Testing the effectiveness of a motivational interviewing-based brief intervention for substance use as an adjunct to usual care in community-based AIDS service organizations: study protocol for a multisite randomized controlled trial

Abstract

BackgroundIn 2010, the first comprehensive National HIV/AIDS Strategy for the United States was released and included three goals: (1) reducing the number of people who become infected with HIV, (2) increasing access to care and improving health outcomes for people living with HIV, and (3) reducing HIV-related health disparities and health inequities. In 2013, as part of its effort to help address the National HIV/AIDS Strategy, the National Institute on Drug Abuse (NIDA) funded a type 2 effectiveness-implementation hybrid trial titled the Substance Abuse Treatment to HIV Care (SAT2HIV) Project. Aim 1 of the SAT2HIV Project tests the effectiveness of a motivational interviewing-based brief intervention (MIBI) for substance use as an adjunct to usual care within AIDS Service Organizations (ASOs) as part of its MIBI Experiment. Aim 2 of the SAT2HIV Project tests the effectiveness of implementation and sustainment facilitation (ISF) as an adjunct to the Addiction Technology Transfer Center (ATTC) model for training staff in motivational interviewing as part of its ISF Experiment. The current paper describes the study protocol for the ISF Experiment.MethodsAs part of a multisite randomized controlled trial, individuals with comorbid HIV/AIDS and problematic substance use are randomized to receive either the ASOs’ usual care (control condition) or usual care plus a MIBI for substance use (experimental condition) delivered by trained ASO case-management staff. Primary outcome measures are reductions in days of primary substance use, number of substance-related problems, times engaging in risky behaviors, days of non-adherence to HIV medications, and increases in substance use treatment. As part of this paper, we describe the trial protocol in accordance with the Standard Protocol Items: Recommendations for Interventional Trials guidelines.DiscussionIf successfully able to implement MIBI as an effective adjunct to usual care, the current trial may have a significant impact on increasing the capacity of ASOs to address problematic substance use among individuals living with HIV/AIDS. Reducing the prevalence of problematic substance use among individuals living with HIV/AIDS within the United States may lead to significant improvements on key performance measures (i.e., the HIV Care Continuum and the 90-90-90 target). Trial registration ClinicalTrials.gov: NCT02495402Electronic supplementary materialThe online version of this article (10.1186/s13722-017-0095-8) contains supplementary material, which is available to authorized users.

Substance use and the HIV care continuum: important advances

“…Claborn et al [ 18 ] describes a randomized trial of a tablet-based mobile platform to improve care coordination between HIV and substance use providers. Garner et al [ 19 ] describe protocols for two multi-site, cluster randomized trials: one testing the Addiction Technology Transfer Center change quality improvement strategy with or without an organizational change intervention in AIDS service organizations, and a second trial of motivational interviewing training for AIDS service organization staff versus usual care [ 20 ]. Both trials study intervention effects on client treatment engagement and HIV outcomes.…”

The Implementation & Sustainment Facilitation Strategy improved implementation effectiveness and intervention effectiveness: Results from a cluster-randomized type 2 hybrid trial

“…The MIBI was designed to motivate individuals living with HIV who have an SUD to change their substance use by (a) examining their reasons for change, (b) receiving feedback about common negative interactions of substance use and HIV-related health issues, (c) further developing importance or confidence to reduce or stop their primary substance use, and (d) making a plan for change. For more details, see the study protocol paper (67).…”

“…For analyses of staff-level outcomes, it was estimated that 78 MIBI staff nested within 39 HIV-CBOs would provide 80% power to detect a statistically significant (p < .05) difference for effect sizes .67 or greater (14). For analyses of client-level outcomes, it was estimated that 1,872 clients, nested within 78 MIBI staff, nested within 39 HIV-CBOs would provide 80% power to detect a statistically significant difference for effect sizes .20 or greater (24).…”

Correction to: Testing the effectiveness of a motivational interviewing-based brief intervention for substance use as an adjunct to usual care in community-based AIDS service organizations: study protocol for a multisite randomized controlled trial

“…Following the publication of the original article [ 1 ], it was brought to our attention that the abstract contained a minor, yet important error. The last sentence of the abstract’s background section noted: “The current paper describes the study protocol for the ISF Experiment.” However, this sentence should have read: “The current paper describes the study protocol for the MIBI Experiment.” In addition to noting this change as part of the current correction, the original article has been updated to include the correct sentence.…”