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
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Background: In 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 MIBI Experiment. Methods: As 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. Discussion: If 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: NCT02495402
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In Garner et al. (2017), whole organizations were randomized to receive the implementation strategy rather than randomizing staff within the same organization.
“In this scenario, whole organizations were randomized to receive the implementation strategy rather than randomizing staff within the same organization.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Garner et al. (2017)
The Methods section (Assignment of interventions > Allocation; page unavailable) says client participants were randomized within each of the 39 organizations, rather than whole organizations being randomized to an implementation strategy. The Statistical methods section mentions an organization-level condition but does not say that organizations were randomized to it. (LLM, conf=0.85)
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Experimental — accuracy not yet measuredGarner et al. (2017) provides an example of dual-randomization at both organizational and client level.
“Garner et al. (2017) provides an example of dual-randomization at both the organizational and client level.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Garner et al. (2017)
Methods > Assignment of interventions states that clients are randomized within each AIDS service organization. Methods > Data collection, management, and analysis mentions an organization-level condition, but does not say organizations were randomized to it. The organizational-randomization part of the claim is therefore unsupported by our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredGarner et al. (2017) tested the impact of an implementation strategy, implementation and sustainment facilitation (ISF), as an adjunct to training.
“testing the impact of an implementation strategy, implementation and sustainment facilitation (ISF), as an adjunct to training”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Garner et al. (2017)
Garner et al. (2017) tested the effectiveness of a motivational interviewing-based brief intervention (MIBI) for substance use as an adjunct to usual care (UC) in AIDS service organizations.
“testing the effectiveness of a motivational interviewing-based brief intervention (MIBI) for substance use as an adjunct to usual care (UC) in AIDS service organizations”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Garner et al. (2017)
To test effectiveness of MIBI, Garner et al. used a multisite randomized controlled two-group (UC vs. UC + MIBI) in which there was client-level assignment to the UC + MIBI condition.
“To test effectiveness of the MIBI intervention, Garner et al. used a multisite randomized controlled two-group (UC vs. UC + MIBI) in which there was client-level assignment to the UC + MIBI condition.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Garner et al. (2017)
To measure impact of ISF, Garner et al. used a cluster randomized design at the organizational level.
“To measure the impact of the implementation strategy, ISF, they used a cluster randomized design at the organizational-level.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Garner et al. (2017)
The Background and rationale section says the ISF Experiment’s protocol was prepared separately. The Methods > Assignment of interventions section describes randomization of clients in the MIBI Experiment, not organizations in the ISF Experiment. Our copy does not establish whether the ISF Experiment used organizational-level cluster randomization. (LLM, conf=0.76)
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References 50 · Cited by 31
Research works printed but not linked: 1
- [68]Institute of Medicine Improving the quality of health care for mental and substance-use conditions: quality chasm series 2006 Washington, DC National Academy Press 20669433
- Authors
- Garner, B. R., Gotham, H. J., Tueller, S. J., Ball, E. L., Kaiser, D., Stilen, P., Speck, K., Vandersloot, D., Rieckmann, T. R., Chaple, M., Martin, E. G., & Martino, S.
- Affiliations
- RTI International (US)
- University of Missouri–Kansas City (US)
- University of Nebraska–Lincoln (US)
- Oregon Health & Science University (US)
- National Development and Research Institutes (US)
- State University of New York (US)
- Yale University (US)
- Corresponding author
- Garner, Bryan R.
- ORCID
- Venue
- Addiction Science & Clinical Practice
- Published
- 2017-11-17
- Volume
- 12
- Issue
- 1
- Pages
- 31-31
- ISSN
- 1940-0632 (ISSN-L)
- 1940-0640
- PMC
- PMC5693500
- OpenAlex
- W2769368130
- Cited by
- 31
- References
- 50
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 8 · 2023: 3 · 2022: 3 · 2021: 5 · 2020: 2 · 2019: 2 · 2018: 2 · 2017: 1 · 2014: 1
- FWCI
- 1.50
- Type
- journal article
- Language
- en
- Update notices
- correction (2018-02-21)
- Open access
- gold
- doi.org
- Locations
- Addiction Science & Clinical Practice (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- National Institute on Drug Abuse (R01-DA038146)
- Topics
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Epidemiology › HIV, Drug Use, Sexual Risk
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Keywords
- motivational interviewing, brief intervention, substance use, HIV/AIDS, AIDS service organizations, substance use comorbidity, HIV care continuum, HIV treatment adherence, addiction treatment, case management, National HIV/AIDS Strategy, hybrid effectiveness-implementation trial
- MeSH terms
- Clinical Protocols, Female, Humans, Male, Motivation, Patient Education as Topic, Patient Participation, Research Design, United States, HIV Infections, Randomized Controlled Trials as Topic, Substance-Related Disorders, Motivational Interviewing, Patient Navigation
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