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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to reduce the risk of HIV, hepatitis C, and drug overdoses among Puerto Rican people who inject drugs in New York City. It involves training Gancheros—individuals who provide injection services in exchange for drugs or money—to share crucial prevention tips and supplies, such as sterile syringes and naloxone (a medication that can reverse overdoses), with their clients. Known as the Ganchero Intervention, the trial takes place in two Bronx neighborhoods to assess the intervention's effectiveness. Suitable candidates for this trial include Puerto Rican Gancheros and their clients in the Bronx who regularly use injection services. As an unphased trial, this study presents a unique opportunity to contribute to innovative community health solutions.

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.

What prior data suggests that this intervention is safe for participants?

Research shows that the Ganchero Intervention aims to lower the risks of HIV, hepatitis C, and overdoses among Puerto Rican people who inject drugs in New York City. This program trains Gancheros to share prevention tips and supplies, such as naloxone (a medication that can reverse opioid overdoses) and clean syringes, with their clients.

For safety, the intervention includes educational sessions and outreach activities. Participants do not need to take any medication or treatment, so there are no physical side effects. The focus remains on teaching and providing tools to reduce health risks. As a behavioral program rather than a medical treatment, safety concerns are minimal. Participants will use well-known prevention tools like naloxone and clean syringes, which have already proven safe and effective in reducing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Ganchero Intervention because it offers a community-focused approach to tackling drug overdose and infection risks. Unlike standard harm reduction strategies, which typically involve providing clean syringes and basic education, the Ganchero Intervention leverages local influencers, or "Gancheros," to engage directly with their communities. This unique peer-led model aims to build trust and facilitate more effective communication and support among those at risk, potentially leading to more significant behavior changes and health outcomes in underserved neighborhoods.

What evidence suggests that the Ganchero intervention is effective for reducing HIV, HCV, and overdose risk among Puerto Rican PWID?

Research shows that the Ganchero program might help lower the risk of HIV, hepatitis C (HCV), and overdose among Puerto Rican people who inject drugs in New York City. Studies have found that these individuals face a higher risk for these health problems. In this trial, researchers will implement the Ganchero intervention in two distinct neighborhoods. The program trains Gancheros to encourage safe practices, like using clean needles and carrying naloxone, a medicine that can reverse opioid overdoses. Early results suggest that when Gancheros share prevention tips and supplies, their clients may experience better health. By focusing on community-led efforts, the program aims to reduce infection rates and overdoses. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06316739

The Ganchero Intervention for Migrant People Who Inject ... The Ganchero intervention is an HIV, hepatitis C virus (HCV) and overdose prevention intervention for migrant people who inject drugs (PWID) from Puerto Rico ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9435813/

Toward Community Empowerment: The Puerto Rican ... People who inject drugs (PWID) who migrate from Puerto Rico (PR) to New York City (NYC) are at elevated risk for hepatitis C (HCV), HIV and drug overdose.

3. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/0091450920964576

The Puerto Rican Ganchero - C. Gelpí-Acosta, H. Guarino, ... People who inject drugs (PWID) who migrate from Puerto Rico (PR) to New York City (NYC) are at elevated risk for hepatitis C (HCV), ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36061616/

Toward Community Empowerment: The Puerto Rican ... People who inject drugs (PWID) who migrate from Puerto Rico (PR) to New York City (NYC) are at elevated risk for hepatitis C (HCV), HIV and drug ...

5. researchgate.net researchgate.net/publication/346137537_Toward_Community_Empowerment_The_Puerto_Rican_Ganchero

Toward Community Empowerment: The Puerto Rican ... People who inject drugs (PWID) who migrate from Puerto Rico (PR) to New York City (NYC) are at elevated risk for hepatitis C (HCV), HIV and drug overdose.

6. reporter.nih.gov reporter.nih.gov/search/SXXiskMnP0exYDMfbO0xyA/project-details/10699316

The Ganchero Intervention - NIH RePORTER In this 3-year study, we will develop an innovative and culturally tailored HIV, HCV, and overdose risk- reduction intervention for migrant PR PWID in NYC that ...

7. sciencedirect.com sciencedirect.com/science/article/am/pii/S0955395919300763

Injection risk norms and practices among migrant Puerto ... A risk- reduction intervention that incorporates the Ganchero figure may be a credible way to help migrants reduce injection risk and accept OAT and Syringe ...