Introduction to New HIV Prevention Technologies Training Module

Transcription

1 Introduction to New HIV Prevention Technologies Training Module Training Module This training module was developed to enhance frontline providers knowledge of New HIV Prevention Technologies (NPTs) and is intended to compliment CPHA s Introduction to New HIV Prevention Technologies continuing education elearning course. This training module is to be used by facilitators in the training of frontline providers on New HIV Prevention Technologies (NPTs) and as an online resource. The module presents a general overview of NPTs as of March 2012 and can be completed in approximately 1 hour. The module comes complete with Power Point presentation and facilitator notes. Facilitators that have experience working with HIV are encouraged to adapt the materials to fit the content and purpose of their respective sessions. To navigate through the training module material please click on the various sections listed in the sidebar or simply download the facilitator notes and Power Point presentation. Module Overview The Canadian Public Health Association was funded by the Public Health Agency of Canada (PHAC) and Canadian HIV Vaccine Initiative (CHVI) to undertake a project entitled, Preparing the Canadian Public Health Community for New HIV Prevention Technologies. The goal of the new HIV prevention technologies (NPTs) project was to develop an appropriate education and training module that would increase public health workers and frontline providers knowledge, skills and capacity regarding NPTs as they relate to public health core competencies and existing prevention technologies and approaches. Module Objectives The objectives of the training module are to: o improve frontline providers knowledge of what NPTs are, the current state of evidence for NPTs, how they might work, and their role as part of a comprehensive approach to HIV prevention;

2 o o understand the services, mechanisms, guidance and resources needed for NPT implementation; and, develop frontline providers capacity to communicate effectively about NPTs. Module Target Audience This module has been developed for frontline providers working in HIV prevention. Frontline providers carry out the bulk of day-to-day tasks in the public health sector. They work directly with clients, including individuals, families, groups and communities. Responsibilities may include information collection and analysis, fieldwork, program planning, outreach activities, program and service delivery, and other organizational tasks. This includes individuals working in, but not limited to, settings such as public health units, regional health authorities, AIDS service organizations, community health centres and other organizations that work with priority populations such as Mental Health Services, Police Services, Social Housing, Youth Services, Shelters etc. Production of this elearning module has been made possible through a financial contribution from the Public Health Agency of Canada. The views expressed herein do not necessarily represent the views of Public Health Agency of Canada. Copyright 2012 Canadian Public Health Association For more information, contact: Canadian Public Health Association Carling Avenue, Ottawa, Ontario K1Z 8R1 Tel: Fax: info@cpha.ca

3 Table of Contents 1. Training Module Introduction Section 1: HIV/AIDS in Canada - HIV/AIDS in Canada - Existing Prevention Options Section 2: Why are New HIV Prevention Options Needed? - Vignette - Can t we just Promote Condoms? - Efficacy vs. Effectiveness - Condoms and NPTs Section 3: NPTs as Part of a Comprehensive Approach to HIV Prevention - NPTs as Part of a Comprehensive Approach - Imagine a Full Spectrum of Interventions Section 4: New HIV Prevention Options - New HIV Prevention Options - What are new HIV Prvention Technologies - ARV-Based Prevention Options - HIV Prevention - Treatment as-prevention - Pre-Exposure Prophylaxis - Vaginal and Rectal Microbicides - Vaccines Section 5: NPT Implementation Issues - NPT Implementation Issues - NPTs Measuring Impact - Next Steps Conclusion 2. Acronyms 3. Evaluation 4. Acknowledgments 5. Disclaimer

4 Introduction: New HIV Prevention Technologies Introduction: Slide 1 Facilitator Notes: HIV and AIDS represent one of the greatest public health threats in the last few centuries. Worldwide, almost 60 million have been infected with HIV and 25 million people have been killed by this deadly disease - and in Canada, the number of people living with HIV continues to rise. The development of vaccines and other new prevention technologies (or NPTs) to prevent HIV infection offers one of the best hopes for slowing the epidemic. In , new HIV prevention technologies began to show great promise. Several large efficacy trials recently demonstrated proof-of-concept or established efficacy for vaccines, pre-exposure prophylaxis, microbicides, and treatment-as-prevention. This introductory module sets the stage for discussion and positive action around new HIV prevention technologies by providing an overview of key information regarding NPTs in Canada. This module is also designed to link NPTs to specific core public health competencies that enhance knowledge and understanding of NPTs, and improves the capacity of front-line providers to communicate NPT information effectively. Core Competencies for Public Health: Slide 2 Facilitator Notes: The Core Competencies for Public Health in Canada are the essential knowledge, skills and attitudes necessary for the practice of public health. They transcend the boundaries of specific disciplines and are independent of program and topic. They provide the building blocks for effective public health practice, and the use of an overall public health approach. There are 36 competencies organized into 7 domains, including Public Health Sciences; Assessment and Analysis; Policy and Program Planning, Implementation and Evaluation; Partnerships, Collaboration and Advocacy; Diversity and Inclusiveness; Communication; and Leadership. Among other things, the Core Competencies can provide a basis for developing curricula and training opportunities, encourage service delivery that is collaborative, populationfocused, ethical, equitable, standardized and client-centred, and provide an opportunity to improve recognition and understanding of practitioners roles in public health. Throughout this presentation, links between course content and the competency domains will be made though the use of the Core Competency icons. This helps identify for the learner where the course content is supporting the acquisition or maintenance of public health core competencies. We invite you to learn more about Core Competencies by clicking on the highlighted icons embedded on each screen throughout this presentation. Learn More: For further information about the public health core competencies, please consult the Public Health Agency of Canada website:

