Highlights
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29.9% of screened HIV patients were found to have hypertension.
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Over half of enrolled participants were overweight or obese (63.9%).
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Only 25.8% continued prior antihypertension treatment.
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Findings highlight the need to integrate hypertension control into HIV care in Nigeria.
ABSTRACT
Background
Improved access to antiretroviral therapy (ART) has increased survival among people living with HIV (PLWH) but also the burden of cardiovascular risk factors like hypertension. While the task-strengthening strategy for hypertension control (TASSH) is a viable integrated care model, evidence of its clinical impact in Africa is limited. This report presents baseline findings from a trial evaluating 2 implementation strategies for integrating TASSH into HIV care across primary health centers (PHCs) in Lagos, Nigeria.
Methods
A total of 3,504 PLWH on antiretroviral therapy in 30 PHCs were screened, and 830 were enrolled. Baseline data on patient sociodemographic, clinical, laboratory results, and lifestyle characteristics were gathered.
Results
Among the 3,504 screened, 1,046 (29.9%) had hypertension. Of the 830 enrolled, mean [SD] age was 49.4 [9.5] years, 63.5% were women, 69.5% had at least secondary school education, 92.3% were employed, and 84.6% earned less than 100,000 Naira (64.74 USD) monthly. The median BP was 150.0/95.3 mmHg, and 63.9% were overweight or obese. 25.8% continued previously prescribed antihypertensive medications, while 66.3% received new prescriptions. Additionally, 25.1% and 1.8% were alcohol users and current smokers, while 30.9% were physically inactive.
Conclusions
The prevalence of hypertension among PLWH was higher than previously reported. Although most participants adopted healthy lifestyle behaviors, the majority were overweight or obese, and many were not on antihypertensive medications. These findings highlight the importance of integrating hypertension control into HIV care across PHCs in Nigeria.
Trial Registration
ClinicalTrials.gov (NCT04704336). Registered on January 11, 2021. https://clinicaltrials.gov/study/NCT04704336 .
Introduction
Sub-Saharan Africa accounts for 70% of the global HIV burden, and about two-thirds of HIV infections in West and Central Africa occur in Nigeria. , While expanded access to antiretroviral therapy (ART) has improved survival among people living with HIV (PLWH), they remain at elevated risk for noncommunicable diseases (NCDs). Compared to the general population, PLWH have higher cardiovascular disease (CVD) morbidity and mortality due to the increased burden of hypertension. ,, Thus, there is an urgent need for strategies to reduce the burden of hypertension among PLWH in Nigeria, especially those aimed at the efficient use of available resources.
There is growing consensus that integration of hypertension management into HIV care platforms may be cost-effective for addressing the rising burden of hypertension among PLWH. , By leveraging the established infrastructure, resources, and patient base of HIV clinics, healthcare systems can efficiently expand access to screening, diagnosis, and treatment of hypertension. Although the need for integrated HIV/NCD care is recognized, evidence supporting context-specific strategies in Africa is limited. In addition, despite the availability of evidence-based interventions for hypertension control, shortages of healthcare workers in Nigeria remains a major barrier to hypertension management. In 2022, there were 38 health workers and 3.9 physicians per 10,000 people, below the recommended World Health Organization (WHO) threshold of 44.5 health workers and global average density of 17.2 physicians per 10,000 people. The acute shortage of physicians limits Nigeria’s capacity to control hypertension in PLWH at the level of primary healthcare centers (PHCs), where the majority of citizens receive care. To address this deficit, the Nigerian Ministry of Health developed a task shifting policy to be implemented at national and sub-national levels of its healthcare system. ,
Task shifting, a strategy that involves delegating specific healthcare tasks from physicians to other healthcare workers, such as nurses, pharmacists, and community health workers, has shown promise to improve access to healthcare services in resource-constrained settings. By empowering these healthcare workers with the necessary trainings and resources to manage hypertension, task shifting can reduce patient waiting times and enhance the quality of care provided to the populace. While “Task-shifting and Task-sharing Policy for Essential Health Care Services in Nigeria” has been instituted since 2014, there is no evidence of its implementation as a strategy to integrate NCD management into the HIV care cascade. The Task-Strengthening Strategy for Hypertension Control (TASSH) based on the WHO Package of Essential Non-Communicable Disease Intervention for Primary Care (WHO PEN) is an evidenced-based application of task shifting specifically focused on addressing CVD risk factors using hypertension as an entry point. ,,,
Practice facilitation (PF) is a practical implementation strategy that provides external expertise on practice redesign and promotes a tailored approach in implementing system changes to improve patient outcomes. This involves practice facilitators (typically nurses) and a structured process to help primary care teams build capacity and adopt evidence-based strategies such as task shifting. ,,,, Although previous studies have demonstrated the effectiveness and sustainability of PF in implementing evidence-based strategies for preventive services, this is the first study to use PF as an implementation strategy to integrate a nurse-led intervention within the HIV care cascade in Nigeria. ,,,
The integration of the TASSH strategy into HIV care in Nigeria trial was designed to evaluate the comparative effectiveness of 2 implementation strategies (PF versus self-directed condition) for integrating TASSH into care of PLWH across 30 PHCs in Lagos, Nigeria. In this manuscript, we characterize baseline data of trial participants and provide valuable information for future interventions.
Methods
A detailed description of the rationale, study design, and sample size calculation of this trial has been published elsewhere. Briefly, this study was conducted in 3 phases using a mixed-methods hybrid type II effectiveness-implementation design. Two implementation frameworks: the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM) guided the study. The 3 sequential phases contained a preimplementation phase that used the CFIR to develop a context-specific PF strategy for integrating TASSH into HIV clinics; an implementation phase that conducted a cluster randomized controlled trial of 30 PHCs and 830 PLWH with uncontrolled hypertension in Lagos, Nigeria and compared the effect of PF versus a self-directed condition on systolic blood pressure (SBP) reduction at 12 months; and a postimplementation phase that used RE-AIM to compare the effect of PF versus self-directed condition on adoption and sustainability of TASSH at 12 and 24 months, respectively.
The primary outcome is a change in SBP from baseline to 12 months of TASSH implementation and the secondary outcomes are to evaluate the rate of adoption and sustainability of the TASSH intervention across the PHCs at 12 and 24 months, respectively. The rate of adoption of TASSH is defined as the proportion of patients who are correctly diagnosed with hypertension and receive lifestyle counseling and antihypertensive treatment from the interventionists. The sustainability of TASSH is defined as the maintenance of TASSH uptake at the PHCs 1-year post-trial.
The Nigerian Institute of Medical Research (NIMR) served as the Research Coordinating Center for the study. The study was conducted in collaboration with the Lagos State Primary Healthcare Board. This study was approved by the institutional review boards of New York University Grossman School of Medicine and NIMR. A Data and Safety Monitoring Board provided independent governance oversight. The project baseline study and the analysis reported were funded by the National Heart, Lung, and Blood Institute (NHLBI). The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents.
Study recruitment
NIMR selected 30 of the 67 PHCs registered with the Lagos State Primary Healthcare Board. Eligible PHCs were selected to ensure geographic diversity across Lagos State, with a balanced distribution of 15 urban and 15 rural sites. The vast majority of eligible PHCs were public, government-operated clinics. On average, clinic providers cared for approximately 394 PLWH per month, with the number of hypertensive HIV patients ranging from 5 to 73 per facility. Additional details on the characteristics of eligible PHCs have been published elsewhere.
Recruitment was conducted using an iterative, practice-informed approach across PHCs. Initial recruitment relied primarily on routine in-clinic identification of eligible patients receiving ART at the selected PHCs for at least 6 months, with enrollment facilitated by trained nurses and clinical healthcare officers (CHOs). As recruitment progressed, enrollment trends and site-level challenges were reviewed regularly, and recruitment strategies were modified to address observed barriers to participation (Supplementary Table 1). These modifications included expanding recruitment roles to pharmacists who frequently interact with PLWH in the community, aligning screening and enrollment visits to reduce travel burden, extending cohort onboarding periods, and increasing recruitment staffing capacity.
To improve equitable access to all qualified patients, free antihypertensive medications were extended to indigent participants, additional community-based referral pathways (“feeder sites”) were introduced, and incentives were provided to frontline nurses to support sustained recruitment and follow-up. Detailed recruitment challenges have been described elsewhere. In summary, recruitment performance and operational challenges varied across sites due to differences in patient volume, staffing capacity, and local context, including chronic workforce shortages, competing clinical responsibilities, variability in clinic workflows (e.g., patients presenting only for medication refills), and disruptions related to the COVID-19 pandemic. These factors necessitated site-specific adjustments in recruitment timing, staffing deployment, and referral mechanisms. Regular cross-site communication and monitoring of enrollment progress facilitated shared learning and coordination among study teams, enabling timely adaptation of recruitment strategies and contributing to successful enrollment. The study contained 5 enrollment waves of 6 PHCs each, with recruitment targets ranging from 111 to 289 patients per wave, and an overall target of 992 patients (see Supplementary Table 2).
