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

Not Applicable

Completed

Conditions: HIV Infections
Substance Use
Stigmatization

Interventions: Behavioral: ACT Therapy

Registration Number: NCT03695393

Lead Sponsor: Boston Medical Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention- ACT Therapy	ACT Therapy	Participants randomized to this group will receive three ACT sessions over 1 month

Primary Outcome Measures

Name	Time	Method
Number of Participants Satisfied With the Intervention	1 month	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.
Change in Substance Use Stigma	baseline, 1 Month	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.
Change in HIV Stigma Score	baseline, 1 month	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.

Secondary Outcome Measures

Name	Time	Method
Engagement in Substance Use Care	6 months	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.
Change in the Total Number of Injections in the Previous 30 Days	baseline, 6 months	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.
Number of Participants Who Participated in the Intervention	Throughout the study to completion at 6 months	Defined as the number of participants who participated in three ACT intervention sessions
Overall Fidelity to Intervention	Throughout the study to completion at 6 months	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.
Initiation of HIV Care	6 months	Defined as self-report of antiretroviral therapy (ART) initiation in the past 6 months.