- Email: [email protected]
Social Justice, Public Health Ethics, and the Use of HIV Pre-Exposure Prophylaxis
Social Justice, Public Health Ethics, and the Use of HIV Pre-Exposure Prophylaxis Sean Philpott, PhD, MSBioethics
Background
R
ecent large-scale clinical trials in the U.S., Latin America, Africa, and Asia have demonstrated the effectiveness of pre-exposure prophylaxis (PrEP), which is the use of HIV treatment medications to protect uninfected individuals from HIV infection. Incorporating PrEP into existing HIV prevention programs, however, poses a number of challenges. In the U.S., those programs that are most likely to be cost effective may nevertheless fail to achieve one of the most important objectives of public health: improving the health of the community while addressing the needs of the most disadvantaged. This paper reviews some of those implementation challenges through the lens of social justice, suggesting that some trade-offs may be necessary in order to address the needs of those most at risk for acquiring HIV.
The Use of Pre-Exposure Prophylaxis for HIV Prevention An estimated 1.2 million people in the U.S. are currently living with HIV/AIDS, with nearly 50,000 more infected each year.1 Those most at risk tend to be socially or economically marginalized, such as injection drug users, commercial sex workers and men who have sex with men (MSM). Such marginalization can make current HIV prevention messages and tools—abstinence, condoms, and mutual monogamy—inaccessible to many. There thus is a need to develop new user-controlled HIV prevention tools, such as PrEP, that will enable these individuals to protect themselves. In recent years, three large-scale RCTs of daily oral PrEP for HIV prevention have had positive fındings.2– 4 Not all such trials have shown promising results,5 and there are, as yet, no data on the real-world effectiveness of PrEP among large populations of at-risk individuals in the U.S. and elsewhere. Nevertheless, current data suggest that the prophylactic use of antiretroviral drugs may be a useful From the Center for Bioethics and Clinical Leadership (Philpott), Union Graduate College, Schenectady, New York Address correspondence to: Sean M. Philpott, PhD, MSBioethics, Union Graduate College, 80 Nott Terrace, Schenectady NY 12308. E-mail: philpots@ uniongraduatecollege.edu. 0749-3797/$36.00 http://dx.doi.org/10.1016/j.amepre.2012.09.029
addition to comprehensive HIV prevention strategies, and in July of this year the U.S. Food and Drug Administration (FDA) approved the marketing of Truvada® (emtricitabile/tenofıvir disoproxil fumarate) as PrEP.6 Prior to this, however, many physicians were already prescribing Truvada off-label to patients at increased risk for HIV infection. At-risk individuals in the U.S. and Europe also have been using antiretroviral drugs for PrEP for years (e.g., the use of so-called MTV or Party Packs containing methamphetamine, tenofovir, and Viagra® by gay and bisexual men at circuit parties), despite warnings from HIV prevention experts that such “disco dosing” may be not only ineffective but also might prove harmful. In early 2011, the CDC released interim guidance on the use of antiretroviral PrEP by MSM,7 and in mid-2012, they released interim guidance for heterosexually active adults.8 More extensive guidelines on the use of PrEP are expected from the CDC and WHO later this year. Such guidance is eagerly awaited by public health offıcers working here in the U.S., as these offıcials now face the challenge of delivering PrEP to those who need it but in a way that meets the obligations of public health ethics and social justice. For a new public health intervention such as a PrEPbased prevention program, current ethical frameworks9 require that PrEP be provided in a manner that is cost effective, so that public health efforts to promote and provide it compare favorably with other HIV prevention approaches in terms of dollars spent per number of infections prevented. Pre-exposure prophylaxis– based prevention programs also must be implemented fairly, so that the benefıts and burdens of these programs are distributed fairly. Finally, PrEP needs to be provided in a way that addresses the needs of the most vulnerable, reduces economic disparities, and improves the health of the public.10 Meeting this latter requirement will prove challenging, as most current HIV prevention tools are relatively cheap and readily accessible, need to be used only intermittently, and protect against other sexually transmitted infections (STIs). By contrast, PrEP will likely be expensive, must be taken daily, will require prescription and frequent medical monitoring, and will not protect against other STIs. The studies described above, along with mathematical models of PrEP in both resource-rich and resource-poor
© 2013 American Journal of Preventive Medicine • Published by Elsevier Inc.
