A Framework for Ethical Engagement with Key Populations in PEPFAR Programs
Chris Beyrer MD, MPH1, Christine Grady RN PhD*2, Linda-Gail Bekker3, James McIntyre, FRCOG4,5, Mead Over6, Don Des Jarlais PhD7
1. Johns Hopkins Center for Public Health and Human Rights, Johns Hopkins University, Baltimore, MD. 2. U.S. National Institutes of Health Clinical Center, Bethesda. 3. Desmond Tutu HIV Research Center, University of Cape Town, Cape Town, South Africa. 4. Anova Health Institute, Johannesburg, South Africa. 5. School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa. 6. Center for Global Development, Washington, DC. 7. Beth Israel Medical Center, New York City, NY.
*The views expressed are those of the author and do not necessarily represent those of the NIH or DHHS.
Key words: ethics, HIV, PEPFAR, inclusion, non-discrimination, pragmatism, human rights
Corresponding Author: Chris Beyrer MD, MPH, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe, St, E 7152, Baltimore, MD, 21210. Tel: 410 614 5247, Fax 410 614 8371, email@example.com
The President’s Emergency Plan for AIDS Relief (PEPFAR) is the largest assistance program for a single disease in U.S. history.1 Initiated by a 5 year 15 billion USD commitment by the Bush administration in 2003, and re-authorized in 2008, PEPFAR is now active in 88 countries and provides HIV treatment and care for some 3.5 million adults and children worldwide.2 PEPFAR has achieved remarkable gains in access to care, quality, and in reducing AIDS related morbidity and mortality.2 In 2011 alone is estimated to have prevented some 200,000 pediatric HIV infections.1 It is a vital component of U.S. engagement internationally, and has enjoyed unusually sustained bipartisan support. Perhaps most importantly, PEPFAR has become an integral part of many partner country HIV programs and health systems. PEPFAR’s integration into those systems and longer-term sustainability are currently being tested as the program moves toward a policy of national ownership--the devolving of authority to recipient country partners.3
PEPFAR has made substantial investments in efforts to prevent HIV infection. Initial prevention expenditures in 2003 were set at 20% of overall funding, and have remained considerable. While there has been little controversy over treatment, the prevention programs have been more contentious.4 At its inception, the coalition which developed PEPFAR included many conservatives and faith-based leaders. Without these constituencies PEPFAR might never have garnered lasting bipartisan support. But out of this coalition came a prevention focus on the promotion of abstinence, and a still-contested program known as “ABC” an acronym for Abstinence; Be Faithful; and Condoms, promoted for risk reduction for persons with multiple partners and others. Prevention scientists argued that the promotion of abstinence was not an evidence-based approach to HIV prevention.4 And there was little evidence for the efficacy of efforts to promote monogamy, however useful as an HIV prevention strategy in theory.5
Two components were also included in the initial PEPFAR authorization: a continuation of the U.S. federal funding ban for sterile injecting equipment for persons who inject drugs (IDU); and the “Prostitution Pledge,” policy which required PEPFAR program recipients to pledge to oppose prostitution and sex trafficking.6 The needle and syringe exchange ban was reversed by the Obama Administration in 2009, but reinstated as part of compromises required to ensure continued funding. The “Prostitution Pledge” policy was maintained, and was contentious for some groups, who argued its conflation of sex work and trafficking could limit services.
Key Populations and PEPFAR
Key Populations, defined in PEPFAR as men who have sex with men (MSM), people who inject drugs (IDU), sex workers (SW) and Transgender persons (TG), bear disproportionate burdens of HIV infection.7-10 These are persons for whom inclusion in HIV prevention, treatment, and care services are necessary to achieve the goal expressed by U.S. Secretary of State Clinton, of an AIDS free generation. This goal will require marked increases in the coverage of services , and, arguably, changes in programs to better suit the needs of these individuals and their communities.7
Yet the evidence suggests that key populations are consistently under-served, and that low service coverage remains an important driver of ongoing HIV transmission.8,11,12 At the core of these inequities are the social and structural barriers of stigma and social discrimination, including discrimination in health care settings, and the criminalization of substance use, sex work, and same sex behavior. These social and structural realities can generate risk environments which undermine public health goals, violate human rights, and limit safe and effective provision of services.10 In contrast, even in settings where laws are unlikely to be changed and social stigma likely to remain, pragmatic public health approaches can help develop enabling environments where inclusion in HIV services can be progressively realized.
