1.  Getting Outside of the Box: Designing and Implementing Innovative Ways to Prevent Infection Willo Pequegnat, Ph.D., Salix Health Consulting/USAID Susan Newcomer, Ph.D., NIH

2. Box 1: Discipline  First US Government-wide Meeting in 1983  HIV was an infectious disease; biomedical community mobilized to develop cure  However, in beginning recognition that this was a social disease spread by behavior  Neither biomedical or behavioral and social scientists would have all the answers

3. Box 2: Adapting Language  Collaboration required new language to collaborate  Adapted drug phases of clinical trials to behavior  Phase I – discovery (KAB)  Phase II – development (assess potential intervention)  Phase III – efficacy (RCT)

4. Box 3: Not Assuming You Have All Answers  Ethnographic methods were adopted early  Observation, focus groups, in-depth interviews with affected community  Used to help design intervention and assessment and interpret results (CABs)  Representatives from affected community were put on policy, review, research teams

5. Box 4: Identified Active Ingredients  Initially began at individual level; adapted social cognitive approach  Perception that HIV was in the community  Perception that individual at risk  Understand transmission process  Learn skills to protect self

6. Box 4 (continued)  Role play so can implement skills when required  Learn triggers to risky behavior  Learn to avoid situations that stimulate triggers and to handle them  Evaluate what can do better

7. Box 5: Alternative Sources of Evidence  Expanding beyond RCT:  Randomized Encouragement Designs  Nonrandom Quantitative Assignment of Treatment  Observational Studies

8. Box 6: Moving Up the Intervention Ladder  Individual  Couples  Families  Communities  Societal (media, policy)

9. Box 7: Overcoming Scaling Up Gap  Phase IV – Effectiveness  Phase V – Implementation  Moving beyond journal article publication as the final outcome  Asking questions associated with a successful scale up

10. Box 8: Redefining Fidelity based on Common Factors  Establish a framework to understand behavior change  Convey issue- and population specific information  Build cognitive, affective, and behavioral self-management  Address environmental barriers to implement new behaviors  Provide tools to develop ongoing social and community support

11. Box 9: Identify What is Working/Not Working  Continue to ask the affected community at every stage to ensure that you are having the impact that you are planning  Careful analysis of what is and is not working  Look beyond the numberr

12. Questions?  Far better an approximate answer to the right question than an exact answer to the wrong question. - John Tukey