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

NCT03695393 | Completed Results DMC

• 2 other identifiers: H-38069R00DA041245
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Stigmatization; Substance Use

Keywords

Injection drug use; Stigma; HIV

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Number of Participants Who Participated in the Intervention

  Throughout the study to completion at 6 months

• Overall Fidelity to Intervention

  Throughout the study to completion at 6 months

• Initiation of HIV Care

  6 months

• Engagement in Substance Use Care

  6 months

• Change in the Total Number of Injections in the Previous 30 Days

  baseline, 6 months

Other Outcomes (4)

• Depression

  6 months

• Anxiety

  6 months

• Intersectional Stigma

  6 months

Study Arms (2)

Intervention- ACT Therapy

EXPERIMENTAL

Participants randomized to this group will receive three ACT sessions over 1 month

Behavioral: ACT Therapy

Standard of Care

NO INTERVENTION

Participants in the control group will receive standard care as normally provided to patients by civil society organizations.

Interventions

ACT Therapy BEHAVIORAL

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.

Intervention- ACT Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

First St. Petersburg Pavlov State Medical University

Saint Petersburg, Russia

Location

Related Publications (1)

• Luoma JB, Rossi SL, Sereda Y, Pavlov N, Toussova O, Vetrova M, Bendiks S, Kiriazova T, Krupitsky E, Lioznov D, Blokhina E, Lodi S, Lunze K. An acceptance-based, intersectional stigma coping intervention for people with HIV who inject drugs-a randomized clinical trial. Lancet Reg Health Eur. 2023 Mar 20;28:100611. doi: 10.1016/j.lanepe.2023.100611. eCollection 2023 May.

  PMID: 37180745 DERIVED

MeSH Terms

Conditions

HIV Infections; Stereotyping; Substance-Related Disorders; Social Stigma

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Results Point of Contact

• Title: Karsten Lunze, MD
• Organization: Boston Medical Center and BU School of Medicine

lunze@bu.edu

617-638-6933

Study Officials

• Karsten Lunze, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 4, 2018
• Study Start: October 10, 2019
• Primary Completion: October 16, 2020
• Study Completion: March 10, 2021
• Last Updated: September 5, 2021
• Results First Posted: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)