KEY ELEMENTS FOR SUCCESSFUL INTERVENTION - Political

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

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 • Immediate results • Requires confirmation, if informing patient

9. STRATEGIES TO PREVENT HIV INFECTION - BLOOD • Reduced use of whole blood • Screening of blood donors • Screening of blood donations • Processing of blood products • 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 • Improve access to and acceptability of testing • 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 • Selection of marital partners • Testing before marriage • Monogamy • Education of spouses • Routine testing and effective treatment of STDs • 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