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| ID | Type | Description | Link |
|---|---|---|---|
| R00DA041245 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention- ACT Therapy | Experimental | Participants randomized to this group will receive three ACT sessions over 1 month |
|
| Standard of Care | No Intervention | Participants in the control group will receive standard care as normally provided to patients by civil society organizations. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Overall Fidelity to Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | Measured via the Patient Health Questionnaire-9, a 9-item questionnaire with higher scores corresponding to greater depression severity. | 6 months |
| Anxiety | Measured via the Generalized Anxiety Disorder-7 scale, a 7-item questionnaire with higher scores corresponding to greater anxiety severity. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karsten Lunze, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First St. Petersburg Pavlov State Medical University | Saint Petersburg | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37180745 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention- Acceptance and Commitment Therapy (ACT) | Participants randomized to this group will receive three ACT sessions over 1 month Acceptance and Commitment Therapy (ACT): 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. |
| FG001 | Standard of Care | Participants in the control group will receive standard care as normally provided to patients by civil society organizations. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention- ACT Therapy | Participants randomized to this group will receive three ACT sessions over 1 month ACT Therapy: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who completed the 1-month assessment and attended at least one session. 64 of the 66 intervention participants completed the 1-month assessment AND at least one intervention session. | Posted | Count of Participants | Participants | 1 month |
|
Adverse event data were collected over the course of the 6-month study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention- ACT Therapy | Participants randomized to this group will receive three ACT sessions over 1 month ACT Therapy: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to HIV progression | Immune system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HIV progression | Immune system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karsten Lunze, MD | Boston Medical Center and BU School of Medicine | 617-638-6933 | lunze@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2021 | Aug 4, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 14, 2020 | Jul 1, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D013240 | Stereotyping |
| D019966 | Substance-Related Disorders |
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
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|
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 |
| Initiation of HIV Care | Defined as self-report of antiretroviral therapy (ART) initiation in the past 6 months. | 6 months |
| 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 |
| 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 |
| 6 months |
| Intersectional Stigma | Measured by both substance use stigma and HIV stigma scales, with high scores on both indicating intersectional stigma | 6 months |
| Psychological Flexibility | Measured via Acceptance and Action Questionnaire - Substance Abuse, an 18-item questionnaire. Higher scores correspond to higher psychological flexibility | 6 months |
| BG001 | Standard of Care | Participants in the control group will receive standard care as normally provided to patients by civil society organizations. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| HIV internalized stigma | Mean HIV internalized stigma score at baseline. 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. | Mean | Standard Deviation | Units on a scale |
|
| Substance use stigma | Substance use stigma score between at baseline. 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. | Mean | Standard Deviation | Units on a scale |
|
| OG001 | Standard of Care | Participants in the control group will receive standard care as normally provided to patients by civil society organizations. |
|
|
| 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. | Participants who completed the 1-month assessment | Posted | Mean | Standard Deviation | units on a scale | 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. | Participants who completed the 1-month assessment | Posted | Mean | Standard Deviation | Units on a scale | 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 | Only intervention arm participants analyzed for this outcome. | Posted | Count of Participants | Participants | 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. | Each intervention session was divided into 3 segments, totaling to 9 segments over 3 sessions. The first segment was discarded, as it only included introductions and no intervention content. The total number of segments throughout the intervention was 104 (8 segments of 13 groups). 30% of these segments were randomly selected to code to assess for fidelity, which resulted in 33 segments coded. This outcome is assessing the intervention segments, not the participants. | Posted | Count of Units | Intervention segments | Throughout the study to completion at 6 months | Intervention segments | Intervention segments |
|
|
|
| Secondary | Initiation of HIV Care | Defined as self-report of antiretroviral therapy (ART) initiation in the past 6 months. | Participants who completed the 6-month assessment | Posted | Count of Participants | Participants | 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. | Participants who completed the 6-month assessment | Posted | Count of Participants | Participants | 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. | Participants who completed the 6-month assessment | Posted | Mean | Standard Deviation | Number of injections | baseline, 6 months |
|
|
|
| Other Pre-specified | Depression | Measured via the Patient Health Questionnaire-9, a 9-item questionnaire with higher scores corresponding to greater depression severity. | Not Posted | 6 months | Participants |
| Other Pre-specified | Anxiety | Measured via the Generalized Anxiety Disorder-7 scale, a 7-item questionnaire with higher scores corresponding to greater anxiety severity. | Not Posted | 6 months | Participants |
| Other Pre-specified | Intersectional Stigma | Measured by both substance use stigma and HIV stigma scales, with high scores on both indicating intersectional stigma | Not Posted | 6 months | Participants |
| Other Pre-specified | Psychological Flexibility | Measured via Acceptance and Action Questionnaire - Substance Abuse, an 18-item questionnaire. Higher scores correspond to higher psychological flexibility | Not Posted | 6 months | Participants |
| 3 |
| 67 |
| 5 |
| 67 |
| 2 |
| 67 |
| EG001 | Standard of Care | Participants in the control group will receive standard care as normally provided to patients by civil society organizations. | 1 | 33 | 1 | 33 | 0 | 33 |
| Hospitalization due to pulmonary tuberculosis | Infections and infestations | Non-systematic Assessment |
|
| Death due to stroke | Nervous system disorders | Non-systematic Assessment |
|
| Death due to cerebral edema | Nervous system disorders | Non-systematic Assessment |
|
| Death due to cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | Non-systematic Assessment |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |