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Human Immunodeficiency VirusTASSH NIMRNCT04704336

Integration of Hypertension Management Into HIV Care in Nigeria

A study of Human Immunodeficiency Virus and Hypertension, run by NYU Langone Health at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Human Immunodeficiency Virus, Hypertension
Could I receive a placebo?
No, everyone receives an active treatment
How many people
830 participants
Where
2 sitesin 2 countries
Study dates
13 Sep 2021to 31 Jan 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site
  • Saint Louis University (SLU)

    St Louis, Missouri, 63103

Other trials in United States

Nigeria1 site
  • Nigerian Institute of Medical Research (NIMR)

    Yaba, Lagos

Other trials in Nigeria

About this study

Official title: Integration of Hypertension Management Into HIV Care in Nigeria: A Task Strengthening Strategy

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.

Read the 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

Being tested
Task-shifting strategy for HTN control (TASSH) protocol
Keywords
Hypertension, Implementation science research, Integrated models, Practice Facilitation, People living with HIV, Human Immunodeficiency Virus, Cluster trial
Medical subject headings
Acquired Immunodeficiency Syndrome, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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

Study groups in NCT04704336
Study groupRoleWhat they receive
Self-directed without Practice Facilitation (PF)No interventionParticipants will be identified from HIV clinics during routine visits and provided standard of care.
With Practice Facilitation (PF)ExperimentalParticipants will be identified from HIV clinics during routine visits and will receive the task-shifting strategy for HTN control (TASSH) protocol.
Receives: Behavioral: Task-shifting strategy for HTN control (TASSH) protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Month 12

Secondary outcomes (14)
  1. Rate of Adoption of TASSH Across PHCs at 12 Months

    Rate of adoption of TASSH is defined as the proportion of patients who were diagnosed with HTN by the HIV nurses; received lifestyle counseling and antihypertensive treatment from HIV nurses. For this purpose, adoption will be assessed as a composite of the following measures: 1) the number of hypertensive patients diagnosed by the nurses using the WHO CVD risk assessment; 2) proportion of patients with HTN who received lifestyle counseling from the nurses; and 3) proportion of patients for whom the HIV nurses initiated treatment with antihypertensive medications. In order to assess this measure, the nurses will complete a questionnaire inquiring about the number of patients with uncontrolled HTN who received medication treatment and lifestyle counseling.

    Measured: Month 12

  2. Sustainability of TASSH Across PHCs at 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 composite quantitative measure similar to adoption 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).

    Measured: Month 24

  3. Implementation Climate Across PHCs at 12 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 is an 18-item questionnaire that comprises six subscales. Each item is rated on a 5-point Likert scale from 0-4; each subscale score is calculated as the mean score of the associated items; the total score is the average of the six subscale scores and ranges from 0-4. Higher scores indicate a climate that is highly supportive of implementing EBPs.

    Measured: Month 12

  4. Implementation Climate Across PHCs at 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 is an 18-item questionnaire that comprises six subscales. Each item is rated on a 5-point Likert scale from 0-4; each subscale score is calculated as the mean score of the associated items; the total score is the average of the six subscale scores and ranges from 0-4. Higher scores indicate a climate that is highly supportive of implementing EBPs.

    Measured: Month 24

  5. Implementation Leadership Across PHCs at 12 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). Each item is rated on an item-specific Likert scale. Each subscale score is calculated as the mean score of the associated items; the total score is the average of the four subscale scores and ranges from 0-4. Higher scores indicate greater implementation leadership.

    Measured: Month 12

  6. Implementation Leadership Across PHCs at 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). Each item is rated on an item-specific Likert scale. Each subscale score is calculated as the mean score of the associated items; the total score is the average of the four subscale scores and ranges from 0-4. Higher scores indicate greater implementation leadership.

    Measured: Month 24

  7. Change in Proficiency Across PHCs at 12 Months

    Proficiency will be assessed using the Organizational Culture domain of the Organizational Social Context Scale, 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'). The total score is the sum of responses and ranges from 15-75; higher scores indicate more proficient organizational cultures. Alpha reliability for the proficient culture scale is .89.

    Measured: Month 12

  8. Change in Proficiency Across PHCs at 24 Months

    Proficiency will be assessed using the Organizational Culture domain of the Organizational Social Context Scale, 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'). The total score is the sum of responses and ranges from 15-75; higher scores indicate more proficient organizational cultures. Alpha reliability for the proficient culture scale is .89.

    Measured: Month 24

  9. Change in Organizational Readiness to Change - Evidence Across PHCs at 12 Months

    Organizational Readiness to Change - Evidence 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. The total score is the sum of responses and ranges from 12 to 60; higher scores indicate greater strength of the evidence for the proposed change/innovation.

    Measured: Month 12

  10. Change in Organizational Readiness to Change - Evidence Across PHCs at 24 Months

    Organizational Readiness to Change - Evidence 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. The total score is the sum of responses and ranges from 12 to 60; higher scores indicate greater strength of the evidence for the proposed change/innovation.

    Measured: Month 24

  11. Change in External Change Agent Support Across PHCs at 12 Months

    External change agent support is assessed using 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 from 1-5 and the Cronbach α=0.77. The total score is the sum of responses and ranges from 3-15; higher scores indicate greater external change agent support.

    Measured: Month 12

  12. Change in External Change Agent Support Across PHCs at 24 Months

    External change agent support is assessed using 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 from 1-5 and the Cronbach α=0.77. The total score is the sum of responses and ranges from 3-15; higher scores indicate greater external change agent support.

    Measured: Month 24

  13. Change in Organizational Readiness to Change - Facilitation Across PHCs at 12 Months

    Organizational Readiness to Change - Facilitation is measured using the Facilitation Scale (8-items) 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. The total score is the sum of responses and ranges from 8-40; higher scores indicate greater organizational capacity to facilitate change.

    Measured: Month 12

  14. Change in Organizational Readiness to Change - Facilitation Across PHCs at 24 Months

    Organizational Readiness to Change - Facilitation is measured using the Facilitation Scale (8-items) 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. The total score is the sum of responses and ranges from 8-40; higher scores indicate greater organizational capacity to facilitate change.

    Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2021
  2. Study start13 Sep 2021
  3. Primary completion5 Aug 2024
  4. Study completion31 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
830 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04704336
Sponsor's protocol ID
20-00009
Other IDs
R01HL147811-01A1
Acronym
TASSH NIMR
Status last verified
May 2026
First submitted
8 Jan 2021
Last updated
24 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification.

Publications

  • 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.

    PubMed 41803985
  • 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.

    PubMed 41713761
  • 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.

    PubMed 35428342
  • 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.

    PubMed 34789277

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