The Ganchero Intervention for Migrant People Who Inject Drugs From Puerto Rico in New York City

NCT06316739 | Active Not Recruiting DMC

• 1 other identifier: R34DA057166
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot clinical trial is to learn if an intervention that trains Gancheros (people who provide injection services in exchange for drugs or money) to conduct risk-reduction outreach could help lower risk for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and overdose among migrant Puerto Rican people who inject drugs (PWID) in New York City. The main questions it aims to answer are:

• 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.

Conditions

HIV Infections; HCV; Overdose

Keywords

people who inject drugs (PWID); Puerto Ricans; peer intervention; HIV prevention; injection drug use; naloxone

Outcome Measures

Primary Outcomes (1)

• sterile syringe use

  number of sterile syringes per day each client reports using, with an offset term for the number of injections per day

  past 30 days; assessed at the end of Cycle I (each Cycle is a total of 7 months long)

Secondary Outcomes (1)

• naloxone carriage

  past 30 days; assessed at the end of Cycle I (each Cycle is a total of 7 months long)

Other Outcomes (5)

• Feasibility of intervention - Ganchero Engagement

  7 months

• Feasibility of intervention - Client Engagement

  4 months

• Acceptability of the intervention's training component to Gancheros

  3 weeks, assessed at the end of the Ganchero training which will consist of 6 sessions scheduled over 3 weeks

Study Arms (2)

Immediate intervention neighborhood

EXPERIMENTAL

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).

Behavioral: Ganchero intervention

Delayed intervention neighborhood

EXPERIMENTAL

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).

Behavioral: Ganchero intervention

Interventions

Ganchero intervention BEHAVIORAL

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; Immediate intervention neighborhood

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A migrant person who injects drugs (PWID) from Puerto Rico living in one of 2 pre-selected neighborhoods in the Bronx, New York City (NYC)
• Past experience providing Ganchero services in Puerto Rico
• Currently provides Ganchero services to ≥10 clients/day
• Speaks Spanish or English

You may not qualify if:

• Planned travel away from NYC for 2 weeks or longer over the next 24 months
• Inability to comprehend trial information or provide informed consent (e.g., due to intoxication)
• Client participants:
• 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
• Inability to comprehend trial information or provide informed consent (e.g., due to intoxication)

Sponsors & Collaborators

• North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI): lead
• City University of New York, School of Public Health: collaborator

Study Sites (1)

CUNY Graduate School of Public Health & Health Policy

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

HIV Infections; Drug Overdose

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized wait-list controlled trial. The intervention will be implemented in 2 neighborhoods (in the Bronx, New York City) sequentially. Outcomes among participants in the immediate intervention neighborhood will be compared to outcomes among participants in the delayed intervention neighborhood.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 18, 2024
• Study Start: May 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

US (1)