NCT03695393: SCRIPT

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

Completed NA Results posted Last updated 5 September 2021

What this trial tests

NA trial testing ACT Therapy in HIV Infections in 100 participants. Completed in 10 March 2021.

Timeline

10 October 2019

Primary endpoint
16 October 2020

10 March 2021

Quick facts

Lead sponsor	Boston Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	10 October 2019
Primary completion	16 October 2020
Estimated completion	10 March 2021
Sites	1 location across Russia

Drugs / interventions tested

• ACT Therapy

Conditions studied

• HIV Infections — all drugs for HIV Infections →
• Stigmatization — all drugs for Stigmatization →
• Substance Use — all drugs for Substance Use →

Sponsor

Boston Medical Center

Who can join

18 and older, any sex, with HIV Infections or Stigmatization. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Satisfied With the Intervention Primary · 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.

Group	Value	95% CI
Intervention- ACT Therapy	61
Standard of Care	0

Change in HIV Stigma Score Primary · 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.

Group	Value	95% CI
Intervention- ACT Therapy	0.45	± 1.42
Standard of Care	-0.06	± 1.05

Change in Substance Use Stigma Primary · 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.

Group	Value	95% CI
Intervention- ACT Therapy	-1.42	± 7.14
Standard of Care	0.06	± 7.81

Number of Participants Who Participated in the Intervention Secondary · Throughout the study to completion at 6 months

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

Group	Value	95% CI
Intervention- ACT Therapy	54
Standard of Care	0

Overall Fidelity to Intervention Secondary · 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.

Group	Value	95% CI
Intervention- ACT Therapy	33
Standard of Care	0

Initiation of HIV Care Secondary · 6 months

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

Group	Value	95% CI
Intervention- ACT Therapy	13
Standard of Care	1

Engagement in Substance Use Care Secondary · 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.

Group	Value	95% CI
Intervention- ACT Therapy	15
Standard of Care	2

Change in the Total Number of Injections in the Previous 30 Days Secondary · 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.

Group	Value	95% CI
Intervention- ACT Therapy	-1.78	± 14.60
Standard of Care	7.16	± 22.34

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected over the course of the 6-month study period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention- ACT Therapy

Serious: 5/67 (7%)

Deaths: 3/67

Standard of Care

Serious: 1/33 (3%)

Deaths: 1/33

Serious adverse events (5 terms)

Reaction	System	Intervention- ACT Therapy	Standard of Care
Death due to cerebral edema	Nervous system disorders	—	—
Hospitalization due to HIV progression	Immune system disorders	—	—
Hospitalization due to pulmonary tuberculosis	Infections and infestations	—	—
Death due to stroke	Nervous system disorders	—	—
Death due to cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Intervention- ACT Therapy	Standard of Care
HIV progression	Immune system disorders	—	—
Pulmonary tuberculosis	Infections and infestations	—	—

Most-reported serious reactions: Death due to cerebral edema, Hospitalization due to HIV progression, Hospitalization due to pulmonary tuberculosis, Death due to stroke, Death due to cancer.

Data from ClinicalTrials.gov NCT03695393 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. An acceptance-based, intersectional stigma coping intervention for people with HIV who inject drugs-a randomized clinical trial.
   Luoma JB, Rossi SL, Sereda Y, Pavlov N, et al · · 2023 · cited 9× · PMID 37180745 · DOI 10.1016/j.lanepe.2023.100611
2. Addressing intersectional stigma as a care barrier for HIV-positive people who inject drugs: Design of an RCT in St. Petersburg, Russia.
   Rossi SL, Sereda Y, Luoma JB, Pavlov N, et al · · 2021 · cited 6× · PMID 34888430 · DOI 10.1016/j.conctc.2021.100861
3. COVID-19 pandemic-related stress and substance use behaviors among people with HIV - a mixed method analysis.
   Rossi SL, Cheng DM, Sereda Y, Truong V, et al · · 2026 · PMID 42207818 · DOI 10.1371/journal.pone.0349567