DOI: 10.1111/1471-0528.12912
Commentary
www.bjog.org
Policy implications for multipurpose prevention technologies service delivery H Rees,a,b A Forbesc a Wits Reproductive Health & HIV Institute, Johannesburg, South Africa b Department of Obstetrics & Gynaecology, University of Witwatersrand, Johannesburg, South Africa c Independent Consultant, Kensington, MD, USA Correspondence: H Rees, Wits Reproductive Health & HIV Institute, PO Box 18512, Hillbrow, Johannesburg, 2038, South Africa. Email [email protected]
Accepted 7 May 2014. Please cite this paper as: Rees H, Forbes A. Policy implications for multipurpose prevention technologies service delivery. BJOG 2014; 121 (Suppl. 5): 19–22.
In 1994 the United Nations Conference on Population and Development endorsed the concept of sexual and reproductive health and emphasised the linkages between contraception and sexually transmitted infections (STIs) including HIV. One of the structural changes emerging from this new approach was a call for the integration of family planning services, STI services and HIV/AIDS care. The benefits of integration are compelling, particularly in terms of reaching women and girls in underserved, vulnerable and marginalised populations1,2 and strengthening over-extended healthcare delivery systems.3 A decade ago modelling suggested that contraceptive access would significantly reduce mother-to-child transmission and demands were made to prioritise this aspect of service integration.4 Strong recommendations emerged from a 2003 consultation convened by the World Health Organization (WHO) and the United National Family Planning Association (UNFPA) for linkages to bridge ‘the gaps between services for women accessing family planning, testing and counselling, or antenatal care programmes’.5 Despite the many efficiencies and cost-savings associated with such integration, commensurate investment and political support for it has been frustratingly slow. As awareness of the need for linked services increased, the need for technologies that can prevent both HIV and unintended pregnancy has become a research priority. The diaphragm is recognised as a moderately effective contraceptive method that also protects against some upper genital tract infections. However, a randomised control trial investigating the effectiveness of the contraceptive diaphragm in preventing HIV acquisition in women failed to show effectiveness. So to date the male and female condoms are the only effective dual protection methods available6 but the public health impact of female condoms is lessened by limited access. The diaphragm is sometimes also listed
ª 2014 Royal College of Obstetricians and Gynaecologists
as a dual protection method because it can reduce risk of some STIs as well as prevent pregnancy6,7 but it is omitted in this case only because its capacity as a dual protection device is far more limited than that of condoms. The acceptability of condoms is also affected by gender norms, stigma, provider attitudes and other cultural factors. In addition, the differing views of condoms generally taken by family planning providers versus HIV service providers is also likely to affect condom promotion and uptake. Family planning professionals tend not to prioritise condom promotion because the contraceptive effectiveness of condoms is lower than that of coitally independent methods such as hormonal contraception, and dual method use by women using modern contraceptive methods is not widely promoted. In contrast, HIV services tend to focus on condoms for disease prevention but ignore the importance of fertility counselling and contraceptive provision for their patients. Between 1998 and 2005, one literature review of HIV/AIDS, STI, obstetrics and gynaecology journals located only 13 articles mentioning ‘dual protection’ and only two in which the words ‘condoms’ and ‘emergency contraception’ were both present.8 In reality, it is a global challenge to get women to use two technologies for different purposes every time they have sex, and pushing this agenda in the hope that it will eventually answer this challenge, is not based on the real world of sex and of relationship dynamics. The lack of interaction between the fields of family planning and HIV, reinforced by siloed funding and staffing, largely inhibited discussion of the need for dual prevention methods for at least the first two decades of the HIV/AIDS epidemic. In the mid-2000s, however, a confluence of events began to change this dynamic. According to UNAIDS estimates, women comprised half of the adult population living with HIV for the first time in 2003 and have
19
Rees and Forbes
