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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04853394
Other study ID # 2020-0795
Secondary ID R01DA050464
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2021
Est. completion date May 28, 2023

Study information

Verified date March 2024
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 420
Est. completion date May 28, 2023
Est. primary completion date May 4, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
MASLIHAT
peer educator intervention
TANSIHAT
health education intervention

Locations

Country Name City State
Russian Federation PRISMA Research Center Moscow

Sponsors (3)

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

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other injection equipment sharing frequency of using shared injection equipment 3 months
Primary syringe sharing frequency of injecting with a previously used syringe 3 months
Primary sex without condom frequency of vaginal or anal sex without a condom in the past 3 months 3 months
Primary alcohol use Number of days drinking alcohol in past month 30 days
Secondary HIV infection incident HIV infection 12 months
Secondary hepatitis C infection incident HCV infection 12 months
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