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Preparing for Microbicide Introduction, Rollout, and Sustained Access

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Book cover Microbicides for Prevention of HIV Infection

Part of the book series: Current Topics in Microbiology and Immunology ((CT MICROBIOLOGY,volume 383))

Abstract

Two topical vaginal microbicide candidates for HIV prevention are at an advanced stage of clinical testing, with efficacy results from three clinical trials expected within the next 2 years. Therefore, preparations for introducing and ensuring access to these products in the event that they are proven safe and effective now require increased attention. Microbicides are expected to fill an important global public health need for HIV prevention options for women. They have been developed almost exclusively with public and private funding through academic and nongovernmental institutions and minimal involvement of commercial pharmaceutical partners. Efficient and rapid introduction of a new public health technology requires a broad range of expertise and collaborations, some of which are new to the microbicide field as products are at last completing late-stage pivotal licensure studies. Strong leadership, political commitment, and considerable financial investments will be required to ensure successful distribution as well as uptake and continued access to this new product class. This paper highlights work conducted since 2000 by scientists, advocates, and public health officials to prepare for microbicide introduction, and discusses some of the needed actions to ensure that products will become readily accessible to the women who need them.

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References

  • Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE et al (2010) Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 329(5996):1168–1174

    Google Scholar 

  • Abdool Karim SS, Richardson BA, Ramjee G, Hoffman IF, Chirenje ZM, Taha T et al (2011) Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women. AIDS 25(7):957–66 Epub 2011/02/19

    Article  CAS  PubMed  Google Scholar 

  • Alliance for Microbicide Development (2007) Mapping the microbicide effort. Alliance for Microbicide Development, Silver Spring

    Google Scholar 

  • Alliance for Microbicide Development (2006) The microbicide development strategy. Alliance for Microbicide Development, Silver Spring

    Google Scholar 

  • Amico KR (2012) Adherence to pre-exposure chemoprophylaxis: the behavioral bridge from efficacy to effectiveness. Curr Opin HIV AIDS 7(6):542–8 Epub 2012/09/12

    Article  PubMed  Google Scholar 

  • UNAIDS/AVAC (2011) Good participatory practice: guidelines for biomedical HIV prevention trials. UNAIDS, Geneva

    Google Scholar 

  • AVAC (2013) Research and Reality: AVAC Report 2013. Global Advocacy for HIV Prevention, NewYork

    Google Scholar 

  • Becker JD, Cooper D, Harries J, Hoffman M, Orner P, Moodley J, McGrory E, Bracken H (2003) Paving the path: preparing for microbiocide introduction. Report of a qualitative study in South Africa. Engender Health, New York

    Google Scholar 

  • Bentley ME, Fullem AM, Tolley EE, Kelly CW, Jogelkar N, Srirak N et al (2004) Acceptability of a microbicide among women and their partners in a 4-country phase I trial. Am J Public Health 94(7):1159–64

    Article  PubMed Central  PubMed  Google Scholar 

  • Brady E, McGrory E (2012) Shaping the Operations Research Agenda for Antiretroviral-Based Prevention products for Women: Gels and Rings. Population Council, New York

    Google Scholar 

  • Brady E, McGrory E (2007) Day of Dialogue. Insights and Evidence from Product Introduction: Lessons for Microbicides. Report of a meeting. Population Council, New York

    Google Scholar 

  • Brooks A, Smith TA, de Savigny D, Lengeler C (2012) Implementing new health interventions in developing countries: why do we lose a decade or more? BMC Public Health 12:683 (Epub 2012/08/23)

    Google Scholar 

  • Brown G, Raghavendran F, Walker S (2007) Planning for microbicide access in developing countries: lessons from the introduction of contraceptive technologies. International Partnership for Microbicides, Silver Spring

    Google Scholar 

  • Braunstein S, Van De Wijgert J (2005) Preference and practices related to vaginal lubrication: implications for microbicide acceptability and clinical testing. J Women Health 14(5):424–433

    Article  Google Scholar 

  • Coplan PM, Mitchnick M, Rosenberg ZF (2004) Regulatory challenges in microbicide development. Science 304(5679):1911–2 Epub 2004/06/26

    Article  CAS  PubMed  Google Scholar 

  • Darroch JE, Frost JJ (1999) Women’s interest in vaginal microbicides. Fam Plan Perspec 31(1):16–23

    Article  CAS  Google Scholar 

  • Elias C, Coggins C (2001) Acceptability research on female-controlled barrier methods to prevent heterosexual transmission of HIV: where have we been? where are we going? J Women Health Gen-B 10(2):163–73

    Article  CAS  Google Scholar 

  • EMA (2012) Reflection paper on the non-clinical and clinical development for oral and topical HIV pre-exposure prophylaxis (PrEP). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/03/

  • Evangeli M, Engelbrecht SK, Swartz L, Turner K, Forsberg L, Soka N (2009) An evaluation of a brief motivational interviewing training course for HIV/AIDS counsellors in Western Cape Province. South Africa. AIDS Care 21(2):189–96 Epub 2009/02/21

    Article  Google Scholar 

  • FACTS (2014) FACTS001 study. http://www.facts-consortium.co.za

  • FDA (2012) Draft guidance for industry—vaginal microbicides: development for the prevention of HIV infection. Food and Drug Administration, Center for Drug Evaluation and Research, Rockville

    Google Scholar 

  • FDA (2012b) Guidance for Industry: Vaginal Microbicides Development for the Prevention of HIV Infection. Food and Drug Administration, Rockville

    Google Scholar 

  • FHI360 (2014) Advocacy brief: gender considerations for microbicide introduction. http://www.Fhi360.org/advocacybrief. Accessed Dec 2013

  • Frost LJR MR (2009) Access: how do good health technologies get to poor people in poor countries? Harvard Center for Population and Development Studies, Boston

    Google Scholar 

  • Hankins CA, Dybul MR (2013) The promise of pre-exposure prophylaxis with antiretroviral drugs to prevent HIV transmission: a review. Curr Opin HIV AIDS 8(1):50–8 Epub 2012/12/04

    Article  CAS  PubMed  Google Scholar 

  • Harrison P (2007) Origins, mandate, and activities of the “quick” clinical trials working group. In: Presentation to the Institute of Medicine committee on methodological challenges in HIV prevention trials. Washington DC, 6–7 Feb 2007

    Google Scholar 

  • Harrison PF (1999) A new model for collaboration: the Alliance for Microbicide Development. Int J Gyn Ob 67(Suppl 2):S39–53 Epub 2000/02/08

    Article  Google Scholar 

  • Herman L, Oudin A (2010) PDP access strategy discussion paper. In: PDP Access Workgroup. http://citesource.trincoll.edu/apa/apaworkingpaper.pdf

  • Hilber AM et al (2007) Vaginal practices, microbicides and HIV: what do we need to know? Sex Trans Infec 83(7):505–508

    Article  Google Scholar 

  • Hoffman S, Cooper D, Ramjee G, Higgins JA, Mantell JE (2008) Microbicide acceptability: insights for future directions from providers and policy makers. AIDS Ed Prev 20(2):188–202 Epub 2008/04/25

    Article  Google Scholar 

  • IPM (2007) Microbicide access forum draft meeting report. Nairobi, Kenya, International Partnership for Microbicides, Silver Spring

    Google Scholar 

  • IPM (2008) Microbicide access forum meeting report. Mexico City, International Partnership for Microbicides, Silver Spring

    Google Scholar 

  • IPM (2014) IPM 027-The Ring Study. http://www.ipmglobal.org/our-work/research/ipm-027-ring-study-02012

  • Kim SC, Becker S, Dieffenbach C, Hanewall BS, Hankins C, Lo YR et al (2010) Planning for pre-exposure prophylaxis to prevent HIV transmission: challenges and opportunities. J Int AIDS Society 13:24 (Epub 2010/07/14)

    Google Scholar 

  • Mandelbaum-Schmid J (2004) New generation of non-profit initiatives tackles world’s “neglected” diseases. B World Health Organ 82(5):395–6 Epub 2004/08/10