been the majority of this global population since 2004.9 With the 2007 release of the ‘second-generation’ female condom and a renewed emphasis on the female condom promoted by UNFPA, as well as renewed optimism and investment in microbicide research, the possibility of developing new dual prevention technologies came to the fore. Combination formulations that are less user-dependent than condoms, such as rings and injectables, were developed for clinical trials. Interest grew in the possibility of multipurpose prevention technologies (MPTs) that are less user-dependent than condoms and that would deliver protection from at least two of the following: unintended pregnancy, HIV and other STIs. However, an unforeseen outcome of microbicide and PreP trials dampened this enthusiasm when low levels of product adherence undermined the integrity of a number of trials. In these studies only a minority of women adhered well to their study products while the majority were partial or non-users.10–12 Although trial settings do not replicate real life, these adherence problems nevertheless raised a number of questions of whether women would be more willing to use a product correctly and consistently if it provided them with both contraceptive and disease prevention benefits rather than only one or the other. As well as expanded protection, MPTs potentially offer time- and resource-saving advantages. In well functioning services, counselling about contraceptive and disease prevention methods should be offered to clients or patients. It may be time saving for providers and their clients if a single counselling session for a combined prevention technology were offered, rather than counselling for two methods with different functions. Cost to the consumer is another consideration. Like other new technologies, the MPTs under development are likely to cost more than currently available products. Building on the global experiences of negotiating affordable prices for new vaccines and anti-retrovirals, it should be possible to make MPTs affordable for even the poorest developing countries. By predicting demand from countries and negotiating tiered pricing according to national GDPs, MPT manufacturing can be profitable for companies, which is an important consideration for sustainable supply. Using existing global pricing models, agencies such as the Global Fund are well suited to negotiate with industry and to potentially co-fund MPTs with the poorest countries who require these products. Finally, as female condom studies have shown, access to multiple protective methods can increase consistent use of some form of protection and decrease the incidence of unprotected sex acts.13–15 Access to MPT options that, unlike condoms, are coitally independent could make consistent dual protection achievable for many more women. In a national survey of 1444 providers of family planning and HIV/STI
20
care in South Africa and Zimbabwe, 85% identified a need for ‘new female-initiated multipurpose prevention technologies’.16 The Initiative for Multipurpose Prevention Technologies (IMPT) was established in 2009 to build support for MPT development. Composed of reproductive health researchers, healthcare providers, policy-makers, advocates, product developers and donors, the IMPT is mobilising resources, encouraging collaboration among scientific disciplines to expedite product development, and advocating for the testing, prompt regulatory review and eventual introduction of successful candidates. In 2011, the IMPT began drafting Target Product Profiles (TPPs) to identify ‘key attributes and parameters for MPT products that would lead to the highest potential public health impact’.17 Commonly used in pharmaceutical development, TPPs serve as templates for candidate product assessment. This methodology enables the IMPT to identify the most potentially beneficial candidates, estimate resource needs and see where duplication of effort in the product development pipeline might be avoided.18 As part of the process, the USA, African and Indian healthcare providers were asked to identify vital attributes for a successful MPT. Those polled included 593 US-based members of the Association of Reproductive Health Professionals, 289 African providers at the 2011 International Conference on Family Planning in Dakar, and 34 Indian providers attending the 2012 Regional Conference on MPTs in New Delhi.17 These participants were asked to identify: 1 The combination of prevention options to which they assigned highest priority (unintended pregnancy plus HIV, unintended pregnancy plus other STIs, HIV plus other STIs), 2 The STI, other than HIV, that they saw as most important to prevent, and 3 The combination product formulation most acceptable to the women they served (selecting from the following options: topical, oral, injection, implant, intrauterine device, sustained release device such as a vaginal ring).17 Their opinions varied by region. Prevention of unintended pregnancy and HIV was the highest priority combination for 66% of African providers. Unintended pregnancy and non-HIV STI prevention was most important to US and Indian providers (66 and 59%, respectively). On question two, all three groups agreed that HPV was the highest prevention priority among non-HIV STI,17 possibly reflecting an increase in HPV awareness created by the introduction of HPV vaccine. Responses to the third question reflected the contraceptive formulations already well-accepted and in widespread use in each region. Indian providers identified a sustained release formulation as most acceptable (44%), while US
