- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00271908
C2P (With Venues): Connect to Protect® Partnerships For Youth Prevention Interventions
Connect to Protect® Partnerships for Youth Prevention Interventions Phase III: Full Evaluation
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Phase III's objective is to initiate and complete a community mobilization intervention aimed at reducing HIV incidence and prevalence among youth. The intervention will consist of guiding C2P coalitions through a strategic planning process that will result in the development and implementation of a local action plan. The action plan will focus on changing structural elements of the affected communities that are believed to be associated with youth HIV acquisition and transmission. The effectiveness of the intervention will be evaluated by tracking venues where the population of interest congregates and trends in risk factors associated with HIV acquisition and transmission.
ATN 040b evaluates annual anonymous data collection of two cohorts per participating ATN/C2P site. Both cohorts will represent a site's population of focus, but will be recruited in different ways and for different activities.
Cohort #1 will be referred to the site via Official Community Partners and word of mouth. Each year of the study, 10 to 20 individuals will be recruited to complete venue-tracking surveys as described in Section 2.1 (N = 40-80 per site over four years). The results will either confirm that the population of focus can still be reached at previously identified congregation venues or reveal new ones that should be considered for further research activities. Each year, based on data from Cohort #1, ATN/C2P site staff will go to two to three of the confirmed and/or new congregation venues to recruit 20 to 30 participants per venue for Cohort #2. These participants will complete the HIV-related risk survey, with the addition of the HIV-Ab assay in the final year only (N = 160-360 per site over four years). Data will be used to evaluate the intervention within and across ATN/C2P sites.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
-
San Juan, Puerto Rico, 00936
- University Pediatric Hospital
-
-
-
-
California
-
Los Angeles, California, Verenigde Staten, 90054
- Childrens Hospital of Los Angeles
-
San Francisco, California, Verenigde Staten, 94143
- University of California at San Francisco
-
-
District of Columbia
-
Washington, District of Columbia, Verenigde Staten, 20010
- Childrens Hospital National Medical Center
-
-
Florida
-
Tampa, Florida, Verenigde Staten, 33606
- University of South Florida
-
-
Illinois
-
Chicago, Illinois, Verenigde Staten, 60612
- Stroger Hospital of Cook County
-
-
Maryland
-
Baltimore, Maryland, Verenigde Staten, 21201
- University of Maryland
-
-
New York
-
New York, New York, Verenigde Staten, 10128
- Mount Sinai Medical Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- An individual who provides verbal confirmation that his or her age falls within the range of the site's population of focus (which must be within 12 through 24 years, inclusive);
- Verbal confirmation of demographic and sexual orientation/experience profile reflective of the site's population of focus;
- Must report engaging in any voluntary sexual activity (vaginal, anal or oral sex) within the past 12 months, regardless of sexual abuse history; and
- Ability to understand and willingness to provide verbal informed consent/assent in English or Spanish.
Exclusion Criteria:
- Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood; exhibiting manic, suicidal, or violent behavior);*
- Visibly intoxicated or under the influence of psychoactive agents#; or
Presents as acutely ill.
Although it is very unlikely that an individual from the community will overtly show signs of suicidality, youth with any of these exclusion criteria may be approached at a later date if encountered again at the venue and earlier exclusionary conditions are resolved.
- For sites targeting drug users, this may pose challenges. Potential participants who are visibly under the influence are to be further assessed in terms of their level of alertness, coherency, and abilities to understand and respond to questions. This is to be done keeping staff and participant safety in mind, as well as follow-up procedures such as providing service referrals.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Dwarsdoorsnede
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
Cohort #1
Venue-tracking survey subjects recruited annually for 4 years: N= 320-640 (10-20 members of the population of focus per site, per year).
The purpose of this cohort is to identify and track venues at which the population of focus congregates.
|
ATN 040b is the evaluation sub-study for ATN 040, Phase III of C2P.
Phase III is a community mobilization intervention aimed at reducing HIV rates among youth via community structural change.
