1. KEY ELEMENTS FOR SUCCESSFUL INTERVENTION - Political Mobilization of political will and commitment Unified national planning Community involvement Reduce stigmatization and discrimination

2. KEY ELEMENTS FOR SUCCESSFUL INTERVENTION - Programmatic Good surveillance Learn and adapt from past experiences Access to intervention tools; e.g. condoms, testing Rapid implementation Focused intervention, especially to marginalized groups Promote testing Provide treatment

3. MODES OF TRANSMISSION Blood Sexual activities Mother to child

4. NEED TO RETURN TO PUBLIC HEALTH PRINCIPLES Discard concept of exceptionalism Primary responsibility to protect the uninfected Promote testing Prevent transmission

5. USING ANXIETY AS A PUBLIC HEALTH TOOL Level of Anxiety Too little  Sufficient  Too much  Consequences No action Appropriate action Fatalism and no action

6. DETERMINANTS OF TRANSMISSION FROM AN INFECTED PERSON Duration of infection/stage of disease Risk of transmission per sexual act –Viral RNA level –Presence/absence of concurrent STD and other infections –Condom use Circumcision status Partner exchange rate –Mixing pattern –Patterns of sexual behavior (anal, vaginal, etc.) –Injection equipment sharing

7. TARGET GROUPS FOR INTERVENTION STRATEGIES Men who have sex with men Injection drug users Promiscuous heterosexuals Health care workers Biomedical laboratory workers Blood/plasma donors Pregnant women in high-risk populations Youth 13-25 years

8. STRATEGIES TO PREVENT HIV INFECTION Rapid Testing 1.Immediate results 2.Requires confirmation, if informing patient

9. STRATEGIES TO PREVENT HIV INFECTION - BLOOD 1.Reduced use of whole blood 2.Screening of blood donors 3.Screening of blood donations 4.Processing of blood products 5.Institutionalization of routine safety procedures for health workers and biomedical laboratory technicians

10. STRATEGIES TO PREVENT HIV INFECTION – INJECTION DRUG USERS 1.Prevent drug use 2.Reduce needle sharing 3.Use of bleach or boiling 4.Needle exchange programs 5.Drug replacement programs 6.Health education/behavioral intervention for intravenous drug users 7.Improve access to and acceptability of testing 8.Condom promotion

11. STRATEGIES TO PREVENT HIV INFECTION - SEXUAL ACTIVITIES (MALE-FEMALE, MALE-MALE) (1) Health education/behavioral intervention Increase knowledge of HIV/AIDS at an early age Eliminate/reduce high-risk practices Promote use of condoms with every intercourse Promote monogamy/celibacy Improve early sex education in schools

12. STRATEGIES TO PREVENT HIV INFECTION - SEXUAL ACTIVITIES (MALE-FEMALE, MALE-MALE) (2) ● Reduce opportunities for promiscuity (e.g., close bath houses, reduce number of partners, avoid anonymous partners) Regular screening and treatment for sexually transmitted diseases Use of syndromic approach and counseling to treat STDs More acceptable STD treatment facilities

13. STRATEGIES TO PREVENT HIV INFECTION - SEXUAL ACTIVITIES (MALE-FEMALE, MALE-MALE) (3) Premarital testing Routine testing of sex workers for STDs and HIV, with treatment for those infected Regulation of commercial sex Improve access to and acceptability of testing Voluntary partner notification Promote circumcision

14. STRATEGIES TO PREVENT HIV INFECTION – HIGH-RISK HIGH- FERTILITY WOMEN 1.Selection of marital partners 2.Testing before marriage 3.Monogamy 4.Education of spouses 5.Routine testing and effective treatment of STDs 6.Improve access to and acceptability of HIV testing (e.g., routine testing) 7.Promote condom use 8.Empowerment

15. STRATEGIES TO PREVENT HIV INFECTION- MOTHER TO INFANT (1) Routine testing Women in high-risk groups Pre-pregnancy testing Antenatal Counseling Antiretroviral treatment Prenatal Postnatal

