Tajik Migrant Health Education Study

March 7, 2024 updated by: Mary Ellen Mackesy-Amiti, University of Illinois at Chicago

MASLIHAT Intervention for Tajik Male Migrants Who Inject Drugs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MASLIHAT peer education
A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.
Behavioral: MASLIHAT
peer educator intervention
Sham Comparator: TANSIHAT health education
A health education program consisting of five weekly 2-hour sessions small group sessions.
Behavioral: TANSIHAT
health education intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
syringe sharing
Time Frame: 3 months
frequency of injecting with a previously used syringe
3 months
sex without condom
Time Frame: 3 months
frequency of vaginal or anal sex without a condom in the past 3 months
3 months
alcohol use
Time Frame: 30 days
Number of days drinking alcohol in past month
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV infection
Time Frame: 12 months
incident HIV infection
12 months
hepatitis C infection
Time Frame: 12 months
incident HCV infection
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
injection equipment sharing
Time Frame: 3 months
frequency of using shared injection equipment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Institute on Drug Abuse (NIDA)
Prisma Research Center

Investigators

  • Principal Investigator: Mary E Mackesy-Amiti, Ph.D., University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2021

Primary Completion (Actual)

May 4, 2023

Study Completion (Actual)

May 28, 2023

Study Registration Dates

First Submitted

April 16, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0795
  • R01DA050464 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The final data will be shared by depositing it in a public data repository. The final dataset will include self-reported sociodemographic characteristics, HIV transmission knowledge and risk awareness, sexual partners and risk behavior, illicit drug use and injection risk behavior, prevention self-efficacy, and injection drug use network interactions at 5 time points, and HIV and HCV test results at 2 time points. No identifying information will be included in the final dataset.

IPD Sharing Time Frame

The data will be made available upon study completion.

IPD Sharing Access Criteria

Access will be provided upon request with a description of the intended use.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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