    Google Scholar 

  • Mantell JE, Needham SL, Smit JA, Hoffman S, Cebekhulu Q, Adams-Skinner J et al (2009) Gender norms in South Africa: implications for HIV and pregnancy prevention among African and Indian women students at a South African tertiary institution. Cult Health Sex 11(2):139–57 Epub 2009/02/28

    Article  PubMed Central  PubMed  Google Scholar 

  • Marrazzo J, Ramjee G, Nair G, Palanee T, Mkhize B, Nakabiito C et al (2013) Pre-exposure Prophylaxis for HIV in women: daily oral tenofovir, oral tenofovir/emtricitabine, or vaginal tenofovir gel in the voice study (mtn 003) (paper #26lb). In: 20th conference on retorviruses and opportunistic infections; 3-6 Mar 2013, Georgia World Conference Center, Atlanta

    Google Scholar 

  • McCormack S, Ramjee G, Kamali A, Rees H, Crook AM, Gafos M et al (2010) PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a Phase 3, randomised, double-blind, parallel-group trial. Lancet 376(9749):1329–37

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • McGrory EG, Gupta G (2002) Preparing for microbicides access. The Rockefeller Foundation Microbicide Initiative, NewYork

    Google Scholar 

  • Montgomery CM, Gafos M, Lees S, Morar NS, Mweemba O, Ssali A et al (2010) Re-framing microbicide acceptability: findings from the MDP301 trial. Cult Health Sex 12(6):649–62

    Article  PubMed  Google Scholar 

  • Morin SF, Maiorana A, Koester KA, Sheon NM, Richards TA (2003) Community consultation in HIV prevention research: a study of community advisory boards at 6 research sites. J Acq Immun Def Synd 33(4):513–20

    Article  Google Scholar 

  • Morrow KM, Fava JL, Rosen RK, Christensen AL, Vargas S, Barroso C (2007) Willingness to use microbicides varies by race/ethnicity, experience with prevention products, and partner type. Health Psychol 26(6):777–86 Epub 2007/11/21

    Article  PubMed Central  PubMed  Google Scholar 

  • MTN (Microbicide Trials Network) (2014) A multi-center, randomized, double-blind, placebo-controlled Phase 3 safety and efectiveness trial of a vaginal matrix ring containing dapivirine for the prevention of hiv-1 infection in women (MTN-020). Microbicide trials network. http://www.mtnstopshiv.org/studies/3614

  • Peterson L, Nanda K, Opoku BK, Ampofo WK, Owusu-Amoako M, Boakye AY et al (2007) SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, double-blind, randomized, placebo-controlled trial in Ghana. PloS One 2(12):e1312

    Article  PubMed Central  PubMed  Google Scholar 

  • Pool R, Montgomery CM, Morar NS, Mweemba O, Ssali A, Gafos M et al (2010) Assessing the accuracy of adherence and sexual behaviour data in the MDP301 vaginal microbicides trial using a mixed methods and triangulation model. PloS One 5(7):e11632

    Google Scholar 

  • Ratzan SC (2007) Public-private partnerships for health. J Health Commun 12(4):315–6 Epub 2007/06/15

    Article  PubMed  Google Scholar 

  • Severy L, Newcomer S (2005) Critical issues in contraception and STI acceptability research. J Soc Issues 61(1):45–65

    Article  Google Scholar 

  • Skoler-Karpoff S, Ramjee G, Ahmed K, Altini L, Plagianos MG, Fried-land B et al (2008) Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet 372(9654):1977–87 Epub 2008/12/09

    Article  CAS  PubMed  Google Scholar 

  • Stone A, Harrision P (2010) Microbicides, the way forward. Alliance for Microbicide Development, Silver Spring

    Google Scholar 

  • Stone A (2009) Regulatory issues in microbicide development. http://whqlibdoc.who.int/publications/2010/9789241599436_eng.pdf

  • Tedrow VA, Zelaya CE, Kennedy CE, Morin SF, Khumalo-Sakutukwa G, Sweat MD et al (2012) No “magic bullet”: exploring community mobilization strategies used in a multi-site community based randomized controlled trial: Project Accept (HPTN 043). AIDS Behav 16(5):1217–26 Epub 2011/08/09

    Article  PubMed Central  PubMed  Google Scholar 

  • Terris-Prestholt F, Foss AM, Cox AP, Heise L, Meyer-Rath G, Delany-Moretlwe S et al (2014) Cost-effectiveness of tenofovir gel in urban South Africa: model projections of HIV impact and threshold product prices. BMC Infect Dis 14:14 (Epub 2014/01/11)

    Google Scholar 

  • Tindana PO, Singh JA, Tracy CS, Upshur REG, Daar AS, Singer PA et al (2007) Grand challenges in global health: community engagement in research in developing countries. PLoS Med 4(9):e273

    Article  PubMed Central  PubMed  Google Scholar 

  • Tolley EE, Eng E, Kohli R, Bentley ME, Mehendale S, Bunce A et al (2006) Examining the context of microbicide acceptability among married women and men in India. Cult Health Sex 8(4):351–69 Epub 2006/07/19

    Article  PubMed  Google Scholar 

  • Tolley EF, B Gafos M, Amico R, Van Damme L, Woodsong C, MacQueen K, Mansoor L, McCormack S (in press) Drug delivery and development of Anti-HIV microbicides. In: das Neves J (ed) Socioeconomic and behavioral factors influencing choice, adherence and success of microbicide formulations. Pan Stanford Publishing, Singapore

    Google Scholar 

  • UNAIDS/AVAC (2011) Good Participatory Practice: Guidelines for biomedical HIV prevention trials. UNAIDS, Geneva

    Google Scholar 

  • USAID (2013) USAID proposal for a shared vision and strategic plan for microbicide introduction. USAID, Washington

    Google Scholar 

  • Vallely A, Shagi C, Kasindi S, Desmond N, Lees S, Chiduo B et al (2007) The benefits of participatory methodologies to develop effective community dialogue in the context of a microbicide trial feasibility study in Mwanza, Tanzania. BMC Public Health 7:133

    Article  PubMed Central  PubMed  Google Scholar 

  • Van Damme L, Govinden R, Mirembe FM, Guédou F, Solomon S, Beck-er ML et al (2008) Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission. N Engl J Med 359:463–72

    Article  PubMed  Google Scholar 

  • Van Damme L, Ramjee G, Alary M, Vuylsteke B, Chandeying V, Rees H et al (2002) Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trial. Lancet 360(9338):971–7

    Article  PubMed  Google Scholar 

  • van der Straten A, Montgomery ET, Cheng H, Wegner L, Masenga G, von Mollendorf C et al (2012) high acceptability of a vaginal ring intended as a microbicide delivery method for HIV prevention in African women. AIDS Behav 2012 (Epub 2012/05/31)

    Google Scholar 

  • van der Straten A, Van Damme L, Haberer JE, Bangsberg DR (2012b) Un-raveling the divergent results of pre-exposure prophylaxis trials for HIV prevention. AIDS 26(7):F13–9 Epub 2012/02/16

    Article  PubMed  Google Scholar 

  • Verguet S, Walsh JA (2010) Vaginal microbicides save money: a model of cost-effectiveness in South Africa and the USA. Sex Transm Infect 86(3):212–6

    Article  CAS  PubMed  Google Scholar 

  • Vickerman P, Watts C, Delany S, Alary M, Rees H, Heise L (2006) The importance of context: model projections on how microbicide impact could be affected by the underlying epidemiologic and behavioral situation in 2 African settings. Sex Transm Dis 33(6):397–405

    Article  PubMed  Google Scholar 

  • Walker SM, West S, Raghavendran V (2006) Framework for future microbicide access in developing countries. In: International AIDS conference; Mexico City

    Google Scholar 

  • Watts C, Vickerman P (2001) The impact of microbicides on HIV and STD transmission: model projections. AIDS 15(S):s43–s4

