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Tajik Migrant Health Education Study

MASLIHAT Intervention for Tajik Male Migrants Who Inject Drugs

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04853394
Enrollment
420
Registered
2021-04-21
Start date
2021-10-19
Completion date
2023-05-28
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, HIV Infections, Risk Reduction Behavior, Risky Health Behavior

Keywords

injection drug use, migrant workers, risk behavior

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.

Interventions

BEHAVIORALMASLIHAT

peer educator intervention

BEHAVIORALTANSIHAT

health education intervention

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

cluster-randomized parallel groups

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Syringe Sharing3 monthsinjected with a previously used syringe
Sex Without Condom3 monthsvaginal or anal sex without a condom in the past 3 months
Alcohol Use30 daysNumber of days drinking alcohol in past month

Secondary

MeasureTime frameDescription
HIV Infection12 monthsincident HIV infection
Hepatitis C Infection12 monthsincident hepatitis C virus (HCV) infection

Other

MeasureTime frameDescription
Injection Equipment Sharing3 monthsused shared injection equipment

Countries

Russia

Participant flow

Participants by arm

ArmCount
MASLIHAT Peer Education
A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions. MASLIHAT: peer educator intervention
210
TANSIHAT Health Education
A health education program consisting of five weekly 2-hour sessions small group sessions. TANSIHAT: health education intervention
210
Total420

Withdrawals & dropouts

PeriodReasonFG000FG001
Follow-up InterviewsLost to Follow-up2215

Baseline characteristics

CharacteristicMASLIHAT Peer EducationTANSIHAT Health EducationTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
210 Participants210 Participants420 Participants
Age, Continuous29.7 years
STANDARD_DEVIATION 6.1
30.3 years
STANDARD_DEVIATION 6.3
30.0 years
STANDARD_DEVIATION 6.2
Binge alcohol use45 Participants43 Participants88 Participants
Condomless sex85 Participants85 Participants170 Participants
Days of alcohol use past month5.2 days
STANDARD_DEVIATION 3.2
5.3 days
STANDARD_DEVIATION 3.4
5.3 days
STANDARD_DEVIATION 3.3
Hepatitis C antibody positive test result4 Participants8 Participants12 Participants
HIV positive test result19 Participants9 Participants28 Participants
Race/Ethnicity, Customized
Tajik
210 Participants210 Participants420 Participants
Receptive syringe sharing158 Participants161 Participants319 Participants
Region of Enrollment
Russia
210 participants210 participants420 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
210 Participants210 Participants420 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2100 / 210
other
Total, other adverse events
3 / 2103 / 210
serious
Total, serious adverse events
0 / 2100 / 210

Outcome results

Primary

Alcohol Use

Number of days drinking alcohol in past month

Time frame: 30 days

ArmMeasureGroupValue (MEAN)Dispersion
MASLIHAT Peer EducationAlcohol Use3-months4.5 daysStandard Deviation 2.4
MASLIHAT Peer EducationAlcohol Use6-months4.6 daysStandard Deviation 2.3
MASLIHAT Peer EducationAlcohol Use9-months5.6 daysStandard Deviation 3.4
MASLIHAT Peer EducationAlcohol Use12-months5.7 daysStandard Deviation 2.3
TANSIHAT Health EducationAlcohol Use12-months6.1 daysStandard Deviation 2.4
TANSIHAT Health EducationAlcohol Use3-months5.1 daysStandard Deviation 2.8
TANSIHAT Health EducationAlcohol Use9-months5.3 daysStandard Deviation 2.6
TANSIHAT Health EducationAlcohol Use6-months5.2 daysStandard Deviation 2.6
p-value: 0.0195% CI: [0.77, 0.95]Mixed Models Analysis
p-value: 0.0195% CI: [0.98, 1.45]Mixed Models Analysis
Primary

Sex Without Condom

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

Time frame: 3 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
MASLIHAT Peer EducationSex Without Condom3-months27 Participants
MASLIHAT Peer EducationSex Without Condom6-months25 Participants
MASLIHAT Peer EducationSex Without Condom9-months25 Participants
MASLIHAT Peer EducationSex Without Condom12-months26 Participants
TANSIHAT Health EducationSex Without Condom12-months93 Participants
TANSIHAT Health EducationSex Without Condom3-months77 Participants
TANSIHAT Health EducationSex Without Condom9-months86 Participants
TANSIHAT Health EducationSex Without Condom6-months91 Participants
p-value: 0.0195% CI: [0.46, 0.97]Mixed Models Analysis
Primary

Syringe Sharing

injected with a previously used syringe

Time frame: 3 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
MASLIHAT Peer EducationSyringe Sharing3-month follow-up16 Participants
MASLIHAT Peer EducationSyringe Sharing6-month follow-up15 Participants
MASLIHAT Peer EducationSyringe Sharing9-month follow-up22 Participants
MASLIHAT Peer EducationSyringe Sharing12-month follow-up36 Participants
TANSIHAT Health EducationSyringe Sharing12-month follow-up163 Participants
TANSIHAT Health EducationSyringe Sharing3-month follow-up167 Participants
TANSIHAT Health EducationSyringe Sharing9-month follow-up163 Participants
TANSIHAT Health EducationSyringe Sharing6-month follow-up175 Participants
p-value: <0.0195% CI: [0.21, 0.51]Mixed Models Analysis
Secondary

Hepatitis C Infection

incident hepatitis C virus (HCV) infection

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
MASLIHAT Peer EducationHepatitis C Infection3 Participants
TANSIHAT Health EducationHepatitis C Infection3 Participants
Secondary

HIV Infection

incident HIV infection

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
MASLIHAT Peer EducationHIV Infection0 Participants
TANSIHAT Health EducationHIV Infection0 Participants
Other Pre-specified

Injection Equipment Sharing

used shared injection equipment

Time frame: 3 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
MASLIHAT Peer EducationInjection Equipment Sharing3-months16 Participants
MASLIHAT Peer EducationInjection Equipment Sharing6-months16 Participants
MASLIHAT Peer EducationInjection Equipment Sharing12-months15 Participants
MASLIHAT Peer EducationInjection Equipment Sharing9-months15 Participants
TANSIHAT Health EducationInjection Equipment Sharing9-months160 Participants
TANSIHAT Health EducationInjection Equipment Sharing3-months168 Participants
TANSIHAT Health EducationInjection Equipment Sharing12-months164 Participants
TANSIHAT Health EducationInjection Equipment Sharing6-months170 Participants
p-value: 0.0195% CI: [0.07, 0.19]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026