Integrating Non-Communicable Disease (NCD) Screening to COVID-19 and Human Immunodeficiency Virus (HIV) care in Johannesburg South Africa (SA): a pilot model for low- and middle- income countries.
Study Sites
The study will be conducted at primary health clinics in Johannesburg, South Africa.
Sites will include River Park clinic complex based in Alexandra, Johannesburg. The clinic is being established to be part of an
academic platform (collaboration with University of Witwatersrand and University of Pretoria). The Alexandra community has access to academic care at a community level. The services offered at the clinic are maternal and child health, chronic disease and infectious disease management, men’s health, and vaccines. It is also currently one of the sites offering COVID-19 vaccines as part of the SA government vaccine roll out plan.
The other site is the Sunnyside clinical trial site of Ezintsha Research Centre, a division of Wits Health Consortium (Pty) (WHC), a wholly owned company of the University of the Witwatersrand. Ezintsha Research Centre is part of the School of Clinical Medicine within the Faculty of Health Sciences and has a multidisciplinary research team with considerable expertise and experience in conducting clinical trials and operations research involving people with HIV (PWH). Experience gained from this research has facilitated the Ezintsha research unit’s expansion into COVID-19 treatment and prevention trials to its research portfolio. The sites are near populations and cohorts relevant to research activities. Ezintsha Research Centre has a well-established Community Advisory Board and a proven track record of working effectively with community leaders and residents
Study Period Planned
Approximately 6 months
End of Study
This study is considered completed upon successful completion of screening, management, referral and follow-up for hypertension (HPT), type 2 diabetes (T2D), dyslipidaemia patients receiving COVID-19 vaccines, other vaccines or antiretroviral treatment (ART) until target sample size is achieved.
Background and Rationale
The year 2020 highlighted the important and inescapable link between infectious diseases and NCDs. During the COVID-19 pandemic, it has become evident that people living with a NCD are more at risk of infection thus more likely to die.1 The important link between communicable and NCD moves the solution from a silo-based approach to an integrated approach for treating NCD and infectious diseases. This pilot study aims to look at one such integrated approach.
In SA integrated care is not only looking at COVID-19 vaccine and NCDs but also HIV and NCDs. The dual burden of both COVID-19 and HIV has put a strain on the existing health care system and the cardiovascular (CV) risk factors in HPT, obesity, art (T2D), and dyslipidaemia are not well understood.
This study aims to look at the integrated approach of screening for NCDs in both the COVID-19 vaccine clinic, PHC vaccine clinic and HIV clinic thus offering a value-added service to clinic patients.
Primary Objectives
The primary objective of the study is to assess the prevalence, incidence, and impact of CV risk factors (HPT, obesity, T2D, dyslipidaemia) in patients receiving COVID-19 vaccines, other vaccines or ART.
Primary Endpoints
The primary endpoints is to measure the following and assess:
- Number of newly diagnosed HPT, T2D, and dyslipidaemia patients (specific measurements for diagnosis are specified in Appendix 1).
- Number of poorly controlled HPT, T2D, dyslipidaemia patients (specific measurements for control are specified in Appendix 1). Number of multi-morbidities in the 2 clinic settings CV risk score (see Appendix 1).
- Laboratory indicators for renal disease.
Secondary Objectives
The secondary objective is:
Integrated care: Training and supervision improvement of nurses to establish a primary health care (PHC) model of screening, and management, referral and follow-up for HPT, T2D, dyslipidaemia patients receiving COVID-19 vaccines, other vaccines or ART. Thus, facilitating integration of NCDs and HIV management.
Secondary Endpoints
The secondary endpoints are to measure the following and assess:
- Upskilling of trained nurses and other allied staff
These will be based on protocol training, Good Clinical Practice, data capturing and meeting study targets.
- Linkage of care: referrals of newly diagnosed and uncontrolled NCD patients to doctors.
Collect data on number of referrals. Use of formal referral forms will be reviewed.
Methodology
This is a descriptive quantitative low -interventional, prospective, study.
Inclusion/ Exclusion Criteria
Inclusion Criteria:
- All adults ≥18 years of age.
- Individual that has a mobile phone capable of receiving SMS, or WhatsApp messaging
- Newly diagnosed NCD (HPT/ diabetes/ dyslipidaemia/renal disease) and risk factors (obesity) at screening. or
- Existing NCDs (HPT/ diabetes/ dyslipidaemia/renal disease) that are uncontrolled.
Exclusion Criteria:
- Patients less than 18 years old.
- Participants who refuse consent or who are unable to provide informed consent.
- Vulnerable populations as deemed inappropriate for the study by site Principal Investigator or Study Nurse.
- Personnel (e.g., investigator, sub-investigator, research assistant, pharmacist, study coordinator or anyone mentioned in the delegation log) directly involved in the conduct of the study
- Participant is judged by the Principal Investigator or Study Nurse to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results.
Planned Number of Participants
This study aims to screen between 400-600 participants over a period of 6 months.
Convenience sampling will be performed for the selected patients. Patients will be sampled from the total number of patients initiated between July 2023 and December 2023.
Statistical Methods
Descriptive statistics which includes collection of following data on patient characteristics.
- Age, sex, race
- NCD screening data blood pressure (BP), pulse, body mass index (BMI)
- Point of care (POC) tests: Haemoglobin A1c (HbA1c), Total Cholesterol, High density lipoprotein(HDL), Glucose, Creatine (Crr), estimated glomerular filtrate rate (e-GFR) and urine microalbumin
- Existing NCD condition: HPT, T2D, dyslipidaemia, renal disease. Analytic statistics which includes analysis of the following variables:
- Prevalence and Incidence rate for HPT, T2D, and dyslipidaemia patients
