1. www.global-campaign.org “Standard of Care” The term “Standard of care” refers to the nature of the prevention and/or care that will be provided to participants in research It has been used variously to refer to: – the general care and treatment that investigators agree to provide all participants in clinical research And more specifically to: –the quality of care that should be provided to people in the control arm of a RCT – i.e. those that are not receiving the experimental intervention

2. www.global-campaign.org The specific issues What standard of care should be assured individuals who participate in HIV prevention trials? –Prevention package? (c ondoms, risk reduction counseling, clean needles?) –Care related to the disease under study? –Other ancillary care?

3. www.global-campaign.org The larger issues… Is it ethically necessary to improve health care as we conduct research? Is it ethically permissible to do research in the absence of adequate health care? Is it ethically acceptable to do no research if we are unable to improve health care?

4. www.global-campaign.org The Standard of Care Debate Intense international discussion and debate Debate heated up around controversial HIV trials to prevent mother to child transmission in the developing world Commentators questioned the ethics of trials that used a “placebo” when an existing regimen 076 had been shown to reduce peri-natal transmission of HIV in the United States Defenders argued that the 076 protocol was not “relevant” to the health care needs or priorities of the developing world, because it could not viably be implemented

5. www.global-campaign.org What does ethics guidance say? Individuals in the control arm must receive: –“An established effective intervention” (CIOMS) –“The best current prophylactic, diagnostic and therapeutic method” (Declaration of Helsinki, 2002) –Ideal: “best proven therapy;” Minimum: “highest level of care attainable in light of … the circumstances listed" (UNAIDS vaccine guidance) –Ideal: “best proven;” Minimum: “the best intervention available for the disease as part of the national health system” (Nuffield Council) –“Highest achievable” standard should be the goal (Benatar & Singer, BMJ, 2000)

6. www.global-campaign.org Does placebo debate apply to vaccine & microbicide trials? No….vaccine and microbicides trials do not have classic “no treatment arm” All participants receive standard prevention package (e.g. condoms, counseling, STD treatment) Placebo is used to blind researchers and participants to which group has experimental product Issue is what should be part of “prevention package”

7. www.global-campaign.org SOC Debate as Applied to Microbicides What package of prevention services should participants in the trial be provided? –High standard HIV counseling, condoms, STD screening, treatment, clean needles, methadone treatment? Investigator’s Dilemma The more effective your prevention package is, the more difficult it becomes to determine whether the product works

8. www.global-campaign.org Standard of Care (continued) What other health care should be provided during the trial? –Pap tests? Family Planning? Malaria Rx? What HIV care should individuals who seroconvert during the trial be provided ? –TB prophylaxis, nutrition counseling, support groups, MTCT, ARVs? What care, if any is due women who are screened out of the trial because they are already HIV+?

9. www.global-campaign.org List of Care Issues Debated in Microbicide Trials Enrolled Screened Community Basic HIV education re: transmission M M ? Condom promotion/risk reduction M M ? VCT – pre/post counseling M M ? STI screening M M ? STI treatment M M ? Reliable contraception ? A ? Initial CD4 counts for HIV+ -- M? A MTCT ? A A Cervical cancer screening M? A A Care for cervical dysplasia/cancer M? M? A Psycho-social support for HIV+ women ? ? A Prophylaxis for HIV Ois M? ? A TB/Malaria treatment/other care A A A ARVs ? A A

10. www.global-campaign.org Working within unacceptable realities According to the 2003 Global HIV Prevention Working group and UNAIDS: –Only 1 in 10 people living with HIV have been tested for the virus –Only 5% of pregnant women in sub-Saharan Africa have access to nevirapine to prevent mother to child transmission –In Latin America and the Caribbean only 14% of risky sexual acts are protected with condoms –Only 14% of people in current need of ARVs have access to treatment –In Eastern Europe, only 7.6% of IDUs have access to programmes to help them stay uninfected

11. www.global-campaign.org Standard of Care How do we achieve new ideals? Heightened sensitivity to exploitation Aim for reasonable practical limits Ratchet the standard upwards Build capacity through real partnerships Follow the ‘spirit’ of Declarations Avoid ‘cook-book’ attitudes to ethics Consider: context / safety / logistics / harm/benefit/sustainability

12. www.global-campaign.org Today’s deliberations are part of an on-going conversation South Africa Consultations – SAAVI and SMRI (Dec 2001, August, Nov 2002) Global Campaign/IAVI Treatment Consultation February, 2003 South African National Consultation April, 2003 WHO/UNAIDS Consultation on access to treatment, July, 2003 Global Campaign ethics consultation, October 2003 Ethical considerations in provision of care and treatment in vaccine trials, June 2005 Brazil (follow up to Malawi, March 05) UNAIDS consultations in Abuja, Bangkok, Durban & Geneva The dialogue continues……