Task-Shifting Strategy for High Blood Pressure in HIV Care

(TASSH NIMR Trial)

Recruiting at 1 trial location

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

830 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is the task-shifting strategy for high blood pressure in HIV care safe for humans?

The research does not provide specific safety data for the task-shifting strategy for high blood pressure in HIV care, but it is being implemented in various healthcare settings, suggesting it is considered safe enough for use in these environments. ^{1 2 3 4 5}

How is the TASSH treatment for high blood pressure in HIV care different from other treatments?

The TASSH treatment is unique because it uses a task-shifting strategy, where tasks are delegated to less specialized health workers, like nurses, to manage high blood pressure in people living with HIV. This approach is particularly beneficial in resource-limited settings where there is a shortage of trained healthcare providers. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Task-shifting strategy for HTN control (TASSH) protocol?

Research shows that task-shifting strategies, where healthcare tasks are moved from doctors to trained nurses, have been effective in managing high blood pressure in resource-limited settings like sub-Saharan Africa. This approach has been successfully used for other health interventions, such as HIV care, suggesting it could also help control high blood pressure in people living with HIV. ^{1 2 3 7 8}

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. England pubmed.ncbi.nlm.nih.gov

Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Perspectives of key stakeholders regarding task shifting of care for HIV patients in Mozambique: a qualitative interview-based study with Ministry of Health leaders, clinicians, and donors. [2022]

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

Organizational readiness to implement task-strengthening strategy for hypertension management among people living with HIV in Nigeria. [2023]

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

Sustaining Nurse-Led Task-Shifting Strategies for Hypertension Control: A Concept Mapping Study to Inform Evidence-Based Practice. [2022]

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

Factors influencing the integration of evidence-based task-strengthening strategies for hypertension control within HIV clinics in Nigeria. [2022]

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

Integrating hypertension and HIV care in Namibia: A quality improvement collaborative approach. [2022]

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

Exploring stakeholders' perceptions of a task-shifting strategy for hypertension control in Ghana: a qualitative study. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Nurses' perceptions on implementing a task-shifting/sharing strategy for hypertension management in patients with HIV in Nigeria: a group concept mapping study. [2022]