Trials Sponsors Conditions Drugs Pricing

Conditions

Human Immunodeficiency Virus Hypertension

Keywords

HypertensionImplementation science researchIntegrated modelsPractice FacilitationPeople living with HIVHuman Immunodeficiency VirusCluster trial

Outcome Measures

Primary Outcomes (1)

Change in Systolic Blood Pressure
The primary outcome is change in systolic blood pressure (SBP) from baseline to 12 months. Following the research investigators' existing TASSH protocol, the SBP reduction in patients will assessed as mean change in systolic BP from baseline to 12 months. Blood pressure will be taken with valid automated BP device from the existing TASSH protocol.
Baseline, Month 12

Secondary Outcomes (14)

Rate of Adoption of TASSH Across PHCs at 12 Months
Month 12
Sustainability of TASSH Across PHCs at 24 Months
Month 24

Study Arms (2)

Self-directed without Practice Facilitation (PF)

NO INTERVENTION

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

With Practice Facilitation (PF)

EXPERIMENTAL

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

Behavioral: Task-shifting strategy for HTN control (TASSH) protocol

Interventions

Task-shifting strategy for HTN control (TASSH) protocolBehavioral

The TASSH protocol include the following 4 steps: 1). Identify HIV patients with uncontrolled HTN: trained HIV nurses will take patients' medical history (whether or not they have a diagnosis of diabetes, heart attack, stroke, heart failure, smoking). 2) Next, they will measure the patients' weight, height, waist circumference and BP with a valid automated device following standard procedures and then conduct lab tests with point-of-care testing on blood glucose, lipids and urine dip stick. 3) Initiate lifestyle counseling and medication treatment every 1-3 months: The nurses will next counsel eligible patients on lifestyle behaviors for 20 to 30 minutes (increased intake of fruits and vegetables, moderate physical activity and reduce salt intake). 4). Refer patients with complicated HTN to physicians for further care

With Practice Facilitation (PF)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Be an adult aged 18 years and older.
Attends one of the 30 HIV clinics.

Sponsors & Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
NIHcollaborator
NYU Langone Health
Otherlead

Study Sites (2)

Saint Louis University (SLU)

St Louis, Missouri, 63103, United States

Nigerian Institute of Medical Research (NIMR)

Yaba, Lagos, Nigeria

Related Publications (4)

Nwankwo CH, Odejobi OD, Odubela OO, Mishra S, Onakomaiya D, Kanneh N, Nwasozuru U, Odusola AO, Chen W, Bayonle A, Idigbe I, Oladele D, Tayo BO, Hu J, Musa Z, Aifah AA, Ogedegbe G, Iwelunmor J, Ezechi O. Adaptations to an implementation study for integrating hypertension management into HIV care in Lagos, Nigeria: application of the FRAME. Implement Sci Commun. 2026 Mar 10;7(1):55. doi: 10.1186/s43058-026-00869-3.
PMID: 41803985DERIVED
Chen W, Musa AZ, Odubela O, Onakomaiya D, Mishra S, Kanneh N, Colvin CL, Mariam Y, Idigbe I, Nwankwo C, Odejobi Y, Adewumi A, Oladele DA, Tayo B, Aifah AA, Hu J, Ogedegbe G, Iwelunmor J, Ezechi O. Integration of a task strengthening strategy for hypertension management into HIV care in Nigeria: Baseline characteristics of participants in a cluster randomized controlled trial. Am Heart J. 2026 Jul;297:107383. doi: 10.1016/j.ahj.2026.107383. Epub 2026 Feb 17.
PMID: 41713761

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHypertension

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus Diseases

Results Point of Contact

Title: Olugbenga Ogedegbe, MD
Organization: NYU Langone Health

Study Officials

Olugbenga Ogedegbe, MD
NYU Langone Health
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

830 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: HEALTH SERVICES RESEARCH
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 11, 2021

Study Start

September 13, 2021

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Study Arms (2)

Self-directed without Practice Facilitation (PF)

With Practice Facilitation (PF)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Documents

Locations