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HIV Risk Reduction in Youth in the Bahamas
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00774592
  Purpose

This study will examine whether pairing an 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.


Condition Intervention
HIV Infections
Behavioral: FOYC
Behavioral: GFI
Behavioral: Wonderous Wetlands
Behavioral: CImPACT

MedlinePlus related topics: AIDS
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Adolescent Risk Reduction in the Bahamas-Peers and Parents

Further study details as provided by National Institute of Mental Health (NIMH):

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 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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: 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.
2: Experimental
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: 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.
3: Active Comparator
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.

Detailed Description:

HIV infection in the Bahamas is the leading cause of death among Bahamians between the ages of 15 and 44. It is estimated that 4.13% of adults in the Bahamas are HIV infected, and the Bahamas has the highest annual incidence of AIDS in the English-speaking Caribbean. One cause for these high rates of infection is the prevalence of risky behaviors among Bahamian youth. Among youth between the ages of 13 and 15, 32% are sexually experienced, with that rate rising to 57% among youth age 16 or older. Approximately half of these adolescents have never used birth control, and only one third use birth control consistently.

This study will examine the benefits of combining a youth HIV prevention education program with a parental program focused on communication and monitoring. The youth education program, developed in the United States but modified to address Caribbean culture, is called Focus on Youth in the Caribbean (FOYC). FOYC has already been shown to be effective in increasing condom use, knowledge of HIV, and knowledge of risks associated with unprotected sex and drug use. Including parents in this intervention effort may broaden and sustain its effects. A study of seventh to eleventh graders found that teens were six times less likely to engage in sexual activity if they thought their mothers disapproved of it. The study also found that teens often did not have a clear idea of what their parents approved of or disapproved of, indicating a need for better communication between parents and children. Other studies have shown that parents who monitor their children reduce the likelihood that those children have unprotected sex or use drugs. The parental intervention program, called Caribbean Informed Parents and Children Together (CImPACT), has been shown to increase communication between parents and children and, when paired with a face-to-face intervention, enhance condom skills and lower rates of sex, unprotected sex, cigarette use, and alcohol use. This study will examine whether pairing the FOYC and CImPACT interventions will reduce prevalence of behaviors that present high risk of HIV infection in youth in the Bahamas.

Parents will be randomly assigned to receive either the CImPACT program or a control program called Goal for It (GFI), both of which will be implemented in a 1.5-hour training session. Schools will be randomly assigned to receive either the FOYC program or a control program entitled Wonderous Wetlands. Both programs will be implemented as part of the curriculum in 15 Bahamian elementary schools. Children, therefore, will be part of 1 of 3 groups:

  1. Parent receiving the CImPACT program; school receiving the FOYC program
  2. Parent receiving the GFI program; school receiving the FOYC program
  3. Parent receiving the GFI program; school receiving the Wonderous Wetlands program

Parents and children will be assessed at the beginning of the study and after 6, 12, 18, 24, and 36 months. These assessments will include questionnaires measuring high-risk behaviors, conceptions of risks and rewards involved in high-risk behaviors, and parent and adolescent communication and monitoring.

  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
  Contacts and Locations
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
Investigators
Principal Investigator: Bonita F. Stanton, MD Wayne State University School of Medicine
  More Information

Publications of Results:
Other Publications:
Responsible Party: Wayne State University School of Medicine ( Bonita F. Stanton, MD )
Study ID Numbers: R01 MH069229, DAHBR 9A-ASPC
Study First Received: October 16, 2008
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00774592  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Adolescent Risk Reduction
HIV/AIDS Prevention
Behavioral Change
HIV

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009