Project Title

EDCTP-GSK fellowship: Cardiometabolic Diseases Risk Evaluation and Reduction in African People Living with HIV Infection

EDCTP Project Call

Senior Fellowship (SF)

Project Objectives

The Cardiometabolic Diseases Risk Evaluation and Reduction in African People Living with HIV Infection (CaDERAL) aims to enhance the understanding of common CMDs, and improve their co-detection and co-management in African people living with HIV infection, through a program of research and capacity development based on a network of institutions led by the South African Medical Research Council (SAMRC), and comprising the Nigerian Institute of Medical Research (NIMR), the Clinical Research Education, Networking and Consultancy (CRENC, Cameroon). Specifically we will: 1) Characterise the cardiometabolic profile of adults HIV-infected individuals at their baseline enrolment in Cameroon, using data from the Cameroon arm of the ongoing International Epidemiologic Databases to Evaluate AIDS (IeDEA). 2) Assess the incidence and remission of dyslipidemia and impaired kidney function in people with HIV on ART in Nigeria, using data from the NIMR HIV cohort. 3) Conduct a clinical trial to test the effectiveness of sending weekly SMS-text message in improving health outcomes and supporting medication adherence in South African adults with co-morbid HIV and hypertension. This will be augmented with process evaluation and cost-effectiveness analysis. 4) The three research projects in 1-3 will support the training of a PhD student in each of the three countries, and reinforce the research capacities of junior and senior researchers where appropriate.

Study Design

The core component of the project is a 12-month, individually randomized controlled two-arm trial, open-labelled single blinded, to assess the effect of text messaging vs. usual care on adherence to hypertension medications and outcomes of care among adult South Africans with co-morbid HIV and hypertension. This will be augmented with process evaluation and economic analysis. The trial is based on an adaptation of the StAR trial conducted in the general population in Cape Town. A software algorithm will assigned participants independent of the research team to the intervention and control arms in a 1:1 ratio using a non-deterministic minimization algorithm to ensure balance between groups with respect to key characteristics including gender, age, baseline blood pressure and known duration of hypertension. The treatment group will receive messages to motivate collecting and taking medicine and to provide education about and motivation for secondary adherence, in particular, on healthy lifestyle choices. These messages will be sent three times a week for 52 weeks. Outcome measures will include: Primary – mean difference in SBP and DBP; Secondary – 1) uptake and adherence to BP medications; with adherence measured using the 5 item Medication Adherence Report Scale (MARS) adiminstered at baseline and at the end of the trial;, 2) uptake and adherence to HIV specific medications, 3) mean change in lipid variables, 4) mean change in CD4 count and viral load, 4) mean change in adiposity variables, 5) change in kidney function; Tertiary - 1) Descriptive analysis of the process involved in the intervention, 2) Economic analysis, 3) Quality of life. Using the standard deviation from the baseline work (18 mmHg for SBP)12 and 90% power for a 5mmHg drop in SBP in the intervention as compared to the control arm, 546 participants will be needed per study arm. Allowing for a 20% dropout rate, the total number of participants will be 1300 (650 per arm/site).

Project Summary

Care of people with HIV across sub-Saharan Africa (SSA) is provided through dedicated parallel health streams, primarily designed to address HIV and related infectious co-morbidities. Consequently, the opportunity of addressing co-morbid non-communicable disease (NCD) is not fully realized in this population in regular contacts with the health system. Integration of HIV and NCD care has been suggested to improve the co-detection and co-management of co-morbid HIV and NCDs. Key to the success of this integration is a better understanding of the burden and drivers of NCDs in people with HIV, and appropriate strategies for promoting their care without compromising HIV specific care. We will conduct a 5-year program of research and capacity development, in view of establishing a sustainable network to generate the evidence to inform successful integration of HIV and NCD care in SSA. The proposal builds on an existing platform comprising the South African Medical Research Council (SAMRC, lead institution), the Nigerian Institute of Medical Research (NIMR) and the Clinical Research, Education and Consultancy Network (CRENC) in Cameroon. Our program of research will be developed around three complementary projects. In Nigeria, using data from the NIMR HIV cohort of nearly 24,000 HIV people on ART with over 15 years of follow-up, we will investigate the incidence, remission and determinants (including HIV predictive characteristics) of dyslipidemia and impaired kidney function. In Cameroon, we will use the country arm of the ongoing International Epidemiologic Databases to Evaluate AIDS (IeDEA), to characterize the baseline distribution and determinants of cardiometabolic risk factors in nearly 20,000 adults in care for HIV infections. Across the two country we will assess and strengthen the scope of data collection for improved research on co-morbid NCDs and HIV. In South Africa, we will execute a clinical trial to determine the effect of mobile phone text messaging support, to improve the uptake and adherence and outcome of hypertension care in patients with comorbid HIV and hypertension. The three projects will support the training of three PhD students (one/per country), mentoring of the NIMR biostatistician in handling longitudinal data and a junior SAMR researcher in coordinating clinical trials; and results in many peer-reviewed publications and several communications at conferences.

Host Organisation

Current Organisation

South African Medical Research Council

Current Job Title

Director, Non-Communicable Diseases Research Unit

Biography

Publications