50 mg and losartan 50 mg titrated to 100 mg in patients with essential hypertension. Ikeda, LS., Harm, SC., Arcuri, KE., et al.[2019]

Losartan, an angiotensin receptor antagonist, effectively reduces blood pressure in patients with essential hypertension, with maximum effects seen at doses around 50 mg, and it is safe for once-daily use based on studies involving over 4,000 patients.

The drug has a favorable safety profile, with no significant adverse effects like elevated serum creatinine or potassium levels, and it causes less cough compared to other antihypertensive medications like hydrochlorothiazide or lisinopril.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Losartan: first of a new class of angiotensin antagonists for the management of hypertension. Carr, AA., Prisant, LM.[2019]

A study using data from the South Carolina Medicaid database (1994-2011) found no significant difference in the incidence of hypertension between HIV patients on combination antiretroviral therapy (cART) and a matched non-HIV control group.

However, prolonged exposure to non-nucleoside reverse transcriptase inhibitors and protease inhibitors was linked to an increased risk of developing hypertension in the HIV population, suggesting a need for careful monitoring of blood pressure in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of primary hypertension in a population-based cohort of HIV-infected compared with non-HIV-infected persons and the effect of combined antiretroviral therapy. Tripathi, A., Jerrell, JM., Skelton, TN., et al.[2019]

Hypertension is prevalent among HIV-positive individuals, with rates ranging from 4.7% to 54.4% in high-income countries and 8.7% to 45.9% in low- and middle-income countries, highlighting a significant health concern for this population.

Management of hypertension in HIV-positive patients is similar to that in the general population, but clinicians must be cautious of potential drug interactions between antihypertensive medications and antiretroviral therapies, necessitating careful treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Burden, Determinants, and Pharmacological Management of Hypertension in HIV-Positive Patients and Populations: A Systematic Narrative Review. Nguyen, KA., Peer, N., Mills, EJ., et al.[2022]

Hypertension is more prevalent among HIV-infected individuals, especially those on antiretroviral therapy, compared to those without HIV, highlighting the need for careful cardiovascular risk assessment in these patients.

When treating high blood pressure in HIV patients, ACE inhibitors and thiazide/thiazide-like diuretics are recommended due to potential drug interactions with antiretroviral medications, which can affect the efficacy and safety of both antihypertensive and ARV drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiretroviral Treatment and Antihypertensive Therapy. Robles, NR., Fici, F., Valladares, J., et al.[2022]

In a study of 434 HIV-infected individuals over an average follow-up of 3.4 years, new-onset hypertension was found to occur at an incidence of 29.8 per 1000 person-years, with HIV duration and abnormal urinary albumin excretion identified as significant predictors.

Despite a threefold increase in the use of antihypertensive treatment among patients, only 22% achieved adequate blood pressure control, highlighting the need for improved management and awareness of hypertension in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension and antihypertensive treatment in HIV-infected individuals. A longitudinal cohort study. Manner, IW., Baekken, M., Oektedalen, O., et al.[2012]

A hypertension management model was successfully implemented for HIV-infected individuals in Malawi, addressing a critical health need in this population.

The study highlights the importance of integrating hypertension care into HIV treatment programs to improve overall health outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating HIV and hypertension management in low-resource settings: Lessons from Malawi. Patel, P., Speight, C., Maida, A., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Risk of cardiovascular events and blood pressure control in hypertensive HIV-infected patients: Swiss HIV Cohort Study (SHCS). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Integrating hypertension screening at the time of voluntary HIV testing among adults in South Africa. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Factors associated with blood pressure control in patients with hypertension and HIV at a large urban HIV clinic in Uganda. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Hypertension and isolated office hypertension in HIV-infected patients determined by ambulatory blood pressure monitoring: prevalence and risk factors. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Hypertension burden, treatment, and control among people with HIV at a clinical care center in the Southeastern US, 2014-2019. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Comparative antihypertensive effects of losartan 50 mg and losartan 50 mg titrated to 100 mg in patients with essential hypertension. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Losartan: first of a new class of angiotensin antagonists for the management of hypertension. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Incidence of primary hypertension in a population-based cohort of HIV-infected compared with non-HIV-infected persons and the effect of combined antiretroviral therapy. [2019]

9. Spain pubmed.ncbi.nlm.nih.gov

Burden, Determinants, and Pharmacological Management of Hypertension in HIV-Positive Patients and Populations: A Systematic Narrative Review. [2022]

10. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Antiretroviral Treatment and Antihypertensive Therapy. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Hypertension and antihypertensive treatment in HIV-infected individuals. A longitudinal cohort study. [2012]

12. United States pubmed.ncbi.nlm.nih.gov

Integrating HIV and hypertension management in low-resource settings: Lessons from Malawi. [2019]