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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06316739
Other study ID # R34DA057166
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date November 2025

Study information

Verified date March 2024
Source North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI)
Contact Honoria Guarino, PhD
Phone 347-581-2005
Email honoria.guarino@sph.cuny.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI) City University of New York, School of Public Health

Outcome

Type Measure Description Time frame Safety issue
Other Feasibility of intervention - Ganchero Engagement Gancheros' attendance at 6 training sessions and 16 weekly meetings with Interventionist during outreach period 7 months
Other Feasibility of intervention - Client Engagement Mean number of clients engaged/day by all participating Gancheros during 4-month outreach period 4 months
Other Acceptability of the intervention's training component to Gancheros Average score across 10 0-100mm visual analog scale (VAS) items (anchored by 0-Not at all and 100-A great deal) regarding specific attributes of the Gancheros' HIV, HCV and overdose training, such as: its likeability; the effectiveness and relatability of the Interventionist/trainer; the usefulness and comprehensibility of the didactic content, including the safer drug use/injection practices presented; its relevance to the drug use and injection practices of migrant PWID; and the usefulness of the interactive activities and exercises. 3 weeks, assessed at the end of the Ganchero training which will consist of 6 sessions scheduled over 3 weeks
Other Acceptability of the intervention's outreach component to Gancheros Average score across 10 0-100mm visual analog scale (VAS) items (anchored by 0-Not at all and 100-A great deal) regarding specific aspects of the outreach protocol for Gancheros, such as: the extent to which the training prepared them to conduct risk-reduction outreach in their community; the usefulness and sufficiency of the harm reduction supplies and other resources provided; and the usefulness and sufficiency of the support provided to help Gancheros overcome barriers encountered in the field. 4 months
Other Acceptability of intervention to Clients Average score across 10 0-100mm visual analog scale (VAS) items (anchored by 0-Not at all and 100-A great deal) regarding specific attributes of the intervention such as its likeability, usefulness in promoting safer drug use/injection practices, and relevance to the lives of migrant PWID; the ease of implementing its risk-reduction strategies; the credibility of Gancheros as harm reduction peer leaders; the extent to which it fostered a sense of community empowerment; and the sustainability of behavioral changes spurred by the intervention 4 months
Primary 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 naloxone carriage number of days per week each client reports carrying naloxone past 30 days; assessed at the end of Cycle I (each Cycle is a total of 7 months long)
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