Trial Outcomes & Findings for Integration of Hypertension Management Into HIV Care in Nigeria (NCT NCT04704336)
NCT ID: NCT04704336
Last Updated: 2025-10-31
Results Overview
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.
ACTIVE_NOT_RECRUITING
NA
830 participants
Baseline, Month 12
2025-10-31
Participant Flow
Unit of analysis: Primary Health Centers (PHCs)
Participant milestones
| Measure |
Self-directed Without Practice Facilitation (PF)
Participants will be identified from HIV clinics during routine visits and provided standard of care.
|
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.
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
|
|---|---|---|
|
Overall Study
STARTED
|
353 15
|
477 15
|
|
Overall Study
COMPLETED
|
318 15
|
435 15
|
|
Overall Study
NOT COMPLETED
|
35 0
|
42 0
|
Reasons for withdrawal
| Measure |
Self-directed Without Practice Facilitation (PF)
Participants will be identified from HIV clinics during routine visits and provided standard of care.
|
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.
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
|
|---|---|---|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
33
|
40
|
Baseline Characteristics
Integration of Hypertension Management Into HIV Care in Nigeria
Baseline characteristics by cohort
| Measure |
Self-directed Without Practice Facilitation (PF)
n=353 Participants
Participants will be identified from HIV clinics during routine visits and provided standard of care.
|
With Practice Facilitation (PF)
n=477 Participants
Participants will be identified from HIV clinics during routine visits and will receive the task-shifting strategy for HTN control (TASSH) protocol.
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
|
Total
n=830 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
238 Participants
n=5 Participants
|
289 Participants
n=7 Participants
|
527 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
353 Participants
n=5 Participants
|
477 Participants
n=7 Participants
|
830 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
353 Participants
n=5 Participants
|
477 Participants
n=7 Participants
|
830 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Nigeria
|
353 participants
n=5 Participants
|
477 participants
n=7 Participants
|
830 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12The 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.
Outcome measures
| Measure |
Self-directed Without Practice Facilitation (PF)
n=353 Participants
Participants will be identified from HIV clinics during routine visits and provided standard of care.
|
With Practice Facilitation (PF)
n=477 Participants
Participants will be identified from HIV clinics during routine visits and will receive the task-shifting strategy for HTN control (TASSH) protocol.
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
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
-12.8 Change in SBP (mmHg)
Interval -14.9 to -10.7
|
-15.1 Change in SBP (mmHg)
Interval -16.5 to -13.7
|
SECONDARY outcome
Timeframe: Month 12Rate 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 24Sustainability 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12Implementation 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 24Implementation 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12Implementation 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 24Implementation 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12Proficiency 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 24Proficiency 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12Organizational 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 24Organizational 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12External 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 24External 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12Organizational 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 24Organizational 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.
Outcome measures
Outcome data not reported
Adverse Events
Self-directed Without Practice Facilitation (PF)
With Practice Facilitation (PF)
Serious adverse events
| Measure |
Self-directed Without Practice Facilitation (PF)
n=353 participants at risk
Participants will be identified from HIV clinics during routine visits and provided standard of care.
|
With Practice Facilitation (PF)
n=477 participants at risk
Participants will be identified from HIV clinics during routine visits and will receive the task-shifting strategy for HTN control (TASSH) protocol.
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
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular accident (CVA)
|
0.28%
1/353 • Follow-up until end of Month 24.
Non-systematic.
|
0.63%
3/477 • Follow-up until end of Month 24.
Non-systematic.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/353 • Follow-up until end of Month 24.
Non-systematic.
|
0.42%
2/477 • Follow-up until end of Month 24.
Non-systematic.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/353 • Follow-up until end of Month 24.
Non-systematic.
|
0.21%
1/477 • Follow-up until end of Month 24.
Non-systematic.
|
|
Vascular disorders
Hypertensive Crisis
|
0.85%
3/353 • Follow-up until end of Month 24.
Non-systematic.
|
0.00%
0/477 • Follow-up until end of Month 24.
Non-systematic.
|
|
Nervous system disorders
Bell's Palsy
|
0.00%
0/353 • Follow-up until end of Month 24.
Non-systematic.
|
0.21%
1/477 • Follow-up until end of Month 24.
Non-systematic.
|
|
Renal and urinary disorders
Kidney Problem
|
0.00%
0/353 • Follow-up until end of Month 24.
Non-systematic.
|
0.21%
1/477 • Follow-up until end of Month 24.
Non-systematic.
|
|
Skin and subcutaneous tissue disorders
Chronic Left Leg Ulcer
|
0.00%
0/353 • Follow-up until end of Month 24.
Non-systematic.
|
0.21%
1/477 • Follow-up until end of Month 24.
Non-systematic.
|
Other adverse events
| Measure |
Self-directed Without Practice Facilitation (PF)
n=353 participants at risk
Participants will be identified from HIV clinics during routine visits and provided standard of care.
|
With Practice Facilitation (PF)
n=477 participants at risk
Participants will be identified from HIV clinics during routine visits and will receive the task-shifting strategy for HTN control (TASSH) protocol.
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
|
|---|---|---|
|
Gastrointestinal disorders
Diarrheal Disease
|
0.57%
2/353 • Follow-up until end of Month 24.
Non-systematic.
|
0.00%
0/477 • Follow-up until end of Month 24.
Non-systematic.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place