An ethical framework for engagement of key populations in PEPFAR may have utility in responding to the ethical dilemmas of providing services to persons for whom prevention, treatment and care efforts may be compromised by social and political contexts. Although expressly committed to supporting the advancement of human rights through public health, PEPFAR does not have an explicit overall ethical framework. The PEPFAR Five Year Strategy addressed the need to support marginalized populations as an essential part of country engagement, stating: “Using public health principles as a foundation, PEPFAR supports HIV prevention, care and treatment activities as a mechanism to advance the rights of people who are marginalized, stigmatized, discriminated against, and denied access to essential care.”13 For key populations there is a need for an explicit ethical framework to help guide and ground decisions, especially where country ownership could mean declines in access to services.14
The PEPFAR program is led by an Ambassadorial rank director of the Office of Global AIDS Coordinator (OGAC) housed within the U.S. Department of State. The current director, Ambassador Eric Goosby, created a Scientific Advisory Board (SAB) for the program in 2010, a first for PEPFAR. The SAB has a number of working groups, including a Key Populations Working Group co-chaired by Drs. Des Jarlais and Beyrer. At the request of the Ambassador, this working group was asked to advise the program on two active dilemmas facing PEPFAR in its programs for key populations. These were: 1) The provision of PEPFAR services, including ARVs, to persons in drug detention centers; 2) The provision of PEPFAR services to key populations in settings where their identities, behaviors or practices are criminalized. To respond to this charge, the key populations working group first deliberated on the establishment of core principles of engagement for PEPFAR programs with key populations. This effort led to the development of an ethical framework for the program. The working group then applied this framework to the dilemmas raised by the Ambassador.
AN ETHICAL FRAMEWORK FOR KEY POPULATIONS IN PEPFAR
An ethical framework for the inclusion of key populations must balance the human rights imperatives of equity and non-discrimination in the provision of public health and care services with the reality of operating in countries with legal systems and social and cultural traditions commonly exclude drug users, sex workers, men who have sex with men and transgender persons from HIV services. We propose four core principles which may assist PEPFAR programs with these challenges. The first three principles, inclusion, non-discrimination, and community engagement, reflect commitments that affirm and protect human rights; since the 1980s, attention to human rights has been recognized as integral to an effective public health response to HIV/AIDS. The fourth principle, pragmatism, reflects a commitment for programs and actions to be evidence based and focused on public health while affirming individual rights and dignity.
No one should be excluded from HIV prevention, treatment, and care services on the basis of sexual orientation, gender identity, status as a person who sells sex, or based on past or current substance use. PEPFAR programs should continue to articulate this principle and expand and sustain a focus on bringing services to “where the virus is.”
The principle of inclusion is supported by epidemiologic evidence as well as by the ethical requirements of equity and fairness, yet it is frequently violated, particularly for gay, bisexual and other MSM in settings where homosexuality is criminalized.15 PEPFAR should support the further development of the evidence base for inclusion of key populations in HIV programs, while working with communities, professional organizations, and governments to expand the inclusion of key populations.
One key aspect of inclusion is the provision of prevention and care services to ethnic and racial minority persons. Ethnic and racial minority groups may be over-represented in key populations and are likely to have high rates of HIV prevalence.16 Failure to provide services to racial/ethnic minority persons may lead to diffusion of HIV within racial/ethnic communities.
