Determinants of Cardiovascular Disease, Kidney Disease and Diabetes

November 20, 2020 updated by: King's College Hospital NHS Trust

Determinants of Cardiovascular Disease, Kidney Disease and Diabetes in People of African Ancestry With HIV (CKD Study)

Cardiovascular disease (CVD), chronic kidney disease (CKD), diabetes mellitus (DM) and HIV infection are long-term conditions (LTC) with major health implications for people of African ancestry. These LTC often arise in the setting of an adverse demographic, social, biologic and genetic environment, although this remains poorly understood.

The investigators plan to conduct a comprehensive syndemic evaluation in individuals with and without CVD, CKD and DM in people of African ancestry with HIV to obtain novel insights into the development of LTC in this population. In addition, the investigators will conduct focus groups to explore the role of syndemic factors in the development of LTC and develop and pilot an educational programme to improve knowledge about LTC in the African/Caribbean community.

Study Overview

Status

Unknown

Conditions

Detailed Description

Black African/Caribbean Communities in South London are disproportionally affected by long-term conditions (LTC), with a higher prevalence and an earlier onset (by about 13 years) (1). This population experiences high rates of hypertension, obesity, diabetes mellitus (DM), chronic kidney disease (CKD), cardiovascular disease (CVD) including stroke, social deprivation, poor housing, and mental health conditions such as anxiety and depression (1). HIV infection is also considerably more common in Black African/Caribbean Communities in South London than in the general UK population (2,3) and gives rise to stigma and discrimination, low self-esteem, dysfunctional relationships and loneliness (4).

The relationship between hypertension, obesity, metabolic syndrome, diabetes mellitus and CKD is well recognised. In this population, 'hypertensive nephropathy' is about 10-fold more common than in Caucasians, with earlier onset of end stage kidney disease (ESKD) (5). Although hypertensive nephropathy in people of African ancestry was previously attributed to resistant hypertension, exacerbated by poor engagement with health care services and suboptimal adherence to antihypertensive therapy, there is emerging evidence of strong genetic susceptibility to CKD as a result of prevalent mutations in the apolipoprotein L1 (APOL1), glutathione-S-transferase-μ1 (GSTM1) genes or sickle cell trait (SCT) (6-12). However, despite their strong associations with CKD, many individuals with these genetic variants do not develop kidney disease, suggesting that additional (i) biologic (e.g. coinfections, inflammation), (ii) environmental factors (e.g. obesity, diabetes), and (iii) socio-economic aspects, (e.g. inadequate health care access, stigma) may contribute to the development or progression of CKD although this has not been well studied.

There is growing recognition of the important role of social determinants of health (SDH) and its impact across a wide range of health indicators, settings, and populations (13,14). The World Health Organization (WHO) refers to SDH as conditions to which people are born, grow, work, live and age, linked to personal circumstances and systems (e.g. social, economic and political policies/heath care systems) that influences their daily lives (15-16). The new conceptual framework of syndemics provide an opportunity to study diseases and health conditions in populations that are deepened by the social, economic, environmental and political environment of a given population (17). The definition of a syndemic is 'the presence of two or more disease states (anchored around a core disease, in our case HIV) that adversely interact with each other, negatively affecting the mutual course of each disease trajectory, enhance vulnerability, and which are more harmful by experienced inequities' (18). This approach of a so-called 'syndemic lens' may be helpful in our study to identify the associations between genetic, biologic and social factors that contribute to the development of CKD and DM in people with hypertension, obesity, sub-clinical CKD and/or metabolic syndrome. This systemic approach can offer a new understanding of diseases that can improve public health and treat individual patients at the same time (19).

South London has a large (>200,000) population of African and Caribbean ancestry who are disproportionally affected by HIV and experience a higher burden of CKD, DM and other LTC, often with earlier onset compared to white populations. The investigators aim to study the demographic, clinical, social and genetic factors that associate with CKD, DM and multiple LTC in people with HIV. CKD and DM are key LTC that associate with hypertension, obesity and cardiovascular disease, resulting in or contribute to functional impairment, polypharmacy and impaired bio-psycho-social health outcomes.

The HIV clinics in South London provide a unique opportunity to access a diverse African and Caribbean population of working age in whom LTC can be studied. People with HIV from black African/Caribbean communities experience a high degree of social and economic deprivation, stigma, anxiety and depression which are considered important syndemic factors in the development of LTC. CKD and DM are common LTC, highly relevant to the black population, and relatively early events in the development of multiple and disabling LTC, thus identifying a population for targeted interventions that may reduce the rate of progression from a single to multiple LTC.

HIV infection, itself a LTC, can be effectively controlled with antiretroviral therapy, affording normal life expectancy and interrupting onward transmission. Routine care includes 6-12 monthly assessments for other LTCs, providing opportunities for recruitment of well characterised populations unselected for specific co-morbid conditions.

No studies to date in the UK have examined the contribution of biologic, clinical, social and genetic factors to the development of LTC in African/Caribbean populations with HIV to date. The team will generate detailed information on factors that associate with CKD, DM, CVD and multiple LTC as well as hypertension, sub-clinical CKD, obesity and insulin resistance, which often precede the development of CKD, DM and other LTC in this population. This study is likely to identify novel associations which can be confirmed and further explored in subsequent studies of HIV positive and general African/Caribbean populations. Stored biological samples will allow us to explore pathogenetic mechanisms in subsequent studies.

Key barriers to uptake of existing and novel interventions include low literacy levels, low perception of quality of life, lack of knowledge of LTCs, etc. The investigators will explore how best to overcome these barriers in focus groups and develop a culturally sensitive educational programme, aiming to reach individuals in communities that tend to poorly engage with health care and preventive programmes.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be sampled from an existing cohort from the GEN AFRICA (Genetics Markers of Kidney Disease Progression in People of African Heritage Study). 75 participants with CKD, 75 participants with diabetes, 50 participants with a history of ischaemic heart (IHD)disease/stroke and 200 participants without CKD, diabetes, IHD/stroke will be recruited.

Description

Inclusion Criteria:

  1. Having previously participated in the GEN-AFRICA study
  2. Aged 18-60 years

Exclusion Criteria:

  1. Not having participated in the GEN-AFRICA study
  2. Aged >60 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Participants with CKD
Recruitment is from a cohort of HIV positive individuals of African ancestry with Chronic Kidney Disease CKD defined as eGFR <60 mL/min/1.73m2, and/or albumin/creatinine ratio >30 mg/mmol or protein/creatinine ratio >50 mg/mmol Anticipated n=75
Participants with diabetes

Recruitment is from a cohort of HIV positive individuals of African ancestry with diabetes. Diabetes is defined as being on diabetic medications or HbA1c >48 mmol/mol.

Anticipated n=75
Participants with ischaemic heart disease/stroke
Recruitment is from a cohort of HIV positive individuals of African ancestry with previous ischaemic heart disease or stroke Anticipated n=50
No CKD/DM/CVD cohort

Recruitment is from a cohort of HIV positive individuals of African ancestry who do not have CKD, diabetes or prior ischaemic heart disease/stroke.

Anticipated n=200

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obsity
Time Frame: 24months

• To describe, in African/Caribbean adults with HIV, demographic, clinical, social, biologic, genetic factors associated with CVD, CKD, DM and multiple LTC and the major clinical risk factors for these:

1. Obesity
24months
Hypertension
Time Frame: 24months
• To describe, in African/Caribbean adults with HIV, demographic, clinical, social, biologic, genetic factors associated with CVD, CKD, DM and multiple LTC and the major clinical risk factors for these: 2. Hypertension
24months
CKD
Time Frame: 24months
• To describe, in African/Caribbean adults with HIV, demographic, clinical, social, biologic, genetic factors associated with CVD, CKD, DM and multiple LTC and the major clinical risk factors for these: 3. CKD
24months
Metabolic Syndrome
Time Frame: 24months
• To describe, in African/Caribbean adults with HIV, demographic, clinical, social, biologic, genetic factors associated with CVD, CKD, DM and multiple LTC and the major clinical risk factors for these: 4. Metabolic syndrome
24months
Syndemic aspects and qualitative assessment of contextual factors associated with long term health conditions
Time Frame: 24months
• To explore more subtle variations of contextual factors and experiences about the role of syndemic aspects and provide further insights that may have been missed by the "itemised" quantitative approach in outcome 1. (using validated tools such as DISCUS, HADS, EQ-5D-5L)
24months
Educational
Time Frame: 24months
• To develop and pilot an educational programme on an existing App to improve knowledge about CKD, DM and CVD in the local African/Caribbean community.
24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

November 20, 2020

First Posted (Actual)

November 30, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KingCKD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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