Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs
Sponsor:
Boston Medical Center
Collaborators:
Information provided by (Responsible Party):
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| Tracking Information | |||
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| First Submitted Date ICMJE | October 1, 2018 | ||
| First Posted Date ICMJE | October 4, 2018 | ||
| Last Update Posted Date | October 4, 2018 | ||
| Actual Study Start Date ICMJE | January 2019 | ||
| Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Satisfaction with the intervention[ Time Frame: 2 months ] Assessed via 17-item questionnaire, developed by the study team. Higher scores indicate greater satisfaction with the intervention. Change in HIV Stigma Score from baseline to 2 months[ Time Frame: Baseline, 2 months ] Measured via an HIV Stigma Scale, a 10-item questionnaire developed by Berger et al., with an 11th question added about drug partners. Higher scores correspond to higher HIV stigma. Change in HIV Stigma Score from 2 to 6 months[ Time Frame: 2 Months, 6 months ] Measured via an HIV Stigma Scale, a 10-item questionnaire developed by Berger et al., with an 11th question added about drug partners. Higher scores correspond to higher HIV stigma. Change in HIV Stigma Score from baseline to 6 months[ Time Frame: baseline, 6 Months ] Measured via an HIV Stigma Scale, a 10-item questionnaire developed by Berger et al., with an 11th question added about drug partners. Higher scores correspond to higher HIV stigma. Change in Substance Use Stigma measured via Modified Substance Abuse Self-Stigma Scale from baseline to 2 months[ Time Frame: baseline, 2 Months ] Measured via an HIV Stigma Scale, a 10-item questionnaire developed by Berger et al., with an 11th question added about drug partners. Higher scores correspond to higher HIV stigma. Change in Substance Use Stigma measured via Modified Substance Abuse Self-Stigma Scale from 2 to 6 months[ Time Frame: 2 months, 6 months ] Measured via Modified Substance Abuse Self-Stigma Scale, a 21-item questionnaire developed by Luoma et al. Higher scores correspond to higher substance use stigma. Change in Substance Use Stigma measured via Modified Substance Abuse Self-Stigma Scale from baseline to 6 months[ Time Frame: baseline, 6 Months ] Measured via an HIV Stigma Scale, a 10-item questionnaire developed by Berger et al., with an 11th question added about drug partners. Higher scores correspond to higher HIV stigma. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs |
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| Official Title ICMJE | Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs |
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| 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. |
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| 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. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
100 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | November 2020 | ||
| Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - 18 years or older - HIV-positive - History of injection drug use - Screen high for HIV or substance use stigma - Not currently on 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 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 ED or hospital; mental health medication changes due to worsening symptoms; presence of suicidal ideations) - Enrolled in another research study | ||
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | Russian Federation | ||
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| Administrative Information | Has Data Monitoring Committee | Yes | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | ， | ||
| Study Sponsor ICMJE | Boston Medical Center | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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