Non-discrimination in health care settings and in PEPFAR programs
All persons receiving care have a right to dignity, to confidentiality, and to safety. PEPFAR supported programs can and should insist on respect for the essential human dignity of all persons, and on their right to minimum standards of protection, safety, confidentiality, and fair treatment.
Health personnel can play critical roles in creating enabling environments where those at risk and in need can disclose their behaviors, present with partners and families, and seek needed services without harassment, discrimination, or abuse. PEPFAR can maintain and support programs that promote respect and non-discrimination for all persons receiving its services, including those who report engaging in criminalized activities.
Community engagement is an essential operational principle for Key Populations and a demonstration of respect for communities that are often marginalized. Genuine partnership with these groups, and with their civil society partners and allies, is essential to every step of the HIV prevention and treatment cascade. The Working Group believes community engagement must be elevated to an ethical principal, since it is so critical to “first do no harm” in attempting to expand services in hostile environments. Community engagement has been essential to the successful establishment of PEPFAR funded methadone clinic for injecting drug users in Dar Es Salaam, Tanzania, and for PEPFAR supported clinics for MSM in South Africa.7
Pragmatism and the Risk Environment
PEPFAR’s goal is ultimately to bring about an AIDS free generation, and the evidence suggests that great strides can be made in the provision of services, expansion of treatment, and in the control of HIV spread by focusing on the risk environment and aiming at pragmatic public health goals. While human rights imperatives might compel some to demand structural changes from decriminalization to legalization of behaviors, practices, or identities, public health programs must balance such goals with pragmatism. As an example, while sex work may remain illegal in many settings, the provision of prevention messages and commodities, including condom promotion and distribution programs for sex workers and clients, may have significant impacts reducing sexual risks for HIV. And while injecting drug use is illegal in virtually every country worldwide, there is compelling evidence that the provision of sterile injecting equipment, effective drug treatment, and antiretroviral drugs (ARVs) for IDU living with HIV can virtually eliminate this form of HIV transmission even if laws against substance use do not change.
ETHICAL DILEMMAS FOR PEPFAR—USING THE FRAMEWORK
1) Provision of PEPFAR services, including ARVs, to persons in detention
If we apply the ethical framework principles we have articulated of inclusion, non-discrimination, and pragmatism, the provision of services to persons in detention becomes clearer.
First, no one who needs treatment or care should be excluded from care by virtue of detention and incarceration status.
Second, to discriminate against persons detained for alleged or documented substance use by not providing needed treatments, is bad ethics, bad medicine, and bad public health, since we now know that untreated HIV infection is also transmissible HIV infection.
Detaining people for alleged substance use or sex work can also violate human rights, and human rights and public health groups are clearly in favor of the closure of detention centers.17 Detention is fraught with the potential for abuses, has shown no efficacy for treatment of dependency, and has led to forced labor practices which violate both international labor norms and human rights standards.18
The principle of pragmatism suggests balancing these competing imperatives by supporting the provision of life sustaining ARVs for detainees, while vigorously working with partners to support community based alternatives, and to advocate for closure of such facilities. PEPFAR’s commitment to providing HIV services and collecting additional data about their effectiveness could be used as a lever for progressive change, while pressing for decreases in detention as a failed approach to substance use.
2) Provision of PEPFAR services to key populations in settings where their identities, behaviors or practices may be criminalized
Both non-discrimination and inclusion compel the ethical provision of services to key populations, even where their behaviors or practices are criminalized. The principle of community engagement is critical where discriminatory laws and practices may limit access, increase fear, and impact health seeking behaviors.
Pragmatism helps to negotiate a balance between seeking ways to provide respectful services while recognizing that legal and structural reforms could improve and facilitate services. There is abundant evidence to demonstrate that while legal reform can be an important tool in expanding access and quality of HIV services, it is not essential or sufficient to do so. Programs can focus on provision of services, and governments and security forces on reductions in crime and violence, by engaging with community groups and providers, and focusing on the development and support of enabling environments.
