Trial Outcomes & Findings for Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs (NCT NCT03695393)

Last Updated: 2021-09-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

1 month

Results posted on

2021-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Standard of Care Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
Overall Study STARTED	67	33
Overall Study 1-month	66	32
Overall Study 6-month	64	31
Overall Study COMPLETED	64	31
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Standard of Care Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
Overall Study Death	3	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention- ACT Therapy n=67 Participants 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.	Standard of Care n=33 Participants Participants in the control group will receive standard care as normally provided to patients by civil society organizations.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=5 Participants	33 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38.28 years STANDARD_DEVIATION 4.87 • n=5 Participants	37.67 years STANDARD_DEVIATION 6.39 • n=7 Participants	38.08 years STANDARD_DEVIATION 5.39 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	16 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	17 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	65 Participants n=5 Participants	31 Participants n=7 Participants	96 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Russia	67 Participants n=5 Participants	33 Participants n=7 Participants	100 Participants n=5 Participants
Education Middle school or less	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Education High school/college	47 Participants n=5 Participants	23 Participants n=7 Participants	70 Participants n=5 Participants
Education Higher education	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Marital status Married/domestic partnership	43 Participants n=5 Participants	24 Participants n=7 Participants	67 Participants n=5 Participants
Marital status Long-term relationship but not living together	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Marital status Single/Divorced/Widowed/Separated	20 Participants n=5 Participants	7 Participants n=7 Participants	27 Participants n=5 Participants
HIV internalized stigma	3.31 Units on a scale STANDARD_DEVIATION 1.78 • n=5 Participants	3.52 Units on a scale STANDARD_DEVIATION 1.60 • n=7 Participants	3.38 Units on a scale STANDARD_DEVIATION 1.72 • n=5 Participants
Substance use stigma	31.40 Units on a scale STANDARD_DEVIATION 7.27 • n=5 Participants	32.45 Units on a scale STANDARD_DEVIATION 7.35 • n=7 Participants	31.75 Units on a scale STANDARD_DEVIATION 7.28 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention- ACT Therapy n=64 Participants 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.	Standard of Care Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
Number of Participants Satisfied With the Intervention	61 Participants	0 Participants

PRIMARY outcome

Timeframe: baseline, 1 month

Population: Participants who completed the 1-month assessment

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.

Outcome measures

Outcome measures
Measure	Intervention- ACT Therapy n=66 Participants 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.	Standard of Care n=32 Participants Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
Change in HIV Stigma Score	0.45 units on a scale Standard Deviation 1.42	-0.06 units on a scale Standard Deviation 1.05

PRIMARY outcome

Timeframe: baseline, 1 Month

Population: Participants who completed the 1-month assessment

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.

Outcome measures

Outcome measures
Measure	Intervention- ACT Therapy n=66 Participants 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.	Standard of Care n=32 Participants Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
Change in Substance Use Stigma	-1.42 Units on a scale Standard Deviation 7.14	0.06 Units on a scale Standard Deviation 7.81

SECONDARY outcome

Timeframe: Throughout the study to completion at 6 months

Population: Only intervention arm participants analyzed for this outcome.

Defined as the number of participants who participated in three ACT intervention sessions

Outcome measures

Outcome measures
Measure	Intervention- ACT Therapy n=67 Participants 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.	Standard of Care Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
Number of Participants Who Participated in the Intervention	54 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention- ACT Therapy n=33 Intervention segments 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.	Standard of Care Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
Overall Fidelity to Intervention	33 Intervention segments	0 Intervention segments

SECONDARY outcome

Timeframe: 6 months

Population: Participants who completed the 6-month assessment

Defined as self-report of antiretroviral therapy (ART) initiation in the past 6 months.

Outcome measures

Outcome measures
Measure	Intervention- ACT Therapy n=64 Participants 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.	Standard of Care n=31 Participants Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
Initiation of HIV Care	13 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants who completed the 6-month assessment

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.

Outcome measures

Outcome measures
Measure	Intervention- ACT Therapy n=64 Participants 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.	Standard of Care n=31 Participants Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
Engagement in Substance Use Care	15 Participants	2 Participants

SECONDARY outcome

Timeframe: baseline, 6 months

Population: Participants who completed the 6-month assessment

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.

Outcome measures

Outcome measures
Measure	Intervention- ACT Therapy n=64 Participants 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.	Standard of Care n=31 Participants Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
Change in the Total Number of Injections in the Previous 30 Days	-1.78 Number of injections Standard Deviation 14.60	7.16 Number of injections Standard Deviation 22.34

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Intervention- ACT Therapy n=67 participants at risk 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.	Standard of Care n=33 participants at risk Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
Immune system disorders Hospitalization due to HIV progression	1.5% 1/67 • Number of events 1 • Adverse event data were collected over the course of the 6-month study period.	0.00% 0/33 • Adverse event data were collected over the course of the 6-month study period.
Infections and infestations Hospitalization due to pulmonary tuberculosis	1.5% 1/67 • Number of events 1 • Adverse event data were collected over the course of the 6-month study period.	0.00% 0/33 • Adverse event data were collected over the course of the 6-month study period.
Nervous system disorders Death due to stroke	0.00% 0/67 • Adverse event data were collected over the course of the 6-month study period.	3.0% 1/33 • Number of events 1 • Adverse event data were collected over the course of the 6-month study period.
Nervous system disorders Death due to cerebral edema	3.0% 2/67 • Number of events 2 • Adverse event data were collected over the course of the 6-month study period.	0.00% 0/33 • Adverse event data were collected over the course of the 6-month study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death due to cancer	1.5% 1/67 • Number of events 1 • Adverse event data were collected over the course of the 6-month study period.	0.00% 0/33 • Adverse event data were collected over the course of the 6-month study period.

Other adverse events

Other adverse events
Measure	Intervention- ACT Therapy n=67 participants at risk 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.	Standard of Care n=33 participants at risk Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
Immune system disorders HIV progression	1.5% 1/67 • Number of events 1 • Adverse event data were collected over the course of the 6-month study period.	0.00% 0/33 • Adverse event data were collected over the course of the 6-month study period.
Infections and infestations Pulmonary tuberculosis	1.5% 1/67 • Number of events 1 • Adverse event data were collected over the course of the 6-month study period.	0.00% 0/33 • Adverse event data were collected over the course of the 6-month study period.

Additional Information

Karsten Lunze, MD

Boston Medical Center and BU School of Medicine

Phone: 617-638-6933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place