Integration of Hypertension Management Into HIV Care in Nigeria (TASSH NIMR)

• ClinicalTrials.gov Identifier: NCT04704336
• Recruitment Status: Recruiting
• First Posted: January 11, 2021
• Last Update Posted: December 20, 2021
• Sponsor: NYU Langone Health
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Human Immunodeficiency Virus; Hypertension	Behavioral: Task-shifting strategy for HTN control (TASSH) protocol	Not Applicable

Detailed Description:

Although access to antiretroviral therapy has led to increased survival among people living with HIV (PWH) in Africa, this population now has higher cardiovascular disease (CVD) - mortality than the general population largely due to an increased burden of hypertension. In Nigeria, the acute shortage of physicians limits the capacity to control hypertension among PWH at the primary care level where the majority receive treatment. This study proposes the use of practice facilitation (PF) - which will provide external expertise on practice redesign and a tailored approach to delivery of the evidence-based task strengthening strategy - to integrate hypertension into the HIV care model. Using a clinical-effectiveness implementation design, we will evaluate the effect of a PF strategy for integrating an evidence-based intervention for hypertension (HTN) control into HIV care among 960 patients with uncontrolled HTN in 30 primary health centers (PHCs) in Nigeria. Study is in 3 phases: 1) a pre-implementation phase that will develop a tailored PF intervention for integrating TASSH into HIV clinics; 2) an implementation phase that will compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and 3) a post- implementation phase to evaluate the effect of PF vs. self-directed condition on the adoption and sustainability of TASSH. The PF intervention comprises: (a) an advisory board to provide leadership support for implementing TASSH in HIV clinics; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the HIV nurses

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 960 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Integration of Hypertension Management Into HIV Care in Nigeria: A Task Strengthening Strategy
• Actual Study Start Date: August 24, 2021
• Estimated Primary Completion Date: October 31, 2025
• Estimated Study Completion Date: December 31, 2025

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Self-directed without Practice Facilitation (PF); Participants will be identified from HIV clinics during routine visits and provided standard of care.
Experimental: With Practice Facilitation (PF); 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; 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

Outcome Measures

Primary Outcome Measures :

1. Change in systolic Blood Pressure [ Time Frame: baseline, 6 months, 12 months, 18 months and 24 months ]
   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.

Secondary Outcome Measures :

1. The rate of adoption of TASSH across participating primary health centers (PHCs) at 12- and 24 months respectively. [ Time Frame: 12 months ]
   Rate of adoption of TASSH is defined as the proportion of patients who were correctly diagnosed with hypertension, received lifestyle counseling and antihypertensive treatment from HIV nurses at 12 months. In order to assess this measure, the nurses will complete a questionnaire inquiring about the number of patients with uncontrolled HTN who received lifestyle counseling and medication treatment. For this purpose, all nurses will be required to keep an attendance log sheet for their patients' visits.
2. The rate of sustainability of TASSH across participating primary health centers (PHCs) at 12- and 24 months respectively. [ Time Frame: 24 months ]
   Sustainability of TASSH is defined as the maintenance of TASSH uptake at the HIV clinics at 24 months (one year after the end of the intervention). Sustainability will be assessed with a quantitative measure similar to adoption (as defined above) and qualitatively, based on interviews with nurses and clinic leadership at 24 months. For this purpose, two research coordinators will conduct the interviews with two nurses and one key leadership personnel at each primary health center (PHCs). The interviews will be guided by Consolidated Framework for Implementation Research (CFIR) and inquire about attitudes regarding the implementation of TASSH, barriers, facilitators, and implications for scalability.
3. Change in Implementation Climate of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months. [ Time Frame: 12 months and 24 months ]
   Implementation Climate will be assessed with the Implementation Climate Scale. It measures shared perceptions of policies, practices, procedures, and behaviors that are expected, supported, and rewarded to facilitate effective evidence-based practice (EBP) implementation. It has a Cronbach's alpha of .91. The six subscales of EBP Implementation Climate are: focus on EBP (α=.91), educational support for EBP (α=.84), recognition for EBP (α=.88), rewards for EBP (α=.81), selection for EBP (α=.89), and selection for openness (α=.91).
4. Change in Implementation Leadership of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months. [ Time Frame: 12 months and 24 months ]
   Implementation Leadership will be assessed with the Implementation Leadership Scale (ILS). It is a 12-item measure with four subscales: Proactive Leadership (α=.95), Knowledgeable Leadership (α=.96), Supportive Leadership (α=.95), and perseverant leadership (α=.96) and a total score (α=.98).
5. Change in Proficiency of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months. [ Time Frame: 12 months and 24 months ]
   Organizational Culture domain of the Organizational Social Context Scale is a 15-item Proficiency subscale used to evaluate the practice capacity proficiency level of the primary health centers (PHCs). Proficient Organizational Cultures are those characterized by shared norms and expectations that the nurses are skilled service providers, and have current knowledge of the TASSH protocol. Items are completed using a 5-point rating scale ranging from 1 (never) to 5 (always) with measures such as responsiveness (e.g., 'members of my organizational unit are expected to be responsive to the needs of each patient') and competence (e.g., 'members of my organizational unit are expected to have up-to-date knowledge'). Alpha reliability for the proficient culture scale is .89.
6. Change in Organizational Readiness of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months. [ Time Frame: 12 months and 24 months ]
   Organizational Readiness to Change is assessed with the 12-item Evidence Scale, which evaluates the strength of the evidence for the proposed change/innovation. It will be used to evaluate intervention process measures focused on CFIR's Evidence Strength & Quality and Relative Advantage construct. Each item measures the extent to which a respondent agrees or disagrees with the item statement on a 5-point Likert- type scale (1 = strongly disagree; 5 = strongly agree) and the Cronbach α=0.74.
7. Change in implementation process across the primary health centers (PHCs) at 12 and 24 months. [ Time Frame: 12 months and 24 months ]
   External change agent support is a 3-item tool that evaluates support provided by external facilitators, the expectations about performance and improvement, and the ways to achieve the goal of the project. Items are scored on a 5-point Likert scale and the Cronbach α=0.77.
8. Change in Organizational capacity to change across the primary health centers (PHCs) at 12 and 24 months. [ Time Frame: 12 months and 24 months ]
   Organizational Readiness to Change (Facilitation Scale-8-items), which evaluates organizational capacity to facilitate change will be used to evaluate implementation process measures focused on CFIR Engaging construct. Each item measures the extent to which a respondent agrees or disagrees with the item statement on a 5-point Likert-type scale (1 = strongly disagree; 5 = strongly agree). It has Cronbach α=0.95.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• BP>180/100 mm Hg;
• history of chronic kidney disease, heart disease, diabetes or stroke, pregnancy
• Inability to provide informed consent.
• Refusal to participate in the study.

Contacts and Locations

Contacts

Contact: Olugbenga Ogedegbe, MD; 646-501-3435; Olugbenga.Ogedegbe@nyulangone.org

Contact: Lloyd Gyamfi; 646-501-3469; Lloyd.Gyamfi@nyulangone.org

Locations

United States, Missouri

Saint Louis University (SLU); Not yet recruiting

Saint Louis, Missouri, United States, 63103

Contact: Juliet Iwelunmor, PhD juliet.iwelunmor@slu.edu

Contact: David A Oladele, MB,BS, MPH, MSc David.Oladele@slu.edu

Principal Investigator: Juliet Iwelunmor, PhD

Nigeria

Nigerian Institute of Medical Research (NIMR); Recruiting

Yaba, Lagos, Nigeria

Contact: Oliver C Ezechi, MBBS, MPA, PhD, FWACS, FMCOG +2348033065683 oezechi@yahoo.co.uk

Contact: Tosin Odubela, MD, MPH +2348083946078 amco4all@yahoo.com

Principal Investigator: Oliver C Ezechi, MBBS, MPA, PhD, FWACS, FMCOG

Sponsors and Collaborators

NYU Langone Health

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Olugbenga Ogedegbe, MD; NYU Langone Health

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04704336
• Other Study ID Numbers: 20-00009; R01HL147811-01A1 ( U.S. NIH Grant/Contract )
• First Posted: January 11, 2021
• Last Update Posted: December 20, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All of the individual participant data collected during the trial, after deidentification.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NYU Langone Health:

Hypertension; Implementation science research; Integrated models; Practice Facilitation; People living with HIV; Human Immunodeficiency Virus; Cluster trial

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Hypertension; Immunologic Deficiency Syndromes; Vascular Diseases; Cardiovascular Diseases; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases