- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00271908
C2P (With Venues): Connect to Protect® Partnerships For Youth Prevention Interventions
Connect to Protect® Partnerships for Youth Prevention Interventions Phase III: Full Evaluation
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
San Juan, Porto Rico, 00936
- University Pediatric Hospital
-
-
-
-
California
-
Los Angeles, California, Stati Uniti, 90054
- Childrens Hospital of Los Angeles
-
San Francisco, California, Stati Uniti, 94143
- University of California at San Francisco
-
-
District of Columbia
-
Washington, District of Columbia, Stati Uniti, 20010
- Childrens Hospital National Medical Center
-
-
Florida
-
Tampa, Florida, Stati Uniti, 33606
- University Of South Florida
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60612
- Stroger Hospital of Cook County
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21201
- University of Maryland
-
-
New York
-
New York, New York, Stati Uniti, 10128
- Mount Sinai Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Trasversale
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
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."
Altri nomi:
|
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."
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Collect data that will be used to evaluate the overall efficacy of the community mobilization intervention
Lasso di tempo: 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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Cattedra di studio: Jonathan Ellen, MD, Johns Hopkins University
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
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 (Effettivo)
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
- ATN 040b
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 .
Prove cliniche su Infezioni da HIV
-
University of MinnesotaRitiratoInfezioni da HIV | HIV/AIDS | HIV | AIDS | Problema di Aids/Hiv | AIDS e infezioniStati Uniti
-
Erasmus Medical CenterNon ancora reclutamentoInfezioni da HIV | HIV | Infezione da HIV-1 | Infezione da HIV IOlanda
-
Helios SaludViiV HealthcareSconosciutoHIV | Infezione da HIV-1Argentina
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur du Cameroun e altri collaboratoriSconosciutoHIV | Bambini non infetti da HIV | Bambini esposti all'HIVCamerun
-
University of MinnesotaCompletatoInfezioni da HIV | HIV | ImmunodeficienzaStati Uniti
-
Midway Specialty Care CenterNon ancora reclutamentoInfezioni da HIV | HIV | Infezione da HIV-1Stati Uniti
-
Allegheny Singer Research Institute (also known...Attivo, non reclutanteInfezioni da HIV | Infezione da HIV-1 | Infezione da HIV IStati Uniti
-
University of California, DavisCompletato
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completato
-
University of ZimbabweCompletato
Prove cliniche su Community Mobilization
-
Koç UniversityReclutamento
-
Vanderbilt University Medical CenterCompletatoCancro al seno | Screening mammografico | Operatore Sanitario ComunitarioStati Uniti
-
University of AlbertaCanadian Institutes of Health Research (CIHR); Alberta Health services; Alberta...Completato
-
Kean UniversityCompletato
-
University of CalgaryUniversity of AlbertaCompletatoIpertensione | Diabete mellito, tipo 2 | Malattie renali croniche | Broncopneumopatia cronica ostruttiva | Asma | Cardiopatia ischemica | Insufficienza cardiaca congestiziaCanada
-
University of CalgaryCompletatoIpertensione | Diabete mellito, tipo 2 | Malattie renali croniche | Broncopneumopatia cronica ostruttiva | Asma | Cardiopatia ischemica | Insufficienza cardiaca congestiziaCanada
-
University of CalgaryUniversity of AlbertaCompletatoIpertensione | Diabete mellito, tipo 2 | Malattie renali croniche | Broncopneumopatia cronica ostruttiva | Asma | Cardiopatia ischemica | Insufficienza cardiaca congestiziaCanada
-
International Rescue CommitteeUniversity of Southern California; Jordan University of Science and TechnologyTerminatoIpertensione | Diabete mellito, tipo 2 | Diabete mellito, tipo 1 | Comorbidità e condizioni coesistentiStati Uniti
-
Duke-NUS Graduate Medical SchoolMinistry of Health, Singapore; The Tsao FoundationSconosciutoDeterioramento cognitivo | DemenzaSingapore