Study population and eligibility
Participants were eligible for the study if they met the following criteria: aged 18 years or older with uncontrolled hypertension (defined as SBP between 140 and 179 mmHg or diastolic blood pressure (DBP) between 90 and 109 mmHg), received HIV treatment care at the selected 30 PHCs, and were able to provide consent. Individuals with severe hypertension (defined as BP ≥180/110 mmHg), a history of chronic kidney disease, diabetes, heart disease, stroke, ongoing pregnancy or breastfeeding mothers were excluded. All eligible participants provided written informed consent. A total of 3,504 participants were assessed for eligibility between 2021 and 2023, of which 2,661 were excluded. Among the 843 eligible and consented participants, 13 didn’t enroll due to personal reasons and 830 were successfully enrolled into the study. Randomization occurred at the level of the PHCs in 5 enrollment waves, with wave sizes ranging from 118 to 211 participants ( Figure 1 ). Figure 1 illustrates the flow of participants in a CONSORT diagram.
Flow of participants through study recruitment and enrollment.
Intervention
As described in the study protocol, participating PHCs were randomized equally to either the PF enhanced (PF + TASSH) arm or the self-directed control (TASSH only) arm. Nurses/CHOs in both arms received training on the TASSH protocol (cardiovascular risk assessment, lifestyle counseling, medication prescription using Nigeria’s hypertension treatment protocol, and referral procedures for PLWH with complicated hypertension) and delivering the intervention components using the 5A’s counseling strategy (Ask, Assess, Advise, Assist, and Arrange).
In addition to this core training, PHCs randomized to the PF enhanced arm received ongoing implementation support from trained practice facilitators over a 12-month period. Each practice facilitator conducted 13 site visits (2 in the first month, and monthly thereafter), supplemented by monthly peer-to-peer telephone support calls. PF activities included coaching, problem solving, audit and feedback, and performance monitoring to support fidelity and uptake of TASSH. The intensity, frequency, and content of PF activities were standardized across sites and are described in detail in the published study protocol.
Inter-site coordination and monitoring
At the operational level, implementation of the study protocol was monitored by the Nigeria-based study team, including the in-country principal investigator and dedicated research staff, who met bi-weekly to review study progress, recruitment and retention, data quality, and adherence to the study protocol and good clinical practice. These meetings facilitated timely identification of site-specific challenges, including variability in staffing capacity, clinic workflows, and external disruptions. All challenges were communicated with the site-specific nurses and CHOs for corrective actions or tailored support as needed. Monthly meetings between Nigeria-based teams and investigators outside the country ensured shared decision-making, consistent application of study procedures, and rapid resolution of cross-site issues.
Baseline assessments
Participants data were collected via self-reported surveys and standardized measurement of vital signs, laboratory assessments, and urinalysis. Research coordinators and nurses/CHOs collected participants’ sociodemographic, clinical, laboratory results, and lifestyle characteristics using valid measures (Supplementary Table 3).
Among the characteristics, the socioeconomic status was calculated from household wealth index using Demographic Health Surveys guideline. The wealth index was categorized into low, medium, and high based on its tertiles in ascending order, as household socioeconomic status. Body mass index (BMI) was calculated using participants’ height and weight and classified as underweight (<18.5), normal (18.5-24.9), overweight (25.0-29.9), and obese (≥30.0).
BP measurement techniques and protocol reported in the manuscript aligned and was in accordance with standard clinic BP measurements that have been utilized in major clinical trials and according to the American Heart Association and BP measurement guidelines. Three BP readings were taken by trained research coordinators using validated Omron M2 Basic (HEM-7121J-E) BP monitors with participant seated comfortably for 5 minutes prior to the measurement. The average of 3 BP readings were used as the baseline BP measurements. The same brand of BP monitors was used across all sites and measurements were obtained during daytime clinic hours (usually in the morning). All participants refrained from alcohol and tobacco consumption for at least 30 minutes prior to BP assessments. Antihypertensive medications were administered either in the morning or evening and were scheduled at least 2 hours before or after ART to minimize potential drug interactions. Although the timing of antihypertensive administration relative to blood pressure measurement could not be fully standardized, prior studies have not demonstrated clinically meaningful differences in blood pressure levels based on morning versus evening dosing. Resting heart rate was measured after participants had been seated quietly for at least 5 minutes.