Am J Prev Med 2013;44(1S2):S137–S140 S137
Philpott / Am J Prev Med 2013;44(1S2):S137–S140
S138 11–13
countries, suggest that use of antiretroviral drugs for HIV prevention can be an effective public health intervention if and only if (1) the drugs are made widely available to those at highest risk; (2) the drugs are used consistently; (3) the drugs are provided as part of a comprehensive counseling program, including frequent followup testing; and (4) widespread risk compensation (e.g., decreased condom use or increased numbers of sexual partners) does not occur. Failure to achieve these goals may result not only in a program that is costly or ineffective but also in increased transmission of drug-resistant strains of HIV within the community. Given clear regional and socioeconomic differences in the nature of the AIDS pandemic, programs to promote the safe and effective use of PrEP will need to be tailored to individual countries and communities. It will likely be easier to create such a program in a country such as the U.S., where there are fewer cultural, economic, logistic, or regulatory barriers to the use of PrEP. The prevalence of HIV is less than 0.1% of the adult population, and the epidemic is concentrated primarily in well-known at-risk groups. Almost two thirds of all new HIV infections in the U.S. occur in the MSM population,14 a group that seems to be both willing to use and interested in using PrEP. Although current awareness and use of antiretroviral drugs for HIV prevention is low among American MSM, one recent survey of more than 5000 men found that almost 80% of respondents would be interested in using PrEP.15 Tenofovir also is approved for use as an HIV treatment, albeit at some cost, but the CDC and others are working with insurance companies to ensure coverage for its use as PrEP. Some insurance providers and Medicaid programs are willing to pay for PrEP, and Gilead (the manufacturer of Truvada) recently announced a medication assistance program for fınancially needy patients. Finally, confıdential HIV counseling and testing services are widely available. An effective PrEP program might thus target high-risk groups such as American MSM specifıcally, in the context of a meaningful physician–patient relationship, with the costs of the antiretroviral drugs covered by individual health insurance plans or third-party payers. However, designing such a program would not be as simple as it looks and would raise a number of ethical and logistic concerns. First and foremost, recent cuts to the budgets of the CDC and other public health agencies means that any money used to promote and provide PrEP for HIV prevention may need to be diverted from existent prevention or treatment programs. Redirecting scarce resources to PrEP-related programs should not be done in a way that cripples existing prevention programs or that exacerbates existing public health disparities in HIV prevention and
treatment. It is important to consider, however, that a well-designed PrEP program could have substantial benefıts that justify a redistribution of public health resources. For example, the requirement that those seeking and using PrEP undergo regular HIV screening may destigmatize testing, increase public knowledge of serostatus and preventive behaviors, and get those who are infected into treatment as soon as possible (which both improves their own health outcome and reduces the likelihood that they will transmit the virus to others). Risk compensation is also a serious concern. In surveys of PrEP use and acceptability, for example, many MSM report that they will likely increase their sexual risktaking while on PrEP, including a substantial percentage who will stop using condoms with casual partners.16,17 The magnitude and impact that this risk compensation would have on the effectiveness of PrEP programs is unclear,12 but it highlights the importance of offering PrEP as only part of a comprehensive risk-reduction program. If it should turn out that risk compensation among those using antiretroviral drugs for HIV prevention is a pervasive problem, reaching levels that raise questions about the effectiveness of PrEP programs, public health offıcials also would face a diffıcult dilemma. Social justice requires that public health policies strive to improve the public health while addressing the needs of the most vulnerable. Continuing an ineffective PrEP program would mean that scarce resources are spent on interventions that fail to produce a public health benefıt (or might even put individuals at increased risk of HIV or other STIs), but ending such a program would burden unduly those who might otherwise lack access to safe and effective HIV prevention tools. Inequities in health care, including access to HIV testing and treatment, are not as pervasive in the U.S. as they are in the developing world, but they do persist. This is particularly true for racial and ethnic minorities. Although Krakower and his colleagues15 found widespread interest in PrEP among the largest at-risk group, MSM, those surveyed tended to be older, affluent, and better educated. A majority of the survey respondents were also white, and most had health insurance. Some models suggest that the most cost-effective PrEP programs would be those that target this very group: white, wealthy, educated, and urban MSM.18 However, HIV infection is highly prevalent among MSM of color. Nearly 60% of new infections now occur among black and Latino men,14 many of whom live in the rural South and who do not self-identify as gay or bisexual. Some investigators19 argue that current HIV prevention efforts targeting gay and bisexual men specifıcally miss this key at-risk group. The PrEP programs thus www.ajpmonline.org
