HIV Infections Clinical Trial
— SCRIPTOfficial title:
Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs
Verified date | September 2021 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | First St. Petersburg Pavlov State Medical University | St. Petersburg |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | National Institute on Drug Abuse (NIDA) |
Russian Federation,
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 |
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