Ndlovu Research Consortium activities end 2016
Ndlovu Cohort Study (NCS)

Backbone of the NRC research activities remains the NCS which started with its data collection in 2014. The NCS is a multidisciplinary study which compares HIV-positive and HIV-negative subjects to investigate HIV and (lifestyle-related) chronic conditions. Multiple research questions will be addressed over the course of the anticipated ten years of follow-up. Research questions are formulated by the various disciplines involved: epidemiology, infectious diseases, social sciences, virology and immunology. The NCS has a special focus on cardio-vascular diseases (CVD), an important co-morbid condition in HIV-infected individuals, whereby antiretroviral treatment might be an extra risk factor. The cohort aimed to include 1000 HIV-positive as well as a comparison group of 1000 HIV-negative individuals, which is one of the strengths of this research study.
By the end of 2016, 1,903 participants entered the NCS, 859 HIV-positive (46%) and 1042 HIV-negative, 1039 women (55%).  50% of female participants are HIV+ and 40% of the males. Recruitment was also supported by the referral of HIV-positive participants from other research projects.

Data are entered in an electronic database developed by the Julius Centrum at the University Medical Centre Utrecht. After 6 months participants are called by telephone to collect data concerning changes in their health, HIV-status and lifestyle. After 12 months participants are coming at the research site for a new interview, physical examination, PWV (as decided in 2015) and blood drawing. At month 18 participants are contacted again by telephone and in January 2017 participants will be asked to come back for their 24-month visit for again a new interview, physical examination, ultrasound measurement and blood drawing. So at the yearly visits ultrasound and PWV measurements are alternating.  

The intake of HIV-negatives was slowed down and stopped once the target number was reached, to be able to focus on recruitment of HIV-positive participants in the PSP database and at the Ndlovu medical clinic. 1450 in 1601 (91%) participants were reached by telephone at month 6 by the end of 2016, and 260 in 556 (50%) at month 18. 897 in 1095 (82%) who were called back after 12 months attended their appointment within a timeframe of 2 months.  Special attention is given to retention within the cohort by sending text messages and following-up defaulters with home visits after 2 months.

Related projects with independent funding.

ITREMA – Evaluation of an Intensified TREatment Monitoring strategy to prevent Accumulation and spread of HIV-1 drug resistance in low- and middle-income countries (funded by ZonMw, UMC Utrecht Infection and Immunity)

The ITREMA project – PhD student Lucas Hermans, PI Annemarie Wensing (UMCU) - consists of a randomized controlled trial which investigates a novel monitoring strategy for HIV-infected patients during antiretroviral therapy (ART). This investigational monitoring strategy consists of intensive monitoring of viral load combined with additional diagnostic testing in case of viral rebound. This strategy will be compared to the current South African standard of care for monitoring of ART. The trial will be coupled to a cost-effectiveness analysis to ascertain the cost-effectiveness of the investigational strategy. In addition, researchers are collecting data on predictors of therapy adherence in order to gain insights in risk factors for non-adherence and therapy failure. Enrolment is currently still ongoing. This project is a collaborative effort between Ndlovu Care Group, translational virology and immunology UMCU, the Utrecht University Social Sciences department, Radboud University in Nijmegen the Netherlands and WRHI.

NORAST: Ndlovu Oraquick Self-Test Study:
This study looked into the usability of the saliva Oraquick HIV-test as a self-test in our rural community in the Moutse area. This saliva self-test is now FDA approved and is used in high income countries to increase the proportion of high risk persons that know their HIV antibody status. Whether this self-test can also be used in a rural population in low income countries is unknown and so the aim was to study to what extent people can read and follow the instructions, perform the test and interpret the test results and to what extent the test performance was robust against procedural errors. The study recruited 1391 participants among whom 113 tested HIV-positive. The test showed to be robust against processing errors by participants with a low failure rate of 3.5%.  All positive test-results were confirmed to be positive. About one quarter of HIV positives in South Africa  do not know that they are HIV infected and this study shows that the saliva self test can help in identifying these persons which is in their own interest – early therapy – and will lower transmission in the community.  The study was funded by the Orasure Company.

HOMELINK: Biometric linkage to care in Home based oral mucosal HIV Testing and Counselling programme (financed by Aids Fonds):
The extension of existing HCT activities through a home based programme aims at testing more local residents, more men, and more HIV-positives in an earlier phase of their infection which is important for themselves and for the community. The programme is connecting early diagnosis through Electronic Health Management Systems and unique locater usage to early care seeking behaviour and disease management. The project started in the second part of 2016. A database system was developed whereby households and participants are registered in the field in real time. The database makes it possible to monitor a number of indicators for process and output evaluation. By the end of 2016, 598 households with 2024 family members were registered. 421 persons were tested (45% men) and 16 turned out to be HIV-positive. Other persons knew their status and/or tested at other health care facilities

Unmasking a Silent Killer: Diabetes Care in HIV-Positive patients In a Rural Medical Clinic In South Africa.D M-Alert
In Sub-Saharan Africa (SSA) Human Immunodeficiency virus (HIV) infection is a major health problem. Large scale programmes of Antiretroviral therapy (ART) have resulted in increasing a number of people accessing ART and therefore increasing life expectancy. As a result SSA will be faced with an ageing HIV positive population. HIV itself is increasingly recognized as a driver of accelerated ageing and non-communicable disease risk. Diabetes Mellitus type 2(DMII) is one of the most prevalent non-communicable diseases (NCD) associated with HIV. Screening and care for NCDs is currently not fully integrated in HIV care in the SSA region. Insight into the prevalence of undiagnosed DMII in HIV-infected patients attending a public rural HIV treatment programme, efficacy of treatment of previously diagnosed HIV positive DMII patients and adherence to national guidelines on diabetes care are urgently needed to assess the current state of diabetes care in HIV treatment facilities and its integration in routine HIV care.
Joint PhD proposals
Two new proposals were developed by the Faculty of Social and Behavioural Sciences Utrecht University, in cooperation with our NRC partner WRHI, University of Witwatersrand. The aim is to develop two joint PhD studies between the universities Utrecht and Witwatersrand. For both these PhD programs South African candidates will be chosen and their degree will be obtained in both Utrecht and Johannesburg. A MoU between both universities is in development and both will contribute financially to both studies which are described below

    Beating co-morbidity using mobile interventions
PhD proposal under the supervision of Prof. Claudi Bockting, Clinical Psychology, Faculty of Social and Behavioural Sciences Utrecht University, in cooperation with NRC partner WRHI, University of Witwatersrand.
Depression is highly frequent among HIV infected persons, also in low- and middle-income countries, but few studies have been done in rural populations and interventions applicable in low- and middle- income countries are urgently needed. We are developing a PhD project on depression in HIV patients in rural and urban South Africa which has the potential for mobile and/or apps development for diagnosis, care and treatment support in low- and middle-income countries. In this project we will compare rural with urban settings in the implementation of mobile support for the management of depression in HIV-positive participants.

    SA-PATH: self-affirmation to promote adjustment and treatment of HIVSA-PATH: self-affirmation to promote adjustment and treatment of HIV
PhD proposal under the supervision of Prof. John de Wit, Denise de Ridder & Ine Vanweesenbeeck, Faculty of Social and Behavioural Sciences, Utrecht University in cooperation with our NRC partner WRHI, University of Witwatersrand.
Timely initiation and consistent use of ART is critical for personal health and public health benefits, as is the consistent use of pre-exposure prophylaxis to prevent HIV infection. However, a minority of people with HIV are not taking ART, even in contexts where it is widely available and accessible and ART refusal has also been noted in resource limited settings. The objective of this PhD project is to contribute to increasing understanding and development of effective policy and practical tools to support initiation and consistent use of ART among people with HIV in South Africa. The specific aim of this project is to assess the role of identity threat resulting from the stigma and discrimination attached to HIV, and how alleviating this identity threat can promote ART initiation and consistent use by people with HIV in South Africa. This PhD research proposal will also compare rural and urban settings and will be performed in Elandsdoorn and in Johannesburg.

Witwaterandsuniversity PhD/MSc
·         Pain Laboratory of the Brain Function Research Group at the University of the Witwatersrand
Half to three-quarters of people living with HIV experience pain, which is most frequently experienced as moderate to severe in intensity. Recent work by us indicates that the local HIV-positive population maintains high levels of physical activity despite high levels of pain (High Pain / High Activity; HP/HA), which is in contrast to the behaviour observed in European and North American studies. We believe that the reasons for this difference are rooted in the local socioeconomic environment, where pain has a low priority compared to more basic needs (e.g., achieving food security), and overt pain behaviours may well perpetuate HIV-related stigma.

·         Wits Sleep Laboratory of the Brain Function Research Group at the University of the Witwatersrand
Sleep disruption is reported in all HIV cohorts in the world, either associated with pre-ARV treatment infection period, specific antiretroviral drugs such as efavirenz, chronic pain syndromes or depression. In addition, in our first cross sectional study in 2012, we had found that increased CD4 counts and pain predicted higher sleep disruption. In the context of a rural study, another aspect could also impact on sleep quality: the access to artificial lighting (which has been shown to modify the timing of endogenous circadian rhythms and therefore induce sleep disruption).
With life expectancies of people living with HIV becoming longer and closer to that of people who are not HIV positive, non communicable diseases have increasingly been contributing to worse quality of life and mortality in the HIV positive population.
Sleep disruption is associated with increased depression, increased sensitivity to pain and with worse quality of life scores, comparable to those seen in chronic illnesses such as diabetes or rheumatoid arthritis. In addition, decreased sleep duration has been associated with higher risk of metabolic syndrome in several cohorts and higher cardiovascular risk in women in large epidemiology cohorts.

Julius Clinical Centre
·         Collection of cervical specimen for cancer research for assay development and cancer research

Read more about the IPM Research trial here

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