HIV Risk Reduction in Youth in the Bahamas - Full Text View

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Bonita F. Stanton, MD

Wayne State University

More Information

Publications:

Deveaux L, Stanton B, Lunn S, Cottrell L, Yu S, Brathwaite N, Li X, Liu H, Marshall S, Harris C. Reduction in human immunodeficiency virus risk among youth in developing countries. Arch Pediatr Adolesc Med. 2007 Dec;161(12):1130-9.

Deveaux L, Lunn S, Bain RM, Gomez P, Kelly T, Brathwaite N, Russell-Rolle G, Li X, Stanton B. Focus on youth in the Caribbean: beyond the numbers. J Int Assoc Physicians AIDS Care (Chic). 2011 Sep-Oct;10(5):316-25. Epub 2011 Mar 23. PubMed PMID: 21430238; PubMed Central PMCID: PMC3128882.

Chen X, Stanton B, Gomez P, Lunn S, Deveaux L, Brathwaite N, Li X, Marshall S, Cottrell L, Harris C. Effects on condom use of an HIV prevention programme 36 months postintervention: a cluster randomized controlled trial among Bahamian youth. Int J STD AIDS. 2010 Sep;21(9):622-30.

Chen X, Lunn S, Harris C, Li X, Deveaux L, Marshall S, Cottrell L, Stanton B. Modeling early sexual initiation among young adolescents using quantum and continuous behavior change methods: implications for HIV prevention. Nonlinear Dynamics Psychol Life Sci. 2010 Oct;14(4):491-509.

Stanton B, Deveaux L, Lunn S, Yu S, Brathwaite N, Li X, Cottrell L, Harris C, Clemens R, Marshall S. Condom-use skills checklist: a proxy for assessing condom-use knowledge and skills when direct observation is not possible. J Health Popul Nutr. 2009 Jun;27(3):406-13.

Stanton B, Chen X, Koci V, Deveaux L, Lunn S, Harris C, Brathwaite N, Gomez P, Li X, Marshall S. Effect of a grade 6 HIV risk reduction intervention four years later among students who were and were not enrolled in the study trial. J Adolesc Health. 2012 Mar;50(3):243-9. Epub 2011 Sep 3.

Yu S, Deveaux L, Lunn S, Liu H, Brathwaite N, Li X, Cottrell L, Marshall S, Stanton B. At greatest risk: pre- and early adolescent Bahamian youth experiencing anal intercourse. Int J STD AIDS. 2007 Jun;18(6):396-401.

Yu S, Marshall S, Cottrell L, Li X, Liu H, Deveaux L, Harris C, Brathwaite N, Lunn S, Stanton B. Longitudinal predictability of sexual perceptions on subsequent behavioural intentions among Bahamian preadolescents. Sex Health. 2008 Mar;5(1):31-9.

Gong J, Stanton B, Lunn S, Deveaux L, Li X, Marshall S, Brathwaite NV, Cottrell L, Harris C, Chen X. Effects through 24 months of an HIV/AIDS prevention intervention program based on protection motivation theory among preadolescents in the Bahamas. Pediatrics. 2009 May;123(5):e917-28. Epub 2009 Apr 20.

Chen X, Lunn S, Deveaux L, Li X, Brathwaite N, Cottrell L, Stanton B. A cluster randomized controlled trial of an adolescent HIV prevention program among Bahamian youth: effect at 12 months post-intervention. AIDS Behav. 2009 Jun;13(3):499-508. Epub 2008 Dec 31.

Liu H, Yu S, Cottrell L, Lunn S, Deveaux L, Brathwaite NV, Marshall S, Li X, Stanton B. Personal values and involvement in problem behaviors among Bahamian early adolescents: a cross-sectional study. BMC Public Health. 2007 Jul 2;7:135.

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 May 16, 2013