Behavioral, biomedical, and structural interventions are needed to prevent HIV. Behavioral interventions have been successful but suffer from low uptake, and few have been designed to accompany the biomedical innovations on the horizon. Biomedical advances hold promise, but most are years away from dissemination, not likely to be 100% effective, and require broad uptake and adherence. The impact of structural interventions is difficult to assess using scientific standards of evidence, but structural interventions are innately tied to behavioral and biomedical preventive efforts via funding and policy decisions (Padian et al. 2008
). Prevention researchers, donor agencies, and policy makers must reframe their norms on design, delivery, and diffusion of EBIs and biomedical preventive technologies. Some sources of innovation for the next generation of HIV prevention may include (a
) basing EBI development and adaptation on common factors underlying the efficacy of all EBIs; (b
) creating a science of design and dissemination of EBIs using a continuous quality improvement (CQI) paradigm rather than a model of replication with fidelity; (c
) utilizing business principles from marketers and entrepreneurs to facilitate design, diffusion, and utilization; (d
) reframing prevention from a disease-management framework into a wellness perspective that reinforces HIV as a chronic disease; and (e
) moving prevention from health-care settings and personnel to community sites and leaders.
Common Factors to Support Dissemination and Adaptation of Evidence-Based Interventions
The current mode of disseminating EBIs uses a technology-transfer framework, with emphasis on fidelity to specific core elements in each EBI (Eke et al. 2006b
). This approach has limited evidence for success due to a lack of integrated dissemination research and because local adaptation was not considered in designing the dissemination initiative spearheaded by the Centers for Disease Control and Prevention (Dworkin et al. 2008
). In contexts where EBI dissemination infrastructure is not available (e.g., in developing countries or organizations that do not receive EBI dissemination funding), the urgency of the HIV epidemic has required implementation of interventions to run ahead of evidence for effectiveness (Hallett et al. 2007
). Adopting and implementing an EBI is a resource-intensive process (McKleroy et al. 2006
). Staff persons in agencies who wish to implement EBIs often do not have the skills or capacities to pull a manualized EBI off the shelf and implement it effectively (Dworkin et al. 2008
EBIs are currently disseminated with a goal to maintain fidelity to core elements (i.e., the factors believed to be responsible for an EBI’s efficacy), which vary dramatically in scope and specificity across EBIs (Rotheram-Borus et al. 2008
). There is no consensus on the level at which to define core elements and the causal mechanisms implied. There are not typically data on the EBI to identify that specified core elements are indeed the causal mechanisms necessary for behavior change or for program success. Core elements are typically defined by the EBI researcher-developers and may (or may not) incorporate key skills, specific activities, target population characteristics, and/or recruitment and outreach strategies, or intermediate outcomes that intervention participants should achieve to support behavior change. All EBIs also include core elements that suggest the importance of building skills and social support, yet the specificity and explicitness of these factors are quite variable across EBIs (Rotheram-Borus et al. 2008
Despite apparent differences among EBIs, the programs share underlying common factors (Rotheram-Borus et al. 2008
), principles (M.J. Rotheram-Borus, B.L. Ingram, & D. Flannery, manuscript in revision), processes (Ingram et al. 2008
), theory-based strategies (Albarracin et al. 2005
), and other practice elements (e.g., Chorpita et al. 2007
, Garland et al. 2008
, Kaminski et al. 2008
) that support EBI efficacy. For example, at the broadest level of abstraction, common factors in EBI (i.e., what all effective programs do or should do) are argued to include: (a
) establishing a framework to understand behavior change; (b
) conveying issue-specific and population-specific information needed for healthy actions; (c
) building cognitive, affective, and behavioral self-management skills; (d
) addressing environmental barriers to implementing new behaviors; and (e
) providing tools to develop ongoing social and community support for adherence and maintenance of healthy practices (Rotheram-Borus et al. 2008
Rather than promote replication with fidelity to specific EBIs and activities reflected in core elements, fidelity to common factors that are consistently implemented in every EBI will focus on effective practices across EBIs (Rotheram-Borus et al. 2008
). If prevention modules were built on the common components across the shared evidence base, existing EBIs could be more broadly framed as prototype models including all core elements. Ideally, EBIs then would be more broadly accessible to more communities in less time, more quickly developed to meet the evolving epidemic, and more easily replicated and adapted to local priorities and preferences; in addition, the design cost could be lower (Chorpita et al. 2005
). By utilizing common core elements as anchors for EBI fidelity, prevention providers would build capacities each time they implemented and adapted an EBI. These capacities would be more readily generalizable for each new EBI adopted, implemented, and adapted.
Science of Delivery or Implementation
We need and lack a science of delivery and dissemination. The funding and political will are now in place to support global scale-up of HIV prevention, treatment, and care (Chan 2007
). However, a paradigm shift is needed to support integration of research into the design and evaluation of programs in conjunction with scale-up (Chan 2007
, Cooper et al. 2007
, Madon et al. 2007
). Currently, we build preventive EBIs in a lockstep manner, from efficacy to effectiveness to dissemination over a 20-year time frame (Flay et al. 2005
). A CQI paradigm (Rapkin & Trickett 2005
), rather than replication with fidelity to specific EBIs, would ensure faster but effective adaptation and diffusion of preventive interventions (Rotheram-Borus et al. 2004a
These approaches require reframing norms on application of the gold-standard RCT and adopting dramatically different research designs. Although RCTs are typically used only for early-stage efficacy trials and are not considered viable for larger-scale effectiveness trials, there is precedence for using RCTs in national-level public health programs (Feachem 2004
). Fractional factorial designs, which systematically test different combinations of intervention components (adopted from CQI processes in engineering), can identify the independent and synergistic effects of intervention components in multicomponent interventions (Nair et al. 2008
). It is typically not feasible to implement RCTs that can accomplish this goal, yet almost all interventions incorporate multiple components (Nair et al. 2008
). When RCTs are not feasible to implement at all, alternative designs such as randomized encouragement designs and interrupted time series designs can still provide valid information regarding the causal effects of interventions, often with greater external validity than that of RCTs (West et al. 2008
). Biomedical RCTs often fail to demonstrate efficacy because of real-world limitations of non-adherence and lack of statistical power to detect effects in comparison with standard-care controls, often a condom-promotion-only program (Weiss et al. 2008b
). Thus, alternative designs show great promise, particularly if used in conjunction with RCTs as part of a larger research program (West et al. 2008
Ultimately, a programmatic research agenda is needed to identify how to effectively disseminate EBIs identified in efficacy trials. This agenda might include, for example, analyzing existing EBI manuals to identify common factors, gathering data from EBI providers and facilitators regarding real-world implementation, and conducting consumer research among prevention clients or end-users. Utilizing a CQI paradigm for research and evaluation would support alternative standards of evidence (Flay et al. 2005
), new research agendas would emerge, and far more attention would be focused on building platforms for global dissemination of EBIs.
Wellness Perspective and Integration of Prevention for All Local Health Priorities
A paradigm shift is also needed to support integrated prevention, treatment, and care for HIV (Weis et al. 2008
). The health-care system has the responsibility for HIV care, yet the system is overwhelmed by HIV: more than one million health-care workers are needed immediately (Shah 2008
). Costs to train the needed health-care providers will require billions of dollars of investment. Yet, 65,000 physicians and 75,000 nurses immigrated from developing countries to the United Kingdom during the 1990s (Shah 2008
), and the drain continues. In Zimbabwe, 1200 physicians were trained in-country, but only 360 remain (Shah 2008
). Health care alone cannot meet the challenge of HIV.
From the consumer’s perspective, the health-care provider is not the desirable person responsible for prevention. Historically, and certainly in the context of overwhelming and overlapping HIV and tuberculosis epidemics, systems for delivering health care are not consumer friendly. Clinic waiting lines are long, clinics are difficult to access, and, in many countries, are expensive (World Health Org. 2007
). Globally, one billion people do not have access to health care (Shah 2008
). Consumers often struggle to know whether a problem is severe enough to require treatment; the responsibility and choice for seeking care is with the consumer. Consumers who decide to seek care often face a complex process that involves getting referrals to the right clinic, dealing with long wait times for appointments, taking time off from work or taking children out of school to accommodate the health-care provider’s available appointment times, paying high rates that are frequently not covered by insurance, and wondering how long the appointment will last and whether it will successfully address the problem about which they are concerned. These are difficult challenges to overcome.