Philpott / Am J Prev Med 2013;44(1S2):S137–S140
predicted to have the greatest impact are also those that will continue to miss one of the most vulnerable groups, requiring public health offıcials to weigh cost effectiveness with other social justice concerns. Of course, MSM are not the only at-risk group in the U.S., and it is important to note that high prevalence of HIV infection among racial and ethnic minorities in the U.S. is not limited to MSM. The prevalence of new HIV infections in the African-American community as a whole is almost ten times that of whites; black men and women represent only 12.6% of the total population but account for half of all HIV/AIDS diagnoses. The prevalence of HIV infection in the Latino community is also elevated, and Hispanic and black Americans are less likely to have health insurance or a usual source of medical care, such as a primary care physician.20 According to Powers and Faden’s21 model of social justice, public health interventions such as HIV prevention programs should pay particular attention to the needs of traditionally disadvantaged groups such as these, ensuring equal access to care and addressing disparities in health outcomes. Unfortunately, the current system of health coverage in the U.S., which is a mixture of private insurance and government programs such as Medicare and Medicaid, tends to exacerbate rather than address these gaps in healthcare access and outcomes. Although the mosteffective PrEP programs in the U.S. are likely to be those that target MSM specifıcally, with drug prescriptions and follow-up testing provided by primary care physicians and paid for by private insurance plans, such programs again may fail to achieve one of the key goals of public health: improving the overall health of the community while addressing the needs of the most vulnerable and disadvantaged. Wealthy, white MSM may benefıt, but other at-risk groups, including MSM of color and other racial and ethnic minorities, will likely be left behind by PrEP programs that fail to target them specifıcally or that they cannot access because of a lack of insurance or a primary care physician. Questions of social justice alone cannot determine how and when PrEP is used for HIV prevention in the U.S. Nevertheless, two key aspects of justice, population-level health improvement and fair treatment of the disadvantaged,10 need to be considered when developing publicly funded PrEP programs. Some trade-offs may be required, as the programs that are most effective are the same programs that are likely to miss some of the most vulnerable and at-risk groups, particularly historically disadvantaged racial and ethnic minorities. So what can or should be done to address this challenge? There is no simple answer or single solution, particularly given the absence of data involving real-world January 2013
S139
use of PrEP. Current mathematical models can be used to predict which PrEP programs are likely to be most successful, but they rely on untested assumptions about the consistency of drug use (including drug effectiveness when used intermittently) and the magnitude and effect of risk compensation. In order to design these programs, additional studies of PrEP acceptability, use, and effectiveness need to be conducted among at-risk individuals, particularly women and MSM of color. This will be diffıcult given historical distrust of medical research by racial and ethnic minorities in the U.S., but it may help identify barriers to effective communication and program implementation, increase awareness of PrEP and other prevention tools in those populations most heavily affected by HIV, and provide a bridge to other prevention and treatment programs. It also will be important to continue and expand programs such as the privately funded Gilead Medication Assistance Program, as well as create publicly funded approaches (perhaps modeled after existing HIV treatment programs such as the Ryan White Program or the AIDS Drug Assistance Program) that will ensure that at-risk individuals who otherwise lack access to health care can obtain the drugs, counseling, and medical services necessary. Publication of this article was supported by the CDC through the Association for Prevention Teaching and Research (CDCAPTR) Cooperative Agreement number 11-NCHHSTP-01. No fınancial disclosures were reported by the author of this paper.
