Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs

Study Overview
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Brief Summary
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This study is a randomized controlled trial (RCT) among 100 HIV-positive people with injection drug use, which aims to test the feasibility of the SCRIPT intervention and evaluate its effectiveness on the reduction of internalized stigma, as well as entry into substance use treatment or initiation of antiretroviral therapy.

Detailed Description
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People who inject drugs often experience multiple layers of stigma when they are living with HIV. Stigma is defined as the social exclusion and dehumanization of individuals in an undesirable social category. Interventions to help affected people who inject drugs living with HIV cope with the dual stigma related to HIV and substance use have not been studied specifically in this population. Among people living with HIV, stigma adversely impacts all aspects of the care cascade: timely HIV testing, diagnosis, treatment, adherence and retention in care. Among people who inject drugs, drug use may add to adverse social factors and create particular stigma vulnerability. Russia is a country where people who inject drugs and other HIV key populations are highly stigmatized and face discrimination. Further qualitative findings suggest that in the absence of public anti-stigma campaigns in Russia, stigma reduction interventions should address internalized stigma and their determinants to help affected people cope with the dual stigma. Stigma interventions should be adapted to address not only affected people's shame and guilt, but also their felt hopelessness. These emotions and related feelings such as avoidance and fear of being rejected may negatively affect people's agency and mental health. We are proposing Acceptance and Commitment Therapy (ACT) as a potential behavioral intervention to target the emotions underlying internalized stigma and thus empower affected people. ACT has been shown to increase engagement in addiction care. Its use and efficacy to reduce stigma has not yet been explored among HIV-positive people who inject drugs. The objective of this study, Stigma, Risk Behaviors and Health Care among HIV-positive Russian People Who Inject Drugs (SCRIPT),is to implement and evaluate, the feasibility of ACT as an intervention to reduce dual HIV and substance use stigma via a two-armed randomized controlled trial among 100 HIV-positive people who inject drugs. The central hypothesis is that SCRIPT is feasible and can be delivered to decrease HIV and substance use stigma scores.

Official Title
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Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs

Conditions
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HIV Infections, Stigmatization, Substance Use

Intervention / Treatment
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* Behavioral: ACT Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older HIV-positive Current injection drug use (past 30 days) Not currently on antiretroviral therapy (ART) Provision of contact information for two contacts to assist with follow-up Address within 100 kilometers of St. Petersburg Possession of a telephone (home or cell) Able and willing to comply with all study protocols and procedures over 6 months Available at the specific days of the week and times that the group sessions will be occurring for the subsequent 3-4 weeks (to ensure that participants randomized into the intervention arm will be able to receive the intervention) Exclusion Criteria: Not fluent in Russian Cognitive impairment resulting in ability to provide informed consent based on research assessor (RA) assessment Acute severe psychiatric illness (i.e., answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the Emergency Department (ED) or hospital; mental health medication changes due to worsening symptoms; presence of suicidal plans) and research assessor clinical observation (i.e. clinical observation or prior knowledge of severe personality disorder; past three months active mania; past three months active psychosis) Enrolled in another research study Participated in the pilot portion of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention- ACT Therapy<br>Participants randomized to this group will receive three ACT sessions over 1 month | Behavioral: ACT Therapy<br>* The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.<br>|
| No Intervention: Standard of Care<br>Participants in the control group will receive standard care as normally provided to patients by civil society organizations. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Satisfied With the Intervention | Number of participants with satisfaction score of ≥ 3 out of 5. Score determined by an average of a 3-item Likert scale (1-5) questionnaire, developed by the study team. | 1 month | 
| Change in HIV Stigma Score | Mean change in HIV internalized stigma score between baseline and 1 month. Measured via a modified HIV internalized stigma scale, a 7-item questionnaire. Each item had yes/no options. Scores ranged from 0 to 7. Higher scores correspond to higher HIV stigma. | baseline, 1 month | 
| Change in Substance Use Stigma | Mean change in substance use stigma score between baseline and 1 month. Measured via Modified Substance Abuse Self-Stigma Scale, an 12-item questionnaire. Each item was assessed on a 5-point Likert scale. Scores ranged from 12 to 60. Higher scores correspond to higher substance use stigma. | baseline, 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Participated in the Intervention | Defined as the number of participants who participated in three ACT intervention sessions | Throughout the study to completion at 6 months | 
| Overall Fidelity to Intervention | Defined using the Adherence Raters' Manual for Stigma Treatment Study to rate the recorded intervention tapes. This outcome reports the number of intervention segments that meet adequate fidelity. Overall fidelity rated on a score of 1 (low) to 5 (high). Score of a 3 or above was considered adequate fidelity. | Throughout the study to completion at 6 months | 
| Initiation of HIV Care | Defined as self-report of antiretroviral therapy (ART) initiation in the past 6 months. | 6 months | 
| Engagement in Substance Use Care | Defined as self-report of treatment of a substance use disorder in an outpatient clinic, inpatient setting, or attendance of 12-step recovery program in the past 6 months. | 6 months | 
| Change in the Total Number of Injections in the Previous 30 Days | Defined as self-report of any change in injection drug use in the previous 30 days measured via a modified Risk Behavior Survey. Participants report total number of injections in the past 30 days. | baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Injection drug use, Stigma, HIV