MICROBICIDES: Efficacy and Effectiveness
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MICROBICIDES: Efficacy and Effectiveness

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What is Good Enough? Who decides?

What is Good Enough? Who decides?
A people-centred perspective

IRMA Global Teleconference 4 December 2009

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  • I thought that it would be useful to look at this question again, because even within MDP, where people have been working on microbicides for 10 years, the answer is still being debated. In the recent months as we were preparing our material for the dissemination of the 301 trial, we did one day spent about an hour arguing about the definition of microbicides. Was it a product, a concept, do they exist or are they only in development, for who are they, and for what use? And I’d like to add a very existentialist question is it mycrobi-sydes or mycrobi-sides? So what I did was to look at existing definitions from different institutional and advocates groups and see what they are saying about this and this is on slide 3.
  • I don’t expect you to be able to read this slide and this is why I have highlighted some recurrent words and concepts found in most of these definitions. Obviously each would reflect the concerns and agenda of the organisation it is coming from, and this is obvious if you look at the IRMA definition with emphasises the rectal use of microbicides. Women and women’s concerns are recurrent but not in all definitions. So, because it was quite difficult to make sense of this, I did a quick text analysis, counting the number of time a word was appearing and the results is shown in slide 4.
  • So here we have 35 words that are present at least 3 times. I am not sure you have the latest version of this slide as there was a small glitch but it is not very different and I’ll come back to that. The size of a word is proportional to the number of time it appears in the 9 definitions taken altogether. I took the word microbicides out as it would have distorted the representation It’s not surprising to see that HIV (11) has a prominent position but also condoms which is present 9 times, whilst women is present 7 times and there is a lot of condoms too. What is also interesting to note is the size of the word rectal which is on the latest version of this slide and mostly because of IRMA and finally it is worth noting missing words such as man or men. I am aware that microbicides were primarily developed as a women-controlled then women-initiated HIV prevention method, but I would like to believe that they could be used by men and women together or independently whilst engaging in various sexual activities. So what I am going to present you with is 5 snapshots of potential microbicides users, people that I call stakeholders, and try to very briefly go over what we thing they needs, and should have and what they think they needs and would like.
  • On slide number 6 you have the 5 snapshots together, and we have participants and staff of the MDP 301 trial, a UK glossy magazine reader, that I didn’t want to call “your standard housewife” some commercial sex workers in Cambodia, a couple of Gay clubbers in London and finally a MSM in South East Asia. I am sure that you have already heard what I am going to tell you but I think it is important to put different stakeholders and their needs and wants in perspectives to answer the “efficacy” question. Obviously I will make huge generalisation, I am very conscious of this, and I ask you to be mindful that there is a broad range of different people out there, with different life, different needs and different expectation and this is why I chose to present “snapshots”. So, let’s start with the first snapshot on slide 7, agroup of women in south Africa.
  • So here we have a group participant and staff of the MDP 301 trial of the PRO 2000 vaginal microbicide at one of the South African Trial Centre. Women account for half of all people living with HIV worldwide, and nearly 60% of HIV infections in sub-Saharan Africa. T hough they have access to condoms, their main problem is to get their partner and most importantly their regular partner to use condoms. This is something they have little control over and that is where microbicides would come useful. But it is also important to keep in mind that the desire to conceive, or the social & cultural pressure to conceive is an obstacle to condom use. These partly reflect women’s position in a society where 1 in 4 man admitted to have rapped a women in his life. In this context, microbicides raise a lot of issues and if acceptability is an important one, their interference with cultural practices such as dry sex and their potential interference within a relationship are important factors too. Remarkably, at this trial’s site, more than 50% of the participants disclosed using the gel to their partner, and remarkably, men liked the gel too. This is why I think it is important to keep men in the prevention equation and include them as stakeholder too. Ultimately what these women will tell you when it comes to efficacy and my thanks goes here to Mitzy Gafos for sharing her experience, is that anything is better than nothing.
