A breakdown of an in-house meeting around the issues surrounding the many aspects of HIV Treatment and Prevention and questions needing to be answered in dealing with it.

1. POLITICS LANDSCAPE 3 Legs Scientists Money Support Politicians need to be able to say “The scientists say we should do this” Need scientists to sign a statement they agree on Makes it happen Grass roots Legislatively To do legal work Major Topic Sub-Category Multiple breaks indicate various related issues Which are more thoroughly broken out into the elements discussed Search For A Cure July 8 th 2009 6:30 P.M. MA Prevention Program Group Discussion I MEETING SUMMARY: The following is a series of flowcharts and diagrams breaking down the major topics under discussion at the Reducing HIV Transmission Summer, 2009 Group Discussion I Conducted by Search For A Cure and involving you, the public health experts and knowledgeable physicians. The flowcharts directly correlate with the group discussion conducted and are broken down into topics and categories for ease and for more clearly managing the volume of content discussed. Additionally, the meeting transcript has been included as an email attachment for reference. See the description below for an overview of the organization of the included charts :

2. TREATMENT AT RISK ACUTE EXPOSURE ACUTE INFECTION LATENT INFECTION Risky behavior not necessarily typical ‘normative’ behavior Intent to serosort that fails Acute increase in risk due to environmental factors Drug/alcohol use New relationship Just broke up Eroticized environment Most of these people don’t know what PREP/PEP is. Awareness Don’t know what is risky Admit to behavior that is ‘at risk’ But perceive self as not ‘at risk’ Testing Kathy has hard time getting tests now Really need HIV test in every medical record as standard of care Ideally insurance should pay for at least 1 per year Reality Refusal to test Could have info to give refusers to think over & steps to get tested 1/3 in study refuse test Don’t want to deal with it Don’t believe at risk Don’t want to test then, with that physician Might test at other appointment or at home Normalize / Standardize Studies Current Practice Public will accept it if it is routine S. Africa Project ACCEPT, Tom Coates, UCLA Community size control groups Results in 2 years Physicians base HIV risk on how patient looks Needs to just be standard Cost/Benefit would say it is crazy Consider it like immunization (standard of care) Buy test for 6 million to Test 300,000 at risk to ID 4,000 unknowing positives to Prevent 1,000 new infections Hypothetical situations If testing is standard Who tests? Worried well Who doesn’t? People who really need it Package program with other issues Make it look like search is for all of them Herpes Pregnancy Syphilis Chlamydia Remember risk varies Ex. Oral is better for HIV but can still give Syphilis Operational Strategy Cost effectiveness Targets Which tests? How Often? How to get them in to be tested Who are they? What do they want? What are they dealing with? Where are they? Strategies Incentivize it Standardize it Free at home Priority Acute Exposure/Infection Early diagnosis Stigma People more afraid of HIV then other STD’s Danger of singling out groups/communities Reality Do you need to prove efficacy in an operational study? 1/2 year fairly instructive 2 1/2 years potentially conclusive, depending on samples and results Just as interested in operational strategy data as efficacy Efficacy data coming fairly fast FLOWCHART 1

3. TREATMENT AT RISK ACUTE EXPOSURE ACUTE INFECTION LATENT INFECTION ID Prevention Services Not on pills whole life Prevention Services Time sensitive PEP Definitely Works How to make it available? There is no Standard Approach MA is only state with guaranteed access to PEP Not enough consumer demand to keep it going Rapid drop in last 3 to 4 years People not asking for it Physicians not prescribing it People don’t know about it Need education Reaction to being told is outrage info not shared Don’t want to create demand before the supply Even Pentecostal Bishop outraged Retort: Will he tell his congregation? It may be time to tell them It is hard to get Weekend primary care Doc uncomfortable writing for HIV Never write for Truvada, want to know who will follow in a week with createnine Must refer Even if patient knows about it it is hard to get Story of lawyer from Ptown Only at Fenway Only at Fenway Only because doing study Hard to keep good contacts at key points in chain to get it (CD’s & Clinics) DPH priority to restoke the system PREP Not shown to work yet in humans Good logical argument for “why wouldn’t this work?” ‘ work’ = cost effectiveness Is it 50% or 80% effective How many pills did it take to get there? How can you ‘trust’ people to take them? Used for years in fetuses Good animal data Good examination of bioavailability of virus on mucosal linings Take all the time or as needed? Will there be significant behavioral disinhibition? Is adherence going to be good enough? Proposed cost effectiveness ratio that is high compared to other things That is not good Based on unfinished data and market price of drugs so inconclusive Qualitative study Need education if proven to be effective People still think are old nasty drugs People unwilling to take drugs that change appearance 2 1/2 years potentially conclusive data Depending on samples and results 4 possible outcomes Low efficacy with Low adherence = wash Low efficacy with High adherence = useless High efficacy with Low adherence = great! Low efficacy with High adherence = need adherence intervention plus ARV FLOWCHART 2

