- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00183118
Russia PREVENT (HIV Prevention Partnership in Russian Alcohol Treatment)
HIV Prevention Partnership in Russian Alcohol Treatment
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A randomized controlled trial of an HIV prevention intervention in a narcology hospital using a stratified randomization design (by gender and substance use diagnosis) will be implemented.
We will conduct a trial among 180 inpatient subjects undergoing treatment at the LRCA. This adapted HIV prevention intervention (adapted Enhanced-RESPECT), Project RESPECT, is a 2-session, one-on-one HIV prevention counseling and testing activity with a trained health educator. By random assignment, half of the subjects will receive the Enhanced-RESPECT intervention, which will include 3 additional booster sessions. And half will receive CDC post-test counseling or standard of care depending on the results of their HIV antibody test. The post-test counseling will follow CDC counseling and testing guidelines. Subjects in the Control group who are not HIV-infected will receive the current standard of care in Russia for non-infected patients; receipt of negative test results by a clinician. HIV pre-test counseling occurs within the first 48 hours of patient arrival at LRCA. CDC post-test counseling guidelines represent a higher standard of care than currently exists within this facility for HIV-infected patients and is equivalent to the standard of care recommended for US HIV testing facilities.
All study participants will be evaluated regarding substance abuse and HIV risk behaviors at baseline and follow-up. Follow up interviews will take place at 3 time points (just before discharge from the hospital and at 3 and 6 months post-randomization). All Intervention participants will receive the basic 2-session adapted RESPECT intervention while inpatients; booster sessions for adapted Enhanced-RESPECT HIV Intervention participants will take place after discharge. Booster sessions will be offered once a month for 3 months.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age 18-70 years old;
- In-patient at LRCA (i.e., primary diagnosis of alcohol or drug dependence);
- Abstinence from alcohol and other substances of abuse for 4 days;
- Willingness to undergo HIV testing as per standard narcology hospital counseling and testing protocol or known positive HIV serostatus;
- Provision of contact information (e.g., name, home address, telephone number) of two relatives or close friends who can be contacted to share information that may be used to assist with follow-up;
- Stable address within St. Petersburg or districts within 100 kilometers of St. Petersburg; and
- Self-reported unprotected anal or vaginal sex in the last 6 months;
Exclusion Criteria:
- Not fluent in Russian;
- Severe cognitive impairment (Clinically apparent dementia, active psychosis, or severe paranoid disorder) as judged by a narcology hospital clinician and stated in the records;
- Inability to provide informed consent;
- Suspected or diagnosed pulmonary tuberculosis, not receiving treatment;
- Pending legal charges with potential impending incarceration.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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HIV risk behaviors:
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risky alcohol use
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risky drug use
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risky sex behavior
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Sekundære resultatmål
Resultatmål |
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RAB score
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Addiction Severity Index (ASI)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Jeffrey H. Samet, MD, MA, MPH, Boston Medical Center
- Ledende efterforsker: Evgeny Krupitsky, Leningrad Regional Center of Addictions Institution: Pavlov State Medical University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H23052
- R21AA014821 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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