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

HIV Infections Clinical Trial

— SCRIPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695393
• Other study ID #: H-38069
• Secondary ID: R00DA041245
• Status: Completed
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: March 10, 2021

Study information

• Verified date: September 2021
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 10, 2021
• Est. primary completion date: October 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Stigmatization
• Substance Use

Intervention

Behavioral:
• ACT Therapy
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.

Locations

Country	Name	City	State
Russian Federation	First St. Petersburg Pavlov State Medical University	St. Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression	Measured via the Patient Health Questionnaire-9, a 9-item questionnaire with higher scores corresponding to greater depression severity.	6 months
Other	Anxiety	Measured via the Generalized Anxiety Disorder-7 scale, a 7-item questionnaire with higher scores corresponding to greater anxiety severity.	6 months
Other	Intersectional Stigma	Measured by both substance use stigma and HIV stigma scales, with high scores on both indicating intersectional stigma	6 months
Other	Psychological Flexibility	Measured via Acceptance and Action Questionnaire - Substance Abuse, an 18-item questionnaire. Higher scores correspond to higher psychological flexibility	6 months
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Initiation of HIV Care	Defined as self-report of antiretroviral therapy (ART) initiation in the past 6 months.	6 months
Secondary	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
Secondary	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