C2P (With Venues): Connect to Protect® Partnerships For Youth Prevention Interventions
Connect to Protect® Partnerships for Youth Prevention Interventions Phase III: Full Evaluation
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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San Juan, Portoriko, 00936
- University Pediatric Hospital
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California
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Los Angeles, California, Spojené státy, 90054
- Childrens Hospital of Los Angeles
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San Francisco, California, Spojené státy, 94143
- University of California at San Francisco
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District of Columbia
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Washington, District of Columbia, Spojené státy, 20010
- Childrens Hospital National Medical Center
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Florida
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Tampa, Florida, Spojené státy, 33606
- University of South Florida
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- Stroger Hospital of Cook County
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Maryland
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Baltimore, Maryland, Spojené státy, 21201
- University of Maryland
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New York
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New York, New York, Spojené státy, 10128
- Mount Sinai Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Průřezový
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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.
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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."
Ostatní jména:
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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.
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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."
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Collect data that will be used to evaluate the overall efficacy of the community mobilization intervention
Časové okno: 4 years
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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.
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4 years
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Jonathan Ellen, MD, Johns Hopkins University
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ATN 040b
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