ª 2014 Royal College of Obstetricians and Gynaecologists
Policy implications for MPT service delivery
providers opted for oral administration (46%). African providers expressed a broader range of opinions, with injection and sustained release devices seen as slightly preferable to the alternatives (by 22 and 20%, respectively).17 A group of 15 MPT researchers and product developers were also polled regarding their views on ideal product attributes and minimally acceptable parameters. Most agreed that HIV and pregnancy prevention was the most important combination to pursue, with HIV and STI prevention identified as secondary. Due to adherence challenges, they assigned the highest priority to the development of sustained release products that do not require daily use. They also recommended prioritising the development of topically administered products over oral formulations, and saw on-demand administration (products used before or after sex) as more valuable than products taken daily. From a technical standpoint, the researchers identified three key attributes that the new MPTs should have: ability to withstand storage temperatures up to 40°C, a shelf life of up to 36 months and a concealable presentation.19 This input from providers, researchers and developers became the basis for discussions held by the IMPT Working Groups that yielded a ‘consensus TPP’ capable of shaping ‘general development priorities and fundamental design targets that would, in turn, guide funder investment prioritisation and [research and development] focus’.18 Although the IMPT process did not survey women in various regions directly regarding their priorities and product preferences, the TPPs developed should nevertheless help to stream-line the MPT research and development pipeline and optimise the use of the limited resources available for this urgent pursuit. As healthcare providers are frequently reminded, the uptake and successful use of any prevention method ultimately depends on two things: access and acceptability, as framed by the attitudes and perceptions that end users and their partners bring to the method. Factors affecting the accessibility and acceptability may include the following: 1 Is it available over-the-counter or only by prescription? 2 How visible is it? Can its use be concealed? Can it be stored and transported unobtrusively? 3 Is skilled clinical involvement required and, if so, how extensively (e.g. at every visit or only very occasionally— as with intrauterine device insertion and removal)? 4 Is HIV testing required before prescription and at every refill of the method (e.g. for products combining antiretroviral drugs with other ingredients)? 5 What is involved in adherence to the method regimen? Does the patient use it daily, whether she is having sex or not, or only before or after sex? Does it have to be
ª 2014 Royal College of Obstetricians and Gynaecologists
replaced periodically, as with a sustained release method? 6 If the method is only partially effective, how will the patient ensure her ability to use supplemental protection as well? Products that enable providers to give ‘user-friendly’ answers to these questions are likely to be perceived as more acceptable and accessible than those that do not. A broad method mix is critical so that each woman can make choices to balance her unique concerns regarding convenience, cost, unobtrusiveness, continuous versus coitally dependent protection. The better a woman can match an acceptable, affordable multipurpose product to her current needs, the more likely it is that she will use it consistently. As MPT development moves forward, we cannot allow the best to be the enemy of the good. If a method has significant contraceptive effectiveness and partially reduces the user’s risk of disease acquisition or transmission without generating other health risks, it merits serious consideration—not only by product developers but also by donors, research institutions and policy-makers. The urgency with which such products are needed is palpable, especially in countries heavily burdened by HIV and maternal mortality. It imposes on us an ethical timeline that allows for debate, research and careful consideration but does not permit either distraction or diminution of our effort.
Disclosure of interests None.
Contribution to authorship HR was the lead author (concept, planning, development and final preparation of article), AF, the co-author, contributed to drafting and research.
Details of ethics approval None required as this is a commentary.
Funding None.
Acknowledgements None. &
References 1 World Health Organization. Making the Case for Interventions Linking Sexual and Reproductive Health and HIV in Proposals to the Global Fund to Fight AIDS, Tuberculosis and Malaria. Geneva: World Health Organization, 2010. [http://whqlibdoc.who.int/hq/2010/ WHO_RHR_10.02_eng.pdf]. Accessed 10 March 2014. 2 United National Family Planning Association. Preventing HIV/AIDS: linking HIV/AIDS with sexual and reproductive health. n.d. [www.unfpa.org/hiv/linking.htm]. Accessed 10 March 2014.
21
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3 FHI360. Strengthening family planning in a large-scale PEPFAR-supported HIV program [Internet]. Report. 2012. Durham, NC. [www.fhi360.org/sites/default/files/media/documents/ ZPCTIIbrief1.pdf]. Accessed 10 March 2014. 4 Stover J, Fuchs N, Halperin D, Gibbons A, Gillespie D. Adding family planning to PMTCT sites increases the benefits of PMTCT. Issue Brief: Population and Reproductive Health. USAID, October 2003. 5 World Health Organization. Glion consultation on strengthening the linkages between reproductive health and HIV/AIDS: family planning and HIV/AIDS in women and children [Internet]. 2006. Geneva. [www.who.int/hiv/pub/advocacymaterials/glionconsultationsummary_ DF.pdf]. Accessed 12 March 2014. 6 Ramjee G, van der SA, Chipato T, de Bruyn G, Blanchard K, Shiboski S, et al. The diaphragm and lubricant gel for prevention of cervical sexually transmitted infections: results of a randomized controlled trial. PLoS ONE 2008;3:e3488. 7 Minnis AM, Padian NS. Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions. Sex Transm Infect 2005;81:193–200. 8 Berer M. Dual protection: more needed than practised or understood. Reprod Health Matters 2006;14:162–70. 9 Joint United Nations Programme on HIV/AIDS (UNAIDS). UNAIDS Report on the Global AIDS Epidemic—2013. Geneva: UNAIDS, 2013. [www.unaids.org/en/media/unaids/contentassets/documents/ epidemiology/2013/gr2013/UNAIDS_Global_Report_2013_en.pdf]. Accessed 11 March 2014. 10 Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med 2012;367:411–22. 11 Marrazzo J, Ramjee G, Nair G, Palanee T, Mkhize B, Nakabiito Taljaard M, et al. Pre-exposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofovir/emtricitabine or vaginal tenofovir gel in the VOICE study (MTN 003). Presented 4 March 2013 at the 20th CROI, Atlanta, GA. Oral Abstract 26LB
22
12 McCormack S, Ramjee G, Kamali A, Rees H, Crook AM, Gafos M, et al. PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial. Lancet 2010;376:1329–37. 13 Vijayakumar G, Mabude Z, Smit J, Beksinska M, Lurie M. A review of female-condom effectiveness: patterns of use and impact on protected sex acts and STI incidence. Int J STD AIDS 2006;17:652–9. 14 Musaba E, Morrison C, Sunkutu M, Wong EL. Long-term use of the female condom among couples at high risk of human immunodeficiency virus infection in Zambia. Sex Transm Dis 1998;25:260–4. 15 Choi K-H, Hoff C, Gregorich SE, Grinstead O, Gomez C, Hussey W. The efficacy of female condom skills training in HIV risk reduction among women: a randomized controlled trial. Am J Public Health 2008;98:1841–8. 16 Holt K, Blanchard K, Chipato T, Nhemachena T, Blum M, Stratton L, et al. A nationally representative survey of healthcare provider counselling and provision of the female condom in South Africa and Zimbabwe. BMJ Open [Internet] 2013;3:pii:e002208. 17 Manning J, Romano J. Aligning investments in R&D, and the critical path to introduction. Paper presented at European Society of Contraception and Reproductive Health First Global Conference on Contraception, Reproduction and Sexual Health; Copenhagen; 22– 25 May 2013. [http://cami-health.org/documents/ESC2013/ ESC-Manning-Aligning-Investments-MPT.pdf]. Accessed 11 March 2014. 18 Harrison P, Hemmerling A, Romano J, Whaley K, Young Holt B. Developing multipurpose reproductive health technologies: an integrated strategy. AIDS Res Treat 2013;2013:1–15. 19 Rees H. Vaginal delivery of multipurpose technologies: new drugs, new delivery systems. Paper presented at STI and AIDS World Conference; Vienna; 2013 July 15. [http://sti.medroom.at/Elearning/ 2/video.html]. Accessed 12 March 2014.
ª 2014 Royal College of Obstetricians and Gynaecologists
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Commentary
www.bjog.org
Policy implications for multipurpose prevention technologies service delivery H Rees,a,b A Forbesc a Wits Reproductive Health & HIV Institute, Johannesburg, South Africa b Department of Obstetrics & Gynaecology, University of Witwatersrand, Johannesburg, South Africa c Independent Consultant, Kensington, MD, USA Correspondence: H Rees, Wits Reproductive Health & HIV Institute, PO Box 18512, Hillbrow, Johannesburg, 2038, South Africa. Email [email protected]
Accepted 7 May 2014. Please cite this paper as: Rees H, Forbes A. Policy implications for multipurpose prevention technologies service delivery. BJOG 2014; 121 (Suppl. 5): 19–22.
