Tajik Migrant Health Education Study

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04853394

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), Prisma Research Center (Other)

420

Enrollment

Location

Arms

38.4

Anticipated Duration (Months)

10.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Hepatitis C Risky Health Behavior Risk Reduction Behavior	Behavioral: MASLIHAT Behavioral: TANSIHAT	N/A

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

Study Type:

Interventional

Actual Enrollment :

420 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

cluster-randomized parallel groupscluster-randomized parallel groups

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

MASLIHAT Intervention for Tajik Male Migrants Who Inject Drugs

Actual Study Start Date :

Oct 19, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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

Primary Outcome Measures

syringe sharing [3 months]
frequency of injecting with a previously used syringe
sex without condom [3 months]
frequency of vaginal or anal sex without a condom in the past 3 months
alcohol use [30 days]
Number of days drinking alcohol in past month

Secondary Outcome Measures

HIV infection [12 months]
incident HIV infection
hepatitis C infection [12 months]
incident HCV infection

Other Outcome Measures

injection equipment sharing [3 months]
frequency of using shared injection equipment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	PRISMA Research Center	Moscow		Russian Federation

Sponsors and Collaborators

University of Illinois at Chicago
National Institute on Drug Abuse (NIDA)
Prisma Research Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

First Posted:

Apr 21, 2021

Last Update Posted:

May 5, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mary Ellen Mackesy-Amiti, Research Associate Professor, University of Illinois at Chicago

injection drug use

migrant workers

risk behavior

Additional relevant MeSH terms:

Hepatitis C

Study Results

No Results Posted as of May 5, 2022