Clinical trial NCT03695393: Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs
Official title: Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Stigmatization
Substance Use
Keywords: Injection drug use
Stigma
HIV
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Satisfied With the Intervention
timeFrame: 1 month
measure: Change in HIV Stigma Score
timeFrame: baseline, 1 month
measure: Change in Substance Use Stigma
timeFrame: baseline, 1 Month
Secondary outcomes:
measure: Number of Participants Who Participated in the Intervention
timeFrame: Throughout the study to completion at 6 months
measure: Overall Fidelity to Intervention
timeFrame: Throughout the study to completion at 6 months
measure: Initiation of HIV Care
timeFrame: 6 months
measure: Engagement in Substance Use Care
timeFrame: 6 months
measure: Change in the Total Number of Injections in the Previous 30 Days
timeFrame: baseline, 6 months
Other outcomes:
measure: Depression
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
measure: Intersectional Stigma
timeFrame: 6 months
measure: Psychological Flexibility
timeFrame: 6 months
Locations:
city: St. Petersburg
country: Russian Federation
facility: First St. Petersburg Pavlov State Medical University
Study officials:
affiliation: Boston Medical Center
name: Karsten Lunze, MD
role: PRINCIPAL_INVESTIGATOR
References: