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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to manage high blood pressure in people living with HIV who have already controlled their virus. Researchers focus on helping these patients adhere to their blood pressure medication routine to lower their risk of heart problems. The study tests the effectiveness of education and regular health monitoring in improving medication adherence. People with HIV who have a stable viral load, receive care at the Duke HIV clinic, and have uncontrolled high blood pressure may be suitable for this trial. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could improve health outcomes for others with similar conditions.

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 prior data suggests that this protocol is safe for improving hypertension control in HIV patients?

Research has shown that educating and monitoring people with HIV to manage high blood pressure can be safe and effective. One study found that control of high blood pressure improved from 73.5% to 78.5% without affecting HIV treatment, indicating these methods are generally well-tolerated.

Another study discovered that phone-based health tools can enhance the quality of life for those with both HIV and high blood pressure, suggesting these tools can safely aid in managing high blood pressure.

Overall, evidence suggests that focusing on education and monitoring for high blood pressure in people with HIV is a safe approach, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this approach to managing high blood pressure in people living with HIV because it focuses on education and monitoring, rather than just medication. Unlike standard treatments that primarily rely on pharmaceutical interventions to manage hypertension, this method empowers patients by improving their understanding and adherence to their treatment plans. By actively engaging patients in their own care, the approach aims to achieve better blood pressure control, potentially leading to improved overall health outcomes for individuals with HIV.

What evidence suggests that this education and monitoring intervention is effective for high blood pressure control in HIV patients?

Research has shown that education and regular check-ups can significantly help people with HIV manage their blood pressure. In one study with 1,061 participants in Uganda, the percentage of individuals with good blood pressure control rose from 14.4% at the start to 66.1% after six months. Another study found a 7% improvement in controlling high blood pressure over a year. This trial will assess the feasibility and acceptability of an adapted health care delivery intervention that focuses on education and monitoring to enhance adherence to anti-hypertensive medication and blood pressure control in people living with HIV. These findings suggest that emphasizing education and regular check-ups aids individuals in adhering to their blood pressure medication plans. This approach not only improves blood pressure but also enhances adherence to overall HIV care plans. ^{2 5 6 7 8}

Who Is on the Research Team?

Charles Muiruri, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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 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]

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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-human-immunodeficiency-virus-type-1-hiv-1-infection-6-2022-c927d

Education and Monitoring for High Blood Pressure Control ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6822379/

Hypertension Control and Retention in Care Among HIV ... However, sustained control of hypertension for >1 year improved by 7 percentage points (p<0.001), adherence to HIV care improved by 6.8 percentage points (p< ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10463385/

Using the RE-AIM framework to evaluate the implementation ... We studied the effectiveness and implementation of a WHO HEARTS intervention to integrate the management of hypertension into HIV care.

4. implementationsciencecomms.biomedcentral.com implementationsciencecomms.biomedcentral.com/articles/10.1186/s43058-024-00640-6

Integrating hypertension detection and management in HIV ... This study will address knowledge gaps around implementation of cardiovascular disease preventive practices in HIV care in South Africa.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949856225000285

Examining the influence of mHealth interventions on ... mHealth interventions demonstrate potential in improving QoL for individuals living with HIV and/or hypertension.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11285256/

Designing an implementation science clinical trial to ... Our study aims to develop and test strategies to close the HTN care gap in PLWH, through integration into HIV care.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8896410/

Integrated multi-month dispensing of antihypertensive and ... Hypertension control improved from 73.5% to 78.5% (p = 0.01) without a significant difference in the proportion of patients with HIV viral ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2049080120300637

Clinical care & blood pressure control among hypertensive ... After 12 months of follow-up, 60.2% of HIV-positive and 53% of HIV-negative patients showed uncontrolled blood pressure. The overall perception of self- ...