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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA026739-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Using a randomized clinical trial (RCT), this study is designed to assess the effectiveness of HIV (human immunodeficiency virus) risk-reduction interventions targeting injection drug users (IDUs) in three Ukraine oblasts (regions). The investigators propose to compare the effectiveness of a revised and updated manually-driven HIV testing and counseling intervention, the Counseling and Education (C & E) model developed by NIDA, with the C & E plus a manualized network intervention. At each site, Odessa, Donetsk and Nikolayev, 250 "index members" and 500 of their network members will be recruited through street outreach over a 32-month period and randomly assigned to C & E alone or C & E plus the network intervention. Participants will be tested for drug metabolites, interviewed using ACASI (Audio Computer-Assisted Self-Interviewing), and given a rapid test for HIV at baseline, 6 and 12-months. At six-months, network members will be asked to recruit two others they inject with but who are not in the study. Primary outcomes include knowledge, self-efficacy, injection and sex-related risk behavior reduction and partner disclosure among indexes and primary and secondary network members and intervention diffusion to secondary network members. The investigators hypothesize more positive and significant change, including injection and sex risk reduction, intervention diffusion, and partner disclosure, among indexes as well as first and second network members in the network plus C & E arm compared to C & E alone. Specific aims include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Network plus HIV Counseling&Education | Experimental | Social network peer education model plus HIV testing and counseling; the C & E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening." |
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| HIV Counseling and Education (C&E) only | Active Comparator | HIV testing and counseling C&E; the C & E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening." |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Education Model | Behavioral | The peer education intervention will be delivered by trained outreach workers in a group format with 8-10 indexes over five sessions spanning three weeks. The sessions will focus on knowledge of HIV transmission, self-efficacy and skills-building regarding HIV risk reduction, with an emphasis on the dissemination of such information and skills to network members. |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Knowledge | Follow-up interviews at 6 and 12 months | |
| Self-efficacy regarding HIV risk reduction | Follow-up interviews at 6 and 12 months | |
| Injection risk behavior reduction | Follow-up interviews at 6 and 12 months | |
| Sex-related risk behavior reduction | Follow-up interviews at 6 and 12 months | |
| Intervention diffusion to secondary network members | Follow-up interviews at 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Booth, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NGO | Donetsk | Ukraine | ||||
| NGO |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27658879 | Derived | Booth RE, Davis JM, Dvoryak S, Brewster JT, Lisovska O, Strathdee SA, Latkin CA. HIV incidence among people who inject drugs (PWIDs) in Ukraine: results from a clustered randomised trial. Lancet HIV. 2016 Oct;3(10):e482-9. doi: 10.1016/S2352-3018(16)30040-6. Epub 2016 Jul 29. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| HIV Counseling and Education Model | Behavioral | The C & E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening." |
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| Nikolayev |
| Ukraine |
| NGO | Odesa | Ukraine |
| 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 |
| D001519 | Behavior |