5 Learning Objectives: Slide 3 Facilitator Notes: By the end of this module, participants will be able to describe the current state of HIV in Canada; describe existing HIV prevention options; describe emerging HIV prevention options and how they work; explain why there is a need for additional HIV prevention options in Canada; describe how NPTs fit into comprehensive prevention and complement the existing spectrum of HIV interventions; and identify means of taking action, staying informed and getting involved in work related to new HIV prevention technologies.

6 Section 1: HIV/AIDS in Canada HIV/AIDS in Canada: Slide 5 Facilitator Notes: Here is a brief snapshot of HIV in Canada. It is important to note that these are nationally compiled statistics from 2008, and that the picture at the provincial/territorial and local levels can be quite different. But this snapshot does provide important indicators about HIV in Canada. 1. The number of people living with HIV in Canada is increasing as a result of a combination of new infections and better treatments that allow people to live longer. 2. We can see that the number of new infections has stabilized between 2005 and This suggests that either prevention efforts have been successful to some degree, or there are lower rates of testing. 3. Although the number of new infections have stabilized, they are not decreasing, which emphasizes the limitations of our current prevention efforts and the need for HIV prevention in Canada to improve. 4. Gay men and other men who have sex with men (or MSM) still represent the group with the highest number of new HIV infections in Canada. Heterosexual transmission accounts for a little over a third of new infections, with a disproportionate number of these occurring within communities that come from parts of the world where HIV is endemic. This means countries where the HIV epidemic is predominantly transmitted through heterosexual contact among the general population. Injection drug use accounts for a little less than one-fifth of new infections. 5. In Canada, an estimated one out of four people living with HIV are unaware that they are infected. They do not know they are carrying the virus. This is an important point to keep in mind as we think about how to improve HIV prevention efforts, and the role that new HIV prevention options might play. Learn More: For further information on HIV epidemiology in Canada, including information on various populations, consult the Public Health Agency of Canada Epi Updates. Warm Up Exercise: Purpose This exercise can be used as a warm up, ice breaker and bring participants up to date on epidemiological information regarding the transmission of HIV in Canada. Materials Using the Public Health Agency of Canada s 2010 EPI report split the participants into several groups and hand out the summary of epidemiological information for each key population. Facilitators Ask the particpants to pass around the summaries when they finish reading them and then lead an open discussion on the information provided and its significance.

7 Existing Prevention Options: Slide 6 Facilitator Notes: There are already a range of tools available to Canadians for HIV prevention. The tools shown in green are the ones that have been proven to be effective if they are used consistently. The tools that are still being investigated are in blue. The ones that are in red have recently been shown to be at least partially effective in some cases, and some trials are still ongoing to obtain further information. Many existing interventions that have been proven to be effective are still not widely available to those populations and individuals at highest risk of HIV. Much work remains to be done in this regard. For example, needle exchange programs are not available in Canadian prisons. Access to non-occupational post-exposure prophylaxis (or PEP) varies greatly across the country. Female condoms are often unavailable or unaffordable to people at risk of HIV. Pre-exposure prophylaxis (or PrEP) would still need to be prescribed off-label at this time. Also, little to no public health guidance exists for PEP, PrEP and treatment-as-prevention. Here is a short description of some of the existing prevention interventions available at the moment. Voluntary counselling and testing. Voluntary counselling and testing (VCT) is an important strategy for both HIV prevention and care. It facilitates behaviour change, and it is an important entry point for care and support for those who test positive. Clean injecting equipment. Providing clean injecting equipment to people who inject drugs, such as through needle exchange, reduces the risk of HIV transmission. Male and female condoms. Used consistently and correctly, both male and female condoms protect against HIV, sexually transmitted infections (STIs), and pregnancy by providing a barrier to prevent the exchange of bodily fluids. Post-exposure prophylaxis (PEP). Post-exposure prophylaxis is an intervention in which people who have already been potentially exposed to HIV take a brief course (usually 28 days) of antiretroviral (ARV) medications as soon as possible after exposure, (and certainly beginning within 72 hours of exposure). Prevention of vertical transmission. This is also known as prevention of mother-tochild transmission (PMTCT). Giving the HIV-positive mother antiretroviral drugs before and during delivery, and giving them to the baby after delivery, have been associated with a reduced risk of HIV transmission. Behaviour change. This strategy promotes risk-reducing behaviour, including delaying sexual debut, reducing the number of sexual partners, using condoms, reducing risky sexual and drug-using activities, and promoting needle exchange. Male circumcision. Trial data has shown that HIV-negative circumcised men had approximately 60-70% less chance of acquiring HIV through penile-vaginal intercourse than non-circumcised men.

