Ganchero Intervention for Drug Overdose and Infection Risk

Overseen By Camila Gelpi-Acosta, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI)

Disqualifiers: Travel plans, Intoxication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

69 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on training and outreach rather than medication changes.

How does the Ganchero Intervention treatment differ from other treatments for drug overdose and infection risk?

The Ganchero Intervention is unique because it may incorporate novel strategies or components not typically used in standard overdose treatments, such as naloxone, which is a common opiate antagonist. While standard treatments focus on reversing overdose effects, Ganchero might address both overdose and infection risks, potentially offering a more comprehensive approach. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for migrant Puerto Rican people who inject drugs (PWID) and Gancheros in the Bronx, NYC. Eligible participants are those providing or using injection services, speak Spanish or English, and have experience with Ganchero services in Puerto Rico. The study excludes individuals not meeting these specific criteria.

Inclusion Criteria

Client participants:

Ganchero participants:

A migrant PWID from Puerto Rico living in one of 2 pre-selected neighborhoods in the Bronx, NYC

Exclusion Criteria

Ganchero participants:

I understand the trial details and can give informed consent.

Client participants:

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Gancheros attend a 6-session training on HIV, HCV, and overdose prevention

3 weeks

6 sessions (in-person)

Outreach

Gancheros conduct risk-reduction outreach, sharing prevention messages and supplies with clients

4 months

16 weekly meetings (in-person)

Follow-up

Participants are monitored for safety and effectiveness after outreach activities

4 weeks

Treatment Details

Interventions

• Ganchero Intervention

Trial Overview The trial tests a 'Ganchero intervention' where trained Gancheros provide risk-reduction outreach to their clients. It includes a 6-session training on HIV, HCV, overdose prevention and supplying naloxone and sterile syringes during a 4-month outreach to see if it reduces disease risk and overdose.

Participant Groups

Group I: Immediate intervention neighborhood Experimental Treatment 1 Intervention

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).

Group II: Delayed intervention neighborhood Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI)

Lead Sponsor

Trials

1

Recruited

70+

City University of New York, School of Public Health

Collaborator

Trials

27

Recruited

36,200+

Findings from Research

Heroin overdoses have become more common, with risk factors including recent abstinence and polydrug use, highlighting the urgent need for effective prevention strategies.

Naloxone is a safe and effective treatment for reversing heroin overdose effects, as it quickly counteracts respiratory depression and sedation, making it a crucial tool for overdose prevention in communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription naloxone: a novel approach to heroin overdose prevention. Sporer, KA., Kral, AH.[2022]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Opioid overdose risk during and after drug treatment for heroin dependence: An incidence density case-control study nested in the VEdeTTE cohort. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Exploratory study of factors associated with adverse clinical features in patients presenting with non-fatal drug overdose/self-poisoning to the ambulance service. [2012]

3. England pubmed.ncbi.nlm.nih.gov

Heroin and cocaine dependence and the risk of accidental non-fatal drug overdose. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Prescription naloxone: a novel approach to heroin overdose prevention. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Prognostic impact of psychoactive substances use during hospitalization for intentional drug overdose. [2012]