  • If we now look at a snapshot of a different group of women living in a different society, the women I will call, without offense, the “glossy magazine reader”. One could think that they know more or know better about HIV than women in Africa, thought I would dispute this. These women will have different concerns and it is quite difficult to know what they are because there are a limited number of studies looking at western women and microbicides. So I supplemented my reading by asking a number of people at work and amongst my friends what they level of efficacy they would expect from a microbicide. For the glossy mag reader, condom’s availability and enforcement is not an issue on the same scale as it is for the African women we looked at before. Issues around disclosure are interesting as research shows that women would be more willing to tell their regular partner about using microbicides, but would not feel the need to do so with a casual partner. One major difference is the expected contraceptive property required of a microbicide which is an important factor if they are to be used instead of condom. Overall, in my discussion, I found that the expectation are high when it comes to efficacy, even if the risk are much lower than for women in Africa, and there are some important concerns regarding the potential protection that a microbicides would offer against others STIs and pregnancy. Moving now east onto the next slides, slide number 8.
  • The young women pictured here are sex workers in Cambodia. Their main customers are not white men on a sex trip, but Asian men, nationals or from richer countries such as Japan and China. Again condom availability and enforcement are an issue but for different reasons. Condoms are overall available and can be enforceable with customers, Thailand and its 100% condom use in brothels in the 90s is a good example of a policy that worked and led to a reduction in the number of infection. Of course this is not always true. For example the chance of a sex worker to enforce condom use are quite different if she is working near the train station in Bangkok for 50 cents, or if she is trading in the touristic district of Patpong for 50 USD. The problem with condoms is that they can be used by the police to harass women and make them criminal by proxy because carrying condoms is associated with and illegal activity. The government is also sending very mixed messages regarding condoms, one day promoting them, another criminalising their promotion. A major problem arising from the potential introduction of microbicides is that customer’s demand both in term of sexual practice and in their dominant position as client can lead to condom migration and towards the use of a product that is not as efficient as condom, or of no product as all. This is where microbicides lose their women-initiated or women-control advantage. Beside, microbicides if added to the panoply of HIV prevention tools would also add an extra cost at the charge of the sex worker. For these sex workers, what they really need is a product that work in different contexts and that offer a protection as good as condoms that they are already using. It also has to be a product that they can afford. Now what would these Sex workers tell you about efficacy, I am not sure, because very few are aware of such products being developed.
  • But let’s move away from women for a moment and look at men. On slide 9 we have a couple of gay clubbers in London. In the UK, the HIV epidemic disproportionally affects gay men. 1 in 10 is HIV positive in London, and 1 in 3 does not know that he is HIV positive. Condoms are widely available, and their enforcement is not an issue. The problem is simply that they are not used consistently and about 30% of gay men have had unprotected sex with someone they don’t know the HIV status. The introduction of a microbicide in the gay community would need it to work for anal intercourse, and as we know, there is not enough interest in developing such products. A microbicides would also have to protect against STI which disproportionately affect Gay men too. But the main issue I see with microbicide is that of design and practicality of use. As you can see from the photo there is not much room here to carry a 15 cm long applicator. Design and user friendliness will be a huge issue that can probably sorted out. But overall, the need is for a product that works as good as condoms. What are the want I am not sure because when I speak to gay men about microbicides, very few have heard of them.
  • Moving on to our last snapshot, that of MSM in a South Asian country. You will note that I am using MSM rather than gay as many MSM do not identify as Gay. There, issues of protection are a mix of what I have described before. Condoms are available in most of South East Asia and are promoted with the caveat that sometimes the government sends mixed messages about HIV prevention. Interestingly condoms are also used and two recent publications show that condom use is higher in Thailand and Cambodia than it is in the UK. But what affect MSM most is stigma and discrimination. Again a microbicide would have to work for anal intercourse and should protect against STI and be affordable. Now what my friend Alex here pictured or any other MSM in the region would want in terms of efficacy I don’t know. And I don’t know because a) he does not know what efficacy means, and b) he has never heard of microbicides. And that’s particularly worrying when up to 1 in 10 MSM in Cambodia and 1 in 3 in Bangkok is HIV positive.
