The Feasibility of Modified Directly Observed Therapy for HIV-Seropositive African American Substance Users

Abstract

Recently, modified directly observed therapy (MDOT) has emerged as a promising intervention to address nonadherence for hard-to-reach populations infected with HIV. To date, there are no existing data on MDOT focusing exclusively on African Americans. The present study sought to determine the feasibility of MDOT among 31 HIV-seropositive African American substance users in the South. An outreach worker observed the participants' medication intake 5 days per week (once per day) for a period of 3 months (intensive phase). This phase was followed by a transition phase of 3 months during which the frequency of MDOT was gradually tapered from 5 days to once weekly. Assessments to gather demographic information, HIV risk behaviors, substance use, depression, and medication adherence were conducted at baseline, 3 months, and 6 months. Results indicated that more participants adhered to their medication regimen and had viral loads of less than 400 copies per milliliter at 3 and 6 months compared to baseline. Participants reported significantly less depressive symptoms at the 6-month assessment compared to baseline and 3 months. With regard to acceptability, 95% of participants indicated they liked having the outreach visits, 100% reported MDOT helped them take their medications, and only 5% felt MDOT was a violation of privacy. These results suggest MDOT is feasible among African American substance users in the South and a larger controlled study of MDOT with this population is warranted.

Directly observed antiretroviral therapy improves adherence and viral load in drug users attending methadone maintenance clinics: A randomized controlled trial

“…In fact, among TAU participants with undetectable baseline VL, 21% experienced viral rebound. While several DOT studies have reported decreases in VL (Altice et al, 2007; Conway et al, 2004; Lucas et al, 2006; Macalino et al, 2007) and modest improvements in self-reported adherence (Altice et al, 2007; MA et al, 2008; Pearson et al, 2007), ours is one of the few DOT trials to report improvements in objectively measured adherence at multiple time points.…”

“…Since these same goals apply to HIV treatment, it is reasonable to extend the DOT model to antiretroviral therapy for HIV, particularly among populations at risk for non-adherence (Lanzafame et al, 2000; Mitty et al, 2002; Ford et al, 2009). Antiretroviral DOT programs have been successfully implemented in community settings using outreach workers (Altice et al, 2004; Behforouz et al, 2004; Khanlou et al, 2003; Ma et al, 2008; Mitty et al, 2005; Wohl et al, 2006), and in settings with infrastructures allowing frequent contact, such as prisons (Babudieri et al, 2000; Kirkland et al, 2002), housing facilities (Tinoco et al,2004), and methadone clinics (Clarke et al, 2002; Conway et al, 2004; Lucas et al, 2004). While these studies have demonstrated feasibility and acceptability, few have examined efficacy using randomized designs, and none has evaluated methadone clinic-based DOT in a randomized trial.…”

Effect of Directly Observed Therapy for Highly Active Antiretroviral Therapy on Virologic, Immunologic, and Adherence Outcomes: A Meta-Analysis and Systematic Review

“…4,9,102,103 Qualitative data suggest that other mechanisms may also mediate DOT-HAARTeffectiveness, including positive effects on patients’ trust and communication with providers; increased patient motivation to engage in daily activities and become involved in the community; improved adherence to other aspects of medical care; and greater the utilization of other forms of social and adherence support. 30,44,65,104–106 …”

“…51 Unlike many other HAART adherence interventions, DOT-HAART has been successfully “test-driven” in real-world settings and has been delivered to more than 12,000 individuals to date. 28,44,51–69 However, efficacy data from controlled trials are mixed, and interventions vary widely in terms of the nature of DOT-HAART (eg, site and frequency of DOT, additional support provided, DOT worker background); target populations (eg, substance users, HAART-naive resource-poor settings); and assessment (eg, duration of follow-up, outcomes). 51 The question of translating evidence into implementation 70 is not “can DOT-HAART be implemented,” but rather, “should it, how, and for whom”?…”

A Systematic Review of Antiretroviral Adherence Interventions for HIV-Infected People Who Use Drugs

“…Second tier data also suggest promising outcomes for DAART in improving virologic outcomes among heterogeneous populations, including African American HIV-infected PWUDs [55], treatment-naïve HIV-infected IDUs in Italian prisons [56], and HIV-infected cART experienced PWUDs [57]. Second and third tier data for interventions that incorporated both DAART and MMT were somewhat consistent with data from the Berg et al [51] trial, although suggested persistence of virologic and immunologic improvements at longer-term follow-up points.…”