- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00218699
Pre-HIV Test Counseling Intervention to Reduce HIV Infection Risk Behavior in Men Who Are Not HIV Infected
Changing Sexual Behavior in Gay Male Repeat HIV Testers: A Randomized Trial of a Single Session Counseling Intervention
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In San Francisco, HIV infection rates among men who have tested for HIV three or more times is almost triple the HIV infection rates of all other testers. Past research has shown that HIV uninfected gay and bisexual men who receive counseling are less likely to engage in high-risk sexual behavior. Counseling provided by trained mental health professionals within a clinical study setting helped individuals identify and re-evaluate their "self-justifications," which are their thoughts, attitudes, and beliefs when deciding to engage in unprotected sex. This study will focus on implementing a "real-world" counseling intervention designed specifically for men who are at the greatest risk of becoming infected with HIV: men who engage in high-risk sexual activity with other men and who repeatedly test for HIV. This specialized intervention will be administered by trained paraprofessional counselors during a pre-test counseling session prior to an HIV test. The purpose of this study is to evaluate the effectiveness of the specialized pre-test counseling intervention versus a standard pre-test counseling intervention in promoting safer sexual activity among HIV uninfected men. The men will have reported having unprotected sex with males of unknown HIV status or known HIV infection.
This 12-month study will enroll 300 men who will be recruited upon scheduling an anonymous HIV test at the participating clinic. Participants will be randomly assigned to receive either the enhanced pre-test counseling session or a standard pre-test counseling session prior to an HIV test. Outcome measurements will be assessed 6 and 12 months after the counseling session and will include self-reports of unprotected anal sex with non-primary partners and reported satisfaction levels with the pre-test counseling.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
California
-
San Francisco, California, Forente stater, 94102
- UCSF AIDS Health Project
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- History of two or more HIV antibody tests prior to study entry
- History of at least one episode of unprotected anal intercourse (receptive or insertive) within 12 months prior to study entry
Exclusion Criteria:
- History of injection drug use within 12 months of study enrollment
- Insufficient proficiency in English
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Reduction in HIV infection risk behavior; measured at Months 6 and 12
Tidsramme: 6 and 12 months
|
6 and 12 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: James W. Dilley, MD, UCSF AIDS Health Project
- Hovedetterforsker: William J. Woods, PhD, UCSF Center for AIDS Prevention Studies
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Infeksjoner
- Ervervet immunsviktsyndrom
Andre studie-ID-numre
- R01MH065138 (U.S. NIH-stipend/kontrakt)
- DAHBR AZ-Q
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på HIV-infeksjoner
-
Universidad del DesarrolloFullførtHealthcare Associated InfectionChile
-
Imelda Hospital, BonheidenFullførtHealthcare Associated InfectionBelgia
-
Centre Hospitalier Universitaire de NīmesRekrutteringEldre | Healthcare Associated InfectionFrankrike
-
Centre Hospitalier Universitaire, AmiensFullførtHealthcare Associated Infection | IglerFrankrike
-
University of PennsylvaniaFullførtAntimikrobiell resistensForente stater, Botswana
-
University of Maryland, BaltimoreVA Office of Research and DevelopmentFullførtMenneskelig mikrobiomForente stater
-
Universidad Autonoma de Nuevo LeonUkjentHelsetilknyttede infeksjoner
-
Johns Hopkins UniversityFullførtHealthcare Associated Infection | Multiresistente organismer
-
University of Colorado, DenverUniversity of IowaFullførtHealth Care Associated Infection | HåndhygieneForente stater
-
Aionx, Inc.UkjentHealthcare Associated Infection
Kliniske studier på Cognitive-Behavioral Intervention
-
VA Office of Research and DevelopmentFullført
-
VA Office of Research and DevelopmentRekruttering
-
VA Office of Research and DevelopmentMichael E. DeBakey VA Medical Center; Dallas VA Medical CenterRekrutteringDepresjon | Muskel- og skjelettsmerter | Aldring | Kroniske ryggsmerterForente stater
-
Spaulding Rehabilitation HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbeidspartnereHar ikke rekruttert ennåSlag | Hjerneslag følgetilstander | Hemiparese; Postslag/CVAForente stater
-
The University of Texas Health Science Center,...Eunice Kennedy Shriver National Institute of Child Health and Human Development...RekrutteringKandidat for fedmekirurgi | Overvekt, ungdomForente stater
-
UConn HealthNational Heart, Lung, and Blood Institute (NHLBI)Fullført
-
Queen's UniversityCanadian Institutes of Health Research (CIHR)Fullført
-
Baylor College of MedicineRekruttering
-
IDeA States Pediatric Clinical Trials NetworkNational Institutes of Health (NIH)Fullført
-
University of North Carolina, Chapel HillNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Johns Hopkins... og andre samarbeidspartnereHar ikke rekruttert ennåHIV-forebygging | Usunn alkoholbrukVietnam