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Peer Leaders as HIV Risk Reduction Change Agents Among Injection Drug Users (IDUs) in Ukraine

17 juni 2019 uppdaterad av: University of Colorado, Denver

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:

  1. To compare the effectiveness of the C & E alone with the additive effect of a network intervention plus C & E in increasing knowledge about HIV and increasing self-efficacy to practice safer injection and sex-related behaviors among indexes, primary and secondary network members.
  2. To assess the effectiveness of the C & E alone with the additive effect of a network intervention plus C & E in reducing drug and sex risk behaviors among indexes, primary and secondary network members.
  3. To compare the extent of intervention diffusion to second wave network members in the two arms.
  4. To evaluate the extent of disclosure by HIV positive indexes and network members in the two arms

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

2304

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Donetsk, Ukraina
        • NGO
      • Nikolayev, Ukraina
        • NGO
      • Odessa, Ukraina
        • NGO

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

16 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • active drug injector
  • 16 years of age or older
  • not too intoxicated to give informed consent
  • not planning to leave the area in the next 6 months and no pending court date that might result in incarceration
  • agree to HIV testing and counseling
  • not involved in prior project research activities in teh previous 24 months
  • Indexes: must be able to recruit two eligible network members into the study
  • Network: agree to participate in five peer educator training sessions

Exclusion Criteria:

  • being too intoxicated at the time of the interview
  • impaired mentally due to physical or psychological problems to the point that they cannot voluntarily consent to participate in the study and/or respond to the interview
  • have a known reason why they will not be available for the intervention or the follow-up interview
  • have been involved in prior project research activities in the previous 24 months

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Network plus HIV Counseling&Education
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."
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.
The C & E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening."
Aktiv komparator: HIV Counseling and Education (C&E) only
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."
The C & E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening."

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
HIV Knowledge
Tidsram: Follow-up interviews at 6 and 12 months
Follow-up interviews at 6 and 12 months
Self-efficacy regarding HIV risk reduction
Tidsram: Follow-up interviews at 6 and 12 months
Follow-up interviews at 6 and 12 months
Injection risk behavior reduction
Tidsram: Follow-up interviews at 6 and 12 months
Follow-up interviews at 6 and 12 months
Sex-related risk behavior reduction
Tidsram: Follow-up interviews at 6 and 12 months
Follow-up interviews at 6 and 12 months
Intervention diffusion to secondary network members
Tidsram: Follow-up interviews at 6 and 12 months
Follow-up interviews at 6 and 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Robert Booth, PhD, University of Colorado, Denver

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2010

Primärt slutförande (Faktisk)

1 november 2015

Avslutad studie (Faktisk)

1 mars 2017

Studieregistreringsdatum

Först inskickad

8 juli 2010

Först inskickad som uppfyllde QC-kriterierna

8 juli 2010

Första postat (Uppskatta)

9 juli 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 juni 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 juni 2019

Senast verifierad

1 juni 2019

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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