GHF2008 – PS35 – Clinical Research on Infectious Diseases

Session Outline

Parallel session PS35, Wednesday, May 28 2008, 11:00-12:30, Room 16
Chair(s): Marcel Tanner, Director, Swiss Tropical Institute, Switzerland
Clinical Research on Infectious Diseases: Tuberculosis
Michael Grobusch, Professor, Division of Clinical Microbiology and Infectious Diseases, NHLS and University of the Witwatersrand, South Africa 
Establishing a Malaria Clinical Research Site in Africa: Experiences from Bagamoyo, Tanzania
Salim Abdulla, Ifakara Health Research and Development Centre, United Republic of Tanzania 
HIV in Bangladesh: An Emerging Epidemic
Tasnim Azim, Laboratory Sciences Division and HIV Programme, ICDDR,B, Dhaka, Bangladesh 

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Session Report

Contributors: Ann Galea (ICVolunteers)

Photo © V. Krebs, ICVolunteers.org

Research is generating sound evidence on the treatment and prevention strategies for the three diseases of poverty - namely tuberculosis, malaria and HIV/AIDS - thanks to a number of partnerships that already exist between developed and developing countries. While innovation and implementation studies attract significant funding, clinical research on validation needs more support. Descriptive research can make a significant contribution to these important diseases. Efforts must be made to resist studies focusing research only in the 'easy areas' and for partners to take the 'hit and run' approach. In certain areas where research can be more difficult, such as multi-drug resistant tuberculosis (MDR-TB), clinical research can start 'from scratch' and be simply based on clinical observations.

The worsening epidemiological situation in South Africa, the concurrent humanitarian issues and the significant challenges that need to be faced on the ground were addressed by Prof. M. P. Grobusch (Infectious Disease Unit, Division of Clinical Microbiology and Infectious Diseases, NHLS and University of the Witwatersrand, Johannesburg, South Africa). Ranked as 7th on a global scale for Tuberculosis Incidence, it is estimated that 95% of tuberculosis cases in South Africa are co-infected with HIV. In a setting where public health service needs drastic improvement and a health system that is still rooted in the original designs of the pre-apartheid era, the tuberculosis control programme cannot keep up with the sheer number of patients. The recent reports of MDR-TB and the extensively drug resistant tuberculosis (XDR-TB) "outbreak" in South Africa reported in 2006 (Gandhi et al, Lancet, 6.11.06) bring to the front major faults in the system especially with reference to inadequate hospital facilities for isolation and infection control, ineffective planning and poor information systems, prolonged laboratory turn around time and poor defaulter tracing. The Sizwe Tropical Diseases Hospital in Guateng was changed into an exclusive MDR-TB hospital in an effort to improve the prognosis of MDR-TB and XDR-TB patients. Encouraging treatment results were observed from clinical care which later facilitated cutting edge clinical trials on novel second line anti-TB drugs. Treatment regime and duration for XMDR-TB is often based on empirical decisions and ethical and moral considerations concerning enforced treatment and isolation important. The unique problems of attracting and retaining staff to work at the Sizwe hospital such as the history of violent behaviour among patients, some of whom are ex-detainees, as well as the high HIV infection rate among the potential pool of health care workers for whom such work is contra-indicated.

The establishment of Malaria clinical care research sites in Bagamayo, Tanzania, was the focus of the talk by Salim Abdulla, (Ifakara Health Research and Development Centre, Bagamayo, Tanzania). This study was set against a background of much stakeholder interest for the generation of new drugs and vaccines against malaria. Lacking a strong health infrastructure, significant external investment is needed to establish and maintain such sites. The paucity of clinical research training among medical graduates, the ethics of community involvement and the importance of maintaining the service to the community once the research is complete are important considerations. The experience from this site was generally very favourable. The quality of care to the community improved, the project was found to have a good acceptability among the community with high community participation. The main challenge was to maintain the high quality of the service that was provided after the research funds dried up. Case definitions and harmonisation of malaria parasite quantification by blood slide reading ensured consistency of results.

Practical implications are:

  • The possibility of networking of multiple sites to avoid duplication.
  • The potential of such centres to be used for research into other common diseases such as TB and HIV.
  • The movement away from "research site" thinking and on to "centre creation" to have a longer lasting application.

The emerging problem of HIV infection in Bangladesh was presented by Tasnim Azim (Laboratory Sciences Division and HIV Program, ICDDR,B, Dhaka, Bangladesh). While sharing much of its border with India and India's high HIV rates, HIV is still an emerging problem in Bangladesh. The total number of people living with HIV in Bangladesh in 2007 is reported to be 1207 and it is estimated that HIV prevalence among high risk groups is still less than 1 %. Infection remains concentrated in specific areas especially in Dhaka. There are two main risk groups, namely intravenous drug users and returning migrant workers who acquire the infection while working abroad often as contract workers in the Middle East.

Important issues come to light

  • Many intravenous drug users (IVDU) share needles and the limited needle exchange programme needs to be fully implemented to cover all days of the week including weekends.
  • The HIV strains among the two groups remain separately distinct but there is a fear that this will follow a similar course to that which was observed in other countries such as Thailand.
  • Homelessness among IVDU increases the risk of being infected with HIV and rates observed so far show a five-fold difference from other drug users.
  • Services outside of Dhaka are not available and the few scattered cases in rural areas can not be reached.
  • Anti-retroviral drugs are still not freely available and only 26% of patients are receiving some form of therapy.
  • Three out of 18 strains tested have shown drug resistance but this could be related to the small sample size and trends need to be observed closely.
  • The migrant worker group constitutes workers who are deported because of HIV positive tests while working in other countries. These often get infected through heterosexual spread and not because of intravenous drug abuse.
  • The data that is available does not include the below 15 age group, but intravenous drug use in the young is not a common problem in Bangladesh.
  • The drug regime used is that recommended by WHO where three drugs are given if the CD4 count is less than 200. Other countries are in fact using more aggressive standards.

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