Browsing by Author "Zemanay, Widaad"

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    Open Access
    A review of recruitment strategies within the Clinical Infectious Diseases Research Initiative (Cidri) Group from 2007-2013, 4 studies
    (2018) Goliath, René; Zemanay, Widaad
    The Clinical Infectious Diseases Research Group [CIDRI] has conducted high impact research over the last decade in Cape Town specifically in the townships of Khayelitsha and Mannenberg. None of this research would have been possible without robust strategies to recruit and retain study participants. Four different completed studies with different study designs have been selected, which will show the different approaches to participant recruitment into clinical research. This review will evaluate this process in relation to the approved protocol recruitment strategy, the amendments, which were required for modifications, the ability to retain participants to the end and the composition of staff used to achieve study outcomes. This entire process has been recognised as a necessary research skill and the term recruitmentology has become a practice pivotal to the research process. Recruitmentology has been unpacked to illustrate how minorities have been recruited, overlooked and over researched in the United States (US), and that experience has given a new perspective to the processes involved. Although in the South African context we do not have the identical issues to the US, these ideas can be translated in our circumstances, as both research populations can be considered as marginalised. We are challenged in the township of Khayelitsha with service disparities, which are generally impacted by the presence of clinical research groups. Although Khayelitsha has three large Day Hospital facilities, a newly built 150 bedded secondary level hospital and 11 local clinics, offering a consistently high standard of care; it remains a challenge. The CIDRI group partnered with the health services, supporting them with extra staff in the way of nurses, doctors and clinical research workers, while in return benefiting from the health system by being able to conduct effective studies. This has been and continues to be a mutually beneficial relationship, as CIDRI has been supportive to health services and the service has been a research partner of many research protocols including one of the studies being reviewed. Through the process of reviewing the databases of these four different CIRDI studies, we can examine the successes, challenges and a possible model of recruitment in the township of Khayelitsha. These studies have been chosen as they have been successfully completed by CIDRI and the databases have been locked. Each study has a different study design, from a pragmatic randomised control study, a cross sectional study, a seasonal follow-up and longitudinal study. Close attention will be paid to proposed recruitment strategy as per approved protocols, amendments (which impacted the recruitment process), staff structure, time frames of recruitment, retention and impact on study outcomes. This review will attempt to answer the following: 1. Was the proposed recruitment strategy followed as per study design and approved study protocol? 2. Was the overall recruitment impacted by staffing structure and allocated recruitment time frames? 3. How were study outcomes impacted by recruitment and retention? 4. Tuberculosis/Human Immuno-deficiency Virus TB/HIV were the diseases of study in all four studies, do these two diseases have specific challenges which impact recruitment and retention?
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    Open Access
    Altered protein expression patterns in oesophageal cancer
    (2009) Zemanay, Widaad; Hendricks, Denver
    Oesophageal squamous cell carcinoma presents a significant health burden in South Africa. It is one of the most common causes of cancer-related mortality of South African black males, as a result of its asymptomatic progression leading to late diagnosis and poor prognosis. The aim of this study was to identify membrane or membrane-associated proteins that are expressed at different levels in oesophageal tumour tissue when compared to normal tissue. The identification of such proteins would be an important step towards the development of better diagnostic and therapeutic strategies for this disease. Two proteomic approaches, were employed to identify differentially expressed proteins.
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    Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial
    (Public Library of Science, 2014) Cox, Helen S; Mbhele, Slindile; Mohess, Neisha; Whitelaw, Andrew; Muller, Odelia; Zemanay, Widaad; Little, Francesca; Azevedo, Virginia; Simpson, John; Boehme, Catharina C; Nicol, Mark P
    Background: Xpert MTB/RIF is approved for use in tuberculosis (TB) and rifampicin-resistance diagnosis. However, data are limited on the impact of Xpert under routine conditions in settings with high TB burden. Methods and Findings: A pragmatic prospective cluster-randomised trial of Xpert for all individuals with presumptive (symptomatic) TB compared to the routine diagnostic algorithm of sputum microscopy and limited use of culture was conducted in a large TB/HIV primary care clinic. The primary outcome was the proportion of bacteriologically confirmed TB cases not initiating TB treatment by 3 mo after presentation. Secondary outcomes included time to TB treatment and mortality. Unblinded randomisation occurred on a weekly basis. Xpert and smear microscopy were performed on site. Analysis was both by intention to treat (ITT) and per protocol. Between 7 September 2010 and 28 October 2011, 1,985 participants were assigned to the Xpert (n = 982) and routine (n = 1,003) diagnostic algorithms (ITT analysis); 882 received Xpert and 1,063 routine (per protocol analysis). 13% (32/257) of individuals with bacteriologically confirmed TB (smear, culture, or Xpert) did not initiate treatment by 3 mo after presentation in the Xpert arm, compared to 25% (41/167) in the routine arm (ITT analysis, risk ratio 0.51, 95% CI 0.33–0.77, p = 0.0052). The yield of bacteriologically confirmed TB cases among patients with presumptive TB was 17% (167/1,003) with routine diagnosis and 26% (257/982) with Xpert diagnosis (ITT analysis, risk ratio 1.57, 95% CI 1.32–1.87, p<0.001). This difference in diagnosis rates resulted in a higher rate of treatment initiation in the Xpert arm: 23% (229/1,003) and 28% (277/982) in the routine and Xpert arms, respectively (ITT analysis, risk ratio 1.24, 95% CI 1.06–1.44, p = 0.013). Time to treatment initiation was improved overall (ITT analysis, hazard ratio 0.76, 95% CI 0.63–0.92, p = 0.005) and among HIV-infected participants (ITT analysis, hazard ratio 0.67, 95% CI 0.53–0.85, p = 0.001). There was no difference in 6-mo mortality with Xpert versus routine diagnosis. Study limitations included incorrect intervention allocation for a high proportion of participants and that the study was conducted in a single clinic. Conclusions: These data suggest that in this routine primary care setting, use of Xpert to diagnose TB increased the number of individuals with bacteriologically confirmed TB who were treated by 3 mo and reduced time to treatment initiation, particularly among HIV-infected participants.