Task-Shifting Strategy for High Blood Pressure in HIV Care

(TASSH NIMR Trial)

Not currently recruiting at 2 trial locations

Overseen By Olugbenga Ogedegbe, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Chronic kidney disease, heart disease, diabetes, stroke, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a new care method controls high blood pressure in people living with HIV. The study compares two groups: one receives standard care, while the other uses a new method called "task-shifting," where health workers share tasks to improve blood pressure control. This method is part of the Task-shifting strategy for HTN control (TASSH) protocol. The trial is open to adults who visit specific HIV clinics and have untreated high blood pressure. Participants must manage their blood pressure levels between 140-179/90-100 mm Hg. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could benefit many in the future.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the task-shifting strategy for hypertension control (TASSH) protocol is safe for patients with HIV?

Research has shown that involving other healthcare providers in managing high blood pressure, rather than relying solely on doctors, is generally safe and effective. Studies have found that this approach can improve blood pressure control and support adherence to medication plans. These studies have reported no major safety issues, indicating that this method is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to managing high blood pressure in individuals with HIV. Current standard treatments generally involve medication and lifestyle changes, but this trial investigates a task-shifting strategy to control hypertension. This method empowers non-physician healthcare workers to manage blood pressure, potentially making care more accessible and efficient. Additionally, the trial examines the role of practice facilitation, which could enhance the effectiveness of the task-shifting strategy by providing support and resources to healthcare providers. Ultimately, this approach may lead to more personalized and integrated care for patients, addressing both HIV and hypertension needs simultaneously.

What evidence suggests that the task-shifting strategy for hypertension control is effective for patients with HIV?

Studies have shown that the task-shifting strategy for controlling high blood pressure, known as TASSH, effectively manages this condition. This approach builds on the World Health Organization's Cardiovascular Risk Package, a proven method for addressing high blood pressure. Research indicates that TASSH, particularly when combined with support and guidance for healthcare teams, results in better blood pressure control and medication adherence than traditional care. In this trial, one group of participants will receive the TASSH protocol with Practice Facilitation (PF), while another group will receive standard care without PF. Previous patients demonstrated significant health improvements with this strategy. Overall, the task-shifting method enhances care by involving trained non-doctor health workers in managing high blood pressure. ^{1 2 3 4 6}

Who Is on the Research Team?

Olugbenga Ogedegbe, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Ability to provide consent

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

Attends one of the 30 HIV clinics.

Exclusion Criteria

Inability to provide informed consent

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

I do not want to participate in the study.

Timeline for a Trial Participant

Pre-implementation

Development of a tailored practice facilitation intervention for integrating TASSH into HIV clinics

3 months

Implementation

Comparison of clinical effectiveness of practice facilitation vs. self-directed condition on blood pressure reduction

12 months

Regular visits as per HIV clinic schedule

Post-implementation

Evaluation of the effect of practice facilitation vs. self-directed condition on the adoption and sustainability of TASSH

12 months

Follow-up

Participants are monitored for sustainability of TASSH uptake and long-term outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Task-shifting strategy for HTN control (TASSH) protocol

Trial Overview 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.

How Is the Trial Designed?

Group I: With Practice Facilitation (PF) Experimental Treatment 1 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 Control 1 Intervention

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8597211/

Integration of a task strengthening strategy for hypertension ... This study tests the impact of a proven effective implementation strategy to integrate hypertension management into the HIV care cascade, across 30 PHCs.

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04667-7

study protocol for a cluster randomized controlled trial A Task-Shifting Strategy for HTN control (TASSH) based on the WHO Cardiovascular (CV) Risk Package is an evidence-based strategy for mitigating ...

3. globalheartjournal.com globalheartjournal.com/articles/10.5334/gh.1301

Task Sharing and Task Shifting (TSTS) in the Management ... TSTS improved health outcomes such as blood pressure control and medication adherence when compared with conventional health care. TSTS was ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4063247/

A cluster-randomized trial of task shifting and blood pressure ... This study will evaluate, among 640 hypertensive patients who receive care in CHCs in the Ashanti Region of Ghana, the comparative effectiveness of the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03490695

Uptake of Task-Strengthening for Blood Pressure Control This study will evaluate the effect of Practice Facilitation on the uptake and maintenance of the evidence-based task-shifting strategies for hypertension ...

6. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002561

Health insurance coverage with or without a nurse-led task ... Provision of health insurance coverage plus a nurse-led task shifting strategy was associated with a greater reduction in SBP than provision of health insurance ...