ATN 040b involves annual anonymous data collection with two cohorts per participating ATN/C2P site.
Both cohorts will represent the site's target population, or "population of focus."
Andere namen:
|
Cohort #2
HIV-related risk survey subjects recruited annually for 4 years: N = 1280-2880 (20-30 members of the population of focus per 2-3 congregation venues, per site, per year).
These subjects will complete a survey designed to assess HIV-related risk.
In the fourth and final year only, HIV Antibody [Ab] assays will also be conducted with survey participants to assess HIV serostatus.
The survey and HIVAb assay data will be used to evaluate the intervention within and across sites.
|
ATN 040b is the evaluation sub-study for ATN 040, Phase III of C2P.
Phase III is a community mobilization intervention aimed at reducing HIV rates among youth via community structural change.
ATN 040b involves annual anonymous data collection with two cohorts per participating ATN/C2P site.
Both cohorts will represent the site's target population, or "population of focus."
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Collect data that will be used to evaluate the overall efficacy of the community mobilization intervention
Tijdsspanne: 4 years
|
The aim of ATN 040b is to collect data that will be used to evaluate the overall efficacy of the community mobilization intervention and to assess changes in HIV-related risks over time.
|
4 years
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: Jonathan Ellen, MD, Johns Hopkins University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Ziekten van het immuunsysteem
- HIV-infecties
Andere studie-ID-nummers
- ATN 040b
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op HIV-infecties
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthWervingHiv | HIV-testen | Hiv-koppeling naar zorg | HIV-behandelingVerenigde Staten
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur du Cameroun en andere medewerkersOnbekendHiv | HIV-niet-geïnfecteerde kinderen | Kinderen blootgesteld aan HIVKameroen
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationVoltooidPartner hiv-testen | HIV-counseling voor koppels | Paar communicatie | HIV-incidentieKameroen, Dominicaanse Republiek, Georgië, Indië
-
University of MinnesotaIngetrokkenHIV-infecties | Hiv/aids | Hiv | AIDS | Aids/Hiv probleem | AIDS en infectiesVerenigde Staten
-
Erasmus Medical CenterNog niet aan het wervenHIV-infecties | Hiv | HIV-1-infectie | HIV I-infectieNederland
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... en andere medewerkersWervingHiv | HIV-testen | Koppeling aan zorgZuid-Afrika
-
CDC FoundationGilead SciencesOnbekendHIV Pre-expositie profylaxe | Hiv-chemoprofylaxeVerenigde Staten
-
University of Maryland, BaltimoreIngetrokkenHiv | Niertransplantatie | HIV-reservoir | CCR5Verenigde Staten
-
Hospital Clinic of BarcelonaVoltooidIntegrase-remmers, HIV; HIV PROTEASE INHIBSpanje
-
Helios SaludViiV HealthcareOnbekendHiv | HIV-1-infectieArgentinië
Klinische onderzoeken op Community Mobilization
-
Alabama Physical Therapy & AcupunctureUniversidad Rey Juan CarlosWervingSpanningshoofdpijnVerenigde Staten
-
Centre for Interdisciplinary Research in Rehabilitation...Jewish General HospitalNog niet aan het werven
-
Institut GuttmannUniversity of Vic - Central University of CataloniaWervingVerworven hersenletsel | Geestelijke gezondheidskwestieSpanje
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); Ontario Ministry of Health and...VoltooidKwaliteit van het leven | Continuïteit van zorg
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH); Aurum InstituteVoltooidHiv | Aanhankelijkheid, patiëntZuid-Afrika
-
MetroHealth Medical CenterVoltooidPeer review, onderzoekVerenigde Staten
-
Case Comprehensive Cancer CenterWerving
-
Riphah International UniversityWervingCervicale radiculopathiePakistan
-
Jesse NodoraNational Cancer Institute (NCI)BeëindigdCoronaire hartziekte | Hartfalen | Obesitas | Diabetes mellitus, type 2 | Kanker | Chronische nierziekten | Sikkelcelziekte | COPDVerenigde Staten