8 Learn More: For further information about existing prevention technologies and approaches consult the CATIE website:

9 Section 2: Why are New HIV Prevention Options Needed? Vignette: Slide 8 Facilitator Notes: Given that we have so many effective HIV prevention options at our disposal, why do we need new ones? As we will see, there are several reasons why existing prevention options may have limitations and are not always appropriate for many individuals and populations at risk. Some of the most effective tools currently at our disposal have important limitations for many people most at risk of HIV. For example, male and female condoms prevent conception. They also require the active consent and cooperation of the insertive partner. While the receptive partner whether female or male can often suggest, negotiate or insist on condom use, it is ultimately up to the insertive partner to decide whether or not they will use a male condom. And in many situations, the receptive partner particularly women are not always able to negotiate condom use. Also, many people are unable or unwilling to use condoms; they do not like to use them, they may not find them pleasurable, they may have difficulties maintaining an erection, they may be allergic to latex, they may be tired of condom messaging and want alternatives to reducing risk, and they may see them as a barrier to intimacy. Developing HIV prevention tools that would allow conception while still reducing the risk of HIV infection, that would be more within the control of the receptive partner, and that would enhance sexual pleasure without forming a physical barrier, would provide critical new options that are largely missing from current interventions. The experience of contraception shows us that the more options you provide to people, the more sex acts are protected since people are more likely to find an option that best suits their environment, needs and preferences. Many people do not know that globally, sex with a primary partner is the biggest source of HIV infection. In fact, it is true all over the world and across populations that once trust and love enter a relationship, condoms usually exit. With proper condom promotion programmes, we can help people increase their use of condoms for casual or commercial sex. But few people continue to use condoms once they establish a regular partnership. Even with intense condom promotion efforts, consistent condom use amongst regular partners is difficult to achieve, unless, of course, the couple knows that one of them is infected and one is not. Of course, if both partners are HIV-negative or both HIV-positive, and they are monogamous, this may not be a problem in terms of HIV transmission. However, many people are unaware of their status, and in many couples, one or both partners have sex outside of the relationship. An expanded range of options is needed to fill these HIV prevention gaps. Adapted from PowerPoint slides from Global Campaign for Microbicides.

10 Can t we just Promote Condoms?: Slide 9 Facilitator Notes: Condom promotion is a critical part of HIV prevention. Condoms are inexpensive and highly effective, yet many people choose not to use condoms. In the Canadian context, a recent survey of Canadians over the age of 15 showed that reasons for not using condoms vary quite a bit. But the most common reason is because people are in a long-term relationship. Other reasons include the desire to conceive or being unable or unwilling to use condoms. Some new HIV prevention options, such as microbicides or PrEP, could help overcome many of these barriers. Can t we just Promote Condoms?: Slide 10 Facilitator Notes: This graph shows the percentage of women from various countries who used a condom in their last sex act. As you can see by the pink bars, condom use with primary partners was extremely low. In the Unites States, the rate of reported condom use with a husband or boyfriend was just greater than 15%. In the other countries, it was far lower than that. The authors of this graph noted that surveys of women in 13 countries found that fewer than 7% reported condom use in the last sex act with their regular partner. Condoms continue to be a viable option for many people, and should be made readily available. However, for many people, condom promotion can go only so far. Providing HIV prevention options that can reduce risk while simultaneously allowing for intimacy, conception and sexual pleasure could help bridge a prevention gap that condoms simply cannot cross. Adapted from PowerPoint slides from Global Campaign for Microbicides. (Are People Using Condoms: Current Evidence from Sub-Saharan Africa and Asia and its Implications for Microbicides HIV Tools Research Group, London School of Hygiene and Tropical Medicine and International Family Health.) Efficacy vs. Effectiveness: Slide 11 Facilitator Notes: Efficacy and Effectiveness. These two terms are often used interchangeably, but they express distinctly different concepts. The key difference is captured in the two questions: Does the intervention work under ideal conditions? This refers to efficacy. And: Does the intervention work in everyday life?. This refers to effectiveness. Efficacy is the ability of a product to produce a desired clinical effect, such as protection against a specific infection, at the optimal dosage and schedule in a given population - in

11 other words, how well an intervention works under controlled situations, such as in a clinical trial. Effectiveness refers to how well an intervention works in real-life settings, taking into account the likelihood that people will adhere to it, use it properly, the tolerability or ease of use. For example, condom efficacy is 80-95% when they are used consistently and correctly. However, their effectiveness is 69% because some people don t always use them correctly or consistently. Let s try to see how this difference between efficacy and effectiveness might look visually. Source for stats: L. Heise et al. Apples and oranges? Interpreting success in HIV prevention trials. Contraception Jan;83(1):10-5. Epub 2010 Aug 7. Condoms and NPTs: Slide 12 Facilitator Notes: When considering the potential introduction of new HIV prevention tools, people often compare them to condoms. People often assume that since condoms have a high rate of efficacy, and new HIV prevention tools are usually thought to have lower rates of efficacy, then the introduction of new HIV prevention technologies must necessarily be a bad thing since people will potentially replace highly effective tools with less effective ones. However, we must carefully examine efficacy and effectiveness, through the relationship between rates of efficacy and rates of use. Let s start off by assuming that condoms reduce the risk of HIV infection by 90%, and a hypothetical microbicide reduces the risk by 60%. If both are used 100% of the time, condoms are more effective at preventing HIV. Adapted from Global Campaign for Microbicides. Microbicides Essentials Course. Condoms and NPTs: Slide 13 Facilitator Notes: However, at those same efficacy rates, you will have the same amount of protection if condoms are only used 20% of the time, than if you used microbicides 30% of the time. Condoms and NPTs: Slide 14 Facilitator Notes: And if you use microbicides 75% of the time, you will get better protection than using condoms 20% of the time. So we can see that we must consider the likelihood of people using a product, not only its inherent efficacy. A 100% effective product that never gets used is not reducing anyone s risk in other words, its effectiveness is diminished. By providing options that

12 more people are more likely to use, new HIV prevention technologies could fill an important prevention gap. Learn More: For further information about condom use consult the AIDSMAP website. Suggested Activities Discussion: Ask the following questions as a discussion or debate allowing the participants to break up into groups again and discuss. What do you believe? Should we be looking at new technologies? Should we be focusing on existing prevention interventions?

13 Section 3: NPTs as Part of a Comprehensive Approach to HIV Prevention NPTs as Part of a Comprehensive Approach: Slide 16 Facilitator Notes: Comprehensive HIV prevention is an evidence-based approach that includes efforts to ensure access to proven interventions, the development of new or tailored prevention options that can meet a variety of user needs and preferences, and a focus on structural issues. First, interventions that have been proven to reduce the risk of HIV are made readily available to populations most at risk. In the Canadian context, these behavioural and biomedical interventions typically include HIV education; risk reduction counselling; provision of male and female condoms and lubricant; needle exchange programs; postexposure prophylaxis; prevention of mother-to-child transmission; promotion of and access to HIV testing; and testing and treatment of sexually transmitted infections. Recent studies have added treatment-as-prevention and pre-exposure prophylaxis (or PrEP) to this list of effective HIV prevention strategies. Second, an expanded range of HIV prevention options should be developed to meet a variety of needs, including microbicides and vaccines. Third, addressing structural factors that exacerbate HIV risk for certain populations is paramount. A public health approach includes a commitment to equity, social justice and sustainable development, recognition of the importance of the health of the community as well as the individual, and respect for diversity, self-determination, empowerment and community participation. Structural factors include a range of interventions that address social determinants of health such as housing, socio-economic status, sexism, racism, homophobia; human rights, stigma and discrimination; and systemic conditions such as the criminal justice system and healthcare infrastructure. Combining these elements improves the chances of having a real impact, and allows the tailoring of approaches to meet the needs and address the vulnerabilities of specific atrisk populations. Imagine a Full Spectrum of Interventions: Slide 17 Facilitator Notes: A comprehensive approach to HIV prevention should have many elements. Here is another way to think about what an expanded toolkit of HIV prevention and treatment options would look like visually. Right now, we have many tools that people can use before exposure; right at the point of HIV transmission; and after being infected. We all agree that we need to improve people s access to these existing tools that have been proven to work, shown here in grey. Advocates and researchers around the world are also working to see what new options could be added to this toolkit in the near future. These have yet to be definitively proven to work, and they are shown here in blue.

14 Our focus will be on recently proven or emerging new HIV prevention tools, namely PrEP, preventive vaccines, vaginal and rectal microbicides, and treatment-as-prevention. Learn More: For more information regarding comprehensive approaches to HIV prevention, please visit CATIE:

