- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00103896
Connect to Protect Partnerships for Youth Prevention Interventions: Phase II
Connect to Protect (C2P) Partnerships for Youth Prevention Interventions: Phase II
This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such Adolescent Trials Network (ATN) research activities.
This phase will describe specific locations within high-risk areas where youth, ages 12-24, spend time. HIV risk behaviors, social networking patterns and HIV prevalence among youth at these venues will be assessed by administering anonymous computerized interviews to eligible and willing youth. This information will be shared with community partners during scheduled working group meetings.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such ATN research activities.
During this phase, each ATN site will gather additional information within high-risk areas and solicit community partner input to ultimately pinpoint the specific locations where at-risk youths, ages 12-24, may be recruited for interventions. This will be done by the following methods:
Venues will be identified by HIV+ youth at the ATN site by participation in an anonymous computerized interview. Site staff will then perform brief venue interviews (BVIs) at selected venues to assess the potential yield of youths 12-24 years old. Community partners will also provide the site staff with information on known high-risk venues. High-risk venues will further be identified by the results of anonymous computerized interviews and HIV assays obtained from eligible and willing youth participants at the venues. The interviews will gather information on HIV risk behaviors, social networking patterns and HIV prevalence among youths at these venues. This information will be shared with community partners during scheduled working group meetings.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
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San Juan, Puerto Rico, 00936
- University Pediatric Hospital
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California
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Los Angeles, California, Yhdysvallat, 90054
- Childrens Hospital of Los Angeles
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San Diego, California, Yhdysvallat, 92103
- UCSD Mother, Child & Adolescent HIV Program
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San Francisco, California, Yhdysvallat, 94143
- Univ of Califormia at San Francisco
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District of Columbia
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Washington, District of Columbia, Yhdysvallat, 20010
- Children's Hospital National Medical Center
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Florida
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Ft. Lauderdale, Florida, Yhdysvallat, 33301
- Children's Diag. and Treatment Center
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Miami, Florida, Yhdysvallat, 33101
- University of Miami
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Tampa, Florida, Yhdysvallat, 33606
- USF Peds Div. of Infectious Disease
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Illinois
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Chicago, Illinois, Yhdysvallat, 60612
- Stroger Hospital of Cook County
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Louisiana
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New Orleans, Louisiana, Yhdysvallat, 70112
- Tulane Medical Center
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Maryland
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Baltimore, Maryland, Yhdysvallat, 21201
- University of Maryland
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02115
- Childrens' Hospital of Boston
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New York
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Bronx, New York, Yhdysvallat, 10467
- Montefiore Medical Center, Adolescent AIDS Program
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New York, New York, Yhdysvallat, 10128
- Mount Sinai Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Yhdysvallat, 19104
- Children's Hopsital of Philadelphia
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
Index Subjects:
- Documented HIV-infection
- Acquisition of HIV after age 9 years
- Verbal confirmation of 12-24 years of age
- Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
- Ability to understand and willingness to provide informed consent/assent
BVI subjects:
- Youths who appear to be 12-24 years old
HIV Serosurvey subjects at the venues:
- Verbal confirmation of 12-24 years of age
- Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
- Ability to understand and willingness to provide informed consent/assent
Exclusion Criteria:
- Visibly distraught and/or emotionally unstable (i.e. depressive mood, exhibiting manic, suicidal or violent behavior, etc.)
- Visibly intoxicated or under the influence of psychoactive agents
- Clinically presents as acutely ill
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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HIV Infected Youth in Treatment/Care
HIV infected youth in treatment/care will be interviewed using Audio Computer-Assisted Self-Administered Interview ACASI technology to reveal possible venues where youth at high risk for acquiring the disease may be found (N = 20-30 individuals per ATN site).
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BVI Individuals
Additional data will be gathered on potential recruitment venues by administering a brief venue interview (BVI) to individuals who appear to be between 12 and 24 years old (N = unlimited individuals during 3-5 assessment periods per venue each lasting 5 hours).
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HIV Serosurvey Individuals
HIV Serosurvey Individuals Anonymous structured interview using ACASI technology and an anonymous HIV antibody assay will be administered to 20-30 young women at 2-3 targeted locations and 20-30 young men at 2-3 targeted locations whose HIV status is unknown (N = 160-360 individuals per ATN site)..
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Ascertain specific community venues where at-risk youth can be recruited for interventions within the high-risk areas identified in the first Phase of the study
Aikaikkuna: One time assessment at 10 months
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The outcome measure will be assessed using results from: (a) Phase I mapping; (b) Phase II interviews with HIV-infected youth; and (c) Phase II Brief Venue Interviews (BVIs).
Input from community partners and ethnographic procedures will add critical information.
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One time assessment at 10 months
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Describe HIV risk behaviors of adolescents and young adults recruited from targeted venues
Aikaikkuna: One time assessment at 10 months
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The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
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One time assessment at 10 months
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Describe social networks of adolescents and young adults recruited from targeted venues
Aikaikkuna: One time assessment at 10 months
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The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
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One time assessment at 10 months
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Describe HIV seroprevalence of adolescents and young adults recruited from targeted venues
Aikaikkuna: One time assessment at 10 months
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The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
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One time assessment at 10 months
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Assess the characteristics of the community-researcher partnerships
Aikaikkuna: One time assessment at 10 months
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The outcome measure will be assessed by conducting interviews with C2P staff and their community partners.
Questionnaires will be completed by both parties and detailed documentation kept.
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One time assessment at 10 months
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Assess quality of the community-researcher partnerships
Aikaikkuna: One time assessment at 10 months
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The outcome measure will be assessed by conducting interviews with C2P staff and their community partners.
Questionnaires will be completed by both parties and detailed documentation kept.
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One time assessment at 10 months
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Assess outcomes of the community-researcher partnerships
Aikaikkuna: One time assessment at 10 months
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The outcome measure will be assessed by conducting interviews with C2P staff and their community partners.
Questionnaires will be completed by both parties and detailed documentation kept.
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One time assessment at 10 months
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Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Tutkijat
- Päätutkija: Donna Futterman, MD, Montefiore Medical Center
- Päätutkija: Sue Ellen Abdalian, MD, Tulane Medical Center
- Opintojen puheenjohtaja: Jonathan Ellen, MD, Johns Hopkins Medical Center
- Päätutkija: Ligia Peralta, MD, Division of Adolescent & Young Adult Medicine University of MD, Medical School
- Päätutkija: Marvin Belzer, MD, Childrens Hosp of Los Angeles, Division of Adolescent Medicine
- Päätutkija: Bret Rudy, MD, Children's Hospital of Philadelphia
- Päätutkija: Larry D'Angelo, MD, Children's National Research Institute
- Päätutkija: Cathryn Samples, MD, Boston Children's Hospital
- Päätutkija: Lisa Henry-Reid, MD, John H. Stroger Jr. Hospital and the CORE Center
- Päätutkija: Ana Puga, MD, Children's Diag. and Treatment Ctr of Ft. Lauderdale, FL
- Päätutkija: Lawrence Friedman, MD, University of Miami, School of Medicine, Div of Adolescent Medicine
- Päätutkija: Patricia Emmanuel, MD, University of South Florida, Peds Div of Infectious Disease
- Päätutkija: Linda Levin, MD, Mount Sinai Adolescent Health Center
- Päätutkija: Irma Febo, MD, University of Puerto Rico Medical Sciences Campus
- Päätutkija: Stephen A Spector, MD, UCSD Mother, Child, & Adolescent HIV Program
- Päätutkija: Rolando M Viani, MD, UCSD Mother, Child, & Adolescent HIV Program
- Päätutkija: Barbara Moscicki, MD, UCSF, Division of Adoles. Med
- Päätutkija: Coco Auerswald, MD, UCSF, Division of Adoles. Med
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- ATN 016b
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Kliiniset tutkimukset HIV-infektio
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRekrytointiHIV | HIV-testaus | HIV-yhteys hoitoon | HIV-hoitoYhdysvallat
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University of MinnesotaPeruutettuHIV-infektiot | HIV/AIDS | Hiv | Aids | AIDS/HIV-ongelma | AIDS ja infektiotYhdysvallat
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University of Southampton ja muut yhteistyökumppanitRekrytointiHIV | HIV-testaus | Yhteys hoitoonEtelä-Afrikka
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Hospital Clinic of BarcelonaValmisIntegraasi-inhibiittorit, HIV; HIV-PROTEAASIINHIBEspanja
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University of Maryland, BaltimorePeruutettuHiv | Munuaissiirto | HIV-varasto | CCR5Yhdysvallat
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Erasmus Medical CenterEi vielä rekrytointiaHIV-infektiot | Hiv | HIV-1-infektio | HIV I -infektioAlankomaat
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National Taiwan UniversityRekrytointi
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Helios SaludViiV HealthcareTuntematonHiv | HIV-1-infektioArgentiina
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University of California, DavisValmis
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University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Valmis