Clinical trials demonstrating the efficacy of the use of antiretroviral medications for prevention (eg, chemoprophylaxis, prevention of mother-to-child transmission) improved treatment for HIV-1–infected individuals, and reducing transmission to others rightfully attract the admiration of those in treatment and prevention science and bring hope to those working in the field and to patients with the disease. But although those advances make important contributions to the scientific literature and attract excitement from the public at large, implementing them in ways that affect widespread benefit are considerably more complicated.1
Some have expressed concern that these important advances in treatment and prevention of HIV-1, especially those based in the use of antiretroviral therapy, have greatly reduced or even completely eliminated the need for behavioral or social strategies in HIV-1 prevention.2 After years of HIV-1 prevention clinical trials—using a variety of strategies including treatment of sexually transmitted infections including herpes simplex virus 2 and behavioral counseling—success in preventing transmission of HIV-1 was achieved through male circumcision3–5 and the use of antiretroviral therapies for chemoprophylaxis6 and to prevent transmission from individuals infected with HIV-1 to uninfected individuals in discordant couples,7,8 including prevention of transmission from mothers infected with HIV-1 to their infants during pregnancy and breastfeeding periods.9 Prior research has demonstrated the prevention potential of treating individuals for substance abuse and providing clean needles and syringes to those continuing to use them.10–12
Others and we have advanced the position that behavioral and social strategies are necessary, but not sufficient, for preventing and treating HIV-1 disease.13 All of the evidence points to the importance of behavioral and social strategies to reduce HIV-1 transmission and to treat those with the disease. Examples abound with adherence to HIV-1 medications being one of the greatest barriers to efficacy when antiretroviral medications are used for chemoprophylaxis (whether in pill or gel form6) and prevention of mother-to-child transmission programs are dependent upon individual and system variables.9 The same is true for those infected with HIV-1; the “cascade of treatment” typically shows that 20%–30% of these infected individuals in most jurisdictions in the United States know that they are infected with HIV-1 and are in treatment effective enough to reduce viral load to undetectable levels.13
Our first premise is that biomedical, like behavioral, interventions are necessary but not sufficient for prevention and treatment of HIV-1. Biomedical interventions are similar to behavioral strategies: the biomedical strategies cannot work, nor will they have widespread effectiveness if the conditions for their use are not optimized and if individuals fail to use them in ways that are necessary to ensure that they work and achieve their intended effect.
A NEW FRAMEWORK FOR COMBINATION PREVENTION AND TREATMENT
Our analysis of combination prevention and treatment is based on a second premise, specifically expanding the understanding of “combination prevention and treatment” and of “behavior.” Combination prevention and treatment most frequently is used to define the optimal ways of combining biomedical and behavioral (and sometimes social and structural) and biomedical interventions to prevent or treat the disease.12 We not only incorporate these elements into our definition of combination prevention and treatment but also expand the concept to address the varieties of behaviors—on the part of individuals and larger systems—needed to ensure effective treatment and prevention. Behavior refers to the actions of the individual and the behavior of systems (eg, family or health care systems), those working in those systems, and entire communities.1 Often when behavior is discussed, the emphasis is placed on strategies directed to the individual that aim, for example, to help that person get tested, adhere to treatment or prevention regimens, and/or reduce risk behavior. Undoubtedly, such strategies can play a role in the overall promotion of prevention and treatment. But strategies focused only on the individual are time and labor intensive, although having an effect on reported risk behaviors, have had limited efficacy on HIV acquisition, and may have limited reach and therefore limited efficacy in the community at large.14
The model of HIV-1 prevention and treatment presented in Figure 1 demonstrates this broadened use of behavior. Community awareness and mobilization are essential for ensuring that the services are designed to appeal to the needs of the population and that the individuals for whom the services are designed know about them and are motivated to use them. After mobilization, HIV diagnosis is essential so that infected and uninfected individuals can receive appropriate services. The next phase involves appropriate triage so that those who do not have HIV-1 infection can be counseled in how to avoid it and so that they can access specialized services (eg, male circumcision, drug or mental health treatment, chemoprophylaxis, if available). Those who are infected also need to be counseled in how to avoid spreading HIV-1 to others, how to access specialized treatments if necessary (eg, drug or mental health treatment), and the importance of and linkage to care for their HIV disease not only for their own health benefits but also for the public health.7,8 Adherence is essential for both uninfected and infected individuals, and community support may be essential for adherence at levels needed to ensure that the prevention and treatment strategies can work.1,6
WHAT IS NEEDED TO SUCCESSFULLY CONFRONT THE HIV EPIDEMIC?
An effective HIV-1 prevention and treatment service system in the low-, middle-, and high-income countries needs to incorporate all of the elements necessary for successful deployment of prevention activities and efficacious management of HIV-1 disease. A comprehensive system must include useful prevention activities, early identification of HIV-1–infected individuals in need of care, linkage to care, appropriate initial and continued counseling and other forms of support for continued risk reduction and management of HIV-1 disease, assessment of HIV-1 disease stage, treatment with antiretroviral medications for those who qualify, monitoring while on treatment to ensure efficacy, adherence support, and provision of sexual and reproductive health services.1 All of this would ideally be structured in ways that make access easily available and affordable and that do not require extensive travel, lengthy wait times, loss of income to the individuals being served, and that is done in ways that respect and recognize the dignity of the patients.
