- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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San Juan, Пуэрто-Рико, 00936
- University Pediatric Hospital
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California
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Los Angeles, California, Соединенные Штаты, 90054
- Childrens Hospital of Los Angeles
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San Diego, California, Соединенные Штаты, 92103
- UCSD Mother, Child & Adolescent HIV Program
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San Francisco, California, Соединенные Штаты, 94143
- Univ of Califormia at San Francisco
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District of Columbia
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Washington, District of Columbia, Соединенные Штаты, 20010
- Children's Hospital National Medical Center
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Florida
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Ft. Lauderdale, Florida, Соединенные Штаты, 33301
- Children's Diag. and Treatment Center
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Miami, Florida, Соединенные Штаты, 33101
- University of Miami
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Tampa, Florida, Соединенные Штаты, 33606
- USF Peds Div. of Infectious Disease
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60612
- Stroger Hospital of Cook County
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Louisiana
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New Orleans, Louisiana, Соединенные Штаты, 70112
- Tulane Medical Center
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Maryland
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Baltimore, Maryland, Соединенные Штаты, 21201
- University of Maryland
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02115
- Childrens' Hospital of Boston
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New York
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Bronx, New York, Соединенные Штаты, 10467
- Montefiore Medical Center, Adolescent AIDS Program
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New York, New York, Соединенные Штаты, 10128
- Mount Sinai Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- Children's Hopsital of Philadelphia
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Donna Futterman, MD, Montefiore Medical Center
- Главный следователь: Sue Ellen Abdalian, MD, Tulane Medical Center
- Учебный стул: Jonathan Ellen, MD, Johns Hopkins Medical Center
- Главный следователь: Ligia Peralta, MD, Division of Adolescent & Young Adult Medicine University of MD, Medical School
- Главный следователь: Marvin Belzer, MD, Childrens Hosp of Los Angeles, Division of Adolescent Medicine
- Главный следователь: Bret Rudy, MD, Children's Hospital of Philadelphia
- Главный следователь: Larry D'Angelo, MD, Children's National Research Institute
- Главный следователь: Cathryn Samples, MD, Boston Children's Hospital
- Главный следователь: Lisa Henry-Reid, MD, John H. Stroger Jr. Hospital and the CORE Center
- Главный следователь: Ana Puga, MD, Children's Diag. and Treatment Ctr of Ft. Lauderdale, FL
- Главный следователь: Lawrence Friedman, MD, University of Miami, School of Medicine, Div of Adolescent Medicine
- Главный следователь: Patricia Emmanuel, MD, University of South Florida, Peds Div of Infectious Disease
- Главный следователь: Linda Levin, MD, Mount Sinai Adolescent Health Center
- Главный следователь: Irma Febo, MD, University of Puerto Rico Medical Sciences Campus
- Главный следователь: Stephen A Spector, MD, UCSD Mother, Child, & Adolescent HIV Program
- Главный следователь: Rolando M Viani, MD, UCSD Mother, Child, & Adolescent HIV Program
- Главный следователь: Barbara Moscicki, MD, UCSF, Division of Adoles. Med
- Главный следователь: Coco Auerswald, MD, UCSF, Division of Adoles. Med
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- РНК-вирусные инфекции
- Вирусные заболевания
- Инфекции
- Инфекции, передающиеся через кровь
- Передающиеся заболевания
- Заболевания, передающиеся половым путем, вирусные
- Заболевания, передающиеся половым путем
- Лентивирусные инфекции
- Ретровирусные инфекции
- Синдромы иммунологического дефицита
- Заболевания иммунной системы
- ВИЧ-инфекции
Другие идентификационные номера исследования
- ATN 016b
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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