MedDataX Logo

Tajik Migrant Health Education Study

NCT ID: NCT04853394

Last Updated: 2024-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-19

Study Completion Date

2023-05-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will test the efficacy of a peer-education prevention intervention to reduce risky drug, alcohol, and sexual behaviors among male Tajik labor migrants who inject drugs (MWID) while working in Moscow. The peer educator intervention will be compared to a health education control intervention. Each intervention consists of 5 weekly 2-hour small group sessions. Follow-up assessments will be conducted at 3, 6, 9, and 12 months after the intervention. It is hypothesized that, compared to MWID who receive the health education control intervention, those who receive the peer educator intervention will have a greater reduction in the frequency of risk behaviors. Similar effects are expected for network members of intervention participants.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators will recruit male Tajik migrants who inject drugs from 12 different sites in Moscow, including bazaars and other work sites. In both study arms, the recruited men (index participants) will be required to recruit two eligible MWID peers for interviews prior to being interviewed themselves. Participants will be randomly assigned to either the peer educator intervention program or the health education intervention program. After peer-recruited network members are enrolled and interviewed, the index participant will participate in the peer educator training or the control group activities. All participants and recruited network members will then be followed and re-interviewed at 3-month intervals for one year to assess changes in risky drug, alcohol, and sexual behaviors due to intervention participation and through diffusion to network members. The investigators will also collect data from voluntary HIV and HCV testing conducted at 6 months (HCV only) and at 12 months (HIV and HCV) post-intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections Hepatitis C Risky Health Behavior Risk Reduction Behavior

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

injection drug use migrant workers risk behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

cluster-randomized parallel groups
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MASLIHAT peer education

A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.

Group Type EXPERIMENTAL

MASLIHAT

Intervention Type BEHAVIORAL

peer educator intervention

TANSIHAT health education

A health education program consisting of five weekly 2-hour sessions small group sessions.

Group Type SHAM_COMPARATOR

TANSIHAT

Intervention Type BEHAVIORAL

health education intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MASLIHAT

peer educator intervention

Intervention Type BEHAVIORAL

TANSIHAT

health education intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adult Tajik man
* injected drugs in past 30 days
* living and working as migrant laborer in Moscow

Exclusion Criteria

* does not intend to stay in Moscow for the next 12 months
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Prisma Research Center

UNKNOWN

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mary Ellen Mackesy-Amiti

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mary E Mackesy-Amiti, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

PRISMA Research Center

Moscow, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

References

Explore related publications, articles, or registry entries linked to this study.

Mackesy-Amiti ME, Levy JA, Bahromov M, Jonbekov J, Luc CM. HIV and Hepatitis C Risk among Tajik Migrant Workers Who Inject Drugs in Moscow. Int J Environ Res Public Health. 2023 May 24;20(11):5937. doi: 10.3390/ijerph20115937.

Reference Type BACKGROUND
PMID: 37297541 (View on PubMed)

Luc CM, Levy J, Bahromov M, Jonbekov J, Mackesy-Amiti ME. HIV knowledge, self-perception of HIV risk, and sexual risk behaviors among male Tajik labor migrants who inject drugs in Moscow. BMC Public Health. 2024 Jan 11;24(1):156. doi: 10.1186/s12889-023-17543-1.

Reference Type BACKGROUND
PMID: 38212755 (View on PubMed)

Mackesy-Amiti ME, Bahromov M, Levy JA, Jonbekov J, Luc CM. Changes in risk behaviour following a network peer education intervention for HIV prevention among male Tajik migrants who inject drugs in Moscow: a cluster-randomized controlled trial. J Int AIDS Soc. 2024 Jul;27 Suppl 3(Suppl 3):e26310. doi: 10.1002/jia2.26310.

Reference Type RESULT
PMID: 39030891 (View on PubMed)

Mackesy-Amiti ME, Levy JA, Luc CM, Jonbekov J. Peer education intervention reduced sexually transmitted infections among male Tajik labor migrants who inject drugs: results of a cluster-randomized controlled trial. BMC Public Health. 2025 Jun 10;25(1):2154. doi: 10.1186/s12889-025-23387-8.

Reference Type DERIVED
PMID: 40495129 (View on PubMed)

Mackesy-Amiti ME, Levy JA, Luc CM, Jonbekov J. Peer Education Intervention Reduced Sexually Transmitted Infections Among Male Tajik Labor Migrants Who Inject Drugs: Results of a Cluster-randomized Controlled Trial. medRxiv [Preprint]. 2025 May 1:2024.08.15.24312070. doi: 10.1101/2024.08.15.24312070.

Reference Type DERIVED
PMID: 39185538 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Index Participant

View Document

Document Type: Informed Consent Form: Network Participant

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://osf.io/7g3yh/

Open Science Framework Project page

https://osf.io/krjqs/?view_only=7c93ea8cf8384dce91b2b531000e63e3

Data files

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DA050464

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020-0795

Identifier Type: -

Identifier Source: org_study_id