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Evaluation of Haitian American Responsible Teens (HART)

2 lutego 2016 zaktualizowane przez: Nicole Prudent, Boston Medical Center

The Haitian American Responsible Teen (HART) afterschool program, a cultural adaptation of the BART curriculum, will provide an HIV/AIDS curriculum adapted to Haitian students that consists of eight sessions lasting approximately two hours each over a twelve- week period. The comparison group will receive a nutrition intervention during the same time period. The primary goals of the evaluation are to determine the effectiveness of the HART program on delaying initiation of sexual intercourse, reducing number of sexual partners, and increasing "abstinent" behavior and contraception use among those who were sexually experienced at baseline.

Over a five semester period, the programs will be implemented in 7 or more schools in the greater Boston area, with offerings in the fall, the spring and summer, among approximately 780 male and female Haitian students. The programs will recruit 9th & 10th grade Haitian students who will range in age from 13 to 19 years old. We will implement a randomized controlled trial in which each semester, students within schools will be stratified by gender and then randomly assigned to participate in the HART or the nutrition condition. Students will be recruited annually and enrolled until the summer of 2015. During the spring and summer of 2012, 120 youth will be randomly assigned to a treatment condition. During year three, 180 youth will be randomly assigned to condition each semester (360 youth total during Year 3). During year four, 180 youth will be randomly assigned in the first semester, and 120 youth will be randomly assigned in the second semester (300 youth total during Year 4). The number of times student-level randomization will occur and the number of groups formed will vary depending on the size of the 9th and 10th grade Haitian population served in each school.

Przegląd badań

Status

Zakończony

Interwencja / Leczenie

Szczegółowy opis

This is an intervention with an evaluation component. In each school, students will have equal chance to participate in the sex education class or in the nutrition education class. Each participating school will have two (2) groups:

  • The intervention group which will receive the HART sex education curriculum.
  • The comparison group which will receive a nutrition education curriculum. There will be one PTSD awareness session for both groups.. This session will be provided by mental health professionals from the Haitian Mental Health Network. Each group will consist of about 13-15 student participants, with the groups meeting each week on specific week days. In addition to the ten-week curriculum, there will be sessions at the beginning and end of the cycle to administer the pre- and post-test questionnaires. The 12-week cycle will be repeated 2-3 times through the school year.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

637

Faza

  • Faza 3

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

13 lat do 19 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion criteria

  1. Haitian descent
  2. 13 to 19 years of age
  3. 9th and 10th grade
  4. Having signed assent and parental consent forms
  5. Willingness to participate in the pretest survey

Exclusion criteria

  1. Not of Haitian descent
  2. Age greater than 19 years
  3. Under 13 years of age
  4. Cognitive impairment
  5. Not having signed assent and parental consent forms
  6. Not willingness to participate in the pretest survey

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Intervention

The pregnancy prevention intervention to be tested is an adaptation of Becoming a Responsible Teen (BART), an evidence-based (proven to work by research) HIV prevention curriculum designed primarily for African American adolescents, ages 14-18, in community-based settings.

The culturally-adapted version HART consists of nine sessions, lasting about 2 hours each, and includes interactive group discussions and role plays that are -performed by adolescents. Unlike BART, one PTSD awareness session has been added to address what happens to people who have been exposed to mental trauma and natural disasters.

Skills based sexual education intervention plus PTSD awareness
Brak interwencji: Control or nutrition
Nutrition/fitness curriculum will teach students about ingredients in food that are good for the body and will keep it in good health

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
HIV knowledge measured by having a statistically significant difference between treatment and control participants, in proportion of true or false statements about HIV transmission, prevention and cure that are accurately identified.
Ramy czasowe: One week after the intervention ended
This outcome is collected at one week post intervention using a quantitative self-administered survey. Pre-test measures and key demographic data e.g. age, gender and other covariates of prognostic significance that are found not to have a balanced distribution between the treatment and control are adjusted for using multivariate analysis to increase precision of treatment effect measure
One week after the intervention ended

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Three- cognitive constructs that are causally related with HIV knowledge within the "Information Motivation and Behavioral Skills" framework.. Our study includes : 3 measures of Personal motivation
Ramy czasowe: One week after the intervention ended
  1. A statistically significant posttest difference between treatment and control in proportion of participants reporting definite intent to have sex next year
  2. A statistically significant posttest difference between treatment and control in proportion of participants reporting a definite intent to use condom if have sex in next year
  3. A statistically significant posttest difference between treatment and control in proportion of participants reporting definite intent to use birth control if have sex in next year
One week after the intervention ended
4 measures of Social motivation for preventive behavior
Ramy czasowe: One week after the intervention ended
A statistically significant posttest difference between the treatment and control in proportion of participants reporting not being embarrassed to buy, use, talk about condoms b) A statistically significant posttest difference between the treatment and control in Proportion of participant reporting condom effectiveness to prevent HIV c) A statistically significant posttest difference between the treatment and control in proportion reporting condom effectiveness to prevent pregnancy d) A statistically significant posttest difference between the treatment and control in proportion of participants reporting not believing that condom purchase is a regulation for youth under the age of 16.
One week after the intervention ended
4 measures of Behavioral skills of avoiding risky social situations that could engage in risky sexual behavior.
Ramy czasowe: One week after the intervention ended
  1. A statistically significant posttest difference between the treatment and control in Proportion of participants reporting being alone 3 or more times in the last 3 months with someone very attracted to
  2. A statistically significant posttest difference between the treatment and control in proportion of participants reporting being alone 3 or more times in the last 3 months kissing and touching someone really liked
  3. A statistically significant posttest difference between the treatment and control in proportion of participant reporting being alone 3 or more times in the last 3 months with someone really liked and laid down on a couch or bed
  4. A statistically significant posttest difference between the treatment and control in proportion of participants reporting being alone 3 or more times in the last 3 months, at a party where there were no adults in the house
One week after the intervention ended

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 kwietnia 2012

Zakończenie podstawowe (Rzeczywisty)

1 marca 2015

Ukończenie studiów (Rzeczywisty)

1 września 2015

Daty rejestracji na studia

Pierwszy przesłany

27 stycznia 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 lutego 2016

Pierwszy wysłany (Oszacować)

4 lutego 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

4 lutego 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 lutego 2016

Ostatnia weryfikacja

1 lutego 2016

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • H30298

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

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Badania kliniczne na HART

3
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