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INDO-U.S. Conference on HIV/AIDS Prevention Research

Executive Summary

Tuberculosis Research Centre, Chennai, India
11-12 JANUARY, 2000

Introduction
General Recommendations
Group I: Behavioral Prevention Research
Group II: Other Biomedical Prevention Approaches to HIV/AIDS
Group III: HIV Vaccine Research and Evaluation
Group IV: Vertical (Mother-to-Child) Transmission of HIV
Conclusion

I. Introduction

On January 11-12, 200, the Indian Council of Medical Research (ICMR) and the U.S. National Institutes of Health (NIH) organized the Indo-U.S. Conference on HIV/AIDS Prevention Research. Prof. N. K. Ganguly, Director-General, ICMR, Dr. Gerald T. Keusch, Director, Fogarty International Center, and Mr. Bernard Alter, U.S. Consul General in Chennai opened the ceremony by highlighting the need for Indo-U.S. coordinated research efforts for HIV/AIDS prevention and control. Dr. Keusch noted the growing prominence of global health issues, mentioning that for the first time the United Nations Security Council had considered the importance of health related issues, in particular HIV/AIDS.

Prof. N. K. Ganguly placed special emphasis on ongoing collaboration between Indian and U.S. scientists in this area. The contributions of the ICMR's National AIDS Research Institute and advances in other ICMR institutes received special attention for their HIV research facilities and training programs. Condom use, syndromic management of STD's, and a peer group approach for behavioral change interventions are among the approaches planned for HIV prevention.

In summarizing findings from the recently held conference on HIV/AIDS, tuberculosis, and leprosy in the Pacific Rim, Dr.Sten Vermund, University of Alabama, called for the study of the interaction of HIV and tuberculosis at the cellular and molecular levels. Dr. Vermund also emphasized the need for continued research into more cost-effective methods for HIV vaccines and the development of lower cost therapeutic techniques. Suitable training for management of HIV and STDs, public health system involvement, and community involvement were the crucial elements identified for HIV education.

Dr. Steve Hyman, Director of the National Institute of Mental Health, demonstrated in his keynote address the importance of behavioral research in preventing the spread of HIV. Representatives from USAID, International AIDS Vaccine Initiative, National AIDS Research Institute, and the National Institute of Allergy and Infectious Diseases gave brief presentations addressing prevention techniques, private sector involvement in vaccine development, and research programs aimed at training Indian scientists.

Working groups addressed the primary research questions in four areas: behavioral prevention research, other biomedical prevention research, HIV vaccine research, and vertical transmission of HIV. Each group was asked to identify the collaborative research efforts needed to address primary research questions, and the gaps in research infrastructure, training, communication, and coordination. The findings of each working group, along with general recommendations, are listed below:

II. General Recommendations

U.S.-Indo collaboration in HIV/AIDS prevention research must continue;
Increased communication and collaboration within India and with other international scientific counterparts remain vital to HIV/AIDS prevention and intervention efforts;
Further investigation of high-risk behavioral determinants such as drug and alcohol abuse in HIV/AIDS transmission is necessary;
Research into other cost-effective biomedical HIV/AIDS prevention techniques such as microbicide development and protection of the blood supply must proceed;
Research into the development, production, and testing of indigenous HIV vaccine candidates for clinical trials in India must be expanded;
Research into various interventions to address vertical transmission of HIV must also be expanded; and,
Socially acceptable and effective prevention programs and improved laboratory capabilities are important underpinnings to the successful implementation of these recommendations.

III. Group I: Behavioral Prevention Research

Priority research efforts and questions focused on behavioral prevention programs on selected risk populations to address social stigma/disclosure issues, development and testing of educational materials, and acceptability of an HIV vaccine. Among the topics addressed were:

Basic behavioral research to examine determinants and antecedents of risk behavior, i.e. gender roles, alcohol and drug use, and HIV related behaviors;
Secondary prevention programs such as development and testing of programs to improve the quality of life for HIV+ persons;
Assessment of the role of the family and non-formal health care system in care of HIV+ persons;
Development of appropriate data collection methods, identification of social marketing techniques for behavioral prevention messages, and the creation of culturally appropriate methods to maintain participant confidentiality;
Barriers to Indo-U.S. collaboration in behavioral prevention research such as complex procedures for developing and submitting research applications, lengthy review and approval processes, and lack of an international set of procedures for ensuring ethical and legal behavior; and,
Sexuality, assessment and testing of instruments, and culturally relevant interventions as top priorities as well as continued collaboration on cross-cutting issues like ethics, socio-economic, cultural, and gender factors.