In 1994 the United Nations Conference on Population and Development endorsed the concept of sexual and reproductive health and emphasised the linkages between contraception and sexually transmitted infections (STIs) including HIV. One of the structural changes emerging from this new approach was a call for the integration of family planning services, STI services and HIV/AIDS care. The benefits of integration are compelling, particularly in terms of reaching women and girls in underserved, vulnerable and marginalised populations1,2 and strengthening over-extended healthcare delivery systems.3 A decade ago modelling suggested that contraceptive access would significantly reduce mother-to-child transmission and demands were made to prioritise this aspect of service integration.4 Strong recommendations emerged from a 2003 consultation convened by the World Health Organization (WHO) and the United National Family Planning Association (UNFPA) for linkages to bridge ‘the gaps between services for women accessing family planning, testing and counselling, or antenatal care programmes’.5 Despite the many efficiencies and cost-savings associated with such integration, commensurate investment and political support for it has been frustratingly slow. As awareness of the need for linked services increased, the need for technologies that can prevent both HIV and unintended pregnancy has become a research priority. The diaphragm is recognised as a moderately effective contraceptive method that also protects against some upper genital tract infections. However, a randomised control trial investigating the effectiveness of the contraceptive diaphragm in preventing HIV acquisition in women failed to show effectiveness. So to date the male and female condoms are the only effective dual protection methods available6 but the public health impact of female condoms is lessened by limited access. The diaphragm is sometimes also listed
ª 2014 Royal College of Obstetricians and Gynaecologists
as a dual protection method because it can reduce risk of some STIs as well as prevent pregnancy6,7 but it is omitted in this case only because its capacity as a dual protection device is far more limited than that of condoms. The acceptability of condoms is also affected by gender norms, stigma, provider attitudes and other cultural factors. In addition, the differing views of condoms generally taken by family planning providers versus HIV service providers is also likely to affect condom promotion and uptake. Family planning professionals tend not to prioritise condom promotion because the contraceptive effectiveness of condoms is lower than that of coitally independent methods such as hormonal contraception, and dual method use by women using modern contraceptive methods is not widely promoted. In contrast, HIV services tend to focus on condoms for disease prevention but ignore the importance of fertility counselling and contraceptive provision for their patients. Between 1998 and 2005, one literature review of HIV/AIDS, STI, obstetrics and gynaecology journals located only 13 articles mentioning ‘dual protection’ and only two in which the words ‘condoms’ and ‘emergency contraception’ were both present.8 In reality, it is a global challenge to get women to use two technologies for different purposes every time they have sex, and pushing this agenda in the hope that it will eventually answer this challenge, is not based on the real world of sex and of relationship dynamics. The lack of interaction between the fields of family planning and HIV, reinforced by siloed funding and staffing, largely inhibited discussion of the need for dual prevention methods for at least the first two decades of the HIV/AIDS epidemic. In the mid-2000s, however, a confluence of events began to change this dynamic. According to UNAIDS estimates, women comprised half of the adult population living with HIV for the first time in 2003 and have
19
Rees and Forbes
been the majority of this global population since 2004.9 With the 2007 release of the ‘second-generation’ female condom and a renewed emphasis on the female condom promoted by UNFPA, as well as renewed optimism and investment in microbicide research, the possibility of developing new dual prevention technologies came to the fore. Combination formulations that are less user-dependent than condoms, such as rings and injectables, were developed for clinical trials. Interest grew in the possibility of multipurpose prevention technologies (MPTs) that are less user-dependent than condoms and that would deliver protection from at least two of the following: unintended pregnancy, HIV and other STIs. However, an unforeseen outcome of microbicide and PreP trials dampened this enthusiasm when low levels of product adherence undermined the integrity of a number of trials. In these studies only a minority of women adhered well to their study products while the majority were partial or non-users.10–12 Although trial settings do not replicate real life, these adherence problems nevertheless raised a number of questions of whether women would be more willing to use a product correctly and consistently if it provided them with both contraceptive and disease prevention benefits rather than only one or the other. As well as expanded protection, MPTs potentially offer time- and resource-saving advantages. In well functioning services, counselling about contraceptive and disease prevention methods should be offered to clients or patients. It may be time saving for