15 Section 4: New HIV Prevention Options New HIV Prevention Options: Slide 19 Facilitator Notes: Over the past few years, several new prevention technologies have been proven to be effective in large-scale clinical trials. We are going to discuss these emerging technologies and how they work. The tools shown in green are the ones that have been proven to be effective if they are used consistently. The tools that are still being investigated are in blue. The ones that are in red have recently been shown to be at least partially effective in some cases, and some trials are still ongoing to obtain further information. We are going to spend some time taking a look at those tools that are either still being investigated, such as microbicides and vaccines, or that have recently been shown to be effective, such as treatment-as-prevention and pre-exposure prophylaxis). Here is a short description of some emerging prevention technologies at the moment. Vaccines: A preventive vaccine is a substance that teaches the body to recognize and defend itself against bacteria and viruses that cause disease. Microbicides: Microbicides are products designed to reduce the transmission of HIV and/or other STIs when used in the vagina or rectum. Pre-Exposure Prophylaxis : Pre-exposure prophylaxis (PrEP) is the ongoing use of antiretroviral (ARV) drugs, starting before an exposure and continuing afterwards. It is used by HIV-negative people to reduce their risk of becoming infected. Treatment-as-Prevention: Treatment-as-prevention is a term describing the use of antiretroviral drugs to reduce the risk of passing HIV to others. The strategy would function as a secondary benefit of antiretroviral treatment after its primary purpose of improving an HIV-positive individual s health. Learn More: For further information about existing prevention technologies and approaches, consult the CATIE website: What are new HIV Prvention Technologies: Slide 20 Facilitator Notes: The term new HIV prevention technologies (or NPTs) can be ambiguous. First, the word technologies is sometimes replaced with interventions, tools, approaches or options. Second, alternate phrases are sometimes used, such as biomedical interventions. Third, the exact meaning of new is not always clearly explained. One of the reasons for this is that the list of technologies included as NPTs evolves over time. For example, up until , there were efficacy trials testing whether

16 treatment of herpes simplex 2 (also called HSV-2, or genital herpes) could reduce the risk of HIV infection, and whether a diaphragm or cervical barriers could reduce the risk of acquiring HIV among women. Today, these interventions are no longer included in the list of potential NPTs, since the trials demonstrated no prevention benefit. The term new prevention technologies generally refers to HIV prevention options that are still in clinical trials. Their efficacy might not yet be established, or some trials may have recently demonstrated proof-of-concept, but efficacy still needs to be confirmed through further study. In some cases, the NPTs have been proven to be effective in recent trials, but they are not yet widely available or well integrated into existing HIV prevention programs. Therefore, today, NPTs typically refer to preventive vaccines, vaginal and rectal microbicides, pre-exposure prophylaxis, and treatment-as-prevention. Occasionally, medical male circumcision is still included in discussions of NPTs in some parts of the world, since its HIV prevention efficacy was only proven in trials in While neither non-occupational PEP nor female condoms are generally considered to be NPTs, the issues around their availability and integration into HIV prevention programs are sometimes similar, so they are occasionally included in those discussions. However, we will only focus on the first four items in this course. ARV-Based Prevention Options: Slide 21 Facilitator Notes: The development of new HIV prevention technologies has increasingly relied on methods that use antiretroviral drugs (or ARVs). These drugs are primarily used as treatment for people who are already infected with HIV. Some methods of using ARVs for HIV prevention are already known to work, such as post-exposure prophylaxis (or PEP) and prevention of vertical transmission, sometimes called prevention of mother-to-child transmission (or PMTCT). Some approaches have recently been proven to work or are still in the research stage, such as treatment-as-prevention, pre-exposure prophylaxis (or PrEP), and microbicides. Here is a chart showing all of these interventions, and where the ARV-based prevention options could be used. Prevention of vertical transmission of HIV has many components. Among ARV-based options alone, we know that an HIV-positive woman can receive ARVs during pregnancy and at the time of delivery to help prevent HIV transmission. The baby receives ARV syrup in the weeks following birth. So, this method spans all three time periods. Using PrEP on a routine basis for example, once a day would ensure that a constant level of ARVs is present in a person s system before possible exposure and at the point of exposure. Microbicides could be used well before exposure or immediately before exposure. ARVbased microbicides in the form of gels, suppositories, douches or enemas, for example, might have to be inserted vaginally or rectally shortly before sex, or they could possibly b e used on a daily basis. However, if vaginal microbicides were formulated as rings that

17 slowly release the active ingredient, they could remain in the vagina for weeks at a time, providing protection when a woman has sex. Using treatment-as-prevention means that the HIV-positive person takes ARVs on an ongoing basis to reduce the risk of transmission during sex. We will discuss later how this could reduce the risk of transmitting HIV. Finally, PEP must be started soon after a possible exposure to HIV. People taking PEP after a potential exposure must continue a daily course of ARVs for four weeks. Adapted from PowerPoint slides from Global Campaign for Microbicides. HIV Prevention: Slide 22 Facilitator Notes: This is another visual way of representing HIV prevention options that are either ARV-based or not ARV-based. Male and female condoms, medical male circumcision, vaccines, needle exchange, and voluntary counselling and testing are all examples of prevention interventions that do not include ARVs. The tools that rely on ARVs to be effective include PEP, PrEP, and treatment-asprevention. Some vaginal and rectal microbicides might be based on ARVs, and others might work in other ways. Prevention of vertical (or mother-to-child) transmission includes some tools that are based on ARVs, and others that are not. Here you see these methods listed where the circles overlap, because they may or may not be based on ARVs. Adapted from PowerPoint slides from Global Campaign for Microbicides. Treatment as-prevention: Slide 23 Facilitator Notes: We are now going to look more closely at four NPTs: treatment-asprevention, PrEP, microbicides and vaccines. For each one of these four tools, we will provide a general description, give an overview of what we know about this tool s potential for reducing the risk of HIV, and explore some of the questions that remain to be answered concerning that tool. So first, let s start with treatment-as-prevention. Treatment-as-prevention is a term describing the use of antiretroviral drugs to reduce the risk of passing HIV to others. The strategy would function as a secondary benefit of antiretroviral treatment after its primary purpose of improving an HIV-positive individual s health. We know that individuals who successfully follow an ARV treatment regimen have a reduced amount of virus in their blood and other bodily fluids. This is called their viral load. Lower viral load is associated with lower risk of HIV transmission.

