Trials / Completed
CompletedNCT03695393
Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Boston Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
Timeline
- Start date
- 2019-10-10
- Primary completion
- 2020-10-16
- Completion
- 2021-03-10
- First posted
- 2018-10-04
- Last updated
- 2021-09-05
- Results posted
- 2021-09-05
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT03695393. Inclusion in this directory is not an endorsement.