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

Background

Future DirectionsSpecific Aims

Methods

Diagnostic Laboratory Search Results

Patient Confidentiality Assessment

Conclusions

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.

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.

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.

Investigate the organizational infrastructure of Gandeepam’s 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.

LABORATORY(# hrs from the Siddha clinic)

ELISA TEST

WESTERN BLOT

CD4/CD8COUNT

VIRAL LOADTEST

GENERATOR CAPACITY

Sun DiagnosticClinic

(3 hours-Trichy)

On site Not Available

Meenakshi Mission Hospital

(9 hours-Madurai)

On site On site In Bombay In Bombay Available

Sarath Diagnostics(18 hours-Chennai)

On Site On site In Parent Labs

In Parent Labs

Available

Lister Metropolis(18 hours-Chennai)

On Site On Site On Site In Bombay Available

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, 10029Deeangelee.Pooran@mssm.edu

High-Risk Populations

•Sex Workers•Men who have sex

With men.•IV drug users.

Bridge Populations

•Clients of Sex workers•Migrant/Mobile pop.

•Truck DriversGeneral

Population

•Married women•Children of affected

Parents•Men

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.

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 government’s 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.

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 Research’s 2004 Treat Asia report suggests that the relatively low nationwide prevalence in India underestimates the severity of the epidemic in specific populations.

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.

Siddha Medicine

Clinic

Open-FacedChart

Cabinet

PatientConsultation

Desk

Entrance

Dr’sRm

Chart Location (See Diagram)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 FormatThe 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 patient’s consent form with name and address.

Notes of the patient’s initial and follow-up visits completed the chartTherefore, the structure of the charting system needs to be evaluated carefully in order to prepare for a formal clinical trial.

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.

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.