Developing countries also cannot broadly mount categorically funded (i.e., disease-specific) programs, such as HIV prevention (Halperin 2008
). The health-care budgets are so low as to demand horizontally integrated care, which involves providing care in a single setting for a variety of diseases (Capacity 2008
). This is true for all African countries as well as in the developed world. Yet, efficacious HIV prevention programs have been designed for vertically integrated health-care systems only (i.e., HIV prevention, and not prevention for other diseases, is provided and organized at the clinic, hospital, township, provincial, and national levels) (Myer et al. 2007
). HIV prevention programs typically address a single outcome (reducing HIV transmission or providing HIV care) and are categorically funded and vertically integrated. The Global Fund, the U.S. President’s Emergency Plan for AIDS Relief (a commitment of $15 billion over five years, from 2003–2008), the World Bank, and private donors (e.g., the Gates Foundation and the Clinton Foundation) typically limit funding to HIV-related care only, although this trend is changing. In 33 of 41 African countries (70%), the total health-care budget is less than $30 per person, and only two countries spend more than 10% of their annual budgets on health care. In contrast, the United States spends 15.4% of its annual budget on health care, at $6096 per person annually (World Health Org. 2007
). South Africa spends $390 per person annually, more than double the annual expenditures of 36 other African countries, reflecting 8.6% of its annual budget.
Because HIV is receiving $5 billion annually, it has been argued that HIV is draining resources from other life-threatening diseases (Halperin 2008
). Approximately 300–500 million cases of malaria could be cured for five years with $1.5 billion (Sachs 2008
). The challenges of tuberculosis, malnutrition, alcohol abuse, and depression cannot be addressed if HIV absorbs the primary prevention and care resources. Promoting healthy relationships and routines from cradle to maturity is one health-protection strategy that reduces the burden on the health-care system, especially for chronic diseases (which HIV has become).
However, increasing evidence demonstrates that unprotected sex and drug use are directly linked to a lack of goals and a sense of meaning to one’s life (Patrick et al. 2007
). Unprotected sexual acts or needle-sharing behaviors are not discrete actions, but rather are embedded in daily lives that lack a sense of meaning, coherence, and consistency. Across cultures, healthy daily routines are embedded in a family life that has meaningful and supportive interactions, reflective of one’s values, and in which family resources are allocated in line with these values (Weisner 2002
). With these characteristics, family and members of strong social networks help each other create prosocial roles and identities for themselves and especially for children, who acquire the healthy habits that buffer and sustain an individual through hard times. When encountering risky situations (e.g., offers of drugs or sexual pleasure), the short-term reward of pleasure cannot be overcome unless there is an important long-term reward to sustain motivation in the moment (McClure et al. 2004
). Perceptions of a future, pleasurable daily life, and sexual acts that are embedded within a meaningful relationship, provide the motivation to refuse potentially risky sex and drug use. Building family wellness serves as the foundation for combating HIV and simultaneously sidesteps the stigma that is generated with a narrow, targeted focus on sex and drugs. Although sexual relationships and drug use must still be directly addressed in prevention programs, the framework is placed in the meaning of one’s life, not in a single type of interaction.
A wellness framework also places HIV risk on a par with risky behaviors associated with other chronic diseases. Five risky behaviors account for more than 50% of all morbidity and mortality globally: what we eat, and how much we eat, exercise, use alcohol, and smoke cigarettes (McGinnis & Foege 1993
). Chronic diseases resulting from these five behaviors is predicted to increase by 54% over the next 20 years, further bankrupting the health-care system, especially in the developing world (DeVol & Bedroussian 2007
). With the exception of smoking, the patterns of eating, exercising, and drinking, as well as forming meaningful social and sexual partnerships, are behaviors rooted in everyday routines. Small changes in a family’s behaviors reverberate and make huge cumulative differences in the health outcomes of each family member. For example, encouraging family members to have serially monogamous partnerships rather than concurrent sexual partnerships could virtually eliminate HIV in Africa (Epstein 2007
). Building healthy daily routines among families in a family wellness framework and setting is an alternative strategy for delivering HIV prevention.
