- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00310973
HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks
HIV Prevention Within High-Risk Social Networks
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
HIV is spreading more rapidly in Eastern Europe than anywhere else in the world. Bulgaria and Hungary are still in the early stages of the crisis. However, without efforts to prevent the spread of HIV and AIDS, both countries are likely to fall victim to the HIV/AIDS growth curve that has already affected the rest of Eastern Europe. Bulgarian and Hungarian young men who have sex with men (YMSM) and Roma men and women are at the greatest risk for HIV infection. In both countries, HIV is spread primarily through sexual transmission. Prevention efforts that are undertaken now could help these countries avoid an explosive HIV/AIDS epidemic. YMSM and Roma men in Bulgaria and Hungary are more likely to trust HIV/AIDS information received from someone they know than from an official statement. Therefore, entire social networks will be recruited for this study and the leader of each network will be responsible for delivering the prevention information to his or her peers. This study will evaluate the effectiveness of peer-led HIV/STD risk reduction educational counseling in reducing HIV risk behavior among the social networks of YMSM and Roma men and women in Bulgaria and Hungary.
This study will recruit 40 YMSM and 40 Roma high-risk social networks. Each network will be randomly assigned to receive either standard HIV/AIDS risk reduction or the intervention. Networks assigned to receive the intervention will be assessed sociometrically to determine the 'social influence' leaders of each group. The leaders will then attend a 9-session program over the course of 3 months that will train them to deliver theory-based risk-reduction messages and peer-counseling to their respective social networks. The messages will focus on promoting safer sex knowledge, attitudes, intentions, perceived norms, and self-efficacy. All participants will be offered STD testing and their HIV-risk behavior will be assessed at Months 3 and 12. Participants assigned to receive the standard HIV/AIDS risk reduction will then receive the network intervention for an additional 12 months.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Luoghi di studio
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Sofia, Bulgaria
- Health and Social Development Foundation
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St. Petersburg, Federazione Russa
- Botkin Hospital for Infectious Diseases
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Budapest, Ungheria
- Institute of Sociology, Hungarian Academy of Sciences
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- At least 50% of social network members complete baseline assessments
- At least 50% of assessed members of a social network report unprotected vaginal or anal intercourse outside of a mutually monogamous relationship in the 6 months prior to study entry
Exclusion Criteria:
- Does not meet inclusion criteria
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Separare
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Reductions in the prevalence and frequency of unprotected vaginal or anal intercourse
Lasso di tempo: Months 3 and 12 post intervention
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Months 3 and 12 post intervention
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Lower incidence of sexually transmitted diseases
Lasso di tempo: Months 3 and 12 post intervention
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Months 3 and 12 post intervention
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Change in AIDS-related scales
Lasso di tempo: Months 3 and 12 post intervention
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Months 3 and 12 post intervention
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Yuri A. Amirkhanian, PhD, Medical College of Wisconsin
Pubblicazioni e link utili
Pubblicazioni generali
- Kabakchieva E, Vassileva S, Kelly JA, Amirkhanian YA, DiFranceisco WJ, McAuliffe TL, Antonova R, Mihaylova M, Vassilev B, Khoursine R, Petrova E. HIV risk behavior patterns, predictors, and sexually transmitted disease prevalence in the social networks of young Roma (Gypsy) men in Sofia, Bulgaria. Sex Transm Dis. 2006 Aug;33(8):485-90. doi: 10.1097/01.olq.0000204533.20324.56.
- Amirkhanian YA, Kelly JA, Kabakchieva E, Kirsanova AV, Vassileva S, Takacs J, DiFranceisco WJ, McAuliffe TL, Khoursine RA, Mocsonaki L. A randomized social network HIV prevention trial with young men who have sex with men in Russia and Bulgaria. AIDS. 2005 Nov 4;19(16):1897-905. doi: 10.1097/01.aids.0000189867.74806.fb.
- Takacs J, Amirkhanian YA, Kelly JA, Kirsanova AV, Khoursine RA, Mocsonaki L. "Condoms are reliable but I am not": A qualitative analysis of AIDS-related beliefs and attitudes of young heterosexual adults in Budapest, Hungary, and St. Petersburg, Russia. Cent Eur J Public Health. 2006 Jun;14(2):59-66. doi: 10.21101/cejph.a3373.
- Amirkhanian YA, Kelly JA, Kirsanova AV, DiFranceisco W, Khoursine RA, Semenov AV, Rozmanova VN. HIV risk behaviour patterns, predictors, and sexually transmitted disease prevalence in the social networks of young men who have sex with men in St Petersburg, Russia. Int J STD AIDS. 2006 Jan;17(1):50-6. doi: 10.1258/095646206775220504.
- Amirkhanian YA, Kelly JA, Kabakchieva E, McAuliffe TL, Vassileva S. Evaluation of a social network HIV prevention intervention program for young men who have sex with men in Russia and Bulgaria. AIDS Educ Prev. 2003 Jun;15(3):205-20. doi: 10.1521/aeap.15.4.205.23832.
- Kelly JA, Amirkhanian YA, Kabakchieva E, Csepe P, Seal DW, Antonova R, Mihaylov A, Gyukits G. Gender roles and HIV sexual risk vulnerability of Roma (Gypsies) men and women in Bulgaria and Hungary: an ethnographic study. AIDS Care. 2004 Feb;16(2):231-45. doi: 10.1080/09540120410001641075.
- Amirkhanian YA, Kelly JA, McAuliffe TL. Identifying, recruiting, and assessing social networks at high risk for HIV/AIDS: methodology, practice, and a case study in St Petersburg, Russia. AIDS Care. 2005 Jan;17(1):58-75. doi: 10.1080/09540120412331305133.
- Kelly JA, Amirkhanian YA, Kabakchieva E, Vassileva S, Vassilev B, McAuliffe TL, DiFranceisco WJ, Antonova R, Petrova E, Khoursine RA, Dimitrov B. Prevention of HIV and sexually transmitted diseases in high risk social networks of young Roma (Gypsy) men in Bulgaria: randomised controlled trial. BMJ. 2006 Nov 25;333(7578):1098. doi: 10.1136/bmj.38992.478299.55. Epub 2006 Oct 13.
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Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Infezioni da HIV
Altri numeri di identificazione dello studio
- R01MH064410 (Sovvenzione/contratto NIH degli Stati Uniti)
- DAHBR 9A-ASPG (National Institute of Mental Health (NIMH-DAHBR))
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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