NCT04853394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

October 19, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2023

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 6, 2024

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

1.5 years

First QC Date

April 16, 2021

Results QC Date

November 7, 2024

Last Update Submit

December 2, 2024

Conditions

Keywords

injection drug usemigrant workersrisk behavior

Outcome Measures

Primary Outcomes (3)

  • Syringe Sharing

    injected with a previously used syringe

    3 months

  • Sex Without Condom

    vaginal or anal sex without a condom in the past 3 months

    3 months

  • Alcohol Use

    Number of days drinking alcohol in past month

    30 days

Secondary Outcomes (2)

  • HIV Infection

    12 months

  • Hepatitis C Infection

    12 months

Other Outcomes (1)

  • Injection Equipment Sharing

    3 months

Study Arms (2)

MASLIHAT peer education

EXPERIMENTAL

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

Behavioral: MASLIHAT

TANSIHAT health education

SHAM COMPARATOR

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

Behavioral: TANSIHAT

Interventions

MASLIHATBEHAVIORAL

peer educator intervention

MASLIHAT peer education
TANSIHATBEHAVIORAL

health education intervention

TANSIHAT health education

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • does not intend to stay in Moscow for the next 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRISMA Research Center

Moscow, Russia

Location

Related Publications (5)

  • 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.

    PMID: 37297541BACKGROUND
  • 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.

    PMID: 38212755BACKGROUND
  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

HIV InfectionsHepatitis CHealth Risk BehaviorsRisk Reduction BehaviorRisk-Taking

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System DiseasesHealth BehaviorBehavior

Results Point of Contact

Title
Mary E. Mackesy-Amiti
Organization
University of Illinois Chicago

Study Officials

  • Mary E Mackesy-Amiti, Ph.D.

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: cluster-randomized parallel groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 21, 2021

Study Start

October 19, 2021

Primary Completion

May 4, 2023

Study Completion

May 28, 2023

Last Updated

December 6, 2024

Results First Posted

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations