NCT00774592

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,360

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
7.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

4.3 years

First QC Date

October 16, 2008

Last Update Submit

November 1, 2017

Conditions

Keywords

Adolescent Risk ReductionHIV/AIDS PreventionBehavioral ChangeHIV

Outcome Measures

Primary Outcomes (1)

  • Reduction of high-risk behaviors

    Measured at baseline and after 6, 12, 18, 24, and 36 months

Secondary Outcomes (1)

  • Intentions concerning high-risk behaviors

    Measured at baseline and after 6, 12, 18, 24, and 36 months

Study Arms (7)

1

EXPERIMENTAL

Focus on Youth in the Caribbean (FOYC) plus Caribbean Informed Parents and Children Together (CImPACT)

Behavioral: FOYCBehavioral: Caribbean Informed Parents and Children Together (CImPACT)

2

EXPERIMENTAL

FOYC plus Goal For It (GFI)

Behavioral: FOYCBehavioral: Goal for it (GFI)

3

ACTIVE COMPARATOR

Wonderous Wetlands plus GFI

Behavioral: Wonderous WetlandsBehavioral: Health and Family Life Curriculum (HFLE)

Grade 10-BFOOY+CImPACT

EXPERIMENTAL

Youth receives HIV intervention; parents receive parental monitoring intervention

Behavioral: Bahamian Focus on Older Youth (BFOOY)

Grade 10 BFOOY+GFI

EXPERIMENTAL

Youth receive HIV prevention intervention and parents receive attention control intervention on career planning

Behavioral: Bahamian Focus on Older Youth (BFOOY)

BFOOYand no parent intervention

EXPERIMENTAL

Youth receive HIV prevention intervention; parents receive no intervention

Behavioral: Bahamian Focus on Older Youth (BFOOY)

Health and FAmily life

PLACEBO COMPARATOR

Youth receive standard of care (current curriculum); parents receive no intervention

Behavioral: Health and Family Life Curriculum (HFLE)

Interventions

FOYCBEHAVIORAL

FOYC is a face-to-face, eight-session, group behavioral intervention based on protection motivation theory and emphasizing skills and decision-making.

12

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.

2

Wonderous Wetlands is an eight-session, group intervention for youth. It includes field projects and discussions based on ways to save our environment.

3

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.

1

10 session HIV prevention program

BFOOYand no parent interventionGrade 10 BFOOY+GFIGrade 10-BFOOY+CImPACT

Standard Grade 10 curriculum

Also known as: Standard grade 10 health curriculum
3Health and FAmily life

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University School of Medicine

Detroit, Michigan, 48230, United States

Location

Related Publications (11)

  • 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. doi: 10.1258/095646207781024784.

    PMID: 17609029BACKGROUND
  • 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. doi: 10.1071/sh07040.

    PMID: 18361852BACKGROUND
  • 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. doi: 10.1542/peds.2008-2363. Epub 2009 Apr 20.

    PMID: 19380429BACKGROUND
  • 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. doi: 10.1007/s10461-008-9511-0. Epub 2008 Dec 31.

    PMID: 19116781BACKGROUND
  • 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. doi: 10.1186/1471-2458-7-135.

    PMID: 17605792BACKGROUND
  • 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. doi: 10.1001/archpedi.161.12.1130.

  • 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. doi: 10.1177/1545109710397367. Epub 2011 Mar 23.

  • 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. doi: 10.1258/ijsa.2010.010039.

  • 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. doi: 10.3329/jhpn.v27i3.3383.

  • 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. doi: 10.1016/j.jadohealth.2011.06.012. Epub 2011 Sep 3.

MeSH Terms

Conditions

HIV Infections

Interventions

Health

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Bonita F. Stanton, MD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

September 1, 2004

Primary Completion

December 1, 2008

Study Completion

May 1, 2016

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations