First St. Petersburg Pavlov State Medical University
Saint Petersburg, Russia
NCT Number: NCT03695393
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Saint Petersburg, Russia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Throughout the study to completion at 6 months
Defined as the number of participants who participated in three ACT intervention sessions
Time frame: 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.
Time frame: 6 months
Defined as self-report of antiretroviral therapy (ART) initiation in the past 6 months.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Measured via the Patient Health Questionnaire-9, a 9-item questionnaire with higher scores corresponding to greater depression severity.
Time frame: 6 months
Measured via the Generalized Anxiety Disorder-7 scale, a 7-item questionnaire with higher scores corresponding to greater anxiety severity.
Time frame: 6 months
Measured by both substance use stigma and HIV stigma scales, with high scores on both indicating intersectional stigma
Time frame: 6 months
Measured via Acceptance and Action Questionnaire - Substance Abuse, an 18-item questionnaire. Higher scores correspond to higher psychological flexibility
Boston Medical Center
Other
Acronym: SCRIPT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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