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Training Community Members to Deliver HIV Prevention Programs to Urban Youth

7 марта 2012 г. обновлено: Icahn School of Medicine at Mount Sinai

Community Partnerships to Prevent Urban Youth Health Risks (CHAMPions)

This study will examine methods for involving local community members in programs to teach urban youth about how to prevent transmission of HIV.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

HIV is a sexually transmitted virus that damages or destroys a body's immune system. When the infection progresses to its later stages, AIDS can develop. Several programs have been developed for educating adolescents about how to prevent HIV transmission. Preventing infection is particularly important because there is not yet a way to cure HIV. This study will examine the processes needed to train community members to deliver HIV prevention programs to urban youth.

This study has three steps. In Step 1, an existing group of urban community members who have already delivered the Be Proud! Be Responsible! HIV prevention program will be invited to serve as mentors for new HIV educators in the community. Participants in this step will complete self-administered assessments of their willingness to collaborate with university-based researchers, their confidence in skills necessary for collaborative projects, and any foreseeable obstacles to participation. The goal of this step is to examine the response over time to ongoing HIV leadership.

In Step 2, parents from the targeted community will be recruited and trained in HIV prevention programs. They will be randomly assigned to one of three programs: Becoming a Responsible Teen, Be Proud! Be Responsible!, and Reducing the Risk. All three of these programs involve group meetings with adolescents to discuss puberty, sexuality, communication, self-esteem, HIV/AIDS, and setting and achieving goals and dreams. Participants in this phase will undergo the same assessments as those in Step 1.

In Step 3, the parents trained in Step 2 will be randomly assigned to a middle school or high school where they will deliver the program in which they were trained. Randomly selected adolescent participants from these schools will be assigned to whichever program is being offered at their school. All three prevention programs will include four to six sessions over 4 to 6 weeks. Adolescent participants will be required to complete interviews and questionnaires when they enter the study, after 3 months, and after 15 months. These interviews and questionnaires will measure HIV/AIDS knowledge, self-esteem, intention to protect health, and engagement in risk-taking behaviors. Parent participants in Step 3 will repeat the assessments from Steps 1 and 2 before and after delivering their prevention curriculums.

Тип исследования

Интервенционный

Регистрация (Действительный)

901

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 12 лет до 60 лет (Ребенок, Взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria

  • Adult community HIV educators who are parents of a middle or high school aged child
  • Adult participants must be between 25 and 60 years of age
  • Youth participants must be between 12 and 15 years of age
  • Residents of target communities in Bronx, NY

Exclusion Criteria:

  • Parent or guardian is excluded if youth participant cannot provide informed consent because of mental health or substance abuse diagnosis
  • Significant cognitive impairment that might interfere with understanding of program content or informed consent process

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: BART
Participants will complete the Becoming a Responsible Teen (BART) program.
Поведенческий: Becoming A Responsible Teen (BART)
This program consists of highly structured modules administered using intervention manuals in community-based settings. Each intervention session involves group discussion, videos, games, presentations, demonstrations, role plays, and practice. Youth learn problem solving, decision-making, communication, condom negotiation and use skills, and behavioral self-management. Youth also meet with HIV infected peers to promote risk recognition and improve their perception of vulnerability.
Экспериментальный: Reducing the Risk
Participants will complete the Reducing the Risk program.
Поведенческий: Reducing the Risk
This program consists of instruction on developing social skills to reduce sexual risk-taking behavior and role plays to practice and model skills. Additional activities-such as teaching decision making and assertive communication skills, offering encouragement to obtain relevant health information from stores and clinics, and asking parents about their views on abstinence and birth control-support the premise that students should avoid unprotected intercourse, either by remaining abstinent or using contraceptives.
Активный компаратор: Be Proud Be Responsible
Participants will complete the Be Proud! Be Responsible! program.
Поведенческий: Be Proud! Be Responsible!
This intervention consists of highly structured modules that involve group discussions, videos, games, brainstorming, experiential exercises, and skill building activities. The program encourages participants to be proud of themselves and their community, to behave responsibly for themselves and their community, and to consider their goals for the future and how risk behaviors may interfere with the attainment of their goals.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Youth sexual risk behaviors
Временное ограничение: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
Youth sexual risk behaviors
Временное ограничение: Measured after 3 to 4 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 3 to 4 months
Youth sexual risk behaviors
Временное ограничение: Measured after 15 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 15 months
HIV educators' intentions to collaborate
Временное ограничение: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
HIV educators' intentions to collaborate
Временное ограничение: Measured at post-intervention
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at post-intervention
HIV educators' intentions to collaborate
Временное ограничение: Measured at 3-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 3-month follow-up
HIV educators' intentions to collaborate
Временное ограничение: Measured at 15-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 15-month follow-up
Collaboration by HIV educators
Временное ограничение: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
Collaboration by HIV educators
Временное ограничение: Measured at post-intervention
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at post-intervention
Collaboration by HIV educators
Временное ограничение: Measured at 3-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 3-month follow-up
Collaboration by HIV educators
Временное ограничение: Measured at 15-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 15-month follow-up
Youth sexual behavior
Временное ограничение: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
Youth sexual behavior
Временное ограничение: Measured after 3 to 4 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 3 to 4 months
Youth sexual behavior
Временное ограничение: Measured after 15 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 15 months
Youth negotiation of sexual risk situations
Временное ограничение: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
Youth negotiation of sexual risk situations
Временное ограничение: Measured after 3 to 4 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 3 to 4 months
Youth negotiation of sexual risk situations
Временное ограничение: Measured after 15 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 15 months

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Leadership skills of HIV educators
Временное ограничение: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
Leadership skills of HIV educators
Временное ограничение: Measured at post-intervention
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at post-intervention
Leadership skills of HIV educators
Временное ограничение: Measured at 3-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 3-month follow-up
Leadership skills of HIV educators
Временное ограничение: Measured at 15-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 15-month follow-up
HIV/AIDS knowledge and attitudes of educators and youth
Временное ограничение: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
HIV/AIDS knowledge and attitudes of educators and youth
Временное ограничение: Measured after 3 to 4 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 3 to 4 months
HIV/AIDS knowledge and attitudes of educators and youth
Временное ограничение: Measured after 15 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 15 months
Self-esteem and self-efficacy of HIV educators
Временное ограничение: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
Self-esteem and self-efficacy of HIV educators
Временное ограничение: Measured at post-intervention
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at post-intervention
Self-esteem and self-efficacy of HIV educators
Временное ограничение: Measured at 3-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 3-month follow-up
Self-esteem and self-efficacy of HIV educators
Временное ограничение: Measured at 15-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 15-month follow-up

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Icahn School of Medicine at Mount Sinai

Соавторы

National Institute of Mental Health (NIMH)

Следователи

  • Главный следователь: Mary M. McKay, PhD, Icahn School of Medicine at Mount Sinai

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 марта 2009 г.

Первичное завершение (Действительный)

1 марта 2012 г.

Завершение исследования (Действительный)

1 марта 2012 г.

Даты регистрации исследования

Первый отправленный

6 марта 2009 г.

Впервые представлено, что соответствует критериям контроля качества

6 марта 2009 г.

Первый опубликованный (Оценивать)

10 марта 2009 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

8 марта 2012 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

7 марта 2012 г.

Последняя проверка

1 марта 2012 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • GCO 03-0888
  • DAHBR 9A-ASPA (National Institute of Mental Health)
  • R01MH069934 (Грант/контракт NIH США)

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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