search
Back to results

HIV Risk Reduction in Youth in the Bahamas

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FOYC
Goal for it (GFI)
Wonderous Wetlands
Caribbean Informed Parents and Children Together (CImPACT)
Bahamian Focus on Older Youth (BFOOY)
Health and Family Life Curriculum (HFLE)
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Adolescent Risk Reduction, HIV/AIDS Prevention, Behavioral Change, HIV

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wayne State University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Grade 10-BFOOY+CImPACT

Grade 10 BFOOY+GFI

BFOOYand no parent intervention

Health and FAmily life

Arm Description

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

FOYC plus Goal For It (GFI)

Wonderous Wetlands plus GFI

Youth receives HIV intervention; parents receive parental monitoring intervention

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

Youth receive HIV prevention intervention; parents receive no intervention

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

Outcomes

Primary Outcome Measures

Reduction of high-risk behaviors

Secondary Outcome Measures

Intentions concerning high-risk behaviors

Full Information

First Posted
October 16, 2008
Last Updated
November 1, 2017
Sponsor
Wayne State University
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00774592
Brief Title
HIV Risk Reduction in Youth in the Bahamas
Official Title
Adolescent Risk Reduction in the Bahamas-Peers and Parents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: Parent receiving the CImPACT program; school receiving the FOYC program Parent receiving the GFI program; school receiving the FOYC program 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. In the continuation of this study we will: Recruit 2600 youth (and their parents) from 172 Grade 10 FHLE classrooms over two years in all seven government high schools in New Providence, The Bahamas Randomly assign at the level of the classroom 2400 youth (and their parents) from 160 classes to one of four intervention conditions: 1) HFLE only (no parent intervention); 2) BFOOY only (no parent intervention); 3) BFOOY plus ImPACT (delivered to parent-youth dyads); or 4) BFOOY plus GFI (delivered to parent-youth dyads); Randomly assign one of the seven high schools (with ~12 HFLE classes and ~200 students) to a "control school" condition to permit exploration of possible class-to-class contamination within schools Assess intervention effects on the entire youth sample at 6, 12, 18 and 24 months post-intervention and among parents at 6 and 12 months Conduct sub-group analyses to explore: i) the impact of related and intensive interventions received at two critical junctures during adolescence; ii) the effect of being part of a longitudinal trial on risk/protective behaviors; and iii) the extent of intervention contamination when randomization is conducted at the level of the class rather than the school. Subgroups will include: Exposed youth (youth who received FOYC in Grade 6) and Naïve youth (youth who did not receive FOYC in Grade 6); Enrolled youth (youth who were enrolled in the ongoing evaluation of FOYC whether as controls or intervention (FOYC) youth) and Not-enrolled youth (youth who were never part of the ongoing study); and Control School youth (those randomly assigned to the control condition at the level of the school in Year 2) and Control Class youth (those assigned to the control condition at the level of the class) Intervention effect (primary hypotheses): Youth randomized to HFLE only will exhibit significantly higher rates of HIV risk behavior, intentions and perceptions and lower knowledge and condom skills through 24 months post-intervention than each of the other three groups; Youth randomized to BFOOY plus GFI will exhibit higher rates of abstinence behavior, intentions and perceptions than youth randomized to BFOOY alone through 24 months follow-up Youth randomized to BFOOY plus ImPACT will exhibit lower rates of HIV risk behavior, intentions and perceptions and higher rates of knowledge, condom skills, and STD testing than each of the other three groups through 24 months follow-up; Parents receiving ImPACT will exhibit higher knowledge and condom use skills than GFI or control parents; ImPACT parents and youth will report higher rates of discussion about HIV prevention and safe sex than parents and youth in the other three intervention groups Intervention behavioral effects will be consistent with changes in perceptions and intentions as posited by the PMT, the theoretic model of behavioral change on which BFOOY is based Secondary/exploratory hypotheses will include: At baseline, Exposed Youth will demonstrate higher rates of condom-use and condom-use intentions and perceptions than Naive youth Exposed youth will demonstrate higher protective behaviors, intentions and perceptions compared to Naive Youth within an intervention category (BFOOY or HFLE) throughout the follow-up period Enrolled youth who received FOYC in Grade 6 will not differ from Not-enrolled youth who received FOYC in Grade 6 with respect to intentions, perceptions and knowledge Youth in the Control Classes will not differ from youth in the Control school with respect to HIV knowledge, perceptions and intentions As a result of this study we shall be able to identify of one or more interventions or intervention combinations targeting mid-adolescents to reduce HIV risk behavior and address questions regarding possible interactions between intervention receipt in both the pre-adolescent and mid-adolescent years. With this knowledge, health policy officials globally, including those in The Bahamas, will be able to make evidence-based decisions appropriate to their resources and the epidemiology of the epidemic in their settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Adolescent Risk Reduction, HIV/AIDS Prevention, Behavioral Change, HIV

