Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05704764
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-07-17
First Post:
2023-01-20
Brief Title:
Using the Ending Self-Stigma Intervention to Reduce Internalized Stigma Among People Living With HIV Who Use Substances
Sponsor:
Friends Research Institute Inc
Organization:
Friends Research Institute Inc
Study Overview
Official Title:
IRIS Intervention to Reduce Internalized Stigma IRIS Among People Living With HIV Who Use Substances
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-07
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:
IRIS
Brief Summary:
The goal of this clinical trial is to test an intervention to reduce stigma among people living with HIV who use opioids and cocaine The main question it aims to answer is
- Does reducing internalized stigma about HIV andor drug use lead to improved HIV care outcomes
After a year spent adapting an existing intervention to be applied specifically among people living with HIV who use substances 70 participants will be randomized to receive either treatment-as-usual or the newly adapted intervention The intervention itself will consist of less than ten group-based meetings to discuss and work through the stigmas people commonly associate with HIV andor drug use
- Does reducing internalized stigma about HIV andor drug use lead to improved HIV care outcomes
After a year spent adapting an existing intervention to be applied specifically among people living with HIV who use substances 70 participants will be randomized to receive either treatment-as-usual or the newly adapted intervention The intervention itself will consist of less than ten group-based meetings to discuss and work through the stigmas people commonly associate with HIV andor drug use
Detailed Description:
Different types of stigma eg anticipated enacted internalized associated with illicit substance use SU and HIV positive status impede HIV treatment outcomes incl HIV healthcare retention antiretroviral therapy ART adherence and viral load suppression The premise of this study is that individuals can learn to diminish the personal effects of public stigma thereby reducing internalized stigma and improving expected health outcomes
To this end this study will adapt an existing evidence-based stigma reduction intervention Ending Self-Stigma ESS which has shown efficacy in reducing internalized and anticipated stigma in populations experiencing mental health challenges to be applied specifically among people living with HIV and using opioids and cocaine The new group-based intervention will be called ESS-HSU and will use cognitive behavioral therapy strategies and social cognitive theory constructs to facilitate reductions in internalized stigma
In the first year an iterative process beginning with formative interviews with service delivery key informants and people living with HIVAIDS PLWH who use illicit opioids andor cocaine and ending with two rounds of pilot studies with the PLWH and SU will generate an initial version of ESS-HSU Intervention content will be adapted based on participant feedback and intervention delivery will be adapted for a virtual format Year one will end with two small pilot trials n 8 per trial to elicit participant feedback and further refine the adapted intervention
In years 2-3 a clinical trial testing the newly adapted ESS-HSU intervention will be carried out with 70 participants Group 1 Minimally Enhanced Treatment-as-Usual Group 2 ESS-HSU 11 randomization to determine feasibility and acceptability of the intervention in addition to collecting data on intervening variables incl internalized and anticipated stigma depressive symptoms anxiety and social support Primary HIV-related outcomes will include ART adherence suppressed viral load and retention in HIV healthcare at 6-month follow-up
To this end this study will adapt an existing evidence-based stigma reduction intervention Ending Self-Stigma ESS which has shown efficacy in reducing internalized and anticipated stigma in populations experiencing mental health challenges to be applied specifically among people living with HIV and using opioids and cocaine The new group-based intervention will be called ESS-HSU and will use cognitive behavioral therapy strategies and social cognitive theory constructs to facilitate reductions in internalized stigma
In the first year an iterative process beginning with formative interviews with service delivery key informants and people living with HIVAIDS PLWH who use illicit opioids andor cocaine and ending with two rounds of pilot studies with the PLWH and SU will generate an initial version of ESS-HSU Intervention content will be adapted based on participant feedback and intervention delivery will be adapted for a virtual format Year one will end with two small pilot trials n 8 per trial to elicit participant feedback and further refine the adapted intervention
In years 2-3 a clinical trial testing the newly adapted ESS-HSU intervention will be carried out with 70 participants Group 1 Minimally Enhanced Treatment-as-Usual Group 2 ESS-HSU 11 randomization to determine feasibility and acceptability of the intervention in addition to collecting data on intervening variables incl internalized and anticipated stigma depressive symptoms anxiety and social support Primary HIV-related outcomes will include ART adherence suppressed viral load and retention in HIV healthcare at 6-month follow-up
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 |
|---|---|---|---|
| R34DA055532 | NIH | None | httpsreporternihgovquickSearchR34DA055532 |