References 1. CDC. HIV in the U.S.: at a glance. CDC. 2012. www.cdc.gov/hiv/ resources/factsheets/PDF/HIV_at_a_glance.pdf. 2. Baeten J, Donnell DD, Ndase P, et al.; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012;367(5):399 – 410. 3. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010;363(27):2587–99. 4. Thigpen MC, Kebaabetswe PM, Paxton LA, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med 2012;367(5):423–34. 5. Van Damme L, Corneli A, Ahmed K, et al. The FEM-PrEP Trial of emtricitabine/tenofovir disoproxil fumarate (Truvada) among African women. Conference on Retroviruses and Opportunistic Infections 2012; www.retroconference.org/2012b/Abstracts/45406.htm. 6. Food and Drug Administration. Truvada approved to reduce the risk of sexually transmitted HIV in people who are not infected with the virus. 2012. www.fda.gov/ForConsumers/ByAudience/ForPatient Advocates/HIVandAIDSActivities/ucm312264.htm. 7. CDC. Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. MMWR Morb Mortal Wkly Rep 2011;60(3):65– 8.
S140
Philpott / Am J Prev Med 2013;44(1S2):S137–S140
8. CDC. Interim guidance for clinicians considering the use of preexposure prophylaxis for the prevention of HIV infection in heterosexually active adults. MMWR Morb Mortal Wkly Rep 2012;61(31):586 –90. 9. Kass NE. An ethics framework for public health. Am J Public Health 2001;91(11):1776 – 82. 10. Gostin LO, Powers M. What does social justice require for the public’s health? Public health ethics and policy imperatives. Health Aff (Millwood) 2006;25(4):1053– 60. 11. Supervie V, Barrett M, Kahn JS, et al. Modeling dynamic interactions between pre-exposure prophylaxis interventions and treatment programs: predicting HIV transmission and resistance. Sci Rep 2011;1:85. 12. Supervie V, Garcia-Lerma JG, Heneine W, Blower S. HIV, transmitted drug resistance, and the paradox of preexposure prophylaxis. Proc Natl Acad Sci U S A 2010;107(27):12381– 6. 13. Walensky RP, Park JE, Wood R, et al. The cost-effectiveness of preexposure prophylaxis for HIV infection in South African women. Clin Infect Dis 2012;54(10):1504 –13. 14. Prejean J, Song R, Hernandez A, et al. Estimated HIV incidence in the U.S., 2006-2009. PLoS One 2011;6(8):e17502. 15. Krakower DS, Mimiaga MJ, Rosenberger JG, et al. Limited awareness and low immediate uptake of pre-exposure prophylaxis among men
16.
17.
18.
19.
20. 21.
who have sex with men using an internet social networking site. PLoS One 2012;7(3):e33119. Golub SA, Operario D, Gorbach PM. Pre-exposure prophylaxis state of the science: empirical analogies for research and implementation. Curr HIV/AIDS Rep 2010;7(4):201–9. Brooks RA, Landovitz RJ, Kaplan RL, Lieber E, Lee SJ, Barkley TW. Sexual risk behaviors and acceptability of HIV pre-exposure prophylaxis among HIV-negative gay and bisexual men in serodiscordant relationships: a mixed methods study. AIDS Patient Care STDs 2012; 26(2):87–94. Desai K, Sansom SL, Ackers ML, et al. Modeling the impact of HIV chemoprophylaxis strategies among men who have sex with men in the U.S.: HIV infections prevented and cost-effectiveness. AIDS 2008; 22(14):1829 –39. Rhodes SD, Hergenrather KC, Vissman AT, et al. Boys must be men, and men must have sex with women: a qualitative CBPR study to explore sexual risk among African American, Latino, and White gay men and MSM. Am J Mens Health 2011;5(2):140 –51. Agency for Healthcare Research and Quality. Medicare Expenditure Panel Survey. AHRQ. 2012. meps.ahrq.gov/mepsweb. PowersM,FadenRR.Socialjustice:themoralfoundationsofpublichealthand health policy. New York NY: Oxford University Press, 2006.
Did you know? The AJPM Most Read and Most Cited articles are listed on our home page. Go to www.ajpmonline.org.
www.ajpmonline.org
Background
R
ecent large-scale clinical trials in the U.S., Latin America, Africa, and Asia have demonstrated the effectiveness of pre-exposure prophylaxis (PrEP), which is the use of HIV treatment medications to protect uninfected individuals from HIV infection. Incorporating PrEP into existing HIV prevention programs, however, poses a number of challenges. In the U.S., those programs that are most likely to be cost effective may nevertheless fail to achieve one of the most important objectives of public health: improving the health of the community while addressing the needs of the most disadvantaged. This paper reviews some of those implementation challenges through the lens of social justice, suggesting that some trade-offs may be necessary in order to address the needs of those most at risk for acquiring HIV.
The Use of Pre-Exposure Prophylaxis for HIV Prevention An estimated 1.2 million people in the U.S. are currently living with HIV/AIDS, with nearly 50,000 more infected each year.1 Those most at risk tend to be socially or economically marginalized, such as injection drug users, commercial sex workers and men who have sex with men (MSM). Such marginalization can make current HIV prevention messages and tools—abstinence, condoms, and mutual monogamy—inaccessible to many. There thus is a need to develop new user-controlled HIV prevention tools, such as PrEP, that will enable these individuals to protect themselves. In recent years, three large-scale RCTs of daily oral PrEP for HIV prevention have had positive fındings.2– 4 Not all such trials have shown promising results,5 and there are, as yet, no data on the real-world effectiveness of PrEP among large populations of at-risk individuals in the U.S. and elsewhere. Nevertheless, current data suggest that the prophylactic use of antiretroviral drugs may be a useful From the Center for Bioethics and Clinical Leadership (Philpott), Union Graduate College, Schenectady, New York Address correspondence to: Sean M. Philpott, PhD, MSBioethics, Union Graduate College, 80 Nott Terrace, Schenectady NY 12308. E-mail: philpots@ uniongraduatecollege.edu. 0749-3797/$36.00 http://dx.doi.org/10.1016/j.amepre.2012.09.029
addition to comprehensive HIV prevention strategies, and in July of this year the U.S. Food and Drug Administration (FDA) approved the marketing of Truvada® (emtricitabile/tenofıvir disoproxil fumarate) as PrEP.6 Prior to this, however, many physicians were already prescribing Truvada off-label to patients at increased risk for HIV infection. At-risk individuals in the U.S. and Europe also have been using antiretroviral drugs for PrEP for years (e.g., the use of so-called MTV or Party Packs containing methamphetamine, tenofovir, and Viagra® by gay and bisexual men at circuit parties), despite warnings from HIV prevention experts that such “disco dosing” may be not only ineffective but also might prove harmful. In early 2011, the CDC released interim guidance on the use of antiretroviral PrEP by MSM,7 and in mid-2012, they released interim guidance for heterosexually active adults.8 More extensive guidelines on the use of PrEP are expected from the CDC and WHO later this year. Such guidance is eagerly awaited by public health offıcers working here in the U.S., as these offıcials now face the challenge of delivering PrEP to those who need it but in a way that meets the obligations of public health ethics and social justice. For a new public health intervention such as a PrEPbased prevention program, current ethical frameworks9 require that PrEP be provided in a manner that is cost effective, so that public health efforts to promote and provide it compare favorably with other HIV prevention approaches in terms of dollars spent per number of infections prevented. Pre-exposure prophylaxis– based prevention programs also must be implemented fairly, so that the benefıts and burdens of these programs are distributed fairly. Finally, PrEP needs to be provided in a way that addresses the needs of the most vulnerable, reduces economic disparities, and improves the health of the public.10 Meeting this latter requirement will prove challenging, as most current HIV prevention tools are relatively cheap and readily accessible, need to be used only intermittently, and protect against other sexually transmitted infections (STIs). By contrast, PrEP will likely be expensive, must be taken daily, will require prescription and frequent medical monitoring, and will not protect against other STIs. The studies described above, along with mathematical models of PrEP in both resource-rich and resource-poor
© 2013 American Journal of Preventive Medicine • Published by Elsevier Inc.
