- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01159704
Peer Leaders as HIV Risk Reduction Change Agents Among Injection Drug Users (IDUs) in Ukraine
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:
- 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.
- 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.
- To compare the extent of intervention diffusion to second wave network members in the two arms.
- To evaluate the extent of disclosure by HIV positive indexes and network members in the two arms
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Donetsk, Ukraine
- NGO
-
Nikolayev, Ukraine
- NGO
-
Odessa, Ukraine
- NGO
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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."
|
|
Aktiver 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."
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
HIV Knowledge
Zeitfenster: Follow-up interviews at 6 and 12 months
|
Follow-up interviews at 6 and 12 months
|
|
Self-efficacy regarding HIV risk reduction
Zeitfenster: Follow-up interviews at 6 and 12 months
|
Follow-up interviews at 6 and 12 months
|
|
Injection risk behavior reduction
Zeitfenster: Follow-up interviews at 6 and 12 months
|
Follow-up interviews at 6 and 12 months
|
|
Sex-related risk behavior reduction
Zeitfenster: Follow-up interviews at 6 and 12 months
|
Follow-up interviews at 6 and 12 months
|
|
Intervention diffusion to secondary network members
Zeitfenster: Follow-up interviews at 6 and 12 months
|
Follow-up interviews at 6 and 12 months
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Robert Booth, PhD, University of Colorado, Denver
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- HIV-Infektionen
Andere Studien-ID-Nummern
- 09-0823
- R01DA026739-01A1 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur HIV infektion
-
Jianfeng XieRekrutierungCLABSI – Central Line Associated Bloodstream InfectionChina
-
Assiut UniversityNoch keine RekrutierungCLABSI – Central Line Associated Bloodstream Infection | Peripher eingeführter Zentralkatheter | Nabelschnur venöser Katheter
-
Duke UniversityAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Vereinigte Staaten
-
Catholic University of the Sacred HeartAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
Abbott Medical DevicesThoratec CorporationAbgeschlossenDriveline Heart-assisted Device Related InfectionVereinigte Staaten
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekrutierungCentral Line-associated Bloodstream Infection (CLABSI)Niederlande
-
National Taiwan University Hospital Hsin-Chu BranchAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
University of MalayaTeleflexAbgeschlossenCLABSI – Central Line Associated Bloodstream InfectionMalaysia
-
University of ZurichNoch keine RekrutierungCentral Line-associated Bloodstream Infection (CLABSI) | Katheterbedingte Blutstrominfektion
-
China National Center for Cardiovascular DiseasesChinese Academy of Medical Sciences, Fuwai HospitalAktiv, nicht rekrutierendLungenentzündung | Sepsis | Infektion | Driveline Heart-assisted Device Related InfectionChina
Klinische Studien zur Peer Education Model
-
Saglik Bilimleri UniversitesiAbgeschlossenHumanes Papillomavirus (HPV)Truthahn
-
Saglik Bilimleri UniversitesiAbgeschlossenPflegeausbildung | Frauengesundheit | Klimawandel | Nachhaltige EntwicklungTürkei (türkiye)
-
Istanbul Aydın UniversityAbgeschlossenStudenten der KrankenpflegeTürkei (türkiye)
-
Koç UniversityRekrutierungKlimawandel Angst | Bewusstsein für den KlimawandelTürkei (türkiye)
-
Seçil HürAbgeschlossenHygiene | Gesundheitsverhalten | Peer MentoringTürkei (türkiye)
-
Mansoura UniversityAbgeschlossen
-
Saglik Bilimleri UniversitesiNoch keine Rekrutierung
-
Centers for Disease Control and PreventionAbgeschlossenHIV-Infektionen | Hepatitis CVereinigte Staaten
-
Tarsus UniversityAbgeschlossen
-
NMP Medical Research InstituteAbgeschlossen