16. STRATEGIES TO PREVENT HIV INFECTION - MOTHER TO INFANT (2) Education Exclusive breast-feeding for six months Prophylaxis of infant during breast-feeding Effective screening and treatment of STDs

17. STRATEGIES TO PREVENT AIDS (1) Developed countries Initiate HAART CD4 + cell <250, regardless of symptoms Symptoms of HIV infection present regardless of CD4 + cell level CD4 + cell >250, viral load >30,000 Diagnosis of AIDS Monitoring of HAART response and development of resistance

18. STRATEGIES TO PREVENT AIDS (2) Developing countries  Political commitment  Testing and post-test counseling  Provision of drugs  Development of treatment infrastructure  Expansion and training of treatment personnel  Education on need for adherence to drug regimen  Development of inexpensive, low-tech surrogate tests for monitoring disease course

19. TARGET POPULATIONS Vulnerable groups  Poor  Minorities  Men who have sex with men  Injection drug users  Adolescents  In utero/breast-feeding infants (mothers) Schoolchildren Women

20. INTERVENTION STRATEGIES Educational approaches Behavioral (theory-based) approaches Harm reduction Community intervention

21. EDUCATIONAL APPROACHES School-based Media: newspapers, posters, radio/TV Internet Health professionals –Train the trainers Researchers Administrators Health care providers

22. BEHAVIORAL (THEORY-BASED): “EMPOWER” APPROACHES Stages of behavior change –Knowledge –Persuasion (of ability to change) –Decision –Implementation –Reinforcement

23. ROLE MODELS Formal leaders Popular opinion leaders Informal leaders –Recruitment –Training

24. HARM REDUCTION Condoms (promotion and social marketing) Needle exchange Methadone and other oral drug alternatives

25. COMMUNITY INTERVENTION Have community accept responsibility and initiate appropriate intervention activities Recruit community leaders, teachers, health workers, peer leaders, media Develop appropriate intervention strategies collaboratively with community

26. EDUCATION IS ESSENTIAL BUT INSUFFICIENT

27. CDC, “New Strategies for a Changing Epidemic” HIV testing as a part of routine medical care New models for testing outside medical settings (e.g., community setting) Work with HIV-positive individuals to prevent secondary spread Promote routine testing of pregnant women and infants of untested mothers

28. EVALUATION OF INTERVENTION STRATEGIES Are the appropriate risk groups and areas targeted? Is the intervention strategy culturally/ economically appropriate for the specific risk group/area? How is effectiveness of intervention strategies measured? Is the sentinel surveillance system a part of the evaluation scheme? Has there been an impact? Is the strategy cost-effective?

30. OBJECTIVES OF VACCINATION Prevent infection Prevent disease Prevent transmission

31. REQUIREMENTS FOR A PROPHYLACTIC VACCINE Must be safe Must elicit a protective immune response Must stimulate both humoral and cellular immunity Must protect against different clades of HIV Must provide long-lasting immunity Must be practical to produce, transport and administer Should stimulate mucosal immunity in genital tract, rectum and oral cavity

32. PRIMARY ISSUES FOR CONSIDERATION IN VACCINE DEVELOPMENT (1) No long-lasting natural immunity yet demonstrated in humans Disease progresses despite presence of neutralizing antibody Variability of viral genome Can a group antigen be found to induce immunity? Clades? Frequent mutations Need to induce humoral and especially cytotoxic cellular immunity Potential of some vaccine candidates to induce enhancing antibodies

33. PRIMARY ISSUES FOR CONSIDERATION IN VACCINE DEVELOPMENT (2) Applicability of animal studies to HIV in humans Ethics and sources of volunteers for safety and efficacy trials Efficacy –Against infection –Against disease –Against transmissibility –Acceptable level Who will be vaccinated? Selection of optimal vaccine: safety vs. efficacy

34. TARGET GROUPS FOR VACCINATION Men who have sex with men Injection drug users Promiscuous heterosexuals Sex workers Health workers Biomedical laboratory workers Spouses of risk group members

35. TYPES OF VACCINES Non-live –Whole virus, killed –Subunit with adjuvant Fractionation and use of specific particles Synthetic Anti-idiotypic Live –Whole virus, attenuated –Subunit, recombinant Viral substrate Non-viral substrate (e.g., yeast) DNA vaccines (inject gene coding for antigen) Recombinant vector Artificial “resistance”

36. STAGES IN VACCINE RESEARCH AND DEVELOPMENT Basic research Animal studies –Safety –Immunogenicity (humoral and cell-mediated) –Efficacy Clinical trials –Phase I – safety and immunogenicity in humans – small numbers of subjects Who should be the guinea pigs? –Phase II – safety and immune response in humans – small trials –Phase III – larger population-based trials for efficacy –Effectiveness

37. Whole-Killed/Whole-Inactivated Vaccines Excler J-L, Kochhar S. The vaccine textbook: new strategies for AIDS vaccine development. Sankalp (IAVI India Newsletter), p. 6, November-December 2005.

38. Live Attenuated Vaccines Excler J-L, Kochhar S. The vaccine textbook: new strategies for AIDS vaccine development. Sankalp (IAVI India Newsletter), p. 6, November-December 2005.

39. DNA Vaccines Excler J-L, Kochhar S. The vaccine textbook: new strategies for AIDS vaccine development. Sankalp (IAVI India Newsletter), p. 6, November-December 2005.

40. Recombinant Vector Vaccines Excler J-L, Kochhar S. The vaccine textbook: new strategies for AIDS vaccine development. Sankalp (IAVI India Newsletter), p. 6, November-December 2005.

41. Hecht R. Partnerships and innovative financing: a way ahead for vaccine research – part 1. Sankalp 5(1):7, 2006.

42. Intl AIDS Vaccine Res (1):7, Dec 04- Mar 05.

44. SOCIOPOLITICAL CONSIDERATIONS Cost of development – federal government and/or private industry? Responsibility for liability – federal government, industry, or insurance companies? Priorities for funding and distribution of vaccine

45. Candidate vaccines currently in clinical trials. Source: Science 356(20):2078, 2007

46. SUGGESTED FUTURE DIRECTIONS (1)  Implement public health principles and eliminate concept of “exceptionalism”  Mobilize political will and intervention priority of HIV/AIDS (consensus strategies, not dictates)  International level  National level  Local level # Increase community awareness and acceptance of health threat # Promote community responsibility for intervention # Implement community intervention strategies  Lower cost and improve quality of surveillance, especially of low-risk groups

47. SUGGESTED FUTURE DIRECTIONS (2)  Promote health education for:  Health professionals  Media  Public, especially young, sexually active men and women  School children before majority leave school  Develop, implement, and evaluate culturally sensitive, economically feasible behavioral intervention strategies  Improve treatment potential, especially in developing countries  Promote concept of wealthy nation responsibility towards poorer nations; e.g., drug patent relief  Implement mechanisms for distribution of low-cost treatments  Develop treatment infrastructure  Develop surrogate markers for disease progression and HAART response

48. SUGGESTED FUTURE DIRECTIONS (3)  Implement “risk-free” testing (e.g., rapid saliva testing with resources for confirmation of positives)  Promote widespread routine testing  Reduce stigmatization associated with testing, being HIV-infected, and belonging to a “risk group”  Increases willingness to learn HIV status  Increases testing acceptability  Facilitates earlier identification # Improves treatment effectiveness # Reduces period of unknowing transmissibility # Facilitates premarital testing

49. SUGGESTED FUTURE DIRECTIONS (4)  Improve control and treatment of sexually transmitted diseases  Implement early health and sex education before majority of young people leave school  Promote education of women  Promote harm reduction  Needle exchange, etc.  Condom promotion  Reduce cost and improve quality of blood screening  Reduce acceptance of multiple sexual partners

50. SUGGESTED FUTURE DIRECTIONS (5) Change gender realities (role of men and women) Develop and promote an effective microbicide Develop behavioral interventions that will be sustained Develop strategies to evaluate behavioral interventions Continue intense efforts to develop an effective “vaccine” Promote circumcision