The Ganchero Intervention for Migrant People Who Inject Drugs From Puerto Rico in New York City
NCT ID: NCT06316739
Last Updated: 2025-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
69 participants
INTERVENTIONAL
2024-05-01
2025-11-01
Brief Summary
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* Can the Ganchero intervention be carried out successfully and will Gancheros and their clients like it?
* Could the Ganchero intervention help Puerto Rican PWID who are clients of Gancheros use sterile syringes and carry naloxone (a medication to reverse opioid overdoses) more often?
Gancheros who participate in the trial will be asked to attend a 6-session training on HIV, HCV, and overdose prevention and then to share key prevention messages and supplies (e.g., naloxone, sterile syringes and other injection equipment) with their clients during 4 months of outreach. The intervention will be carried out with Gancheros and their clients in two Bronx neighborhoods, one after the other, so the investigators can see if clients in the neighborhood that received the intervention first have better outcomes than clients in the neighborhood that did not yet receive the intervention.
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Detailed Description
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Risk behaviors of migrant PR PWID in the US are well documented. Compared to non-migrant PWID, migrants regularly engage in syringe- and cooker-sharing. In NYC, PR migrants mostly reside in the Bronx, the county with the largest numbers of PWID, overdose deaths, and new cases of HIV, and very high HCV prevalence in PWID. In a recent National Institute for Drug Abuse (NIDA)-funded ethnographic study (R03DA041892), the Principal Investigators identified normative practices learned while injecting drugs in Puerto Rico as critical influences on migrants' risks in NYC. These practices include: pervasive syringe-sharing after "cleaning" syringes by "air-blowing and water-rinsing"; regular sharing and trading of heavily used cookers which are highly valued for their concentrated drug residue; and low rates of naloxone carriage despite frequent overdoses.
Grounded in a multi-level ecosocial framework, the proposed intervention will directly target these practices by leveraging a key migrant PWID-role in NYC, the Ganchero: an "injection doctor" who exchanges injection expertise for drugs or money. Because migrant PWID regularly require expert injection services due to collapsed veins, Gancheros are central network members well-positioned to promote positive health change. This is aligned with social network diffusion theory, which underlies effective HIV prevention interventions that harness peer influence by relying on PWID to disseminate risk-reduction messages in their networks. PR migrant PWID are highly networked, and a peer-driven intervention relying on their network ties promises to yield sustainable health behavior change. The investigators will develop and conduct an initial evaluation of a Ganchero risk-reduction intervention for Puerto Rico-born PWID that is effective, culturally appropriate, credible, and sustainable.
First, a multi-method, iterative process that will incorporate input from Gancheros and their migrant clients will be used to develop the intervention: a training curriculum and outreach protocol for Gancheros. Building on specific intervention recommendations developed in consultation with a multiple-stakeholder Intervention Advisory Board and endorsed by focus groups of migrant PWID in the investigators' prior study, the intervention will empower Gancheros to promote and model consistent sterile syringe use and naloxone carriage with their clients and in their PWID networks. Targeting two Bronx neighborhoods with high proportions of PR migrants and non-overlapping PWID networks, the investigators will then conduct a pilot clinical trial to evaluate the feasibility, acceptability, and preliminary effectiveness of this innovative intervention.
Aim 1. Engage Gancheros (total n=4) and clients (total n=20) from both target neighborhoods in a series of semi-structured interviews and focus groups to develop a risk-reduction intervention comprised of a training curriculum and outreach protocol for Gancheros to implement with their regular clients in real-world settings.
Aim 2. Conduct a pilot clinical trial using a wait-list control design with 10 Gancheros and 60 clients across the two target neighborhoods to evaluate the intervention's feasibility (assessed via Ganchero and client participation rates), acceptability (assessed by Ganchero and client Visual Analog Scale \[VAS\] ratings and qualitative feedback) and preliminary effectiveness in increasing clients' rates of sterile syringe use (primary effectiveness outcome) and naloxone carriage (secondary effectiveness outcome).
Structured assessments to measure these outcomes will be supplemented with data from Gancheros' Weekly Outreach Reports and systematic ethnographic observations of Gancheros deploying intervention strategies in the field to assess fidelity of implementation, barriers encountered, and any pragmatic adaptations made in response to barriers, to inform future refinement of the intervention and its implementation strategy.
Impact: A Ganchero-led intervention may help prevent HIV outbreaks among PWID in NYC and mitigate the HCV and overdose syndemic among the highly vulnerable Puerto Rico-born PWID in NYC. Results will inform a larger hybrid effectiveness-implementation trial to evaluate a refined intervention for migrant PR PWID in NYC and other urban areas in the US with significant numbers of at-risk migrants.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Immediate intervention neighborhood
According to the trial's wait-list controlled design, the Ganchero intervention will be implemented sequentially in two geographically and socially distinct Bronx neighborhoods with large migrant Puerto Rican populations. In Cycle I, the intervention will be implemented with Gancheros and their clients in neighborhood A, while participants in neighborhood B receive standard access to harm reduction through a local Syringe Services Program (SSP).
Ganchero intervention
The Ganchero intervention is an HIV, hepatitis C virus (HCV) and overdose prevention intervention for migrant people who inject drugs (PWID) from Puerto Rico who are living in New York City. The intervention has two core components, both centered around the key migrant PWID role of the "Ganchero," an individual who provides expert injection services in exchange for money or drugs. First, a sample of Gancheros will be trained in foundational HIV, HCV and overdose risk-reduction knowledge and outreach strategies (over 6 2-hour, in-person, small group sessions facilitated by an Interventionist). Second, during a 4-month outreach period, trained Gancheros will disseminate risk-reduction messages learned in the training, and associated resources (e.g., sterile syringes and other injection equipment, naloxone), to migrant PWID in their neighborhood as they deliver their regular Ganchero services.
Delayed intervention neighborhood
In Cycle II, the Ganchero intervention will be implemented with Gancheros and their clients in neighborhood B, while participants in neighborhood A receive standard access to harm reduction through a local Syringe Services Program (SSP).
Ganchero intervention
The Ganchero intervention is an HIV, hepatitis C virus (HCV) and overdose prevention intervention for migrant people who inject drugs (PWID) from Puerto Rico who are living in New York City. The intervention has two core components, both centered around the key migrant PWID role of the "Ganchero," an individual who provides expert injection services in exchange for money or drugs. First, a sample of Gancheros will be trained in foundational HIV, HCV and overdose risk-reduction knowledge and outreach strategies (over 6 2-hour, in-person, small group sessions facilitated by an Interventionist). Second, during a 4-month outreach period, trained Gancheros will disseminate risk-reduction messages learned in the training, and associated resources (e.g., sterile syringes and other injection equipment, naloxone), to migrant PWID in their neighborhood as they deliver their regular Ganchero services.
Interventions
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Ganchero intervention
The Ganchero intervention is an HIV, hepatitis C virus (HCV) and overdose prevention intervention for migrant people who inject drugs (PWID) from Puerto Rico who are living in New York City. The intervention has two core components, both centered around the key migrant PWID role of the "Ganchero," an individual who provides expert injection services in exchange for money or drugs. First, a sample of Gancheros will be trained in foundational HIV, HCV and overdose risk-reduction knowledge and outreach strategies (over 6 2-hour, in-person, small group sessions facilitated by an Interventionist). Second, during a 4-month outreach period, trained Gancheros will disseminate risk-reduction messages learned in the training, and associated resources (e.g., sterile syringes and other injection equipment, naloxone), to migrant PWID in their neighborhood as they deliver their regular Ganchero services.
Eligibility Criteria
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Inclusion Criteria
* Past experience providing Ganchero services in Puerto Rico
* Currently provides Ganchero services to ≥10 clients/day
* Speaks Spanish or English
* A migrant PWID from Puerto Rico living in one of 2 pre-selected neighborhoods in the Bronx, NYC
* Referred to the study by a participating Ganchero
* Used the services of their nominating Ganchero at least once/week for the past 90 days
* Speaks Spanish or English
Exclusion Criteria
* Inability to comprehend trial information or provide informed consent (e.g., due to intoxication)
2. Client participants:
* Inability to comprehend trial information or provide informed consent (e.g., due to intoxication)
18 Years
ALL
No
Sponsors
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City University of New York, School of Public Health
OTHER
North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI)
OTHER
Responsible Party
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Locations
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CUNY Graduate School of Public Health & Health Policy
New York, New York, United States
Countries
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Other Identifiers
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