providers and their clients if a single counselling session for a combined prevention technology were offered, rather than counselling for two methods with different functions. Cost to the consumer is another consideration. Like other new technologies, the MPTs under development are likely to cost more than currently available products. Building on the global experiences of negotiating affordable prices for new vaccines and anti-retrovirals, it should be possible to make MPTs affordable for even the poorest developing countries. By predicting demand from countries and negotiating tiered pricing according to national GDPs, MPT manufacturing can be profitable for companies, which is an important consideration for sustainable supply. Using existing global pricing models, agencies such as the Global Fund are well suited to negotiate with industry and to potentially co-fund MPTs with the poorest countries who require these products. Finally, as female condom studies have shown, access to multiple protective methods can increase consistent use of some form of protection and decrease the incidence of unprotected sex acts.13–15 Access to MPT options that, unlike condoms, are coitally independent could make consistent dual protection achievable for many more women. In a national survey of 1444 providers of family planning and HIV/STI
20
care in South Africa and Zimbabwe, 85% identified a need for ‘new female-initiated multipurpose prevention technologies’.16 The Initiative for Multipurpose Prevention Technologies (IMPT) was established in 2009 to build support for MPT development. Composed of reproductive health researchers, healthcare providers, policy-makers, advocates, product developers and donors, the IMPT is mobilising resources, encouraging collaboration among scientific disciplines to expedite product development, and advocating for the testing, prompt regulatory review and eventual introduction of successful candidates. In 2011, the IMPT began drafting Target Product Profiles (TPPs) to identify ‘key attributes and parameters for MPT products that would lead to the highest potential public health impact’.17 Commonly used in pharmaceutical development, TPPs serve as templates for candidate product assessment. This methodology enables the IMPT to identify the most potentially beneficial candidates, estimate resource needs and see where duplication of effort in the product development pipeline might be avoided.18 As part of the process, the USA, African and Indian healthcare providers were asked to identify vital attributes for a successful MPT. Those polled included 593 US-based members of the Association of Reproductive Health Professionals, 289 African providers at the 2011 International Conference on Family Planning in Dakar, and 34 Indian providers attending the 2012 Regional Conference on MPTs in New Delhi.17 These participants were asked to identify: 1 The combination of prevention options to which they assigned highest priority (unintended pregnancy plus HIV, unintended pregnancy plus other STIs, HIV plus other STIs), 2 The STI, other than HIV, that they saw as most important to prevent, and 3 The combination product formulation most acceptable to the women they served (selecting from the following options: topical, oral, injection, implant, intrauterine device, sustained release device such as a vaginal ring).17 Their opinions varied by region. Prevention of unintended pregnancy and HIV was the highest priority combination for 66% of African providers. Unintended pregnancy and non-HIV STI prevention was most important to US and Indian providers (66 and 59%, respectively). On question two, all three groups agreed that HPV was the highest prevention priority among non-HIV STI,17 possibly reflecting an increase in HPV awareness created by the introduction of HPV vaccine. Responses to the third question reflected the contraceptive formulations already well-accepted and in widespread use in each region. Indian providers identified a sustained release formulation as most acceptable (44%), while US
ª 2014 Royal College of Obstetricians and Gynaecologists
Policy implications for MPT service delivery
providers opted for oral administration (46%). African providers expressed a broader range of opinions, with injection and sustained release devices seen as slightly preferable to the alternatives (by 22 and 20%, respectively).17 A group of 15 MPT researchers and product developers were also polled regarding their views on ideal product attributes and minimally acceptable parameters. Most agreed that HIV and pregnancy prevention was the most important combination to pursue, with HIV and STI prevention identified as secondary. Due to adherence challenges, they assigned the highest priority to the development of sustained release products that do not require daily use. They also recommended prioritising the development of topically administered products over oral formulations, and saw on-demand administration (products used before or after sex) as more valuable than products taken daily. From a technical standpoint, the researchers identified three key attributes that the new MPTs should have: ability to withstand storage temperatures up to 40°C, a shelf life of up to 36 months and a concealable presentation.19 This input from providers, researchers and developers became the basis for discussions held by the IMPT Working Groups that yielded a ‘consensus TPP’ capable of shaping ‘general development priorities and fundamental design targets that would, in turn, guide funder investment prioritisation and [research and development] focus’.18 Although the IMPT process did not survey women in various regions directly regarding their priorities and product preferences, the TPPs developed should nevertheless help to stream-line the MPT research and development pipeline and optimise the use of the limited resources available for this urgent pursuit. As healthcare providers are frequently reminded, the uptake and successful use of any prevention method ultimately depends on two things: access and acceptability, as framed by the attitudes and perceptions that end users and their partners bring to the method. Factors affecting the accessibility and acceptability may include the following: 1 Is it available over-the-counter or only by prescription? 2 How visible is it? Can its use be concealed? Can it be stored and transported unobtrusively? 3 Is skilled clinical involvement required and, if so, how extensively (e.g. at every visit or only very occasionally— as with intrauterine device insertion and removal)? 4 Is HIV testing required before prescription and at every refill of the method (e.g. for products combining antiretroviral drugs with other ingredients)? 5 What is involved in adherence to the method regimen? Does the patient use it daily, whether she is having sex or not, or only before or after sex? Does it have to be
ª 2014 Royal College of Obstetricians and Gynaecologists
replaced periodically, as with a sustained release method? 6 If the method is only partially effective, how will the patient ensure her ability to use supplemental protection as well? Products that enable providers to give ‘user-friendly’ answers to these questions are likely to be perceived as more acceptable and accessible than those that do not. A broad method mix is critical so that each woman can make choices to balance her unique concerns regarding convenience, cost, unobtrusiveness, continuous versus coitally dependent protection. The better a woman can match an acceptable, affordable multipurpose product to her current needs, the more likely it is that she will use it consistently. As MPT development moves forward, we cannot allow the best to be the enemy of the good. If a method has significant contraceptive effectiveness and partially reduces the user’s risk of disease acquisition or transmission without generating other health risks, it merits serious consideration—not only by product developers but also by donors, research institutions and policy-makers. The urgency with which such products are needed is palpable, especially in countries heavily burdened by HIV and maternal mortality. It imposes on us an ethical timeline that allows for debate, research and careful consideration but does not permit either distraction or diminution of our effort.
Disclosure of interests None.
Contribution to authorship HR was the lead author (concept, planning, development and final preparation of article), AF, the co-author, contributed to drafting and research.
Details of ethics approval None required as this is a commentary.
Funding None.
Acknowledgements None. &
References 1 World Health Organization. Making the Case for Interventions Linking Sexual and Reproductive Health and HIV in Proposals to the Global Fund to Fight AIDS, Tuberculosis and Malaria. Geneva: World Health Organization, 2010. [http://whqlibdoc.who.int/hq/2010/ WHO_RHR_10.02_eng.pdf]. Accessed 10 March 2014. 2 United National Family Planning Association. Preventing HIV/AIDS: linking HIV/AIDS with sexual and reproductive health. n.d. [www.unfpa.org/hiv/linking.htm]. Accessed 10 March 2014.
21
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3 FHI360. Strengthening family planning in a large-scale PEPFAR-supported HIV program [Internet]. Report. 2012. Durham, NC. [www.fhi360.org/sites/default/files/media/documents/ ZPCTIIbrief1.pdf]. Accessed 10 March 2014. 4 Stover J, Fuchs N, Halperin D, Gibbons A, Gillespie D. Adding family planning to PMTCT sites increases the benefits of PMTCT. Issue Brief: Population and Reproductive Health. USAID, October 2003. 5 World Health Organization. Glion consultation on strengthening the linkages between reproductive health and HIV/AIDS: family planning and HIV/AIDS in women and children [Internet]. 2006. Geneva. [www.who.int/hiv/pub/advocacymaterials/glionconsultationsummary_ DF.pdf]. Accessed 12 March 2014. 6 Ramjee G, van der SA, Chipato T, de Bruyn G, Blanchard K, Shiboski S, et al. The diaphragm and lubricant gel for prevention of cervical sexually transmitted infections: results of a randomized controlled trial. PLoS ONE 2008;3:e3488. 7 Minnis AM, Padian NS. Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions. Sex Transm Infect 2005;81:193–200. 8 Berer M. Dual protection: more needed than practised or understood. Reprod Health Matters 2006;14:162–70. 9 Joint United Nations Programme on HIV/AIDS (UNAIDS). UNAIDS Report on the Global AIDS Epidemic—2013. Geneva: UNAIDS, 2013. [www.unaids.org/en/media/unaids/contentassets/documents/ epidemiology/2013/gr2013/UNAIDS_Global_Report_2013_en.pdf]. Accessed 11 March 2014. 10 Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med 2012;367:411–22. 11 Marrazzo J, Ramjee G, Nair G, Palanee T, Mkhize B, Nakabiito Taljaard M, et al. Pre-exposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofovir/emtricitabine or vaginal tenofovir gel in the VOICE study (MTN 003). Presented 4 March 2013 at the 20th CROI, Atlanta, GA. Oral Abstract 26LB
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