Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05704764 |
| Other study ID # |
IRIS-ESS-HSU |
| Secondary ID |
R34DA055532 |
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 17, 2023 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
July 2023 |
| Source |
Friends Research Institute, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 and/or 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 and/or drug use.
Description:
Different types of stigma (e.g., 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 HIV/AIDS (PLWH) who use illicit opioids and/or
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;
1:1 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.