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Focus on Youth in the Caribbean (FOYC) plus Caribbean Informed Parents and Children Together (CImPACT)
Arm Title
2
Arm Type
Experimental
Arm Description
FOYC plus Goal For It (GFI)
Arm Title
3
Arm Type
Active Comparator
Arm Description
Wonderous Wetlands plus GFI
Arm Title
Grade 10-BFOOY+CImPACT
Arm Type
Experimental
Arm Description
Youth receives HIV intervention; parents receive parental monitoring intervention
Arm Title
Grade 10 BFOOY+GFI
Arm Type
Experimental
Arm Description
Youth receive HIV prevention intervention and parents receive attention control intervention on career planning
Arm Title
BFOOYand no parent intervention
Arm Type
Experimental
Arm Description
Youth receive HIV prevention intervention; parents receive no intervention
Arm Title
Health and FAmily life
Arm Type
Placebo Comparator
Arm Description
Youth receive standard of care (current curriculum); parents receive no intervention
Intervention Type
Behavioral
Intervention Name(s)
FOYC
Intervention Description
FOYC is a face-to-face, eight-session, group behavioral intervention based on protection motivation theory and emphasizing skills and decision-making.
Intervention Type
Behavioral
Intervention Name(s)
Goal for it (GFI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wonderous Wetlands
Intervention Description
Wonderous Wetlands is an eight-session, group intervention for youth. It includes field projects and discussions based on ways to save our environment.
Intervention Type
Behavioral
Intervention Name(s)
Caribbean Informed Parents and Children Together (CImPACT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Bahamian Focus on Older Youth (BFOOY)
Intervention Description
10 session HIV prevention program
Intervention Type
Behavioral
Intervention Name(s)
Health and Family Life Curriculum (HFLE)
Other Intervention Name(s)
Standard grade 10 health curriculum
Intervention Description
Standard Grade 10 curriculum
Primary Outcome Measure Information:
Title
Reduction of high-risk behaviors
Time Frame
Measured at baseline and after 6, 12, 18, 24, and 36 months
Secondary Outcome Measure Information:
Title
Intentions concerning high-risk behaviors
Time Frame
Measured at baseline and after 6, 12, 18, 24, and 36 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonita F. Stanton, MD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48230
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17609029
Citation
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.
Results Reference
background
PubMed Identifier
18361852
Citation
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.
Results Reference
background
PubMed Identifier
19380429
Citation
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.
Results Reference
background
PubMed Identifier
19116781
Citation
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.
Results Reference
background
PubMed Identifier
17605792
Citation
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.
Results Reference
background
PubMed Identifier
18056557
Citation
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.
Results Reference
result
PubMed Identifier
21430238
Citation
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.
Results Reference
result
PubMed Identifier
21097734
Citation
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.
Results Reference
result
PubMed Identifier
20887691
Citation
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.
Results Reference
result
PubMed Identifier
19507756
Citation
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.
Results Reference
result
PubMed Identifier
22325129
Citation
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.
Results Reference
result

Learn more about this trial

HIV Risk Reduction in Youth in the Bahamas

We'll reach out to this number within 24 hrs