N/A
N=100
Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs
HIV Infections · Stigmatization · Substance Use
Bottom Line
View on ClinicalTrials.gov: NCT03695393 ↗Enrolled (actual)
100
Serious AEs
6.0%
Results posted
Sep 2021
Primary outcome: Primary: Number of Participants Satisfied With the Intervention — 61; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ACT Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Satisfied With the Intervention |
61; 0 | — |
| PRIMARY Change in HIV Stigma Score |
0.45; -0.06 | — |
| PRIMARY Change in Substance Use Stigma |
-1.42; 0.06 | — |
| SECONDARY Number of Participants Who Participated in the Intervention |
54; 0 | — |
| SECONDARY Overall Fidelity to Intervention |
33; 0 | — |
| SECONDARY Initiation of HIV Care |
13; 1 | — |
| SECONDARY Engagement in Substance Use Care |
15; 2 | — |
| SECONDARY Change in the Total Number of Injections in the Previous 30 Days |
-1.78; 7.16 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03695393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.