Hepatitis C, HIV Infections, Risk Reduction Behavior, Risky Health Behavior
Conditions
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
peer educator intervention
health education intervention
Sponsors
Study design
Intervention model description
cluster-randomized parallel groups
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Syringe Sharing | 3 months | injected with a previously used syringe |
| Sex Without Condom | 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| HIV Infection | 12 months | incident HIV infection |
| Hepatitis C Infection | 12 months | incident hepatitis C virus (HCV) infection |
Other
| Measure | Time frame | Description |
|---|---|---|
| Injection Equipment Sharing | 3 months | used shared injection equipment |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up Interviews | Lost to Follow-up | 22 | 15 |
Baseline characteristics
| Characteristic | MASLIHAT Peer Education | TANSIHAT Health Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 210 Participants | 210 Participants | 420 Participants |
| Age, Continuous | 29.7 years STANDARD_DEVIATION 6.1 | 30.3 years STANDARD_DEVIATION 6.3 | 30.0 years STANDARD_DEVIATION 6.2 |
| Binge alcohol use | 45 Participants | 43 Participants | 88 Participants |
| Condomless sex | 85 Participants | 85 Participants | 170 Participants |
| Days of alcohol use past month | 5.2 days STANDARD_DEVIATION 3.2 | 5.3 days STANDARD_DEVIATION 3.4 | 5.3 days STANDARD_DEVIATION 3.3 |
| Hepatitis C antibody positive test result | 4 Participants | 8 Participants | 12 Participants |
| HIV positive test result | 19 Participants | 9 Participants | 28 Participants |
| Race/Ethnicity, Customized Tajik | 210 Participants | 210 Participants | 420 Participants |
| Receptive syringe sharing | 158 Participants | 161 Participants | 319 Participants |
| Region of Enrollment Russia | 210 participants | 210 participants | 420 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 210 Participants | 210 Participants | 420 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 210 | 0 / 210 |
| other Total, other adverse events | 3 / 210 | 3 / 210 |
| serious Total, serious adverse events | 0 / 210 | 0 / 210 |
Outcome results
Alcohol Use
Number of days drinking alcohol in past month
Time frame: 30 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MASLIHAT Peer Education | Alcohol Use | 3-months | 4.5 days | Standard Deviation 2.4 |
| MASLIHAT Peer Education | Alcohol Use | 6-months | 4.6 days | Standard Deviation 2.3 |
| MASLIHAT Peer Education | Alcohol Use | 9-months | 5.6 days | Standard Deviation 3.4 |
| MASLIHAT Peer Education | Alcohol Use | 12-months | 5.7 days | Standard Deviation 2.3 |
| TANSIHAT Health Education | Alcohol Use | 12-months | 6.1 days | Standard Deviation 2.4 |
| TANSIHAT Health Education | Alcohol Use | 3-months | 5.1 days | Standard Deviation 2.8 |
| TANSIHAT Health Education | Alcohol Use | 9-months | 5.3 days | Standard Deviation 2.6 |
| TANSIHAT Health Education | Alcohol Use | 6-months | 5.2 days | Standard Deviation 2.6 |
Sex Without Condom
vaginal or anal sex without a condom in the past 3 months
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MASLIHAT Peer Education | Sex Without Condom | 3-months | 27 Participants |
| MASLIHAT Peer Education | Sex Without Condom | 6-months | 25 Participants |
| MASLIHAT Peer Education | Sex Without Condom | 9-months | 25 Participants |
| MASLIHAT Peer Education | Sex Without Condom | 12-months | 26 Participants |
| TANSIHAT Health Education | Sex Without Condom | 12-months | 93 Participants |
| TANSIHAT Health Education | Sex Without Condom | 3-months | 77 Participants |
| TANSIHAT Health Education | Sex Without Condom | 9-months | 86 Participants |
| TANSIHAT Health Education | Sex Without Condom | 6-months | 91 Participants |
Syringe Sharing
injected with a previously used syringe
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MASLIHAT Peer Education | Syringe Sharing | 3-month follow-up | 16 Participants |
| MASLIHAT Peer Education | Syringe Sharing | 6-month follow-up | 15 Participants |
| MASLIHAT Peer Education | Syringe Sharing | 9-month follow-up | 22 Participants |
| MASLIHAT Peer Education | Syringe Sharing | 12-month follow-up | 36 Participants |
| TANSIHAT Health Education | Syringe Sharing | 12-month follow-up | 163 Participants |
| TANSIHAT Health Education | Syringe Sharing | 3-month follow-up | 167 Participants |
| TANSIHAT Health Education | Syringe Sharing | 9-month follow-up | 163 Participants |
| TANSIHAT Health Education | Syringe Sharing | 6-month follow-up | 175 Participants |
Hepatitis C Infection
incident hepatitis C virus (HCV) infection
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MASLIHAT Peer Education | Hepatitis C Infection | 3 Participants |
| TANSIHAT Health Education | Hepatitis C Infection | 3 Participants |
HIV Infection
incident HIV infection
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MASLIHAT Peer Education | HIV Infection | 0 Participants |
| TANSIHAT Health Education | HIV Infection | 0 Participants |
Injection Equipment Sharing
used shared injection equipment
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MASLIHAT Peer Education | Injection Equipment Sharing | 3-months | 16 Participants |
| MASLIHAT Peer Education | Injection Equipment Sharing | 6-months | 16 Participants |
| MASLIHAT Peer Education | Injection Equipment Sharing | 12-months | 15 Participants |
| MASLIHAT Peer Education | Injection Equipment Sharing | 9-months | 15 Participants |
| TANSIHAT Health Education | Injection Equipment Sharing | 9-months | 160 Participants |
| TANSIHAT Health Education | Injection Equipment Sharing | 3-months | 168 Participants |
| TANSIHAT Health Education | Injection Equipment Sharing | 12-months | 164 Participants |
| TANSIHAT Health Education | Injection Equipment Sharing | 6-months | 170 Participants |