Am J Prev Med 2013;44(1S2):S137–S140 S137
Philpott / Am J Prev Med 2013;44(1S2):S137–S140
S138 11–13
countries, suggest that use of antiretroviral drugs for HIV prevention can be an effective public health intervention if and only if (1) the drugs are made widely available to those at highest risk; (2) the drugs are used consistently; (3) the drugs are provided as part of a comprehensive counseling program, including frequent followup testing; and (4) widespread risk compensation (e.g., decreased condom use or increased numbers of sexual partners) does not occur. Failure to achieve these goals may result not only in a program that is costly or ineffective but also in increased transmission of drug-resistant strains of HIV within the community. Given clear regional and socioeconomic differences in the nature of the AIDS pandemic, programs to promote the safe and effective use of PrEP will need to be tailored to individual countries and communities. It will likely be easier to create such a program in a country such as the U.S., where there are fewer cultural, economic, logistic, or regulatory barriers to the use of PrEP. The prevalence of HIV is less than 0.1% of the adult population, and the epidemic is concentrated primarily in well-known at-risk groups. Almost two thirds of all new HIV infections in the U.S. occur in the MSM population,14 a group that seems to be both willing to use and interested in using PrEP. Although current awareness and use of antiretroviral drugs for HIV prevention is low among American MSM, one recent survey of more than 5000 men found that almost 80% of respondents would be interested in using PrEP.15 Tenofovir also is approved for use as an HIV treatment, albeit at some cost, but the CDC and others are working with insurance companies to ensure coverage for its use as PrEP. Some insurance providers and Medicaid programs are willing to pay for PrEP, and Gilead (the manufacturer of Truvada) recently announced a medication assistance program for fınancially needy patients. Finally, confıdential HIV counseling and testing services are widely available. An effective PrEP program might thus target high-risk groups such as American MSM specifıcally, in the context of a meaningful physician–patient relationship, with the costs of the antiretroviral drugs covered by individual health insurance plans or third-party payers. However, designing such a program would not be as simple as it looks and would raise a number of ethical and logistic concerns. First and foremost, recent cuts to the budgets of the CDC and other public health agencies means that any money used to promote and provide PrEP for HIV prevention may need to be diverted from existent prevention or treatment programs. Redirecting scarce resources to PrEP-related programs should not be done in a way that cripples existing prevention programs or that exacerbates existing public health disparities in HIV prevention and
treatment. It is important to consider, however, that a well-designed PrEP program could have substantial benefıts that justify a redistribution of public health resources. For example, the requirement that those seeking and using PrEP undergo regular HIV screening may destigmatize testing, increase public knowledge of serostatus and preventive behaviors, and get those who are infected into treatment as soon as possible (which both improves their own health outcome and reduces the likelihood that they will transmit the virus to others). Risk compensation is also a serious concern. In surveys of PrEP use and acceptability, for example, many MSM report that they will likely increase their sexual risktaking while on PrEP, including a substantial percentage who will stop using condoms with casual partners.16,17 The magnitude and impact that this risk compensation would have on the effectiveness of PrEP programs is unclear,12 but it highlights the importance of offering PrEP as only part of a comprehensive risk-reduction program. If it should turn out that risk compensation among those using antiretroviral drugs for HIV prevention is a pervasive problem, reaching levels that raise questions about the effectiveness of PrEP programs, public health offıcials also would face a diffıcult dilemma. Social justice requires that public health policies strive to improve the public health while addressing the needs of the most vulnerable. Continuing an ineffective PrEP program would mean that scarce resources are spent on interventions that fail to produce a public health benefıt (or might even put individuals at increased risk of HIV or other STIs), but ending such a program would burden unduly those who might otherwise lack access to safe and effective HIV prevention tools. Inequities in health care, including access to HIV testing and treatment, are not as pervasive in the U.S. as they are in the developing world, but they do persist. This is particularly true for racial and ethnic minorities. Although Krakower and his colleagues15 found widespread interest in PrEP among the largest at-risk group, MSM, those surveyed tended to be older, affluent, and better educated. A majority of the survey respondents were also white, and most had health insurance. Some models suggest that the most cost-effective PrEP programs would be those that target this very group: white, wealthy, educated, and urban MSM.18 However, HIV infection is highly prevalent among MSM of color. Nearly 60% of new infections now occur among black and Latino men,14 many of whom live in the rural South and who do not self-identify as gay or bisexual. Some investigators19 argue that current HIV prevention efforts targeting gay and bisexual men specifıcally miss this key at-risk group. The PrEP programs thus www.ajpmonline.org
Philpott / Am J Prev Med 2013;44(1S2):S137–S140
predicted to have the greatest impact are also those that will continue to miss one of the most vulnerable groups, requiring public health offıcials to weigh cost effectiveness with other social justice concerns. Of course, MSM are not the only at-risk group in the U.S., and it is important to note that high prevalence of HIV infection among racial and ethnic minorities in the U.S. is not limited to MSM. The prevalence of new HIV infections in the African-American community as a whole is almost ten times that of whites; black men and women represent only 12.6% of the total population but account for half of all HIV/AIDS diagnoses. The prevalence of HIV infection in the Latino community is also elevated, and Hispanic and black Americans are less likely to have health insurance or a usual source of medical care, such as a primary care physician.20 According to Powers and Faden’s21 model of social justice, public health interventions such as HIV prevention programs should pay particular attention to the needs of traditionally disadvantaged groups such as these, ensuring equal access to care and addressing disparities in health outcomes. Unfortunately, the current system of health coverage in the U.S., which is a mixture of private insurance and government programs such as Medicare and Medicaid, tends to exacerbate rather than address these gaps in healthcare access and outcomes. Although the mosteffective PrEP programs in the U.S. are likely to be those that target MSM specifıcally, with drug prescriptions and follow-up testing provided by primary care physicians and paid for by private insurance plans, such programs again may fail to achieve one of the key goals of public health: improving the overall health of the community while addressing the needs of the most vulnerable and disadvantaged. Wealthy, white MSM may benefıt, but other at-risk groups, including MSM of color and other racial and ethnic minorities, will likely be left behind by PrEP programs that fail to target them specifıcally or that they cannot access because of a lack of insurance or a primary care physician. Questions of social justice alone cannot determine how and when PrEP is used for HIV prevention in the U.S. Nevertheless, two key aspects of justice, population-level health improvement and fair treatment of the disadvantaged,10 need to be considered when developing publicly funded PrEP programs. Some trade-offs may be required, as the programs that are most effective are the same programs that are likely to miss some of the most vulnerable and at-risk groups, particularly historically disadvantaged racial and ethnic minorities. So what can or should be done to address this challenge? There is no simple answer or single solution, particularly given the absence of data involving real-world January 2013
S139
use of PrEP. Current mathematical models can be used to predict which PrEP programs are likely to be most successful, but they rely on untested assumptions about the consistency of drug use (including drug effectiveness when used intermittently) and the magnitude and effect of risk compensation. In order to design these programs, additional studies of PrEP acceptability, use, and effectiveness need to be conducted among at-risk individuals, particularly women and MSM of color. This will be diffıcult given historical distrust of medical research by racial and ethnic minorities in the U.S., but it may help identify barriers to effective communication and program implementation, increase awareness of PrEP and other prevention tools in those populations most heavily affected by HIV, and provide a bridge to other prevention and treatment programs. It also will be important to continue and expand programs such as the privately funded Gilead Medication Assistance Program, as well as create publicly funded approaches (perhaps modeled after existing HIV treatment programs such as the Ryan White Program or the AIDS Drug Assistance Program) that will ensure that at-risk individuals who otherwise lack access to health care can obtain the drugs, counseling, and medical services necessary. Publication of this article was supported by the CDC through the Association for Prevention Teaching and Research (CDCAPTR) Cooperative Agreement number 11-NCHHSTP-01. No fınancial disclosures were reported by the author of this paper.
References 1. CDC. HIV in the U.S.: at a glance. CDC. 2012. www.cdc.gov/hiv/ resources/factsheets/PDF/HIV_at_a_glance.pdf. 2. Baeten J, Donnell DD, Ndase P, et al.; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012;367(5):399 – 410. 3. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010;363(27):2587–99. 4. Thigpen MC, Kebaabetswe PM, Paxton LA, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med 2012;367(5):423–34. 5. Van Damme L, Corneli A, Ahmed K, et al. The FEM-PrEP Trial of emtricitabine/tenofovir disoproxil fumarate (Truvada) among African women. Conference on Retroviruses and Opportunistic Infections 2012; www.retroconference.org/2012b/Abstracts/45406.htm. 6. Food and Drug Administration. Truvada approved to reduce the risk of sexually transmitted HIV in people who are not infected with the virus. 2012. www.fda.gov/ForConsumers/ByAudience/ForPatient Advocates/HIVandAIDSActivities/ucm312264.htm. 7. CDC. Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. MMWR Morb Mortal Wkly Rep 2011;60(3):65– 8.
S140
Philpott / Am J Prev Med 2013;44(1S2):S137–S140
8. CDC. Interim guidance for clinicians considering the use of preexposure prophylaxis for the prevention of HIV infection in heterosexually active adults. MMWR Morb Mortal Wkly Rep 2012;61(31):586 –90. 9. Kass NE. An ethics framework for public health. Am J Public Health 2001;91(11):1776 – 82. 10. Gostin LO, Powers M. What does social justice require for the public’s health? Public health ethics and policy imperatives. Health Aff (Millwood) 2006;25(4):1053– 60. 11. Supervie V, Barrett M, Kahn JS, et al. Modeling dynamic interactions between pre-exposure prophylaxis interventions and treatment programs: predicting HIV transmission and resistance. Sci Rep 2011;1:85. 12. Supervie V, Garcia-Lerma JG, Heneine W, Blower S. HIV, transmitted drug resistance, and the paradox of preexposure prophylaxis. Proc Natl Acad Sci U S A 2010;107(27):12381– 6. 13. Walensky RP, Park JE, Wood R, et al. The cost-effectiveness of preexposure prophylaxis for HIV infection in South African women. Clin Infect Dis 2012;54(10):1504 –13. 14. Prejean J, Song R, Hernandez A, et al. Estimated HIV incidence in the U.S., 2006-2009. PLoS One 2011;6(8):e17502. 15. Krakower DS, Mimiaga MJ, Rosenberger JG, et al. Limited awareness and low immediate uptake of pre-exposure prophylaxis among men
16.
17.
18.
19.
20. 21.
who have sex with men using an internet social networking site. PLoS One 2012;7(3):e33119. Golub SA, Operario D, Gorbach PM. Pre-exposure prophylaxis state of the science: empirical analogies for research and implementation. Curr HIV/AIDS Rep 2010;7(4):201–9. Brooks RA, Landovitz RJ, Kaplan RL, Lieber E, Lee SJ, Barkley TW. Sexual risk behaviors and acceptability of HIV pre-exposure prophylaxis among HIV-negative gay and bisexual men in serodiscordant relationships: a mixed methods study. AIDS Patient Care STDs 2012; 26(2):87–94. Desai K, Sansom SL, Ackers ML, et al. Modeling the impact of HIV chemoprophylaxis strategies among men who have sex with men in the U.S.: HIV infections prevented and cost-effectiveness. AIDS 2008; 22(14):1829 –39. Rhodes SD, Hergenrather KC, Vissman AT, et al. Boys must be men, and men must have sex with women: a qualitative CBPR study to explore sexual risk among African American, Latino, and White gay men and MSM. Am J Mens Health 2011;5(2):140 –51. Agency for Healthcare Research and Quality. Medicare Expenditure Panel Survey. AHRQ. 2012. meps.ahrq.gov/mepsweb. PowersM,FadenRR.Socialjustice:themoralfoundationsofpublichealthand health policy. New York NY: Oxford University Press, 2006.
Did you know? The AJPM Most Read and Most Cited articles are listed on our home page. Go to www.ajpmonline.org.
www.ajpmonline.org