Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977881
Status:
RECRUITING
Last Update Posted:
2023-08-07
First Post:
2023-07-27
Brief Title:
Substance Checking Outreach and Pre-Exposure Prophylaxis PrEP Engagement Study
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Impact of a Novel HIV Peer Navigation and Overdose Prevention Intervention on Engagement in the HIV Prevention and Treatment Cascade
Status:
RECRUITING
Status Verified Date:
2024-07
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:
SCOPE
Brief Summary:
Through the proposed Substance Checking Outreach and Pre-Exposure Prophylaxis PrEP Engagement SCOPE study the investigators will design and evaluate an overdose prevention and HIV prevention study among people who use drugs PWUD Specifically SCOPE will provide access to drug-checking services for PWUD to better understand the contents of the drug supply in combination with PrEP for those who are HIV- to both reduce overdose and HIV among PWUD in Baltimore City
Detailed Description:
specific study aims are
1 To prepare the drug-checking technology for deployment in the community through a three-phase process
1 To calibrate drug-checking technology through testing samples of illicit substances on the Bruker Alpha obtained from the Baltimore Police crime lab N335 and those obtained through the SPARC outreach sessions N100
2 To validate the drug-checking technology measuring sensitivity and specificity in detecting illicit substances of public health relevance by testing samples obtained through partnerships through Baltimore-based harm reduction organizations and comparing findings to the gold standard laboratory testing
3 To pilot the study Bruker Alpha Fourier Transform Infrared Spectroscopy FT-IR drug checking machine among People who use drugs PWUD N20
2 To develop a community-level mobile integrated drug checking and PrEP intervention aimed to increase PWUD engagement in the PrEP care continuum and reduce the burden of overdose
3 To recruit a longitudinal cohort of people who use drugs N500 and follow-up at 6-month intervals for 18 months
4 To implement the intervention and evaluate its impact on engagement in PrEP care primary outcome and overdose prevention among PWUD
a To determine the incremental cost-effectiveness of the intervention in terms of HIV cases averted among PWUD
5 To assess changes in drug-related wounds among N100 PWUD in Baltimore who receive wound care services on the intervention van
1 To assess changes in drug-related wounds specifically attributed to xylazine
The initial nonhuman subjects research plan focused on Aims 1 drug checking machine calibration among samples procured from the Baltimore Police Forensics Lab tested in Dr William Clarkes lab and from individuals interacting with SPARC staff during the outreach which occurs 3-4 times per week These activities are referred to as Phase 1 throughout this research plan Based on emerging best practices and in consultation with other drug checking initiatives nationwide the investigators have now expanded Aim 1 of the study to include three steps needed to prepare the machine for deployment in the field The first 1a was calibration of the machine to the local drug supply as described above the second 1b which the investigators are adding in this amendment is an additional validation of the machines functionality and comparison with gold standard technology and the third 1c is piloting the machine with 20 PWUD prior to rolling it out citywide
1 To prepare the drug-checking technology for deployment in the community through a three-phase process
1 To calibrate drug-checking technology through testing samples of illicit substances on the Bruker Alpha obtained from the Baltimore Police crime lab N335 and those obtained through the SPARC outreach sessions N100
2 To validate the drug-checking technology measuring sensitivity and specificity in detecting illicit substances of public health relevance by testing samples obtained through partnerships through Baltimore-based harm reduction organizations and comparing findings to the gold standard laboratory testing
3 To pilot the study Bruker Alpha Fourier Transform Infrared Spectroscopy FT-IR drug checking machine among People who use drugs PWUD N20
2 To develop a community-level mobile integrated drug checking and PrEP intervention aimed to increase PWUD engagement in the PrEP care continuum and reduce the burden of overdose
3 To recruit a longitudinal cohort of people who use drugs N500 and follow-up at 6-month intervals for 18 months
4 To implement the intervention and evaluate its impact on engagement in PrEP care primary outcome and overdose prevention among PWUD
a To determine the incremental cost-effectiveness of the intervention in terms of HIV cases averted among PWUD
5 To assess changes in drug-related wounds among N100 PWUD in Baltimore who receive wound care services on the intervention van
1 To assess changes in drug-related wounds specifically attributed to xylazine
The initial nonhuman subjects research plan focused on Aims 1 drug checking machine calibration among samples procured from the Baltimore Police Forensics Lab tested in Dr William Clarkes lab and from individuals interacting with SPARC staff during the outreach which occurs 3-4 times per week These activities are referred to as Phase 1 throughout this research plan Based on emerging best practices and in consultation with other drug checking initiatives nationwide the investigators have now expanded Aim 1 of the study to include three steps needed to prepare the machine for deployment in the field The first 1a was calibration of the machine to the local drug supply as described above the second 1b which the investigators are adding in this amendment is an additional validation of the machines functionality and comparison with gold standard technology and the third 1c is piloting the machine with 20 PWUD prior to rolling it out citywide
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01DA053184 | NIH | None | httpsreporternihgovquickSearch5R01DA053184 |