Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04873401 |
| Other study ID # |
8153 |
| Secondary ID |
UG1DA050071-04S1 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2021 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
New York State Psychiatric Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This two-year project will adapt and conduct a trial examining the ability of two recruitment
strategies, chain-referral and credible messenger, to reach those who use opioids and other
substances in order to increase their uptake of onsite point of care COVID-19 testing that
will be delivered in two community based organizations (CBOs): Alliance for Positive Change
and Argus Health Inc. In Phase 1, Adapt two implementation strategies to support COVID-19
testing uptake and sustainability, adapting elements of existing efficacious social
network-based interventions via a CBPR approach. In Phase 2, we will examine and compare the
efficacy of two sets of implementation strategies on (i) reach, (ii) testing uptake, (iii)
service delivery (i.e. quarantine, medical care, contact tracing) and (iv) sustainability for
individuals who use opioids and other drugs. In Phase 3, Elucidate and compare the
system/organizational-, staff-, and individual-level factors that influence implementation
(i.e. fidelity, acceptability, feasibility, sustainability) of the strategies to develop a
plan for dissemination and scale-up in other CBOs who serve opioid and other substance using
individuals in NYC.
Description:
Aims. Building on the expertise and community out-reach infrastructure of two community-based
organizations (CBOs), Argus Community Inc. and Alliance for Positive Change, and following a
CBPR approach, investigators propose to take two implementation strategies that have been
proven to increase the reach, access, and uptake of HIV testing and related services, and
adapt them to support the uptake and sustainability of point-of-service (POS) onsite COVID-19
testing in CBOs that target the underserved population of those who use opioids and other
substances. Guided by social cognitive theory, Andersen's model of health care access and the
EPIS framework, the specific aims are to:
(1). Adapt two implementation strategies to support COVID-19 testing uptake and
sustainability, adapting elements of existing efficacious social network-based interventions
via a CBPR approach; (2). Examine and compare the efficacy of two sets of implementation
strategies on (i) reach, (ii) testing uptake, (iii) service delivery and (iv) sustainability
for individuals who use opioids and other drugs. Use of data drawn from Healthix, a public
health information exchange, will supplement this comparison by generating a baseline of
participant prior testing and health behavior to determine access to underserved populations
as well as long-term influence on future testing behavior; and (3) Elucidate and compare the
system/organizational-, staff-, and individual-level factors that influence implementation of
the strategies to develop a plan for dissemination and scale-up in other CBOs who serve
opioid and other substance using individuals in NYC.
Settings. Alliance for Positive Change and Argus Health Inc have well-established partnership
with members of the parent grant team following partnerships on numerous initiatives
targeting HIV, HCV and STIs prevention, testing and treatment for over 20 years. Argus and
Alliance have had a combined presence in the communities of Washington Heights, Harlem and
the South Bronx for over 50 years, and have subsequently developed considerable trust,
support and "credibility" within these communities.
Design, Sample Size and Randomization. Two distinct social network recruitment strategies
will be adapted and compared. Guided by the EPIS framework, SCT, and Andersen's Model, this
2-year study will comprise three phases. In Phase 1: Adaptation of outreach recruitment
strategies, investigators will work with our project CAB, via a CBPR approach, to adapt
chain-referral and POL strategies for uptake of COVID-19 testing, to finalize recruitment and
on-site testing protocols. In Phase 2: Strategy Efficacy Trial and Implementation Evaluation,
investigators will compare the two strategies in a cross-over design at two CBOs, with
initial strategy assignment randomly determined and rolled out for 4 months before
cross-over. Investigators will examine the impact of each strategy on (i) reach, (ii)
COVID-19 testing/repeat testing, and (iii) service delivery among those who test positive for
COVID-19. In Phase 3: Sustainment, CBOs will implement the strategy with more favorable
outcomes in Phase 2, and investigators will examine their sustainment of the program.
Implementation evaluation will identify participant-, staff-, and organizational-level
factors that influence the feasibility, acceptability, and sustainability of each strategy in
the CBOs.
Phase 1: Adaptation of Outreach Strategies. Investigators will employ a CBPR-guided approach
to adapt the social network-based outreach strategies. To do this, investigators will hold
four 1-hour working groups with our CAB. All CAB members will be reimbursed for their time.
These groups will address how to best employ the different strategies to reach our target
population and motivate testing uptake. Protocols will be shaped by findings from working
group meetings and shared back to the CAB who will provide feedback to inform changes in
content and format, and help identify markers of success and potential challenges.
Phase 2: Strategy Efficacy Trial and Implementation Evaluation Overview. During the first 4
months of Phase II each site will roll out a different recruitment strategy (randomly
assigned 1:1) to the site Following four months of implementation, the sites will conduct a
rapid PDSA through a series of four, weekly workgroups. Revisions to protocols will be made
during these meetings and then the sites will "cross-over" and implement the other
recruitment strategy for the next four months. Participants may be recruited twice, once in
each strategy; any instances of repeat testing will be documented.
Participants. In Phase 2, using two different strategies, investigators aim to enroll N=500
individuals with a history of opioid and/or substance abuse within the past 6 months. Based
on the geographic catchment areas of Argus and Alliance and current demographics of their
current substance using clientele, investigators anticipate participants will be 64% male,
51% African American, 39% Hispanic. Inclusion/exclusion criteria. All participants,
regardless of recruitment strategy, must endorse opioid or other substance abuse in the past
6 months, and must speak English or Spanish; >18years.
Study enrollment, and consent. Once an individual is screened at the agency and determined to
be eligible, Research Assistants (RAs) will obtain written informed consent for study
participation and consent to access their clinical information in Healthix, a large health
information exchange in NYC. Following consent, the RA will administer the baseline
assessment in a private office. Participants will receive remuneration in accordance with
standards in this population. These procedures will occur in the same way regardless of
recruitment method into the study.
Strategy Efficacy Trial and Implementation Evaluation. Chain-referral Strategy. Recruitment
of seed participants. N=16 participants who meet inclusion criteria will be recruited from
among clients at Argus and Alliance (n=8 at each site) to serve as seeds. Seeds will be
stratified by substance use treatment status and gender. Site staff will contact selected
individuals and refer those interested to the research team who will screen for eligibility.
Following the completion of the screen, the participant will be offered COVID-19 testing;
they will be compensated $20 for completing the interview at the end of the visit.
Participants will be given the option to help recruit others to receive a COVID-19 test for a
small incentive. If participants agree, they will receive a brief training on recruitment and
three coupons. The participants will be instructed to give these coupons only to people they
know who use substances.
Chain-referral recruitment: Individuals redeeming coupons will be screened for study
participation, assessed and offered COVID-19 testing. Those eligible and interested will be
enrolled. Procedures for informed consent, study enrollment and peer education training will
be identical to those for seeds. Participants will return after three weeks to receive a
recruitment incentive of $10 for every coupon redeemed. During this second visit they will
complete a brief questionnaire to quantify peer-recruitment attempts.
Sample size: All participants will receive a maximum of four coupons to prevent the
development of "professional recruiters." The process will continue until the sample size
exceeds 125 persons (at each site) or the recruitment period is over. Based on prior work
with similar populations in NYC investigators anticipate being able to recruit 125
participants for a COVID-19 test in 16 weeks.
POL Strategy: Alliance and Argus have existing POL/peer outreach programs with
well-established histories of community involvement. Investigators will leverage this
existing infrastructure and adapt to focus on COVID-19 testing. Based on protocols developed
in Phase 1, POLs will be trained to (i) initiate conversations related to stopping
transmission of COVID-19; (ii) deliver effective messages endorsing benefits of COVID-19
testing, social distancing and mask wearing; (iii) identify and visit those venues known to
them where those with substance use will likely congregate; (iv) set goals to engage in
conversations about COVID-19 testing with the target population and (v) document/track
efforts.
Recruitment of participants via credible messengers: Based on these organizations' previous
POL recruitment, 4 POLs are able to recruit 10 participants per week for HIV testing and
related services. This will permit recruitment of 3-4 participants/week per POL (12-16
total/week), allowing completion of enrollment for outreach strategy in 4 total months.
Participants recruited via POL will be consented and interviewed in the same manner as
described above. Following the interview, participants will then be offered COVID-19 testing;
they will be compensated $20 for completing the interview.
Quality Improvement (QI)/PDSA: Following the completion of the first 4-month recruitment
period, agency staff, CAB members and POLs will participate in quality improvement. Using an
abbreviated PDSA protocol, stakeholders across both agencies will participate to facilitate
information sharing, cross-learning, and capacity building. They will refine messaging,
procedures, and educational content, and make a plan to implement change during the next
recruitment period. The fourth workgroup will address issues associated with internal site
logistics.
Assessment and analysis. Investigators will examine the impact of the intervention on (i)
reach, (ii) testing uptake and (iii) service delivery; and (iv) sustainability for
individuals who use opioids and other drugs as well as potential mediating/moderating
variables from the Andersen, SCT and EPIS models. Data drawn from Healthix on prior and
future COVID-19 testing will augment study data to determine access to underserved
populations and influence on future testing behavior.
Implementation assessment. A multi-method approach will allow us to identify implementation
features that promote optimal testing uptake in the context of these CBOs. To quantify
implementation, investigators will conduct staff survey assessments, monthly process
checklists and a focus group.
Staff recruitment for surveys and focus groups. Staff will be eligible if they are currently
employed at either Argus or Alliance, including POLs participating in Peer programs.
Considerable effort will be taken to ensure that staff do not feel coerced to participate.
Staff and organizational-level EPIS-derived factors will be assessed the launch of the
testing initiative and after 12 months.
Monthly process assessments. Once the recruitment strategy protocols are finalized,
investigators will develop the following monthly process assessments to be completed by
agency staff and POLs. Feasibility: Investigators will develop a strategy specific
feasibility checklist measuring three types of program delivery obstacles: obstacles to
target population participation; concrete obstacles; and site/staffing obstacles. Fidelity:
To assess the relationship between planned and actual implementation, investigators will
design a checklist-based monitoring system with assessments completed by POLs and agency
staff after a) testing/screening, b) education of recruits; recruits will also complete a
brief checklist that documents time and effort in recruiting chains. Acceptability and
Sustainability: Investigators will assess qualitatively implementation challenges to
acceptability and sustainability via a series of two implementation focus groups with agency
staff and POLs following completion of the project.
Analysis overview and main outcomes. The primary outcome of interest comparing the strategies
will be testing occurrence as an indicator of testing uptake. An important secondary outcome
will be reach measured through the number of coupons redeemed.