For sexual and gender minorities the ethical imperatives of inclusion and non-discrimination can be challenged not only by laws and police practices, but also by cultural and religious sanctions. For MSM and TG persons, these realities highlight the primacy of community engagement as they best know what is safe, and how public or hidden services need to be. PEPFAR partnerships can help strengthen their ability to negotiate, legitimize their roles in service provision, and build their capacities.
DISCUSSION AND CONCLUSIONS
An ethical framework of guiding principles can be constructive and foundational, and has at least two valuable functions for PEPFARs engagement with key populations: 1) it allows explicit articulation of the principles to which PEPFAR programs are committed and, 2) it can be a useful guide to action and decision making. Other examples of ethical frameworks and principles, such as the Belmont Report principles articulated by the National Commission in 1979, have guided the policy and practice of ethical research for decades. Although some of the concepts included here are already reflected in PEPFAR’s goals and strategies and expressed commitment to promoting public health in a rights affirming manner, delineating them as particularly critical to program and policy decisions involving key populations strengthens and clarifies these commitments. The framework is a stated commitment to ethically pursue the goal of promoting health for those with or at risk for HIV. As importantly, an articulated set of ethical principles can serve as a guide to decision making in planning and implementing particular programs and establishing evaluation and research priorities. As PEPFAR transitions to increased country ownership and shared responsibility, an ethical framework can help shape the dialogue and the limits of reasonable negotiation necessary for successful transitions.
The clarity and appropriateness of the individual principles included in an ethical framework are critical to its value and utility. Those who use the framework as an action guide must be able to understand and apply the articulated principles to particular contexts and decisions. The principles chosen for inclusion in a framework must make sense given the context and be explained clearly enough to be used and useful. In this regard, the Working Group selected four action-guiding principles particularly important to guiding decisions about the provision of programs and services to key populations who are at particular social and structural risk of exclusion, discrimination, isolation, and HIV. There may be other relevant principles that with careful thought could be added to this framework to inform ethical engagement.
The principle of pragmatism deserves particular attention as a guide to action, as it is not a principle commonly found in ethical frameworks. Pragmatism, defined as a reasonable or practical way of doing things or thinking about problems based on dealing with specific situations recommends focusing on what is practical and possible in the complex and messy real world. There are several potential advantages to articulating pragmatism as an important principle in this framework. It can help to focus the program goals, service goals, and the research agenda on that which is evidence-based, comports with the crucial public health mission and is feasible and may be cost-effective, in spite of difficult and variable political situations and views. Emphasizing pragmatism recommends focusing on evidence based programs such as distribution of condoms to sex workers to reduce HIV transmission even where sex work is a crime, rather than limiting programs to where it is legal.
There are also potential hazards to highlighting pragmatism as a principle. Pragmatism could be understood as prioritizing that which is efficient, feasible, or socially acceptable, regardless of ethics. Some might worry about appeals to efficiency or social acceptability as reasons to compromise ethics. One might argue, for example, that it is not efficient or pragmatic to provide condoms to sex workers who are difficult to locate or access, or it is not socially acceptable- therefore not pragmatic- to provide needles to IDUs, despite evidence that providing condoms and clean needles can protect people from HIV. For these reasons, a framework of principles is best utilized as a framework, whereby each of the included principles is considered in a particular case.
There will doubtless be times when framework principles appear to conflict. For example, in some settings community engagement could publicly identify people as members of key populations, increasing their susceptibility to harm. Careful thought and judgment are necessary when applying the framework. In addition, there will be cases for which reasonable people disagree about how to apply and balance principles. Along with considering the relevant facts and issues, use of the ethical framework can facilitate hard decisions that require judgment, balancing, and negotiation. As a donor, PEFAR has the option of withholding resources from countries whose ethical views appear contradictory, but using the articulated commitments and principles of an ethical framework might facilitate honest negotiation, avoiding potential exclusion and promoting the health of key populations.
 The membership of the PEPFAR SAB Key Populations Working Group includes the co-chairs, and Drs. Over, McIntrye, and Bekker.
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