18 The treatment-as-prevention approach has been conceptualized in different ways and called different things. Test and Treat (sometimes abbreviated as TNT) often refers to the most aggressive approach to treatment-as-prevention. For example, in San Francisco, public health guidelines recommend that treatment be offered immediately to anyone who tests HIVpositive. Seek and Treat is one of the abbreviated names of the British Columbia program STOP AIDS (which stands for Seek and Treat for Optimal Prevention of HIV/AIDS ). Its goal is to diagnose those who are unaware of their HIV status, to diagnose everyone as early as possible, and to support ongoing links to care and treatment programs. The program recommends treatment according to current treatment guidelines. TLC+ (which stands for Treatment and Linkage to Care, Plus offering Treatment) is the name of a US pilot project that has similar goals to British Columbia. What we Know about Treatment-as-Prevention: Slide 24 Facilitator Notes: Treatment for people who are HIV-positive could have prevention benefits in two ways. First, it has been proven to work at the individual level. One clinical trial demonstrated a 96% reduction in risk of HIV transmission in serodiscordant couples (couples in which one partner was HIV-positive and the other was HIV-negative), when the HIV-positive partner was taking ARVs. Almost all the couples in the trial were heterosexual couples. Second, it may work at the population or community level. Some people argue that doing HIV testing on a massive scale, along with providing treatment to those who test HIVpositive, could significantly reduce the number of new infections. Massive testing campaigns would make more people aware of their status. Once they know their status, HIV-positive people could then reduce their risk-taking behaviours and seek treatment. Both a decrease in risk-taking and a decrease in viral load as a result of successful treatment could decrease the rate of new HIV infections. In San Francisco, decreases in community viral load have been associated with lower numbers of new HIV infections. Around the world and in Canada there are demonstration projects, pilot studies and revised public health guidance that are seeking to demonstrate and capitalize on the prevention benefits of treatment. Learn More: For further information about treatment-as-prevention consult the AVAC and CATIE websites: and On-screen text: Adapted from PowerPoint slides from the Global Campaign for Microbicides.

19 Questions about Treatment-as-Prevention: Slide 25 Facilitator Notes: How effective this prevention approach might be at a population level in Canada depends on having a critical mass of HIV-positive people with an undetectable viral load. This requires overcoming several hurdles. First, about one-quarter of HIV-positive Canadians are unaware of their status. Second, not all HIV-positive Canadians who know their status are taking ARVs. Some are not in care, either because they are not linked to care once they test positive, or because they are not retained in care. Some do not want to start treatment or are not eligible for treatment according to current guidelines. There is still inconclusive evidence about whether starting treatment earlier than when current treatment guidelines suggest has positive, negative or neutral clinical benefits for the HIV-positive individual. Third, not all people on treatment achieve undetectable viral levels. This may be because the drugs are not effective for them, because they are not achieving high levels of adherence to treatment, or because they have developed drug resistance. Recent studies in Ontario and the United States have shown that taking into account all of these hurdles, only an estimated 19-32% of HIV-positive individuals have undetectable viral loads. References (Gardner EM et al. The spectrum of engagement in HIV care and its relevance to test-and-treat strategies for prevention of HIV infection. Clin Infect Dis 52: , 2011) (Vital signs: HIV prevention through care and treatment. CDC MMWR. December 2, 2011 / 60(47); ) (Barry Adam. Epistemic fault lines in biomedical and social approaches to HIV prevention. Journal of the International AIDS Society 2011, 14 (Suppl 2):S2) Adapted from PowerPoint slides from the Global Campaign for Microbicides. Pre-Exposure Prophylaxis: Slide 26 Facilitator Notes: Now let s turn our attention to pre-exposure prophylaxis, or PrEP. PrEP involves the ongoing use of one or two antiretroviral drugs by HIV-negative individuals starting before an exposure and continuing afterwards. This is in contrast to post-exposure prophylaxis, or PEP, which is the use of antiretrovirals only AFTER a potential exposure and only for a SHORT period of time (one month). PrEP is a prevention option that could be used to reduce the risk of HIV infection from ongoing exposures to HIV. It is not necessarily something that a person would take for his or her whole life. PrEP may be an option during periods where a person is at higher risk of becoming infected AND is not able to use other prevention strategies. We know that infection does not occur instantly after an exposure to HIV. After an exposure occurs, the virus needs to spread from the site of the exposure (such as the vagina or rectum) to other parts of the body in order to cause an infection. Research shows that it can up to 3 days for HIV to spread to other parts of the body. During this short 3-day window, PrEP may be able to stop HIV from spreading past the site of the exposure to other parts of the body.

