Trial record 2 of 36 for:    " October 01, 2008":" October 31, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

HIV Risk Reduction in Youth in the Bahamas

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bonita Stanton, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00774592
First received: October 16, 2008
Last updated: July 18, 2012
Last verified: June 2012
  Purpose

This study will examine whether pairing a grade 6 in-school HIV education program and a parent training program will reduce prevalence of behaviors that present high risk of HIV infection in youth in the Bahamas.

In a continuation of this study, we shall examine whether an in-school HIV prevention program delivered to grade 10 students reduces HIV risk behavior and the impact of both the grade 6 intervention and the grade 10 intervention compared to the grade 6 intervention alone.


Condition Intervention
HIV Infections
Behavioral: FOYC
Behavioral: Goal for it (GFI)
Behavioral: Wonderous Wetlands
Behavioral: Caribbean Informed Parents and Children Together (CImPACT)
Behavioral: Bahamian Focus on Older Youth (BFOOY)
Behavioral: Health and Family Life Curriculum (HFLE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Adolescent Risk Reduction in the Bahamas-Peers and Parents

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Reduction of high-risk behaviors [ Time Frame: Measured at baseline and after 6, 12, 18, 24, and 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intentions concerning high-risk behaviors [ Time Frame: Measured at baseline and after 6, 12, 18, 24, and 36 months ] [ Designated as safety issue: No ]

Enrollment: 1360
Study Start Date: September 2004
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Focus on Youth in the Caribbean (FOYC) plus Caribbean Informed Parents and Children Together (CImPACT)
Behavioral: FOYC
FOYC is a face-to-face, eight-session, group behavioral intervention based on protection motivation theory and emphasizing skills and decision-making.
Behavioral: Caribbean Informed Parents and Children Together (CImPACT)
CImPACT is a parent intervention addressing parental monitoring and communication with youth. It consists of a 20-minute video, a condom practice, and role play simulating a parent-child discussion.
Experimental: 2
FOYC plus Goal For It (GFI)
Behavioral: FOYC
FOYC is a face-to-face, eight-session, group behavioral intervention based on protection motivation theory and emphasizing skills and decision-making.
Behavioral: Goal for it (GFI)
GFI is a one-session parent intervention consisting of a 20-minute video followed by a discussion regarding the process of setting and reaching goals.
Active Comparator: 3
Wonderous Wetlands plus GFI
Behavioral: Wonderous Wetlands
Wonderous Wetlands is an eight-session, group intervention for youth. It includes field projects and discussions based on ways to save our environment.
Behavioral: Health and Family Life Curriculum (HFLE)
Standard Grade 10 curriculum
Other Name: Standard grade 10 health curriculum
Experimental: Grade 10-BFOOY+CImPACT
Youth receives HIV intervention; parents receive parental monitoring intervention
Behavioral: Bahamian Focus on Older Youth (BFOOY)
10 session HIV prevention program
Experimental: Grade 10 BFOOY+GFI
Youth receive HIV prevention intervention and parents receive attention control intervention on career planning
Behavioral: Bahamian Focus on Older Youth (BFOOY)
10 session HIV prevention program
Experimental: BFOOYand no parent intervention
Youth receive HIV prevention intervention; parents receive no intervention
Behavioral: Bahamian Focus on Older Youth (BFOOY)
10 session HIV prevention program
Placebo Comparator: Health and FAmily life
Youth receive standard of care (current curriculum); parents receive no intervention
Behavioral: Health and Family Life Curriculum (HFLE)
Standard Grade 10 curriculum
Other Name: Standard grade 10 health curriculum

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Attends 1 of the 15 participating Bahamian elementary schools
  • Enrolled in grade 6
  • Participation of at least 1 parent

In second study:

  • Attends 1 of 8 participating government highschools
  • Enrolled in grade 10
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774592

Locations
United States, Michigan
Wayne State University School of Medicine
Detroit, Michigan, United States, 48230
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Bonita F. Stanton, MD Wayne State University
  More Information

Publications:

Responsible Party: Bonita Stanton, Professor of Pediatrics, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00774592     History of Changes
Other Study ID Numbers: R01 MH069229, R01MH069229, DAHBR 9A-ASPC
Study First Received: October 16, 2008
Last Updated: July 18, 2012
Health Authority: United States: Federal Government

Keywords provided by Wayne State University:
Adolescent Risk Reduction
HIV/AIDS Prevention
Behavioral Change
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 26, 2014