Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs
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Boston Medical Center
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | October 1, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | January 2019 | ||
| 预计主要完成日期 | July 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 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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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs | ||
| 正式标题 ICMJE | Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs | ||
| 简要概况 | 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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| 详细说明 | 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. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 干预项目 ICMJE |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
100 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 2020 | ||
| 预计主要完成日期 | July 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 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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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Russian Federation | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Boston Medical Center | ||
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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