ABSTRACT
Treatment services for HIV and OUD have historically been delivered across multiple settings
leading to fragmented and uncoordinated care. Models of behavior change suggest that
addressing multiple health conditions simultaneously through integrated, evidence-based,
interventions has the potential to overcome traditional barriers to optimize engagement and
improve clinical outcomes. Consistent with this perspective, numerous studies have
documented that receipt of opioid agonist treatment, in the context of HIV care, is associated
with ART adherence and decreased HIV viral loads. Recent pharmacological advancements
have led to the development of novel long-acting, injectable, (LAI) medications for both HIV
(cabotegravir co-administered with rilpivirine) and OUD (extended-release buprenorphine).
These therapies have the potential to dramatically improve adherence by eliminating the need
for daily pill-taking. Despite the extensive evidence base supporting LAI for both HIV and OUD,
and clinical guidelines supporting integrated care provision, currently little is known about 1) the
perceived acceptability/feasibility/safety of combining HIV and OUD treatment into a single point
of care; b) which populations and within which type of settings these medications may be
optimally delivered; and c) what factors may impede or facilitate future implementation of these
treatments. Therefore, the goal of the proposed application is to advance integrated treatment
for HIV and OUD by conducting formative research with the target population and key
stakeholders to develop a clinical protocol to guide the delivery of combined LAI treatment;
evaluate the feasibility, acceptability, and safety of this integrated delivery model; and assess
factors to optimize the potential for scalability. The study will be accomplished through two
primary aims: (1) Develop a clinical protocol to guide the delivery of combined LAI for HIV and
OUD by conducting in-depth interviews with prospective patients, clinical content experts, and
other key stakeholders. (2) Conduct an open pilot test of the proposed clinical protocol to
assess feasibility, acceptability, and safety among patients diagnosed with HIV and OUD.
Throughout all phases of the study, we will simultaneously collect information on patient-,
provider-, and organizational-level variables to inform future implementation. Findings from this
study will be used to develop a R01 application to conduct a fully-powered Hybrid Type 1
Effectiveness-Implementation study design.