  • To conclude, the efficacy of an HIV prevention method is only one of the many variables of the bigger equation that will determine its success. The answer to how much is good enough and who decides is context dependent and can’t be assess at the level of a community, though the community is part of the context in which the prevention takes place. It is not easy to reduce the equation to fewer variables but I would propose to look at it considering risk and vulnerability. Risk and vulnerability are different. For instance women in sub-Saharan Africa are in a high risk group because of the high prevalence of HIV. This is also the case of Gay Men and MSM but this is not the case of a housewife in the UK. Women in sub-Saharan African are also highly vulnerable to HIV because of their position and role in society, this is also the case of women in a some developing or war-torn country with low HIV prevalence. But women or Gay men in the UK who have access to prevention and can use it are not as vulnerable. The red on the graph represent the efficiency required for an HIV prevention when risk and vulnerability are combined. The combination of both high risk and high vulnerability, represented in A on the graph, requires a highly effective HIV prevention method and that would represent the situation of women in Sub Saharan Africa. Whilst point B would represent the situation of Gay men in the UK and C the situation of let’s say Women in Afghanistan. This representation help to define what’s needed but not what’s wanted and we have to be realistic and accept that when there is little achievable in the short term anything will help.

MICROBICIDES: Efficacy and Effectiveness MICROBICIDES: Efficacy and Effectiveness Presentation Transcript

  • A people-centred perspective Dr Roger Tatoud IRMA Global Teleconference 4 December 2009
  • What is a Microbicide ?
  • Institutional & Advocate’s definitions
    • Global Campaign for Microbicides The word “microbicides” refers to a range of different products that share one common characteristic: the ability to PREVENT the sexual transmission of HIV and other sexually transmitted infections (STIs) when applied topically. A microbicide could be produced in many forms, including GELS , creams, suppositories, films, or as a sponge or ring that releases the active ingredient over time. Microbicides would be the most important innovation in reproductive health since the Pill.
    • WHO Microbicides are compounds that can be applied inside the VAGINA or RECTUM to protect against sexually transmitted infections (STIs) including HIV. They can be formulated as GELS , creams, films, or suppositories. Microbicides may or may not have spermicidal activity (contraceptive effect). At present, an effective microbicide is not available.
    • International Partnership for Microbicides Microbicides are VAGINAL products being developed to reduce the transmission of HIV during sexual intercourse. Microbicides could take the form of a GEL , film or sponge, or be contained in a VAGINAL ring that releases the active ingredient gradually. A microbicide could also be in a new formulation and use a delivery method yet to be invented. A microbicide would be a useful complement to other HIV PREVENTION measures, including safer sex education, CONDOM distribution, voluntary testing and counseling, testing and treatment of sexually transmitted infections , anti-stigma campaigns, safe blood supplies and (hopefully, one day) a vaccine.
    • Alliance for Microbicides Development Microbicides are products being developed to reduce the transmission of HIV and other sexually transmitted infections. They are being developed in a variety of forms, such as topical GELS , creams, tablets, films, oral pills, alone or in combination with cervical barriers, rings, CONDOM s , and ancillary devices.
    • Microbicides Trial Network Microbicides are substances designed to address the biological factors that make WOMEN more vulnerable to infection that when applied topically to the vagina could PREVENT sexual transmission of HIV . Unlike CONDOM s , microbicides represent a method that WOMEN could control themselves. Theoretically, they could be produced in many forms, including GELS , creams, suppositories, films, or as a sponge or ring that release the active ingredient over time. Some microbicides are also being developed for RECTAL use.
    • Family Health International (FHI) Numerous microbicidal products are under development for the PREVENTION of HIV and other sexually transmitted infections (STIs). Designed to be inserted into the VAGINA and/or RECTUM prior to sexual intercourse, such products have the potential to be female-controlled, enabling WOMEN at risk of HIV to use them for protection without partner consent . Microbicides are formulated as foams, GELS , creams, impregnated sponges, suppositories, and films.
    • Population Council VAGINAL microbicides are being developed primarily as female-initiated methods for reducing male-to-female transmission of HIV and possibly other sexually transmitted infections when used during sex. WOMEN need more options to protect themselves from infection because current PREVENTION strategies are not always feasible. While no effective microbicides yet exist, they would most likely be formulated as GELS , creams, films, or VAGINAL rings.
    • UNAIDS Given the obstacles many WOMEN encounter when trying to negotiate the use of male CONDOMs , there is an urgent need for more PREVENTION options they can initiate themselves . Efforts are under way to develop a microbicide – a GEL or cream that can be applied topically to the VAGINA in much the same way as today’s spermicides. As a PREVENTION method that can be self-administered and might be undetectable to partners , microbicides could increase the options for WOMEN who find it difficult or impossible to persuade their spouses or other sex partners to use a CONDOM . Acceptability studies in South Africa, Uganda and Zimbabwe suggest that WOMEN who seldom or never use CONDOMS would reduce their overall risk of infection if an effective microbicide were available to them at low cost.
    • International Rectal Microbicides Advocates (IRMA) Currently in development, a microbicide is a cream or GEL , or maybe a douche or an ENEMA , that could be used to reduce a person’s risk of HIV infection VAGINALLY or RECTALLY . RECTAL microbicides could offer both primary protection in the absence of CONDOMS and back-up protection if a CONDOM breaks or slips off during ANAL intercourse. For those unable or unwilling to use CONDOMS , RECTAL microbicides could be a safe and effective alternative means of reducing risk, especially if they were unobtrusive and/or enhanced sexual pleasure enough to motivate consistent use. Such alternatives are essential if we are to address the full spectrum of prevalent sexual practices and the basic human need for accessible, user-controlled HIV and STD PREVENTION tools.
  • Words that are present at least 3 times
  •  
  • Snapshots of Stakeholders
    • Condom availability and enforcement
    • Social/cultural pressure or desire to conceive
    • Position of women in society
    • Disclosure & cultural practices
    • Ability to protect herself
  • Snapshots of Stakeholders
    • Condom availability or enforcement
    • Disclosure
    • Alternative to condom need to offer protection against pregnancy
    • as good as condom
    • Should protect against STIs
    • Reliable and effective HIV prevention method
  • Snapshots of Stakeholders
    • Condom availability and enforcement
    • Condom Criminalisation “by proxy”
    • Patron’s demand (unprotected sex/anal sex)
    • Condom migration
    • Economic pressure
    • Self-controlled HIV prevention that works as well as condoms and for different sexual practices
  • Snapshots of Stakeholders
    • Few issues with condom availability or enforcement
    • Should work for AI
    • Should protect against STIs
    • Reliable and effective HIV prevention method as good as condom (when used)
    • Design and usability
  • Snapshots of Stakeholders
    • Condom availability, use and enforcement
    • Condom criminalisation by proxy
    • Position of MSM in society
    • Should work for AI
    • Should protect against STIs
    • Ability to protect oneself
  • Efficacy? Needs, wants, advocates, users, scientists and more… Who decides? Risk Vulnerability B A C HIV Prevention Among Vulnerable Populations: The Pathfinder International Approach, 2008.
  • Selected Further Readings
    • On Women and Microbicides in the US and South Africa
      • Preventing rape and violence in South Africa: call for leadership in a new agenda for action, S.A. MRC Policy Brief November 2009.
      • Should a moderately protective microbicide be made available in communities with high HIV incidence? Opinions of potential end-users from a rural South African community. Gafos et al., personal communication.
      • Preferences and practices related to vaginal lubrication: Implications for microbicides acceptability and clinical testing. Braustein et al., Journal of Women’s health 2005, 14:424-433.
      • The acceptability of an investigational vaginal microbicides, PRO 2000 gel, among women in a phase I trial, Morrow et al., Journal of Women’s health , 2003, 12:655-666.
      • Covert use, vaginal lubrication and sexual pleasure: A qualitative study of urban U.S. Women in a vaginal microbicides clinical trial. Arch Sex behav [ahead of pub, 28 July 2009]
    • On MSM:
      • The global epidemic of HIV infection among men who have sex with men, Van Griesven et al., Current Opinion in HIV and AIDS 2009, 4:300–307.
      • Testing targets: Findings from the United Kingdom Gay Men’s Sex Survey 2007, SIGMA.
      • Mekong Erotics: Men Loving/Pleasuring/Using Men in Lao PDR, Chris Littleton, UNESCO Bangkok.
    • On Sex Worker and new prevention strategies
      • Sex and the new era of HIVV prevention and Care, Cheryl Overs.
      • The role of sex worker clients in transmission of HIV in Cambodia, International Journal of STD & AIDS 2005; 16: 170–174.
      • Acceptability of hypothetical microbicides among women in sex establishments in rural areas in Southern China. Wang et al., Sex Transm Dis. 2008, 35:102-10.