    Google Scholar 

  • Whitehead SJ, McLean C, Chaikummao S, Braunstein S, Utaivoravit W, van de Wijgert JH et al (2011) Acceptability of Carraguard vaginal microbicide gel among HIV-infected women in Chiang Rai Thailand. PloS one 6(9):e14831 Epub 2011/09/15

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • WHO (2012a) Scientific and technical requirements to formulate a female condom generic specific specification and prequalification scheme. WHO, Geneva. (http://www.who.int/entity/reproductivehealth/publications/family_planning/rhr_12_03/en/index.html)

  • WHO (2012b). WHO handbook for guideline development. Geneva, Switzerland: World Health Organization 2012. http://www.who.int/iris/bitstream/10665/75146/1/9789241548441_eng.pdf.

  • WHO (2013a) HIV preventives technology and market landscape. WHO, Geneva. http://www.unitaid.eu/images/marketdynamics/publications/UNITAID-HIV_Preventives_Landscape-1st_edition.pdf

  • WHO (2013b) Prequalification of medicines by WHO. Fact sheet No. 278, updated January 2013. http://www.who.int/mediacentre/factsheets/fs278/en/

  • WHO. WHO expert committee on specifications for pharmaceutical preparations. WHO, Geneva

    Google Scholar 

  • WHO/UNAIDS. (2010) Next steps with 1% tenofovir gel. Johannesburg, South Africa WHO/UNAIDS meeting: WHO/UNAIDS, 25-26 August 2010, WHO, Geneva

    Google Scholar 

  • Widdus R (2005) Public-private partnerships: an overview. T Roy Soc Trop Med H 99(Suppl 1):S1–8 Epub 2005/08/09

    Article  Google Scholar 

  • Wilson DP, Coplan PM (2008) Mathematical models and health economic aspects of microbicides. Curr Opin HIV AIDS 3(5):587–92

    Article  PubMed  Google Scholar 

  • Woodsong C, Alleman P (2008) Sexual pleasure, gender power and microbicide acceptability in Zimbabwe and Malawi. AIDS Educ Prev 20(2):171–87 Epub 2008/04/25

    Article  PubMed  Google Scholar 

  • Woodsong C, Alleman P, Musara P, Chandipwisa A, Chirenje M, Martinson F et al (2012) Preventive misconception as a motivation for participation and adherence in microbicide trials: evidence from female participants and male partners in Malawi and Zimbabwe. AIDS Behav 16(3):785–90 Epub 2011/08/25

    Article  PubMed Central  PubMed  Google Scholar 

  • Woodsong C, Koo HP (2002) Holistic view of acceptability among a multi-ethnic population of adult and teen women and men. In: Paper presented at Microbicides 2002, Antwerp, 12–15 May 2002

    Google Scholar 

  • Woodsong C, MacQueen K, Amico R, Friedland B, Gafos M, Mansoor L, Tolley E, McCormack S (2013) Microbicide clinical trial adherence: insights for introduction. J Int AIDS Society 16(1):18505. doi:10.7448/IAS.16.1.18505

    Article  Google Scholar 

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Acknowledgment

The authors would like to thank Polly Harrison for her review and comments on an earlier draft of this paper.

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Authors and Affiliations

  1. International Partnership for Microbicides, Silver Spring, MD, 20910, USA

    Cynthia Woodsong

  2. Sigma 3 Services Sarl, Scientific and Statistical Solutions, Nyon, Switzerland

    Elizabeth McGrory & Tim Farley

Authors
  1. Cynthia Woodsong
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  2. Elizabeth McGrory
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  3. Tim Farley
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Corresponding author

Correspondence to Cynthia Woodsong .

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Editors and Affiliations

  1. Preclinical Sciences & Product Development, International Partnership for Microbicides, Silver Spring, Maryland, USA

    Jeremy Nuttall

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Woodsong, C., McGrory, E., Farley, T. (2014). Preparing for Microbicide Introduction, Rollout, and Sustained Access. In: Nuttall, J. (eds) Microbicides for Prevention of HIV Infection. Current Topics in Microbiology and Immunology, vol 383. Springer, Berlin, Heidelberg. https://doi.org/10.1007/82_2014_418

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