20 Therefore, the goal of PrEP is to get high concentrations of antiretrovirals at places where a person may be exposed to HIV. The antiretrovirals may be able to stop HIV from spreading beyond the site of exposure to other parts of the body, thereby preventing an infection. Adapted from PowerPoint slides from CATIE: What we Know About PrEP: Slide 27 Facilitator Notes: So, what have studies told us? A number of trials have tested whether PrEP, when provided in combination with a package of prevention services, can reduce the risks of HIV infection. One trial showed that daily Truvada (which is a pill containing the ARVs tenofovir and emthricitabine) can reduce the risk of infection among men who have sex with men (or MSM) and trans women. Two trials showed that daily Viread (which is tenofovir in pill form) or Truvada can reduce the risk of infection when used by heterosexual men and women. However, two other trials were unable to show that either daily Viread or Truvada could reduce the risk of infection when used by heterosexual women. The research strongly emphasizes that PrEP needs to be used consistently for it to work. Participants who used PrEP inconsistently had a much lower level of protection. In fact, poor adherence may explain the results in the two studies among women; however, this is not yet known. No major safety concerns were identified in the studies AND it seems that the risk of side-effects, toxicity, and drug resistance are low. However, the risk of these may seem to be low because of poor adherence to the drugs during the study, and we would not expect participants to experience side effects, toxicity or to develop drug resistance if they aren t using the drug. Adapted from PowerPoint slides from CATIE. Learn More: For further information about pre-exposure prophylaxis, consult the AVAC and CATIE websites: and Questions About PrEP: Slide 28 Facilitator Notes: There are still a lot of things we don t know about PrEP. We still don t know the safety and effectiveness of other important types of PrEP such as non-daily dosing. For example, someone might take their pill intermittently around the time they are potentially exposed to HIV (like around sexual activity). However, some studies of daily PrEP suggest that occasional use of PrEP is much less protective. We also don t know the safety and effectiveness of antiretrovirals other than Viread or Truvada. As we saw, the data for women remains somewhat unclear at this point. We also don t know about the safety and effectiveness of daily Viread and Truvada in populations not included in trials such as adolescents, pregnant women, and people with underlying health conditions. And no studies have been completed yet among people who use

21 injection drugs. We also have to consider that clinical trials are relatively short and don t tell us about the safety or effectiveness of PrEP over a longer period of time. We also don t know about the safety and effectiveness of PrEP when used outside of the tightly controlled setting of a clinical trial. PrEP may be less effective and safe if it is not provided in combination with an intensive package of prevention services such as riskreduction counselling and monitoring of side-effects, toxicity, and HIV status. Also, PrEP has not yet obtained regulatory approval from Health Canada which is Canada s regulatory agency. However, although PrEP has not been approved, people may already be using it off-label. PrEP has been submitted for regulatory approval in the United States, but as of early 2012, the FDA had not yet made its decision. Adapted from PowerPoint slides from CATIE. Vaginal and Rectal Microbicides: Slide 29 Facilitator Notes: A microbicide is any substance that can substantially reduce the risk of acquiring or transmitting sexually transmitted infections, including HIV, when it is inserted in the vagina or rectum. It is important to understand that no proven microbicides are on the market yet. What we are talking about here are products that are still being researched. Microbicides might look a lot like some of the over-the-counter products we already know the gel, lube, douche or enema that have been on the shelves for years. They will not contain the same chemicals as these products, but they will come in some of the same formulations. Scientists are also working on developing new formulations that may eventually make microbicides even more user friendly than gels or creams that are inserted with an applicator. For example, they are working to make formulations that women can leave in place for long periods of time. One possibility is a vaginal ring a device that could slowly release the protective substance over a month and provide round-the-clock protection. Almost all most microbicides in the research pipeline now are based on the antiretroviral drugs, or ARVs, that are used for treating people who are HIV-positive. Adapted from PowerPoint slides from Global Campaign for Microbicides: and International Rectal Microbicide Advocates: What we Know About Vaginal Microbicides: Slide 30 Facilitator Notes: The research is still ambivalent about whether a microbicide as a vaginal gel can reduce the risk of infection among heterosexual women, when provided in combination with a package of prevention services. One trial showed that it can, while another trial was unable to show that it can. The research does strongly emphasize that microbicides need to be used consistently for them to work. Participants who used the gel inconsistently had a much lower level of