IV. Group II: Other Biomedical Prevention Approaches to HIV/AIDS

This group discussed other biomedical prevention approaches to HIV/AIDS. The top three priorities were: (1) the effectiveness of syndromic STD management in various populations, geographic regions, and among different health practitioners; (2) the safety, efficacy, and effectiveness of candidate microbicides and physical barriers to prevent HIV/STDs; and, (3) effective combinations of approaches in reducing risk among injection drug users and their sexual partners.

Other research needs related to these priorities were:

Development of low cost, simple, sensitive diagnostic techniques for STDs;
Testing and distribution of new microbicides in India;
Efficacy and acceptability of barrier technologies such as the female condom and the diaphragm;
Development of lower cost, more acceptable male and female condoms;
Barriers to universal, quality-controlled blood screening in India;
Development of lower cost, more accurate HIV screening tests and appropriate ways to handle positive test results;
Optimal availability of clean needles for India;
Cost-effective approaches to the prophylaxis and management of TB/OIs and post-exposure chemotherapy; and,
Research infrastructure and laboratory support in India for the development and evaluation control programs of HIV/STD and prevention research and diagnosis;

V. Group III: HIV Vaccine Research and Evaluation

The Group addressed the development, production and testing of indigenous HIV vaccine candidates for clinical trials in India. The expansion of laboratory capabilities and the fostering of collaboration remain vital to progress in the vaccine area.

Other related actions proposed were to:

Develop scientific criteria to select base-isolates for vaccines and conduct appropriate studies;
Characterize to a greater degree HIV infections in India, including virological, immunological, and clinical features;
Enhance clinical epidemiological capacity such as protocol development and procedures, manuals, and data management systems;
Interact with community representatives to develop community awareness about vaccines and clinical trials;
Set national and international training priorities in vaccinology, immunology, clinical trials, property issues, etc;
Establish guiding principles for comprehensive multi-site and multi-pronged HIV vaccine development;
Conduct vaccine trials and test vaccines for safety and immunogenicity, while considering other international trials; and,
Clarify the decision-making processes to select products, to approve trials proposed, and to select one or more clinical trial sites.

VI. Group IV: Vertical (Mother-to-Child) Transmission of HIV

The primary research questions were grouped into two categories: higher priority and intermediate priority. The high priority topics addressed were:

The seroprevalence of HIV-1 among pregnant women in India;
The characteristics and risk factors of HIV-infected women in India;
The efficacy and effectiveness of possible interventions to prevent vertical transmission of HIV in India;
The efficacy of post-exposure prophylaxis for infants; and,
The risk factors of postnatal transmission via breastfeeding;

Among the intermediate priority questions/topics were:

The efficacy of peripartum cervicovaginal/infant cleansing;
Nutritional and immunologic characteristics of breastmilk with and without treatments intended to inactivate HIV or to lower viral load; and
The short and long term safety of interventions to prevent vertical transmission of HIV.

In addition, the Group addressed:

National and international research collaborations of HIV vaccines for HIV-infected women and/or children born to HIV-infected women
Management of HIV-infected women and children such as antiretroviral therapy and nutritional management immunizations.

VII. Conclusion

In the concluding session of the conference, the participants again noted the greater realization by the global community of the threat posed by the HIV/AIDS epidemic, not only in health and economic terms, but in a national security context. In order to make progress against this disease, countries such as the United States and India must work together. ICMR and NIH representatives noted some of the mechanisms available to support Indo-U.S. HIV/AIDS research.

The need to lower barriers to cooperation between the two countries was also noted and Dr. Keusch proposed that further discussions on policy issues related to research cooperation be initiated. This suggestion was met with widespread agreement and the NIH and ICMR participants agreed to host such a joint policy forum in the near future.