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An increasingly complex scenario: recent developments in HIV prevention and the combination agenda

An increasingly complex scenario: recent developments in HIV prevention and the combination agenda. Patrick Sullivan Emory University Rollins School of Public Health, Atlanta, Georgia, USA. www.ias2011.org. Underlying Principles.

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An increasingly complex scenario: recent developments in HIV prevention and the combination agenda

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  1. An increasingly complex scenario: recent developments in HIV prevention and the combination agenda Patrick Sullivan Emory University Rollins School of Public Health, Atlanta, Georgia, USA www.ias2011.org

  2. Underlying Principles • In research on man [sic], the interest of science and society should never take precedence over considerations related to the wellbeing of the subject • In any medical study, every patient - - including those of a control group, if any - - should be assured of the best proven diagnostic and therapeutic method

  3. It’s a timely conversation … HET-PrEP Condoms 1% TDF Gel ARV for + Partner MC 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11 AZT for PMTCT MSM PrEP ALVAC/AIDSVAC Partner PrEP

  4. Science to Practice

  5. Efficacy in HIV Prevention

  6. Necessary but not sufficient • Knowledge • HIV testing • Access to condoms, lube • Access to culturally competent care

  7. Changing clinical care guidelines • Increasing CD4 threshold for implementation of therapeutic ARV • Differences in country guidelines/programs • Lag between high-income and LMIC

  8. Resources • Many persons living with HIV in all countries have unmet needs for therapeutic ARVs • Starting a person on ARVs in the context of a trial is a life-long commitment to treatment • Some zero-sum competition for resources (although this should be changed)

  9. What changes after Monday’s results? • New decisions about what constitutes “standard of care” • More participants required to get an answer to the same question about new products (endpoint driven enrollment) • Possible changes in protocols currently in the field • More money required to test new approaches

  10. A changing view of clinical research

  11. Questions • Why do national programs not take up proven effective interventions? • If interventions are proven but not generally implemented, should they be required as part of a SOC package? • Should research “push the margin” in moving forward under-utilized interventions to programs? • As treatment at higher CD4 becomes SOC, does SOC become coercive towards trial participation?

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