Kein Folientitel

1
NEEDS ASSESSMENT STUDY ESTABLISHING A SCIENTIFIC
STUDY OF SIDDHA MEDICINE TREATMENTS OF HIV/AIDS
Deeangelee Pooran, Nils Hennig MD/PhD, Kaylan
Baban, Scott Ikeda, Debbie Indyk PhD, George
Carter, Henry Sacks MD/PhD Thomas C. Chalmers
Clinical Trials Unit, Mount Sinai School of
Medicine, New York, NY 10029 Foundation for
Integrative AIDS Research, New York, NY 11217
Gandeepam Siddha Hospital and Research Center,
Tamil Nadu, India
Methods
Patient Confidentiality Assessment
Background

• Chart Location (See Diagram)

• According to the 2003 Population Foundation of
  India report, India has the third highest
  prevalence of HIV/AIDS among the South and
  Southeast Asian countries with 4.6 million cases
  reported in the year 2002.
• Although these estimates are low compared with
  those in South Africa, the epidemic will sweep
  across the subcontinent and the number of people
  living with HIV/AIDS in India will exceed the
  number in South Africa by 2006 unless there are
  immediate and effectual interventions (AmFAR
  Treat Asia, 2004).
• In fact, the American Foundation for AIDS
  Researchs 2004 Treat Asia report suggests that
  the relatively low nationwide prevalence in India
  underestimates the severity of the epidemic in
  specific populations.

• Investigate the organizational infrastructure of
  Gandeepams Siddha Medicine Clinic for the
  ability to conduct an Evidence-Based Medicine
  Study via
• Efficient chart formation and chart
  organization that respects the patients rights.
• Clinic and office space organization that is
  conducive to both patient
• confidentiality and increased productivity.
• Assess the ability of Diagnostic Laboratories in
  the vicinity of the
• Siddha Medicine Clinic to perform the
  following
• Reliable ELISA (Enzyme-Linked ImmunoSorbent
  Assay) or Western Blot analyses.
• Reliable CD4 CD8 counts.
• Viral Load analyses.
• Store the participants blood samples
  throughout after completion of the study.
• Maintain electricity in the establishment via
  the reliable use of generators.

• On the shelves of an open-faced cabinet.
• Directly opposite of the patient consultation
  desk where all patients sign in and are initially
  evaluated.
• In the main hall of the clinic where all patients
  and workers enter and leave.

• Chart Format
• The front of every chart was tagged with a code
  that was specific to the individual patient.
• There was a photograph of each patient inside the
  front cover of the chart.
• Opposing the photograph was the patients consent
  form with name and address.
• Notes of the patients initial and follow-up
  visits completed the chart

The diagram below (adapted from the Population
Foundation of India report on HIV/AIDS)
demonstrates how the HIV/AIDS epidemic is
perpetuated in India and how specific populations
(sex workers, truck drivers, women, and children)
become affected.

• Therefore, the structure of the charting system
  needs to be evaluated carefully in order to
  prepare for a formal clinical trial.

Diagnostic Laboratory Search Results
Conclusions

• In order to conduct an unbiased study of the
  therapeutic effects of Siddha Medicine treatments
  of HIV/AIDS, the clinic would need two
  independent laboratories who can objectively
  analyze the blood samples obtained from the
  patients participating in the trial.
• The search for reliable laboratories that could
  perform the major diagnostic tests for HIV/AIDS
  patients in the vicinity of the Siddha Medicine
  Clinic demonstrated that a significant lack in
  the availability of the necessary tests. Only a
  few basic tests (ELISA or Western Blot) were
  available near the clinic.

• Based on the results of the diagnostic laboratory
  search and after consultation with collaborators
  at Gandeepam, Meenakshi Mission Hospital Lab and
  Lister Metropolis Labs were two independently run
  facilities that were selected for blood sample
  analysis in the HIV/AIDS trial (in conjunction
  with an efficient transportation mechanism for
  the samples).
• Based on the results of the patient
  confidentiality assessment, the idea of a locked
  cabinet for chart storage as well as a restricted
  area for workers only needs to be introduced into
  the clinic. In addition, the format and content
  (including consistent recording of patient data)
  of each chart needs to be reconsidered.

• The first reported HIV case in India was in 1986
  in Chennai, Tamil Nadu (PFI, 2003). By 2003, the
  state of Tamil Nadu accounted for nearly half to
  the total number of reported AIDS cases in India
  (PFI, 2003).
• Gandeepam is a non-governmental organization in
  Tamil Nadu that utilizes the principles of the
  Siddha Medicine tradition to treat HIV/AIDS
  patients.
• Despite the Indian governments attempt to
  provide free ARV therapy for HIV/AIDS patients,
  many still have no access to treatment and depend
  on local traditional healers for care. Given the
  large number of people that depend on traditional
  care, it is important to scientifically evaluate
  the therapeutic effects of traditional medicine
  systems such as Siddha.

• Tamil is the language spoken in the state of
  Tamil Nadu and presented itself as a barrier
  throughout the Needs Assessment Study. Therefore,
  an objective translator is necessary to
  facilitate a successful collaboration between
  researchers from Gandeepam, researchers from
  MSSM, and the participants in the study.
• Many Siddha Medicine practitioners with various
  training backgrounds work for Gandeepam.
  Therefore, standardization of the diagnostic and
  treatment procedures within Gandeepam is
  necessary to carry out a reliable clinical trial.

Specific Aims
Future Directions

• To assess the infrastructure of Gandeepam and its
  capacity to conduct an objective clinical trial
  in its Siddha Medicine Clinic (See also posters
  by Kaylan Baban Scott Ikeda).
• To seek out certified diagnostic laboratories
  that can analyze samples taken from participants
  in the Siddha Medicine Trial.

• Given the many hours that separate the Siddha
  Medicine Clinic in Namakkal from laboratories
  that could perform the appropriate diagnostic
  tests, the search elicited the need to have a
  portable cooling system for the study
  participants blood samples so that they could be
  safely transported from the clinic to the testing
  site.

• Introduction and implementation of the above
  changes while
• Respecting the boundaries of an international
  collaboration (Cohen, 2000).
• Recognizing the differences in cultural norms so
  that the study designed will be flexible enough
  to accommodate ethnographic considerations
  (Parker Ehrhardt, 2001).
• Realization of the intimate nature of the issues
  surrounding HIV/AIDS helps to develop an
  ethically sound scientific evaluation of Siddha
  Medicine treatments of the illness (Schopper,
  1990).

References -AmFAR Treat Asia (2004) Treat
Asia. American Foundation for AIDS
Research. -Cohen, Jon (2000) Balancing the
Collaboration Equation. Science, 288
2155-2159. -Parker, Richard Ehrhardth, Anke A.
(2001) Through an Ethnographic Lens
Ethnographic Methods, Comparative Analysis, and
HIV/AIDS Research. AIDS and Behavior, 5
105-114. -PFI (2003) HIV/AIDS in India
Population Foundation of India, Population
Reference Bureau. -Schopper, D. (1990) Research
on AIDS Intervention in Developing Countries.
Social Science Medicine, 30 1265-1272.
Reprint Requests or Correspondence should be
directed to Deeangelee Pooran, BA, Mount Sinai
School of Medicine 50 East 98th Street Apt 7J-3,
NY, NY, 10029 Deeangelee.Pooran_at_mssm.edu