Project Enhance: A Randomized Controlled Trial of an Individualized HIV Prevention Intervention for HIV-Infected Men Who Have Sex With Men Conducted in a Primary Care Setting

Men who have sex with men (MSM) constitute, by far, the largest group of individuals living with HIV in the U.S., as well as the group with the highest number of incident infections (CDC, 2010). Although antiretroviral therapy has extended the lives of people living with HIV, treatment does not invariably suppress HIV infectiousness, because of suboptimal adherence for some and/or intercurrent genital tract infections in others that can up-regulate HIV replication (Mayer & Venkatesh, 2010). Thus, individuals who have entered routine care can transmit HIV to others. In fact, individuals who are HIV infected and aware of their status are associated with almost half of the new HIV infections in the U.S (Marks, Crepaz, Senterfitt, & Janssen, 2005). Recently, anti-retroviral therapy has been demonstrated to decrease infectiousness and the efficiency of HIV transmission (Cohen et al., 2011). However, although MSM may be entering and benefitting from treatment, this has not yet been associated with a general decrease in new transmissions among MSM (Prejean et al., 2011). Accordingly, one important strategy to prevent the transmission of HIV is to promote sexual risk reduction for people living with HIV (CDC, 2006). A meta-analysis of 12 studies that was published in 2006, and three notable intervention studies since, have revealed modest or mixed results of psychosocial interventions to decrease HIV transmission-risk behavior (TRB) for individuals living with HIV (Crepaz et al., 2006). Although the meta-analysis found statistically significant reductions in TRB when studies were aggregated, only five of the 12 individual studies examined showed significant effects. The meta-analysis concluded that successful prevention interventions are needed to address participants’ mental health and medical adherence, provide skills for risk reduction, and integrate prevention with routine medical care. Of the other three studies published since the meta-analysis (Mausbach, Semple, Strathdee, Zians, & Patterson, 2007; Morin et al., 2008; Simon Rosser et al., 2010), all found reductions in both the intervention and control groups, with just one finding statistically significant differential improvements favoring the intervention under study (Morin et al., 2008). The one that did find differential improvements, “The Healthy Living Project,” addressed a variety of psychosocial concerns as part of living with HIV, and was considerably more intense, consisting of fifteen 90-min long individual sessions with a counselor (Morin et al., 2008). As a next step to the work referenced above, we sought to address both HIV TRB and other psychosocial concerns for MSM living with HIV, in the context of HIV care, attempting to do so with a relatively brief intervention. To do this, we utilized medical social workers as interventionists who would provide proactive case management and thereby address the psychosocial concerns of MSM living with HIV through referral. We hypothesized that integrating proactive HIV prevention case management to address psychosocial problems, with increasing behavioral skills for reducing HIV sexual TRB would be more effective than standard of HIV care, which included as-needed case management services.