HIV Infections, Stigmatization, Substance Use
Conditions
Keywords
Injection drug use, Stigma, HIV
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.
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.
Interventions
BEHAVIORALACT 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Satisfied With the Intervention | 1 month | 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. |
| Change in Substance Use Stigma | baseline, 1 Month | 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. |
| Change in HIV Stigma Score | baseline, 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Fidelity to Intervention | Throughout the study to completion at 6 months | 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. |
| Initiation of HIV Care | 6 months | Defined as self-report of antiretroviral therapy (ART) initiation in the past 6 months. |
| Number of Participants Who Participated in the Intervention | Throughout the study to completion at 6 months | Defined as the number of participants who participated in three ACT intervention sessions |
| Engagement in Substance Use Care | 6 months | 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. |
| Change in the Total Number of Injections in the Previous 30 Days | baseline, 6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | 6 months | Measured via the Generalized Anxiety Disorder-7 scale, a 7-item questionnaire with higher scores corresponding to greater anxiety severity. |
| Psychological Flexibility | 6 months | Measured via Acceptance and Action Questionnaire - Substance Abuse, an 18-item questionnaire. Higher scores correspond to higher psychological flexibility |
| Depression | 6 months | Measured via the Patient Health Questionnaire-9, a 9-item questionnaire with higher scores corresponding to greater depression severity. |
| Intersectional Stigma | 6 months | Measured by both substance use stigma and HIV stigma scales, with high scores on both indicating intersectional stigma |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 67 |
| Standard of Care Participants in the control group will receive standard care as normally provided to patients by civil society organizations. | 33 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Intervention- ACT Therapy | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 33 Participants | 100 Participants |
| Age, Continuous | 38.28 years STANDARD_DEVIATION 4.87 | 37.67 years STANDARD_DEVIATION 6.39 | 38.08 years STANDARD_DEVIATION 5.39 |
| Education Higher education | 3 Participants | 0 Participants | 3 Participants |
| Education High school/college | 47 Participants | 23 Participants | 70 Participants |
| Education Middle school or less | 17 Participants | 10 Participants | 27 Participants |
| HIV internalized stigma | 3.31 Units on a scale STANDARD_DEVIATION 1.78 | 3.52 Units on a scale STANDARD_DEVIATION 1.6 | 3.38 Units on a scale STANDARD_DEVIATION 1.72 |
| Marital status Long-term relationship but not living together | 4 Participants | 2 Participants | 6 Participants |
| Marital status Married/domestic partnership | 43 Participants | 24 Participants | 67 Participants |
| Marital status Single/Divorced/Widowed/Separated | 20 Participants | 7 Participants | 27 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 65 Participants | 31 Participants | 96 Participants |
| Region of Enrollment Russia | 67 Participants | 33 Participants | 100 Participants |
| Sex: Female, Male Female | 33 Participants | 16 Participants | 49 Participants |
| Sex: Female, Male Male | 34 Participants | 17 Participants | 51 Participants |
| Substance use stigma | 31.40 Units on a scale STANDARD_DEVIATION 7.27 | 32.45 Units on a scale STANDARD_DEVIATION 7.35 | 31.75 Units on a scale STANDARD_DEVIATION 7.28 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 67 | 1 / 33 |
| other Total, other adverse events | 2 / 67 | 0 / 33 |
| serious Total, serious adverse events | 5 / 67 | 1 / 33 |
Outcome results
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.
Time frame: baseline, 1 month
Population: Participants who completed the 1-month assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention- ACT Therapy | Change in HIV Stigma Score | 0.45 units on a scale | Standard Deviation 1.42 |
| Standard of Care | Change in HIV Stigma Score | -0.06 units on a scale | Standard Deviation 1.05 |
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.
Time frame: baseline, 1 Month
Population: Participants who completed the 1-month assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention- ACT Therapy | Change in Substance Use Stigma | -1.42 Units on a scale | Standard Deviation 7.14 |
| Standard of Care | Change in Substance Use Stigma | 0.06 Units on a scale | Standard Deviation 7.81 |
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.
Time frame: 1 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention- ACT Therapy | Number of Participants Satisfied With the Intervention | 61 Participants |
| Standard of Care | Number of Participants Satisfied With the Intervention | 0 Participants |
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.
Time frame: baseline, 6 months
Population: Participants who completed the 6-month assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention- ACT Therapy | Change in the Total Number of Injections in the Previous 30 Days | -1.78 Number of injections | Standard Deviation 14.6 |
| Standard of Care | Change in the Total Number of Injections in the Previous 30 Days | 7.16 Number of injections | Standard Deviation 22.34 |
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.
Time frame: 6 months
Population: Participants who completed the 6-month assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention- ACT Therapy | Engagement in Substance Use Care | 15 Participants |
| Standard of Care | Engagement in Substance Use Care | 2 Participants |
Secondary
Initiation of HIV Care
Defined as self-report of antiretroviral therapy (ART) initiation in the past 6 months.
Time frame: 6 months
Population: Participants who completed the 6-month assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention- ACT Therapy | Initiation of HIV Care | 13 Participants |
| Standard of Care | Initiation of HIV Care | 1 Participants |
Secondary
Number of Participants Who Participated in the Intervention
Defined as the number of participants who participated in three ACT intervention sessions
Time frame: Throughout the study to completion at 6 months
Population: Only intervention arm participants analyzed for this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention- ACT Therapy | Number of Participants Who Participated in the Intervention | 54 Participants |
| Standard of Care | Number of Participants Who Participated in the Intervention | 0 Participants |
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.
Time frame: Throughout the study to completion at 6 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Intervention- ACT Therapy | Overall Fidelity to Intervention | 33 Intervention segments |
| Standard of Care | Overall Fidelity to Intervention | 0 Intervention segments |
Other Pre-specified
Anxiety
Measured via the Generalized Anxiety Disorder-7 scale, a 7-item questionnaire with higher scores corresponding to greater anxiety severity.
Time frame: 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.
Time frame: 6 months
Other Pre-specified
Intersectional Stigma
Measured by both substance use stigma and HIV stigma scales, with high scores on both indicating intersectional stigma
Time frame: 6 months
Other Pre-specified
Psychological Flexibility
Measured via Acceptance and Action Questionnaire - Substance Abuse, an 18-item questionnaire. Higher scores correspond to higher psychological flexibility
Time frame: 6 months