Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316739
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-27
Brief Title:
The Ganchero Intervention for Migrant People Who Inject Drugs From Puerto Rico in New York City
Sponsor:
North Jersey AIDS Alliance dba North Jersey Community Research Initiative NJCRI
Organization:
North Jersey AIDS Alliance dba North Jersey Community Research Initiative NJCRI
Study Overview
Official Title:
Ending HIV and Taming Hepatitis C Virus and Overdose Among Puerto Rican People Who Inject Drugs in New York City The Ganchero Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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 eg 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
Detailed Description:
The threat of human immunodeficiency virus HIV among people who inject drugs PWID in New York City NYC is not over Multiple HIV outbreaks among PWID in rural and urban areas of the United States US have occurred recently from 2015 in rural Indiana to 2018 in northeastern Massachusetts PWID who are racialethnic minorities continue to be disproportionately infected with HIV Among these Puerto Rican PR PWID who started injecting drugs in Puerto Rico and continue to inject drugs in NYC remain highly vulnerable not only to HIV but also to hepatitis C virus HCV and fatal opioid overdose Analyses of two different cycles of the National HIV Behavioral Surveillance NHBS study conducted by the Centers for Disease Control and Prevention CDC in NYC found PR PWID especially those who migrated from Puerto Rico to be the most HIV-vulnerable ethnic group In 2017 the US overdose mortality rate for US-born and Puerto Rico-born PR PWID exceeded the rate for Non-Hispanic Whites and the same holds true in NYC Recent research showed that PR PWID both US- and Puerto Rico-born have significantly higher prevalence of HCV than non-PR-PWID and that Puerto Rico-born migrant PWID have the highest HCV prevalence 86 of all three groups Consequently helping Puerto Rico-born PWID avoid HIV will help prevent HIV outbreaks in NYC Lowering their HCV and overdose risk will help reduce overall HCV prevalence 67 and overdose mortality rates 212 per 100000 in NYCs PWID Meeting these goals is urgent as PWID migration from Puerto Rico to NYC is ongoing as evidenced by their sizeable 25 presence in NHBS studies in the past 15 years
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 n4 and clients total n20 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 interventions 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
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 n4 and clients total n20 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 interventions 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None