22 protection. However, no major safety concerns were identified in the trials, AND it seems that the risk of side-effects, toxicity, and drug resistance are low. Several acceptability studies among different populations of women and men have shown that it would be great to have different microbicides that would meet the following criteria. First, almost all candidates in development right now are based on ARVs. This means that they are not contraceptives because as far as we know ARVs do not have any effect on the reproductive potential of sperm. This is good, because a microbicide that is not contraceptive might enable a woman to become pregnant whilst still protecting herself from HIV. This cannot be done with condoms, so a non-contraceptive microbicide would give women a completely new option. This is one reason why people living with HIV are also interested in microbicides. But many women want something that can protect them from disease and pregnancy at the same time. Once we have an effective microbicide, it may be possible to add contraceptive ingredients to make a dualaction product one that prevents pregnancy and reduces HIV risk. Second, making sure that microbicides will be affordable and accessible is a fundamental goal. Finally, one big advantage of a microbicide would be not needing your partner s active cooperation to use it as you do with male or female condoms. Talking with your partner about using microbicides could be a one-time conversation, and would not have to occur right before sex. Adapted from PowerPoint slides from Global Campaign for Microbicides: and CATIE. Learn More: For further information about microbicides consult the AVAC and CATIE websites: and Questions About Vaginal and Rectal Microbicides: Slide 31 Facilitator Notes: Several questions remain concerning microbicides. First, could microbicides protect against STIs other than HIV? Almost all candidates in development right now are based on ARVs. Therefore, they are unlikely to protect against STIs other than HIV, without adding additional active ingredients beyond ARVs. The one exception to this is tenofovir gel, which in one trial reduced the risk of genital herpes (HSV-2) by half when used vaginally. Second, we must acknowledge that once a microbicide is available in gel form, it is likely to be used both vaginally and rectally. Therefore, ideally, such products should be both safe and effective when used either vaginally or rectally. Research is underway to determine whether this is feasible. Third, we need microbicides that people who are HIV-positive can use. They could help reduce the risk of STIs, and allow for conception, while reducing the risk of infection for serodiscordant couples. Unfortunately, ARV-based microbicides will not be appropriate

23 for use by people already living with HIV, because of the potential for drug resistance to develop. Non-ARV-based microbicides would help alleviate this risk. No rectal microbicide has been tested in large-scale efficacy trials, although some ARVbased gel products are moving through the research pipeline. For many reasons, rectal microbicide research lags behind vaginal microbicide research. Rectal microbicides would be useful for both men and women who have anal sex. Many people use lubricants during sexual intercourse. Yet we know very little about their safety, particularly when used during anal intercourse. Very few studies have examined the effect of lubricants on human rectal tissue, but those that did showed mixed results. However, given that so little research has been done so far, there is still very little information that can be usefully provided to individuals in the context of HIV prevention programmes. More research is urgently needed to determine whether lubricants increase, decrease or have no effect on the risk of acquiring HIV or other STIs. Adapted from PowerPoint slides from Global Campaign for Microbicides: Lubricant information is from International Rectal Microbicide Advocates: Vaccines: Slide 32 Facilitator Notes: A preventive vaccine is a substance (usually a part of the virus) that teaches the body to recognize and defend itself against bacteria and viruses that cause disease. A vaccine causes a response from the immune system the body's defense system preparing it to fight if exposed to a specific infection. A vaccine is not a cure, but prevents infection or slows disease progression. What we Know About Vaccines: Slide 33 Facilitator Notes: After four large-scale clinical trials, one vaccine regimen provided a slight level of protection, one increased the risk of infection in some people, and two other trials showed no protective effect. As of early 2012, no simple vaccine regimen has yet provided a considerable, long-term level of protection. However, there are some encouraging signs. Broadly neutralizing antibodies have been recently discovered for the first time. These are the types of antibodies that could lead to effective vaccine strategies, since they could potentially neutralize HIV. There is precedent for other diseases. We have developed highly successful vaccines against other viral infections. We also have precedents from animal studies. Long-term control of infection has been achieved in vaccinated monkeys.

24 Finally, some individuals, termed long-term non-progressors, have the ability to control their HIV infections. Other groups of individuals carry a gene mutation, and are therefore rendered un-infectable by the virus. Learn More: For further information about HIV vaccines, consult the AVAC and CATIE websites: and Adapted from PowerPoint slides from the HIV Vaccine Trials Network: Questions About Vaccines: Slide 34 Facilitator Notes: Many challenges remain. First, traditional approaches for developing vaccines have either not worked well or would be unsafe when applied to HIV vaccine development, so scientists are using newer techniques. Using these techniques, there is no chance that an HIV vaccine will cause infection. Second, animal models have not yet accurately predicted how vaccine candidates tested in labs will work in humans. Third, the correlates of protection for HIV are mostly unknown. In other words, we don t know much about what immune responses will protect an individual from infection. So we don t know what we re trying to get an HIV vaccine to do, exactly. Finally, HIV mutates a great deal, and there are many different subtypes of HIV. This may mean that a vaccine would not work against all strains of HIV circulating in the world. Adapted from PowerPoint slides from the HIV Vaccine Trials Network: Suggested Activities Discussion This section will no doubt generate allot of discussion. Be sure to have the relevant trial information on hand to refer to and to have a somewhat developed knowledge about these different technologies by reading up on them before hand. Remember: Many of the questions participants will have regarding NPTs remain unknown and can only be answered through further trials, demonstration sites and real world use.