- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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San Juan, Portoryko, 00936
- University Pediatric Hospital
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California
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Los Angeles, California, Stany Zjednoczone, 90054
- Childrens Hospital of Los Angeles
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San Diego, California, Stany Zjednoczone, 92103
- UCSD Mother, Child & Adolescent HIV Program
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San Francisco, California, Stany Zjednoczone, 94143
- Univ of Califormia at San Francisco
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District of Columbia
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Washington, District of Columbia, Stany Zjednoczone, 20010
- Children's Hospital National Medical Center
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Florida
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Ft. Lauderdale, Florida, Stany Zjednoczone, 33301
- Children's Diag. and Treatment Center
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Miami, Florida, Stany Zjednoczone, 33101
- University of Miami
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Tampa, Florida, Stany Zjednoczone, 33606
- USF Peds Div. of Infectious Disease
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60612
- Stroger Hospital of Cook County
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Louisiana
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New Orleans, Louisiana, Stany Zjednoczone, 70112
- Tulane Medical Center
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21201
- University of Maryland
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02115
- Childrens' Hospital of Boston
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New York
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Bronx, New York, Stany Zjednoczone, 10467
- Montefiore Medical Center, Adolescent AIDS Program
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New York, New York, Stany Zjednoczone, 10128
- Mount Sinai Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Children's Hopsital of Philadelphia
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Donna Futterman, MD, Montefiore Medical Center
- Główny śledczy: Sue Ellen Abdalian, MD, Tulane Medical Center
- Krzesło do nauki: Jonathan Ellen, MD, Johns Hopkins Medical Center
- Główny śledczy: Ligia Peralta, MD, Division of Adolescent & Young Adult Medicine University of MD, Medical School
- Główny śledczy: Marvin Belzer, MD, Childrens Hosp of Los Angeles, Division of Adolescent Medicine
- Główny śledczy: Bret Rudy, MD, Children's Hospital of Philadelphia
- Główny śledczy: Larry D'Angelo, MD, Children's National Research Institute
- Główny śledczy: Cathryn Samples, MD, Boston Children's Hospital
- Główny śledczy: Lisa Henry-Reid, MD, John H. Stroger Jr. Hospital and the CORE Center
- Główny śledczy: Ana Puga, MD, Children's Diag. and Treatment Ctr of Ft. Lauderdale, FL
- Główny śledczy: Lawrence Friedman, MD, University of Miami, School of Medicine, Div of Adolescent Medicine
- Główny śledczy: Patricia Emmanuel, MD, University of South Florida, Peds Div of Infectious Disease
- Główny śledczy: Linda Levin, MD, Mount Sinai Adolescent Health Center
- Główny śledczy: Irma Febo, MD, University of Puerto Rico Medical Sciences Campus
- Główny śledczy: Stephen A Spector, MD, UCSD Mother, Child, & Adolescent HIV Program
- Główny śledczy: Rolando M Viani, MD, UCSD Mother, Child, & Adolescent HIV Program
- Główny śledczy: Barbara Moscicki, MD, UCSF, Division of Adoles. Med
- Główny śledczy: Coco Auerswald, MD, UCSF, Division of Adoles. Med
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zakażenia wirusem RNA
- Choroby wirusowe
- Infekcje
- Infekcje przenoszone przez krew
- Choroby zakaźne
- Choroby przenoszone drogą płciową, wirusowe
- Choroby przenoszone drogą płciową
- Infekcje lentiwirusowe
- Zakażenia Retroviridae
- Zespoły niedoboru odporności
- Choroby układu odpornościowego
- Zakażenia wirusem HIV
Inne numery identyfikacyjne badania
- ATN 016b
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Badania kliniczne na Zakażenie wirusem HIV
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Duke UniversityGilead SciencesRekrutacyjnyProfilaktyka HIV | Profilaktyka przedekspozycyjna HIV | Program profilaktyki HIV | Zapobieganie i opieka nad HIV | Stosowanie w profilaktyce przedekspozycyjnej HIVStany Zjednoczone
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Federal University of São PauloGilead SciencesZakończony
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRekrutacyjnyHIV | Test na HIV | Związek HIV z opieką | Leczenie HIVStany Zjednoczone
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University of Alabama at BirminghamNational Institute of Mental Health (NIMH)RekrutacyjnyPrEP | HIV | Profilaktyka HIV | Wychwyt PrEPStany Zjednoczone
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Institute of HIV Research and Innovation Foundation...National Institutes of Health (NIH)RekrutacyjnyProfilaktyka HIV | Przestrzeganie PrEP | Stygmatyzacja związana z HIVTajlandia
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement i inni współpracownicyNieznanyHIV | Dzieci niezakażone wirusem HIV | Dzieci narażone na HIVKamerun
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University of PennsylvaniaNational Institute of Mental Health (NIMH); University of BotswanaRekrutacyjnyCiąża | HIV | Po porodzie | Przestrzeganie terapii przeciwretrowirusowej HIV (ART).Botswana
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University of MinnesotaWycofaneZakażenia wirusem HIV | HIV/AIDS | HIV | AIDS | Problem z AIDS/HIV | AIDS i infekcjeStany Zjednoczone
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National Institute of Allergy and Infectious Diseases...Duke University; Department of Health and Human Services (HHS)Jeszcze nie rekrutacja
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Jecho Biopharmaceuticals Co., Ltd.Jeszcze nie rekrutacja