What side effects are associated with this type of intervention?

Common treatments for high blood pressure, such as antihypertensive medications, can have several side effects. These include dizziness, headaches, fatigue, and gastrointestinal issues. More specific side effects depend on the class of medication: diuretics can cause electrolyte imbalances and dehydration; ACE inhibitors may lead to a persistent cough and elevated blood potassium levels; beta-blockers can cause bradycardia and fatigue; and calcium channel blockers might result in swelling of the lower extremities and constipation. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of high blood pressure, including angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs), and thiazide diuretics. These medications are commonly used due to their efficacy and safety profiles. In the context of the Tailored-Practice Facilitation trial for hypertension management in HIV patients, ACE inhibitors and ARBs are particularly relevant as they are often recommended for their protective effects on the kidneys and cardiovascular system. Examples of these drugs include lisinopril (an ACE inhibitor) and losartan (an ARB).

What other types of research exist?

Promising, novel alternatives to Tailored-Practice Facilitation for hypertension management in HIV patients include: 1) Digital health interventions such as telehealth and mobile health apps for remote monitoring and patient education. 2) Community-based programs that leverage local resources and peer support to enhance adherence and lifestyle modifications. 3) Integrated care models that combine hypertension management with other chronic disease care, ensuring a holistic approach to patient health. These strategies can improve accessibility, patient engagement, and overall health outcomes.

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Task-Shifting Strategy for High Blood Pressure in HIV Care (TASSH NIMR Trial)

N/A

Waitlist Available

Led By Olugbenga Ogedegbe, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a diagnosis of HTN with uncontrolled blood pressure, i.e. BP is 140-179/90-100 mm Hg.

Be an adult aged 18 years and older.

Must not have

History of chronic kidney disease, heart disease, diabetes or stroke, pregnancy

Refusal to participate in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, 12 months, 18 months and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new approach to help HIV patients with high blood pressure in Lagos, Nigeria. Experts will train and support nurses to better manage blood pressure in these patients, aiming to reduce heart disease risks.

Who is the study for?

This trial is for adults over 18 with HIV/AIDS who also have high blood pressure (140-179/90-100 mm Hg) and are receiving care at one of the 30 designated HIV clinics. It's not open to those with extremely high blood pressure, chronic kidney disease, heart disease, diabetes, stroke history, or pregnant individuals.

What is being tested?

The study is testing a tailored-practice facilitation strategy called TASSH aimed at integrating hypertension management into existing HIV care services within primary health centers in Lagos, Nigeria.

What are the potential side effects?

Since this trial involves a healthcare management strategy rather than a drug intervention, specific side effects related to medications are not applicable. However, there may be general risks associated with changes in healthcare practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My blood pressure is high, between 140-179 over 90-100 mm Hg.

Select...

I am 18 years old or older.

Select...

My blood pressure is high, between 140-179 over 90-100.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of chronic kidney disease, heart disease, diabetes, stroke, or am pregnant.

Select...

I do not want to participate in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, 12 months, 18 months and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, 12 months, 18 months and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, 12 months, 18 months and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in systolic Blood Pressure

Secondary study objectives

Change in Implementation Climate of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months.

Change in Implementation Leadership of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months.

Change in Organizational Readiness of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months.

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: With Practice Facilitation (PF)Experimental Treatment1 Intervention

Participants will be identified from HIV clinics during routine visits and will receive the task-shifting strategy for HTN control (TASSH) protocol.

Group II: Self-directed without Practice Facilitation (PF)Active Control1 Intervention

Participants will be identified from HIV clinics during routine visits and provided standard of care.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include calcium channel blockers, thiazide-like diuretics, ACE inhibitors, and ARBs. Calcium channel blockers work by relaxing the blood vessels, making it easier for the heart to pump blood. Thiazide-like diuretics help the kidneys remove excess sodium and water from the body, reducing blood volume. ACE inhibitors and ARBs both target the renin-angiotensin-aldosterone system (RAAS) to relax blood vessels and reduce blood pressure. These mechanisms are crucial for high blood pressure patients as they help prevent complications such as heart attack, stroke, and kidney damage by effectively lowering blood pressure.

Lifestyle factors in hypertension drug research: systematic analysis of articles in a leading cochrane report.Rational prescribing in primary care (RaPP): a cluster randomized trial of a tailored intervention.