NCT04704336

Brief Summary

This study evaluates a tailored-practice facilitation (PF) strategy for integrating a task strengthening strategy for hypertension control (TASSH) for the care of patients living with HIV (PWH) within primary health centers (PHCs) in Lagos, Nigeria.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
830

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

September 13, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

October 31, 2025

Status Verified

October 1, 2025

Enrollment Period

2.9 years

First QC Date

January 8, 2021

Results QC Date

September 24, 2025

Last Update Submit

October 17, 2025

Conditions

Human Immunodeficiency VirusHypertension

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

  • Implementation Climate Across PHCs at 12 Months

    Month 12

  • Implementation Climate Across PHCs at 24 Months

    Month 24

  • Implementation Leadership Across PHCs at 12 Months

    Month 12

  • +9 more secondary outcomes

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)

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

You may not qualify if:

  • BP\>180/110 mm Hg;
  • history of chronic kidney disease, heart disease, diabetes or stroke, pregnancy
  • Inability to provide informed consent.
  • Refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint Louis University (SLU)

St Louis, Missouri, 63103, United States

Location

Nigerian Institute of Medical Research (NIMR)

Yaba, Lagos, Nigeria

Location

Related Publications (2)

  • Iwelunmor J, Ezechi O, Obiezu-Umeh C, Oladele D, Nwaozuru U, Aifah A, Gyamfi J, Gbajabiamila T, Musa AZ, Onakomaiya D, Rakhra A, Jiyuan H, Odubela O, Idigbe I, Engelhart A, Tayo BO, Ogedegbe G. Factors influencing the integration of evidence-based task-strengthening strategies for hypertension control within HIV clinics in Nigeria. Implement Sci Commun. 2022 Apr 15;3(1):43. doi: 10.1186/s43058-022-00289-z.

    PMID: 35428342DERIVED

  • Aifah AA, Odubela O, Rakhra A, Onakomaiya D, Hu J, Nwaozuru U, Oladele DA, Odusola AO, Idigbe I, Musa AZ, Akere A, Tayo B, Ogedegbe G, Iwelunmor J, Ezechi O. Integration of a task strengthening strategy for hypertension management into HIV care in Nigeria: a cluster randomized controlled trial study protocol. Implement Sci. 2021 Nov 16;16(1):96. doi: 10.1186/s13012-021-01167-3.

    PMID: 34789277DERIVED

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 DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Olugbenga Ogedegbe, MD
Organization
NYU Langone Health
Olugbenga.Ogedegbe@nyulangone.org
646-501-3435

Study Officials

  • Olugbenga Ogedegbe, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

Primary Completion

August 5, 2024

Study Completion

January 31, 2026

Last Updated

October 31, 2025

Results First Posted

October 31, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data.To achieve aims in the approved proposal. For individual participant data meta-analysis. Requests should be directed to Olugbenga.Ogedegbe@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US(1)NG(1)