AIDS has been reframed as a chronic illness with the introduction of ART (Beaudin & Chambré 1996
). The skills and support required for people living with HIV to manage their health are common across all chronic illnesses (Ingram et al. 2008
). The objectives of chronic disease interventions include improving the independence and quality of life of the person (Kennedy et al. 2001
, Willison & Andrews 2005
). Regardless of the chronic disease, the targets of behavior change are the same, including adoption of a healthy lifestyle (e.g., sufficient sleep, moderation in use of alcohol, good nutrition, weight control, smoking cessation, exercise, and regular health care); adherence to treatment protocols, particularly medication; mental health goals such as stress management and reduction of anger and depression; and communicating effectively with health professionals (Creer et al. 2004
). If the chronic disease is contagious, an additional goal is to prevent transmission. Evidence-based self-management interventions for different chronic diseases have demonstrated success in achieving improved health outcomes; the World Health Organization included as a best-practice strategy to improve clinical care and outcomes for chronic conditions: “Educate and support patients to manage their own conditions as much as possible” (Epping-Jordan et al. 2001
). This applies to both HIV and other local health priorities envisioned in horizontally integrated disease-prevention and wellness promotion.
We need a disruptive innovation (Bower & Christensen 1995
) in HIV prevention. With disruptive innovations, an existing service or program often “overserves” needs, and a simpler, less-expensive alternative is provided that meets most of the same needs in a manner that is “good enough” for the majority of the consumer market. The new, good-enough service is more accessible, scalable, replicable, and sustainable. Examples of disruptive innovations in health care include “minute clinics” in retail pharmacies that provide treatment by nurse practitioners for the ten most common health problems (Schmit 2006
, California Healthcare Foundation 2006
); Doc in a Box
converts shipping containers into health clinics that enable rural farmers to become health providers for common problems in their local community for approximately $1500 (www.doc-in-a-box.net
); and distance learning and similar information technology innovations that enable expert information and consultation support to be provided virtually in remote and resource-limited settings (DelliFraine & Dansky 2008
, Sorensen et al. 2008). This model of thinking about innovations has the potential to revolutionize lives in positive ways for HIV prevention and the host of other local health challenges faced by communities globally.
HIV testing is an example of an overserved need in HIV prevention. When the HIV test was first developed in 1985, no viable treatments existed, and HIV was a death sentence. MSM and IDU were the two populations linked to HIV; both were stigmatized populations that became further stigmatized because of HIV (Herek et al. 2003
). Therefore, the developed world generated norms and procedures that protected the identity of HIV-positive persons by guaranteeing anonymity, providing choices on whether to know one’s status, and providing one hour of pre- and posttest counseling regarding transmission risks. This standard was shipped globally and was required by donor agencies in countries with health-care budgets far lower than $30 per person at that time. Now, 28 years later, multiple prophylactic treatments exist; HIV testing leads to reductions in transmission acts that benefit society as well as the individual; HIV-positive persons immediately reduce transmission acts upon learning their sero status; and HIV pre- and posttest counseling does not change risk behaviors among HIV-negative testers. Yet, we know that pre- and posttest counseling are not delivered with any fidelity, and the technology exists for learning one’s sero status by using dried blood spot (2.5 ml of blood), with results available in 20 minutes. Now an industry has been generated, an industry that will have economic consequences if this technology is encouraged and allowed to blossom. The needs for HIV testing are overserved by our current practices, especially in the developing world. A disruptive innovation for HIV testing may be to broadly distribute cheap, rapid, consumer-controlled HIV tests in a diverse range of settings, including bodegas, pharmacies, and market stalls, that place the decision with the consumer on when to test and what to do if testing positive. The technology moves from health care to community and from one industry to a broad distribution system.
Other examples exist in the world of HIV. Recently, a Swiss team found that highly individualized ARTs provided in resource-rich settings result in virologic outcomes similar to those of programmatic ARTs delivered in resource-limited settings (Keiser et al. 2008
). Thus, programmatic ART with generic drugs that does not require quarterly monitoring of viral load and CD4 (a primary indicator of immune functioning and AIDS progression in HIV-positive patients) may also be a disruptive innovation. Building on these prototypes and the successes of EBIs and biomedical advances, the next generation of HIV prevention can hope to meet its broad goals: universal access to prevention, treatment, and care and elimination of the global HIV pandemic.