4. TREATMENT AT RISK ACUTE EXPOSURE ACUTE INFECTION LATENT INFECTION Highly Infectious ID High social anxiety around HIV Regiment needs to fit personality Hard to achieve Don’t always feel sick at time have to take pill Treatment Services Responsibility Partner Services Safe Practices Compliance Don’t want to believe results Takes 4 tests to believe infected Responsibility Issue Now it is physicians call when patient is ready Shouldn’t be physicians sole responsibility to explain Some physicians don’t stress importance enough Some hold back too long Patients burn through their options too fast and are in bad position Patients get really sick because doc didn’t think they were ready to be compliant Reasons Potential solutions Often pill makes you feel sick “ Why take something when I feel fine that will make me feel sick?” Buddy system Interpersonal relationships to learn Computers Cell Phones MIT pee strip in development Time Sensitive When do you start? Can you make less infectious Day 1? Is earlier better? Not proven for individuals, though likely Net benefit for public regardless Cons Drugs are expensive Drugs are toxic Though less so then used to be FLOWCHART 3

5. RESPONSIBILITIES ETHICS COST Think in terms of Location, Population, Prioritization Address all constituencies Want to be most effective Don’t want to harm people Is that due to testing bias? Increases stigma Uses funds most efficiently Do least invasive thing that honors integrity of individual lives to reduce likelihood of infection Goal: Nothing toxic in you and cheap Ex. Sexual Harm Reduction Location Geographic targeting Prediction that: Undiagnosed prevalence in some way mirrors diagnosed prevalence Despite 30% oblique diagnosis Data from BA suggests this So current population map of HIV should be close to true Balance To Commonwealth To Community To individual Justification Goal: balance of invasive measures (including taking chemical pills) to benefit & price Cost effectiveness Proving cost effectiveness doesn’t mean intervention will be used Promotes use Still usually requires some large upfront sum Who pays? Distal pay offs 384,000 per person discounted 3% per year Money saved will be from a different pot Payer upfront isn’t payer for long-term Pushback argument: “Those transmissions are not going to cost me money until 10 years from now…” HIV tax check box Bringing only $30,000 year now Rapid Tests $10-$15 Argument for public Tax money is going to benefit you Largest sum Drug costs Cut price with reduced use in prevention, or generic use? FLOWCHART 4

6. POLITICS LANDSCAPE ATTACKS LOGISTICS SUPPORT 3 Legs Scientists Money Support Politicians need to be able to say “The scientists say we should do this” Need scientists to sign a statement they agree on Makes it happen Grass roots Legislatively To do legal work Back flack For encouragement of sexual behavior From outrage Counter argument One size does not fit all model Use what part works for you Package of multiple modes of prevention to prevent all transmissions It has been 25 years Might sway responsible opposition to say it is time we stop it Why haven't you done anything about it Have to swallow that have been doing stuff about it More detailed = more obstacles over details Never has chance to get off the ground Most important thing Get rid of written informed consent policy In operational research participation will coincide with consent and negate signing Math model at .9% takes 300 years to wipe out epidemic is that globally? Reality Funding Save in the future? $384,000 per person discounted 3%/year Bad economy Benefit if increases spending But people fighting to keep things funded month to month now Multiple sources Ex. Stimulus 2 Location Targeted resources Seen as inciting stigma Public health data historically used like this Go to where the fire is To direct resources go to where the epidemic is to protect the State Political Partnerships Make it everybody's business Immunization gets enormous support Ex. Statement by Attorney General in favor of testing People don’t go out of their way unless something effects them or they think it effects them Ex. Very few breast cancer advocates compared to those at risk Not poor people saying you’re going to take away my vaccine People in well to do suburbs Who are the other stakeholders and other coalition members who are not so involved in HIV/AIDS? FLOWCHART 5

