Community-Based Interventions for Marginalized Populations

Combination antiretroviral therapy has led to dramatic reductions in morbidity and mortality among patients with HIV/AIDS, including those who present with advanced AIDS and very low CD4⁺ cell counts. Unfortunately, many HIV-infected persons have not realized the benefits of HAART because of difficulties in accessing care or an inability to adhere to medications. The majority of these persons are active substance users, have mental health disorders, or cope with social instability, such as homelessness [1–3]. It is now recognized that innovative approaches are needed to increase access and adherence to HAART, especially among these hard-to-reach populations [4].

In the field of tuberculosis treatment, directly observed therapy (DOT) has achieved tremendous successes in curing tuberculosis among similar hard-to-reach populations [5–7]. DOT even works among crack cocaine users who have multiple transient residences and among people with schizophrenia who are living on the streets in New York City [8]. Because of the success of DOT with tuberculosis, our group and others have questioned whether DOT can be adapted to deliver HAART among hard-to-reach communities [9–12].

Therapy for HIV infection is evolving in such a way that many of the lessons from tuberculosis DOT can be successfully applied to treatment for HIV infection. Therapy for HIV infection used to be given 3–4 times a day; currently, once-daily regimens are increasingly being used. With the availability of more-potent medications that have longer half-lives, it may even be possible in the future to provide medications in an observed fashion every other day. Treatment for tuberculosis is most successful when it is community based. This lesson is also applicable to treatment of HIV infection. DOT for tuberculosis has been linked to supportive services with significant success. We are learning the important lesson that therapy for HIV infection is also more successful when linked with supportive services, such as referral to substance abuse treatment and mental health care.

However, there are significant differences between HIV infection and tuberculosis: tuberculosis is curable, and HIV infection is not; treatment for tuberculosis is finite, and treatment for HIV infection is generally lifelong; and treatment for tuberculosis can be mandated with the force of the law because of the risk of airborne transmission, whereas treatment for HIV infection is voluntary and cannot be compelled. Therefore, DOT for tuberculosis is inflexible, very rigorous, and, in general, nonmodifiable.

Use of the term “DOT” implies that the same intervention used for tuberculosis should be applied to the treatment of HIV infection. “DOT,” therefore, may be a misnomer. The lessons learned from DOT for HIV infection, as described in the following articles, show that flexibility and a partnership between the participant and the program are absolutely critical. Therefore, for the treatment of HIV infection, terms such as “directly administered antiretroviral therapy” and “modified directly observed therapy” (MDOT) may be more appropriate.

Furthermore, the epidemic of HIV infection is not characterized by a single, broad illness that spreads through the population; rather, it is multiple small outbreaks, much like brush fires, that spring up in different communities that are at risk. The overwhelming share of the global HIV infection and disease burden is now seen in resource-limited countries. In the United States, the epidemic of HIV infection is now resurging among men who have sex with men [13]. This epidemic, however, is quite different from the ongoing epidemic of HIV infection among needle-sharing injection drug users or that among those who are infected through heterosexual transmission [14]. Given the unique nature of these different populations, each specific community requires targeted interventions.

The articles in this supplement spell out the potential successes of observed therapy interventions in different settings. These settings range from methadone clinics in urban Baltimore to a community-based outreach program in rural Haiti. The strategies that are used differ depending on the population, be it in this country or in the developing world. It would be a mistake to try to develop a “one size fits all” intervention for MDOT. Flexibility is needed to accommodate the needs of the persons being served. However, it is clear that no matter how the program is designed, the development of a trusting relationship between the care team and the patient is critical for the long-term success of these interventions. Although the goal of each program is the empowerment of patients so that they may be able eventually to take full control of their own therapy, we need to recognize that many patients may never fully achieve this end. In the future, it will be important to try to understand which persons and populations are most likely to benefit from this type of intervention.

For example, among adolescents, who have traditionally had great difficulty with adherence to treatment if they have a chronic illness, MDOT might be enormously successful. MDOT may use near-peer community-based workers who visit HIV-infected adolescents or youth at different intervals depending on their social stability and adherence to treatment. Some persons may benefit from once-weekly visits, whereas others may do better with visits 5 days per week.

Many pregnant and postpartum women face substantial challenges of depression, other mental health illness, or ongoing substance abuse. Furthermore, HIV loads have been shown to increase in the postpartum period, possibly as a result of poor adherence to treatment [15, 16]. MDOT may be an ideal approach for addressing some of these challenges.

The use of observed therapy for HIV-infected inmates being released from the correctional environment into the community is another example of how MDOT may be applied to a population with specific needs. The correctional setting has a tremendous amount of structure, and inmates generally do remarkably well with ongoing treatment while incarcerated [17]. However, after release from prison, these persons tend to engage in high-risk behaviors, particularly unprotected sexual intercourse [18]. The combination of stopping anti-HIV medications, with a subsequent increase in virus load, and engaging in unprotected sexual intercourse would likely result in increased transmission. Linking a community-based MDOT program to secondary prevention makes a lot of sense.

Each of the populations described above may require a different adaptation of community-based interventions to provide HAART. The goal, however, remains the same: to decrease the long-term morbidity and mortality from HIV/AIDS and to limit the development and transmission of drug-resistant virus, particularly in high-risk communities. Programs may be useful for persons who are antiretroviral experienced or antiretroviral naive (unpublished data, ACTG 5073). It is important that, in the process of learning how to adapt observed therapy to the treatment of HIV infection, we develop cost-effective strategies. This will allow MDOT to be generalizable to all communities, including those in resource-poor environments.

During the next 5 years, we hope that improved community-based interventions that include modifications of DOT will lead to significant benefits among the hardest-to-reach communities, including active injection drug users, cocaine users, the mentally ill, and persons with severe social disruption, such as homelessness and poverty. Different modes of delivery, intensity, and incentives all need to be explored. The resources to provide care and support for these persons are available. What we need is the will and the creative energy to develop the best possible programs to benefit those who traditionally “fall between the cracks” and are often forgotten.

Financial support: Lifespan-Tufts-Brown Center for AIDS Research (NIH grant AI-42853), the National Institutes of Health (DA-13767, ACTU AI-46381), the Tufts Nutrition Collaborative, a Center for Drug Abuse and AIDS Research (NIH grant DA-13868).