Clinical trial NCT05886712: Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Official title: Improving Equitable Access to Naloxone to Prevent Opioid Overdose Deaths Within Syringe Service Programs
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overdose
Implementation as Usual
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: Heluna Health
First posted: 2023-06-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare the effectiveness of a multi-faceted implementation strategy, the Systems Analysis and Improvement Approach for Naloxone (SAIA-N), in syringe service programs (SSPs). The main questions it aims to answer are:

* Does SAIA-N improve naloxone distribution (number of doses, number of people receiving naloxone) compared to implementation as usual (IAU)?
* What are the costs associated with SAIA-N and how cost-effective is the strategy?

SSPs randomized to the SAIA-N arm will participate in the strategy for a period of 12-months during which they will meet 1-2 times each month with a SAIA coach who will assist the SSP in optimizing their naloxone distribution.

Researchers will compare SAIA-N to IAU to see if naloxone distribution and costs and cost-effectiveness differ by group.

Detailed description: The investigators plan to examine SAIA-N's impact in SSPs compared to an implementation-as-usual (IAU) condition across three aims and several related hypotheses. Data collection will take place monthly across 21 months of SSP participation. These 21 months comprise a 3-month lead-in period to establish SSP outcome data characteristics, the 12-month active period during which site randomized to SAIA-N will meet with the SAIA coach, and for an additional 6 months afterward (sustainment period) to determine whether impacts are sustained.

Aim 1. This trial's first aim is to test the effectiveness of SAIA-N on improving naloxone distribution within SSPs. The investigators hypothesize that compared with SSPs receiving IAU, SSPs receiving SAIA-N will significantly increase the number of people receiving naloxone and number of naloxone doses distributed during the 12-month active period. Further, the investigators hypothesize that SSPs receiving SAIA-N will significantly increase the number of people receiving naloxone in the 6 months after the active period (the sustainment period) compared with SSPs receiving IAU.

Aim 2. This trial's second aim will estimate the cost and cost-effectiveness of SAIA-N on improving access to naloxone at SSPs, relative to IAU. The investigators hypothesize that, relative to IAU, SAIA-N will be cost-effective at increasing the number of people receiving naloxone from SSPs.

To evaluate these aims, the investigators plan a randomized controlled interrupted time series trial with 32 SSPs in California. Sixteen SSPs will be randomly assigned to the SAIA-N arm and 16 SSPs to IAU (Figure 1). SSPs randomized to the IAU arm will not receive support to improve naloxone distribution. SSPs in California have already adopted naloxone distribution. This trial therefore tests the ability of SAIA-N to optimize naloxone distribution within SSPs. Accordingly, the IAU condition is characterized by the absence of SAIA-N with the goal of comparing whether SAIA-N improves SSPs' Naloxone distribution.

The investigators' naloxone pilot study identified implementation climate and leadership engagement as important implementation determinants that can be influenced by SAIA-N and ultimately improve naloxone distribution among SSPs. Therefore, the present study assesses change in implementation climate and leadership engagement over time. The trial will first collect SSP-specific contextual data at randomization (baseline) and 12 months after randomization from all enrolled sites. The primary contact at each SSP will be asked about basic organizational characteristics (location, number of staff, budget, etc.). Next, the primary contacts as well as other staff involved with naloxone distribution at each SSP will be asked about contextual variables such as implementation climate and leadership engagement for improving naloxone distribution.

The investigators will assess SAIA-N fidelity at the specialist level. Assessment will utilize descriptive statistics such as means/medians, standard deviations/interquartile ranges, and ranges given the small sample of specialists employed by the study (n = 2). Fidelity to SAIA-N focuses on assessing the domains of content, coverage, frequency, duration, quality, and participant responsiveness of SAIA-N. To monitor fidelity, all meetings between SAIA-N specialists and SSPs will be audio recorded, and the specialist will document each meeting with an SSP in a site-specific encounter log that includes the duration of the encounter, the roles of meeting attendees, and which of the three steps the specialist completed. Study staff will rate meeting content, quality, and participant responsiveness by reviewing 20% of recorded sessions using a fidelity checklist. To assess frequency, duration, and coverage, study staff will review and assess each encounter log.

Eligibility criteria: Inclusion Criteria:

* SSP is located and operates in California; SSP is authorized by CDPH; and SSP has distributed naloxone to participants in the past 30 days.

Exclusion Criteria:

* SSPs who participated in the SAIA-Naloxone pilot study (n = 2) or do not distribute naloxone (currently n = 0)

Primary outcomes:
measure: Reach (Aim 1)
timeFrame: 21 months
measure: Fidelity (Aim 1)
timeFrame: 21 months
measure: Cost (Aim 2) (Substance Abuse Services Cost Analysis Program (SASCAP))
timeFrame: 18 months
measure: Cost-effectiveness (Incremental Cost-effectiveness Ratio (ICER))
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: RTI International
state: California
Study officials:
References: