Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05886712 |
| Other study ID # |
00021706 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2023 |
| Est. completion date |
June 30, 2026 |
Study information
| Verified date |
April 2024 |
| Source |
RTI International |
| Contact |
Barrot Lambdin, PhD |
| Phone |
510-665-8254 |
| Email |
blambdin[@]rti.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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)?
- Does SAIA-N improve equitable naloxone distribution (number of doses to Black,
Indigenous, and People of Color (BIPOC) and other sub-groups, number of BIPOC and other
sub-groups receiving naloxone) compared to 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, equitable naloxone
distribution, and costs and cost-effectiveness differ by group.
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 test the effectiveness of SAIA-N on improving naloxone
distribution at SSPs to Black, Indigenous, and People of Color (BIPOC) and other key
subgroups. The investigators hypothesize that SAIA-N will significantly increase the number
of BIPOC and other key subgroups receiving naloxone from them during the 12 months active
period and during the 6-month sustainment period. To test this hypothesis, the investigators
anticipate utilizing a subset of SSPs that report disaggregated outcome data based on
participant level demographics like race, ethnicity, and gender.
Aim 3. This trial's third aim will estimate the cost and cost-effectiveness of SAIA-N on
improving equitable 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. The investigators also hypothesize that, relative to
IAU, SAIA-N will be cost-effective at increasing the number of BIPOC 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.
