MICROBICIDES: Efficacy and Effectiveness What is Good Enough? Who decides?

1. MICROBICIDES:Efficacy and Effectiveness What is Good Enough?Who decides? A people-centred perspective Dr Roger Tatoud Imperial College London IRMA Global Teleconference 4 December 2009

2. What is a Microbicide ?

3. Institutional & Advocate’s definitions • Global Campaign for MicrobicidesThe 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. • WHOMicrobicides are compounds that can be applied inside the VAGINAor RECTUMto 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 MicrobicidesMicrobicides 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 DevelopmentMicrobicides 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, CONDOMs, and ancillary devices. • Microbicides Trial NetworkMicrobicides are substances designed to address the biological factors that make WOMEN more vulnerable to infection that when applied topically to the vagina could PREVENTsexual transmission of HIV. Unlike CONDOMs, 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 VAGINAand/or RECTUMprior 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 CouncilVAGINAL 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. • UNAIDSGiven 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 GELor 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. RECTALmicrobicides 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, RECTALmicrobicides 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 STDPREVENTION tools.

4. A picture is worth 9 definitions Words that are present at least 3 times

5. Snapshots of Stakeholders

6. 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

7. 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

8. 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

9. 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

10. 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

11. Efficacy? Needs, wants, advocates, users, scientists and more… Who decides? A C Vulnerability B Risk HIV Prevention Among Vulnerable Populations: The Pathfinder International Approach, 2008.

12. 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.