7. WE HAD A HIGHLY SUCCESSFUL SHARING SESSION AND MADE SOME SERIOUS HEADWAY IN DIVULGING MOST OF THE PRELIMINARY PARAMETERS THAT WILL INFLUENCE OUR FINAL DECISION PROPOSAL. THE FLOWCHARTS DOCUMENT THE SPECIFICS OF OUR CONVERSATION AND ARE A GOOD START. FOLLOWING IS A BROADER ANALYSIS OF THE MEETING, WHERE WE ARE AT, THE RATIONALE FOR A PROGRAM, AND PROBABLE NEXT STEPS NECESSARY TO FRAME OUR PROGRAM GOALS.

8. TREATMENT PROCEDURE WE ARE HAVING FOUR CONVERSATIONS AT THE SAME TIME WEAVING ELEMENTS FROM PROGRAM START UP AND TREATMENT PROCEDURE, WHICH IS COMBINING MULTIPLES OF VERY SEPARATE THINGS, AND ALLOWING FOR US TO SUCCESSFULLY BAT THEM BACK AND FORTH. How do we get them to do it? How do we get them to know it? How do we get them to feel it? What do we want patients to do? What do we want patients to know? What do we want patients to feel? How do we pay for it? How do we get healthy people to support it? How do we cut off potential attackers? PROGRAM START-UP What do we need from the state? What do we need from the public? What relationships do we need to build? MARKETING PLANNING SUPPORT GROUNDWORK 1 2 3 4 WE WILL NEED TO BREAK THESE EACH OUT FOR SEPARATE CONSIDERATION

9. MARKET TRENDS “ THE TIME IS NOW ,” WHY? CULTURE TRENDS TECH TRENDS Obama HIV is off the radar Political Support Gay is in common culture Early prevention treatments Rapid home tests Better HAART Creating jobs is in demand Stimulus + Stimulus II Gay marriage in MA Reduced stigmatization occurred Young people are more open about sex More opportunity across racial divides CCR5 + FTC + TNF = PREP Communication Technologies: For education, compliance, assistance, organization: Ex . Facebook Application that helps you know your status by getting tests to you and connecting you with professionals Facebook, Twitter, MySpace, Email, Virtual Calendars, PDAs, iPhones Federal Money Foundations Pharmaceuticals Cost/Savings Attractive to State and Feds Financially cheaper to individual Emotionally cheaper to individual OUR MAJOR RATIONALE FOR A PROGRAM IS MAINLY THAT: PLEASE EMAIL ANY ADDITIONAL ELEMENTS YOU CAN THINK OF FOR THE CREATION OF A MASTER RATIONALE WE CAN ALL SHARE AND WORK FROM.

10. NEXT STEP: Defining Our Goals - TOPICS FOR NEXT MEETING What is it? What is the goal of the program? What would success of our program look like? Politically? THE TIME IS NOW, for a “ Program? ” Socially? Legally? Financially? Scientifically? Reduce transmission by 10%? Increase testing by 60%? Remove the written consent policy? Increase the level of standard education by 75%? Viral marketing campaign? Mandatory medical policy changes? More of the same with the new tools? Increase number of restored patients by 40%? Again, these topics each require separate consideration. Our main objective at this time is identifying potential partnerships for support, and preparing for the conference. Please think about and comment on the items included. Thank you. New Term Restored Patients: patients who were acutely exposed, diagnosed early, put on proper early prevention ARVs (PEP) so as to avoid seroconversion.