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Tajik Migrant Health Education Study

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ClinicalTrials.gov Identifier: NCT04853394
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : October 22, 2021
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Prisma Research Center
Information provided by (Responsible Party):
Mary Ellen Mackesy-Amiti, University of Illinois at Chicago

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Hepatitis C Risky Health Behavior Risk Reduction Behavior Behavioral: MASLIHAT Behavioral: TANSIHAT Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: MASLIHAT Intervention for Tajik Male Migrants Who Inject Drugs
Actual Study Start Date : October 19, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. syringe sharing [ Time Frame: 3 months ]
    frequency of injecting with a previously used syringe

  2. sex without condom [ Time Frame: 3 months ]
    frequency of vaginal or anal sex without a condom in the past 3 months

  3. alcohol use [ Time Frame: 30 days ]
    Number of days drinking alcohol in past month


Secondary Outcome Measures :
  1. HIV infection [ Time Frame: 12 months ]
    incident HIV infection

  2. hepatitis C infection [ Time Frame: 12 months ]
    incident HCV infection


Other Outcome Measures:
  1. injection equipment sharing [ Time Frame: 3 months ]
    frequency of using shared injection equipment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853394


Contacts
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Contact: Jonbek Jonbekov, B.A. +992 935676565 jonbek@mail.ru
Contact: Mahbat Bakhromov, M.D. +992 935676565 mahbat.bahromov@akdn.org

Locations
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Russian Federation
PRISMA Research Center Recruiting
Moscow, Russian Federation
Contact: Jonbek Jonbekov    +992 935676565    jonbek@mail.ru   
Principal Investigator: Mahbat Bahromov, M.D.         
Sponsors and Collaborators
University of Illinois at Chicago
National Institute on Drug Abuse (NIDA)
Prisma Research Center
Investigators
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Principal Investigator: Mary E Mackesy-Amiti, Ph.D. University of Illinois at Chicago
More Information
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Responsible Party: Mary Ellen Mackesy-Amiti, Research Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04853394    
Other Study ID Numbers: 2020-0795
R01DA050464 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: The data will be made available upon study completion.
Access Criteria: Access will be provided upon request with a description of the intended use.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary Ellen Mackesy-Amiti, University of Illinois at Chicago:
injection drug use
migrant workers
risk behavior
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
 Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections