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Tajik Migrant Health Education Study

Primary Purpose

HIV Infections, Hepatitis C, Risky Health Behavior

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
MASLIHAT
TANSIHAT
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring injection drug use, migrant workers, risk behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • PRISMA Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

MASLIHAT peer education

TANSIHAT health education

Arm Description

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

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

Outcomes

Primary Outcome Measures

syringe sharing
frequency of injecting with a previously used syringe
sex without condom
frequency of vaginal or anal sex without a condom in the past 3 months
alcohol use
Number of days drinking alcohol in past month

Secondary Outcome Measures

HIV infection
incident HIV infection
hepatitis C infection
incident HCV infection

Full Information

First Posted
April 16, 2021
Last Updated
October 12, 2023
Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Drug Abuse (NIDA), Prisma Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04853394
Brief Title
Tajik Migrant Health Education Study
Official Title
MASLIHAT Intervention for Tajik Male Migrants Who Inject Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
May 4, 2023 (Actual)
Study Completion Date
May 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Drug Abuse (NIDA), Prisma Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hepatitis C, Risky Health Behavior, Risk Reduction Behavior
Keywords
injection drug use, migrant workers, risk behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cluster-randomized parallel groups
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MASLIHAT peer education
Arm Type
Experimental
Arm Description
A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.
Arm Title
TANSIHAT health education
Arm Type
Sham Comparator
Arm Description
A health education program consisting of five weekly 2-hour sessions small group sessions.
Intervention Type
Behavioral
Intervention Name(s)
MASLIHAT
Intervention Description
peer educator intervention
Intervention Type
Behavioral
Intervention Name(s)
TANSIHAT
Intervention Description
health education intervention
Primary Outcome Measure Information:
Title
syringe sharing
Description
frequency of injecting with a previously used syringe
Time Frame
3 months
Title
sex without condom
Description
frequency of vaginal or anal sex without a condom in the past 3 months
Time Frame
3 months
Title
alcohol use
Description
Number of days drinking alcohol in past month
Time Frame
30 days
Secondary Outcome Measure Information:
Title
HIV infection
Description
incident HIV infection
Time Frame
12 months
Title
hepatitis C infection
Description
incident HCV infection
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
injection equipment sharing
Description
frequency of using shared injection equipment
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E Mackesy-Amiti, Ph.D.
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
PRISMA Research Center
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Tajik Migrant Health Education Study

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