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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA050464 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Prisma Research Center | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MASLIHAT peer education | Experimental | A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions. |
|
| TANSIHAT health education | Sham Comparator | A health education program consisting of five weekly 2-hour sessions small group sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MASLIHAT | Behavioral | peer educator intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Infection | incident HIV infection | 12 months |
| Hepatitis C Infection | incident hepatitis C virus (HCV) infection | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Injection Equipment Sharing | used shared injection equipment | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary E Mackesy-Amiti, Ph.D. | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRISMA Research Center | Moscow | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37297541 | Background | 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. | |
| 38212755 | Background | 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. |
| Label | URL |
|---|---|
| Open Science Framework Project page | View source |
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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.
The data will be made available upon study completion.
Access will be provided upon request with a description of the intended use.
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| ID | Title | Description |
|---|---|---|
| FG000 | MASLIHAT Peer Education | A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions. MASLIHAT: peer educator intervention |
| FG001 | TANSIHAT Health Education | A health education program consisting of five weekly 2-hour sessions small group sessions. TANSIHAT: health education intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Interview |
| |||||||||||||
| Intervention Sessions |
| |||||||||||||
| Follow-up Interviews |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MASLIHAT Peer Education | A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions. MASLIHAT: peer educator intervention |
| BG001 | TANSIHAT Health Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Syringe Sharing | injected with a previously used syringe | Posted | Count of Participants | Participants | 3 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MASLIHAT Peer Education | A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions. MASLIHAT: peer educator intervention |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hepatitis C infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary E. Mackesy-Amiti | University of Illinois Chicago | 312-355-4892 | mmamiti@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2021 | Mar 5, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Index Participant | Mar 24, 2022 | Mar 5, 2024 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Network Participant | Mar 24, 2022 | Mar 5, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006526 | Hepatitis C |
| D000073599 | Health Risk Behaviors |
| D040242 | Risk Reduction Behavior |
| D012309 | Risk-Taking |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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cluster-randomized parallel groups
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| TANSIHAT |
| Behavioral |
health education intervention |
|
| 39030891 | Result | 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. |
| 40495129 | Derived | 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. |
| 39185538 | Derived | 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. |
| Data files | View source |
| NOT COMPLETED |
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| NOT COMPLETED |
|
|
A health education program consisting of five weekly 2-hour sessions small group sessions.
TANSIHAT: health education intervention
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Receptive syringe sharing | injecting with a previously used syringe in the past 3 months | Count of Participants | Participants |
|
| Condomless sex | any condomless sex in the past 3 months | Count of Participants | Participants |
|
| Binge alcohol use | six or more drinks at a time at least once a month | Count of Participants | Participants |
|
| Days of alcohol use past month | Mean | Standard Deviation | days |
|
| HIV positive test result | Among participants with reported test results | Count of Participants | Participants |
|
| Hepatitis C antibody positive test result | Among participants with reported test results | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Sex Without Condom | vaginal or anal sex without a condom in the past 3 months | Posted | Count of Participants | Participants | 3 months |
|
|
|
|
| Primary | Alcohol Use | Number of days drinking alcohol in past month | Posted | Mean | Standard Deviation | days | 30 days |
|
|
|
|
| Secondary | HIV Infection | incident HIV infection | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Hepatitis C Infection | incident hepatitis C virus (HCV) infection | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Injection Equipment Sharing | used shared injection equipment | Posted | Count of Participants | Participants | 3 months |
|
|
|
|
| 0 |
| 210 |
| 0 |
| 210 |
| 3 |
| 210 |
| EG001 | TANSIHAT Health Education | A health education program consisting of five weekly 2-hour sessions small group sessions. TANSIHAT: health education intervention | 0 | 210 | 0 | 210 | 3 | 210 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
| 9-months |
|
| 12-months |
|
| 9-months |
|
| 12-months |
|
| Mixed Models Analysis |
Mixed effects Poisson regression model with random intercepts for participant and network cluster |
| .01 |
| Risk Ratio (RR) |
| 1.19 |
| 2-Sided |
| 95 |
| .98 |
| 1.45 |
Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up |
| Superiority |
| 9-months |
|
| 12-months |
|