Additionally, participants’ physical activity profiles were assessed using the Global Physical Activity Questionnaire version 2 (GPAQv2) during one-on-one interviews, with the aid of show cards to facilitate responses. , The GPAQv2 comprises 16 items designed to quantify participants’ habitual physical activity during a typical week. The duration (minutes per day) and frequency (days per week) of physical activity were collected across 3 domains: occupational activity, transport-related activity, and recreational activity. Physical activities were classified by intensity as vigorous (8 metabolic equivalents of task [METs]) or moderate (4 METs), in accordance with the GPAQ scoring protocol. Total physical activity volume was expressed as MET-minutes per week, calculated by multiplying activity duration, frequency, and the corresponding MET values. Rigorous data cleaning was implemented to minimize bias inherent in self-reported process, following the GPAQ scoring protocol. Specifically, the following steps were applied:
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Verification and correction of time entries across all activity sub-domains to address common data-entry errors.
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Exclusion of participants from all analyses if their responses contained implausible maximum values, inconsistent answers, or other violations of GPAQ validity criteria in any sub-domain.
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For participants reporting unusually high durations of moderate- or vigorous-intensity activity (i.e., more than 4 hours per day) within any sub-domain, responses were reverified with the interviewee and consultation with the corresponding data collection team.
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Cross-domain consistency checks were conducted to identify and exclude cases with implausible total time spent on physical activity across all domains.
According to the WHO recommendations, adults should engage in at least 150 minutes of moderate-intensity physical activity, 75 minutes of vigorous-intensity physical activity, or an equivalent combination of both achieving at least 600 MET-minutes per week. Participants were subsequently classified as physically active or physically inactive based on whether they met this guideline.
Data collection and monitoring
Data were collected and recorded by trained HIV nurses/CHOs on case record forms and were entered into the web-based Research Electronic Data Capture (REDCap) system, with all data securely hosted on a server at NIMR. We have described the statistical methods used to handle missing data elsewhere. Additionally, REDCap included built-in validation and consistency checks to ensure data quality. Data managers at NIMR conducted weekly data monitoring, including outlier identification and data query generation, which were communicated to nurses/CHOs via research coordinators for verification and corrections. Data were reviewed by the principal investigators, data managers, and statisticians monthly, with identified issues communicated to the research coordinators.
Analytic objectives and statistical analysis
In this manuscript, we aim to describe the baseline sociodemographic, clinical, laboratory results, and lifestyle characteristics of trial participants to identify potential barriers to hypertension control among PLWH. Additionally, we described differences between enrollment waves at the baseline visit.
The study population was stratified by enrollment wave to conduct descriptive analysis without knowledge of the randomization assignment. Frequencies with corresponding percentages were reported for categorical variables. For continuous variables, the Shapiro-Wilk test was performed to measure the normality of data, the variables were summarized as means with standard deviations (SD) or medians with interquartile ranges (IQR), as appropriate. Statistical analysis was conducted with R 4.3.1.
Results
Sociodemographic characteristics
The baseline sociodemographic characteristics of enrolled participants are presented in Table 1 . The mean (SD) age of participants at enrollment was 49.4 (9.5) years, with a consistent distribution across 5 enrollment waves ranging from 48.2 to 50.7 years. Females constituted 63.5% of participants and 69.5% of total participants had at least secondary school degree. More than half of participants were married, and a significant proportion of the study population were employed and earned less than 100,000 Naira (64.74 USD) monthly. Ethnically, Yoruba and Igbo groups represented the largest proportion.
Table 1
Participants’ baseline sociodemographic characteristics overall and by enrollment wave
| Variables |
Overall
( n = 830) |
Enrollment wave 1
( n = 118) |
Enrollment wave 2
( n = 163) |
Enrollment wave 3
( n = 211) |
Enrollment wave 4
( n = 136) |
Enrollment wave 5
( n = 202) |
|---|---|---|---|---|---|---|
| Age, mean (SD) (years) ( n = 830) | 49.4 (9.5) | 49.8 (9.2) | 50.7 (9.4) | 48.9 (10.0) | 50.3 (9.3) | 48.2 (9.4) |
| Sex, no. (%) ( n = 8 30) | ||||||
| Male | 303 (36.5) | 51 (43.2) | 71 (43.6) | 60 (28.4) | 49 (36.0) | 72 (35.6) |
| Female | 527 (63.5) | 67 (56.8) | 92 (56.4) | 151 (71.6) | 87 (64.0) | 130 (64.4) |
| Education, no. (%) ( n = 829) | ||||||
| Never attended school | 38 (4.6) | 5 (4.2) | 4 (2.5) | 14 (6.6) | 4 (2.9) | 11 (5.4) |
| Primary school | 214 (25.8) | 34 (28.8) | 40 (24.5) | 66 (31.3) | 34 (25.0) | 40 (19.8) |
| Secondary school | 386 (46.5) | 48 (40.7) | 84 (51.5) | 90 (42.7) | 68 (50.0) | 96 (47.5) |
| University or higher degree | 191 (23.0) | 31 (26.3) | 35 (21.5) | 41 (19.4) | 30 (22.1) | 54 (26.7) |
| Missing | 1 (0.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.5) |
| Marital, no. (%) ( n = 830) | ||||||
| Single | 88 (10.6) | 6 (5.1) | 16 (9.8) | 28 (13.3) | 15 (11.0) | 23 (11.4) |
| Married | 480 (57.8) | 72 (61.0) | 104 (63.8) | 112 (53.1) | 80 (58.8) | 112 (55.4) |
| Divorced/Separated | 110 (13.3) | 18 (15.3) | 15 (9.2) | 35 (16.6) | 12 (8.8) | 30 (14.9) |
| Widowed | 152 (18.3) | 22 (18.6) | 28 (17.2) | 36 (17.1) | 29 (21.3) | 37 (18.3) |
| Ethnicity, no. (%) ( n = 826) | ||||||
| Yoruba | 399 (48.1) | 52 (44.1) | 63 (38.7) | 119 (56.4) | 59 (43.4) | 106 (52.5) |
| Igbo | 269 (32.4) | 43 (36.4) | 67 (41.1) | 57 (27.0) | 55 (40.4) | 47 (23.3) |
| Hausa | 27 (3.3) | 4 (3.4) | 6 (3.7) | 8 (3.8) | 2 (1.5) | 7 (3.5) |
| Others | 131 (15.8) | 19 (16.1) | 26 (16.0) | 26 (12.3) | 20 (14.7) | 40 (19.8) |
| Missing | 4 (0.5) | 0 (0.0) | 1 (0.6) | 1 (0.5) | 0 (0.0) | 2 (1.0) |
| Employment, no. (%) ( n = 829) | ||||||
| Employed | 766 (92.3) | 101 (85.6) | 154 (94.5) | 196 (92.9) | 132 (97.1) | 183 (90.6) |
| Unemployed | 63 (7.6) | 17 (14.4) | 8 (4.9) | 15 (7.1) | 4 (2.9) | 19 (9.4) |
| Missing | 1 (0.1) | 0 (0.0) | 1 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Monthly income, no. (%) ( n = 767) | ||||||
| <30,000 Naira/19.42 USD | 288 (34.7) | 49 (41.5) | 44 (27.0) | 88 (41.7) | 50 (36.8) | 57 (28.2) |
|
30,000-100,000 Naira
(19.42-64.74 USD) |
414 (49.9) | 39 (33.1) | 83 (50.9) | 97 (46.0) | 80 (58.8) | 115 (56.9) |
|
100,000-300,000 Naira
(64.74-194.22 USD) |
60 (7.2) | 8 (6.8) | 18 (11.0) | 11 (5.2) | 4 (2.9) | 19 (9.4) |
| >300,000 Naira/194.22 USD | 5 (0.6) | 1 (0.8) | 3 (1.8) | 1 (0.5) | 0 (0.0) | 0 (0.0) |
| Missing | 63 (7.6) | 21 (17.8) | 15 (9.2) | 14 (6.6) | 2 (1.5) | 11 (5.4) |
| Socioeconomic status, no. (%) ( n = 766) | ||||||
| Low | 256 (30.8) | 49 (41.5) | 27 (16.6) | 93 (44.1) | 19 (14.0) | 68 (33.7) |
| Middle | 255 (30.7) | 15 (12.7) | 38 (23.3) | 56 (26.5) | 82 (60.3) | 64 (31.7) |
| High | 255 (30.7) | 41 (34.7) | 88 (54.0) | 41 (19.4) | 29 (21.3) | 56 (27.7) |
| Missing | 64 (7.7) | 13 (11.0) | 10 (6.1) | 21 (10.0) | 6 (4.4) | 14 (6.9) |
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