The Substance Abuse Treatment to HIV Care (SAT2HIV) Project: An example of a completed dual-randomized type 2 hybrid trial

BRYAN R. GARNER, PhD
RTI International

To help “speed the translation of research findings into routine practice” Curran and colleagues (2012) codified three types of hybrid trial designs (i.e., Type 1, Type 2, and Type 3). As part of type 2 hybrid trials they proposed “dual testing of clinical and implementation interventions/strategies.” Despite their note about using the term test in a “liberal manner” (i.e., the clinical and implementation interventions/strategies need not all be tested with randomized, strongly powered designs), in 2014 the National Institute on Drug Abuse funded a dual-randomized type 2 implementation-effectiveness hybrid trial called the Substance Abuse Treatment to HIV care (SAT2HIV) Project. Consistent with theme area 1 (Pragmatic Trial Examples), this presentation/poster will provide a concrete example of what Landes, McBain, and Curran (2019) highlighted as a “rarer” type 2 hybrid trial example.

Thirty-nine HIV service organizations, 78 HIV service organization staff, and 824 people with HIV and a comorbid substance use disorder.

A dual-randomized type 2 implementation-effectiveness hybrid trial, which simultaneously included: 1) a 39-site cluster-randomized implementation trial focused on testing the effectiveness of the team-focused Implementation & Sustainment Facilitation (ISF) Strategy as an adjunct to the staff-focused Addiction Technology Transfer Center.
 
(ATTC) Strategy, and 2) a multisite randomized controlled trial testing the effectiveness of a motivational interviewing-based brief intervention for substance use as an adjunct to HIV service organization’s usual care for substance use disorders. Both staff-level outcomes and client-level outcomes were examined.

The ISF Strategy had a significant impact on implementation effectiveness (i.e., the consistency and the quality of implementation; ? = .65, p = .01), but not on time-to-proficiency (? = ?.02), or level-of-sustainment (? = .09). Additionally, the ISF Strategy had a significant impact on intervention effectiveness (i.e., the effectiveness of the MIBI), at least in terms of significantly decreasing the odds (odds ratio = 0.11, p = .02) of clients using their primary substance daily during follow-up.

Although not for the faint of heart, dual-randomized type 2 hybrid trials can be successfully completed with the right infrastructure and team. Building upon the SAT2HIV Project, the SAT2HIV-II Project is a type 3 hybrid trial that was recently funded by the National Institute on Drug Abuse that is focused on testing a pay-for-performance (P4P) strategy as an adjunct to the ATTC+ISF Strategy found to be most effective as part of the original SAT2HIV Project.