The Tembisa Clinical Research Site (TCRS) is situated on the grounds of the Tembisa Hospital in Ekurhuleni North, in the Gauteng province of South Africa. Tembisa is a township located about 50 kilometres (30 miles) north-east of Johannesburg (the largest city in South Africa). The TCRS has been in operation since 2008 and has been engaged in TB treatment trials, TB vaccine trials and HIV prevention trials over the years. The Tembisa township was established in 1957 when Africans were resettled from Alexandra and other areas in Kempton Park, Midrand and Germiston, including Edenvale and Bedfordview. The name Tembisa comes from the Zulu word "Thembisa" meaning "Give Hope" or roughly translated to "There is Hope”.
About The Research Centre
Over the past 7 years, since our inception, we have established a positive relationship with the study community. Our recruitment and retention figures are evidence of the interest that the community has developed in research studies. Since we have been able to develop recruitment and retention strategies in real time, this proactive approach has been instrumental in reaching the enrollment and retention targets of studies that have been conducted since 2008 (ranging from 12 – 438 patients per study).
Internal and external quality control procedures ensure that we adhere to the research standards. In addition, our on-site data management team is well equipped to carry out either data-faxing or data entry procedures and are able to address data discrepancies timeously. Even though the site experienced some logistical setbacks in the past, mainly caused by infrastructural and connectivity issues, this highly motivated team overcame these challenges, by ensuring that the research studies reached their objectives. Systems have been put in place to ensure that the research studies are implemented to a high standard, internal and external communication is well documented and records efficiently maintained. Importantly, the CRS is able to process large volumes of participants and maintain accurate confidential research records.
The Tembisa population is estimated at 2 465 611, with 77.8% of the population relying on public health services and clinics. HIV treatment services have been decentralised over the last few years, so patients are now able to access wellness clinics and ARV treatment at their local clinic, which increases accessibility to these services. These patients are referred to the Tembisa Hospital for acute care, rehabilitation and specialist review. Prevention of mother-to-child transmission (PMTCT) programs, HIV Counselling and Testing (HCT) programs and TB and HIV integration programs are well established in this district. Approximately one-third of the Ekurhuleni population lives in poverty, which coincides with an unemployment rate in Ekurhuleni of approximately 40%, despite a literacy rate of approximately 84%.
In 2011, antenatal HIV prevalence in the Ekurhuleni district is 27%. From National HIV prevalence report: Gauteng Province estimated HIV incidence in adults age 15-49 is 1.4%1. The Actuarial Society of South Africa (using modelling) estimates HIV incidence in this area at 0.9% per year.
In a retrospective study conducted by Aurum, participants were identified from CD4 count registers and medical records found in clinics in the Ekurhuleni North district. Data from 1 July 2006 to 30 June 2007 were collected, and data from patient files were extracted from the date of the enrolment CD4 count until 30 June 2008. Participants who developed TB were identified from the TB registers in the same clinics by cross matching against the CD4 register using probability matching software. TB cases were defined as definite, probable and possible after reviewing individual TB files. This resulted in a TB incidence of 6.1 per 100 person-years of follow-up, depending on strictness in matching criteria (0.6% for perfect, 1.3% for likely, 4.1% for potential matches). Incidence was 4.0% for those 21-45 years old. Among the 105 TB cases, 5 were definite, 33 probable and 67 possible cases (mostly smear-negative cases).
In order to estimate TB prevalence and TB incidence in an HIV-infected population a cross-sectional and prospective study have been conducted. A total of 839 participants were enrolled and 831 included in the analysis median age 35, 19.7% male, 72% on ART and median CD4 count 524. The overall TB prevalence was 3.5% (95% confidence interval 2.2- 4.7). Prevalence was higher among those with previous TB [Odds Ratio (OR) 5.7] those with BMI< 18.5 [OR 3.8] and those not on ART at enrolment [OR 2.8]. There was no association between CD4 count at enrolment and having prevalent TB. TB incidence will also be determined from this group to allow for accurate planning for TB vaccine phase III trials.
Information extracted from the District Health Information System, 2012 shows that in our catchment area, a total of 5 962 542 patients visited Primary health Care Clinics in the Ekurhuleni District and of those 80 059 TB suspects identified through screening provided sputum for TB testing (1.34%) with 7.27% of those identified to have active TB (5 824 / 80 059)4.
The TB case finding index as reported by the District Health Barometer 2012 / 13 for the Ekurhuleni district is 2.09 which is greater than the national South African target of 2.0. The TB case finding index is defined as the proportion of clinic attendees over five years old who were suspected of having TB and had sputum taken and sent for testing for TB5.