Table 1 lists the full range of activities needed to implement this complex agenda. Easy-to-access services have become the priority for many HIV-1 prevention and treatment systems, as the goal is not only to increase the number of persons on treatment but also to maintain them in prevention and treatment services.
Effective management of prevention and treatment services involves skills and behaviors that have been little studied or addressed in the HIV-1 prevention or treatment literature. The focus of behavioral research has been on the outcome: do individuals engage in behaviors to reduce the chances of acquiring or spreading HIV or optimizing treatment. This narrow perspective has led to studies—most often using strategies targeted at the individual—to reduce certain behaviors (eg, high-risk sexual behavior) or increase others (eg, adherence to medications). The expanded paradigm presented here retains that focus, as ultimately, it is the behavior of individuals that has a large influence on disease outcomes. But the expanded paradigm also widens that focus to recognize that those specific outcomes are influenced strongly by the behavior of systems (eg, systems of prevention and care that facilitate easy access for consumers), other individuals (eg, health care providers), and services offered (eg, all of the tools in the “prevention toolbox,” strategies for diagnosing HIV-1 infection and linking individuals to care, strategies for maintaining standards of prevention and care).1
There is increasing recognition that the behavior of managers and management systems are essential for the effective application of behavioral and biomedical prevention and treatment strategies.15 If those in charge do not appreciate the importance of how to manage personnel in a transparent and fair manner, then those personnel will be disenchanted and unmotivated and that attitude will undoubtedly affect their interactions with patients. If resources are not well utilized and essential supplies are not well managed, then interruptions in service are inevitable, thereby not only affecting the health of clientele but also causing people to lose faith in the health system. Patients will receive less than adequate service if frontline health care providers are not skilled: both medically and interpersonally.
There has been recognition of the increasing importance of community-wide support systems to motivate testing, address educational barriers, and support behavioral risk reduction and adherence needs of community members.16 A variety of evidence-based strategies have been identified to maximize testing coverage and diagnosis and linkage to care of persons infected with HIV-1, and considerable emphasis has been placed on effective initial and ongoing counseling.
Linkage to and maintenance in care remain a work in progress, and most often, using community health workers to walk individuals through systems and follow-up with them when they fail to return. No doubt, other health system behaviors such as easy access and culturally appropriate care are essential as well. Monitoring and maintaining quality of services, especially in low- and middle-income countries, remains a challenge, especially with turnover of staff and difficult working conditions. Maintaining high quality of services remains a challenge, especially as the goal is to expand availability of new biomedical technologies and to continue efforts at task shifting and task sharing, so that diverse types of providers can prescribe and monitor the use of antiretroviral therapies and other efficacious interventions.
The approach to behavior presented in Figure 1 and developed in Table 1 changes the research agenda from a focus on specific behaviors (eg, reductions in sexual risk behaviors; adherence to antiretroviral medications) to a focus on the broader “Essential Elements of Community-Wide Implementation of HIV-1 Prevention and Treatment Programs.” Examples of a broadened research agenda that are inclusive of implementation research questions are presented in Table 2. It is hoped that this expanded paradigm, and the research examples derived from it and presented in Table 2, will provide a stimulus to broaden thinking about the kinds of questions asked in research and the kinds of programmatic interventions developed, to maximize at the individual and societal level the benefits that advances in prevention and treatment science have delivered to us thus far. A planned study, HIV Prevention Trials Network 071 (PopART), aims to take a broad approach to the challenge of preventing HIV transmission at the community level. In the latter study, interventions to be studied include community mobilization, house-to-house HIV testing, use of community health workers to promote linkage and adherence, combined with use of treatment as prevention and referral for male circumcision, promotion of prevention of mother-to-child transmission, and widescale provision of condoms.
There is no question that biomedical advances in HIV prevention and care are transformative and life saving. We now have tools that we did not have only a few years ago. But these technologies can have little effect if they are not used the way that they need to be in order to make a real difference in confronting the epidemic. In this way, efficacy and effectiveness all come back to behavior: of individuals and systems. Simply put, these advances will have little benefit without individual behavior and an understanding and reformation of systems responsible for attracting people to services and keeping them there for the long term.
These optimal packages will cost money, and those funds are difficult to find in these tight economic times. But there is also no doubt that the strategies proven so efficacious in clinical trials will fail to have impact on epidemics in communities, regions, or countries unless the complexity of their implementation is addressed. Vermund and Hayes17 put it eloquently: “Yet as we have more tools for HIV prevention, ‘HIV fatigue’ in donor nations combined with concern from economic downturns form 2008 onwards may result in HIV programs. Past experience suggests, however, that failures in HIV prevention or early treatment will simply cost society more in the long run, given the high direct costs of illness and indirect costs of disability, suffering and death.”
Prevention and treatment programs that incorporate the complexity of behaviors necessary for success are a good investment. They will promote health and productivity among individuals and protect society from further disease.
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