First, do no harm: a call for emphasizing adherence and HIV prevention interventions in active antiretroviral therapy programs in the developing world

Recent months have seen a significant change in the practices of drug companies. Many have either donated or drastically decreased the price of lifesaving highly active antiretroviral therapy (ART) drugs to developing countries. Some countries (e.g. India, Brazil) have decided to ignore traditional patent processes and produce and export cheaper, generic varieties of ‘cocktails’ at a fraction of the regular price. Furthermore, 39 pharmaceutical companies recently dropped a lawsuit seeking to prevent South Africa from importing less expensive generic versions of their anti-AIDS drugs [1]. Partly to make ART medications much more widely available, the UN has recently begun a major worldwide campaign, to which several governments have made major contributions. It is entirely unclear what effect these efforts will have on the many millions of people in developing countries already infected with HIV [2]. Making anti-AIDS drugs more widely available is not likely to be sufficient to improve the situation drastically. If ART treatments are not adhered to consistently and correctly (i.e. adherence rates must be upwards of 90%), there could be disastrous consequences both for individuals on ART, and for the HIV epidemic as a whole [3]. It can be argued that without very substantial behavioral science-based interventions aimed at ensuring adherence, the seemingly humanitarian efforts of drug companies, governments, and the UN could have explosive unintended negative consequences. Individual patients may not benefit, may become treatment resistant, and developing countries could become a veritable ‘petri dish’ for new, treatment-resistant HIV strains. ART regimens can be very complex, and adherence to them is difficult even under optimal conditions, e.g. a reliable supply of medication, an effective healthcare infrastructure, and adequate food, clean water, and electricity [4]. Unfortunately, many of these conditions do not exist in developing countries. Barriers to adherence specific to particular developing nations and their cultures must also be identified and rectified (e.g. the effects of politicians who preach that HIV does not cause AIDS; the reliance on folk healers). Alternatively, factors in some developing nations (e.g. a lower percentage of HIV-infected individuals addicted to drugs) may uniquely favor greater adherence than in developed nations. UN officials recently reported that obstacles such as poverty and the lack of healthcare infrastructure can be overcome, and that adherence can be achieved in developing countries [5]. Brazil, where 69% of ART patients have achieved an 80% adherence rate [6], has been touted as a dramatic example of how free, widely available drug treatment can be effective. Nevertheless, even in these purported ‘successes', adherence rates are generally on a par with those of wealthier nations [5], where they are wholly inadequate. It might be possible to increase adherence by exposing ART recipients to powerful, theory-based, behavioral science interventions (JD Fisher, WA Fisher, KR Amico, J Harman, 2001, in preparation) [7–9]. The Information–Motivation–Behavioral skills model of adherence (JD Fisher, WA Fisher, KR Amico, J Harman, 2001, in preparation) [7–10], which contains the ‘active ingredients’ of most successful health behavior change models [7], asserts that deficits in adherence-related information, motivation, and behavioral skills are fundamental determinants of ART non-adherence, and that remediating these deficits is critical to increasing adherence. Such interventions, coupled with recent government and industry initiatives to provide the necessary drugs and serious attempts to improve healthcare infrastructures, could begin to have a significant impact on the HIV-infected community in developing countries. Simply supplying individuals with antiretroviral drugs free or at reduced prices will likely backfire, and could even have cataclysmic consequences for HIV patients, for their nations, and for the HIV epidemic overall. State-of-the-art behavioral science-based adherence interventions are absolutely critical if recent governmental and industry initiatives are to succeed. Nevertheless, an extensive review of the literature and of recent initiatives suggests that few, if any, such interventions are currently underway or planned (JD Fisher, WA Fisher, KR Amico, J Harman, 2001, in preparation) [9]. In addition to drug regimen adherence, helping HIV-positive individuals with adherence to safer sex and needle use practices is equally critical [11,12]. HIV-positive individuals may continue to practise risky behavior after diagnosis [11,12], and lifetime adherence to safer sex or drug use, like long-term adherence to antiretroviral drug regimens, is difficult. Even though ART may lower viral loads, HIV can still be transmitted through risky sexual or needle use. Because ART helps individuals live longer, healthier lives, they may have more opportunities to spread HIV through risky behavior. Therefore, there is a pressing need to combine ART adherence interventions with effective HIV risk behavior change interventions in seropositive populations on ART. Without strong medical adherence and safer behavior interventions in developing countries now being targeted for free or low-cost antiretroviral drugs, we may be doing great unintentional harm with the intention of doing great good. Danielle Popp Jeffrey D. Fisher