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A School-Based HIV/STD Prevention Program to Reduce Risky Sexual Behaviors Among Adolescents in Liberia

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Liberia
Study Type
Interventional
Intervention
HIV/STD prevention curriculum
General health promotion curriculum
Sponsored by
Pacific Institute for Research and Evaluation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV/STD Prevention, HIV Seronegativity

Eligibility Criteria

13 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A 6th or 7th grader attending school in Liberia

Exclusion Criteria:

  • Not enrolled in the study schools

Sites / Locations

  • University of Liberia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participating schools will deliver HIV/STD prevention modules.

Participating schools will deliver general health promotion modules.

Outcomes

Primary Outcome Measures

Frequency of unprotected sex

Secondary Outcome Measures

Full Information

First Posted
June 13, 2008
Last Updated
May 17, 2013
Sponsor
Pacific Institute for Research and Evaluation
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00698321
Brief Title
A School-Based HIV/STD Prevention Program to Reduce Risky Sexual Behaviors Among Adolescents in Liberia
Official Title
Liberia School-Based HIV/STD Prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pacific Institute for Research and Evaluation
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the effectiveness of a school-based HIV/sexually transmitted disease prevention program in reducing sexual risk behaviors of youth attending school in Liberia.
Detailed Description
Currently, more than 60 million people have been diagnosed with HIV/AIDS worldwide. It is estimated that about two-thirds of all HIV infections are among people in Africa. The African country of Liberia, in particular, is experiencing an increase in HIV/sexually transmitted disease (STD) infections and is in need of improved HIV/STD-related prevention programs. With the majority of the new infections occurring among people who are between 15 and 29 years old, new HIV/STD prevention programs are needed to educate youth about proper condom use and risks associated with sexual behaviors. Previous research has suggested that behavioral interventions can reduce adolescents' sexual behaviors that are tied to risk of acquiring STDs. The evidenced-based HIV prevention program, Making Proud Choices, is an intervention originally designed for community settings in the United States, but is currently being adapted in schools of certain sub-Saharan African countries. Adapting this community-based curriculum to school-based settings and cultural contexts within Liberia may be effective in reducing risky sexual behaviors in Liberian adolescents. This study will compare the effectiveness of a school-based HIV/STD prevention program that draws on the curriculum of Making Proud Choices versus a general health promotion program in reducing sexual risk behaviors of youth attending school in Liberia. Participation in this study will involve two phases. Phase 1 will last 8 months and will be used to adapt the community-based curriculum of Making Proud Choices to school-based settings and contexts within Liberia. Data to guide the integration and cultural adaptation of the curriculum will be collected from school administrators, students, health educators, and community-based organizations through focus groups, group discussions, and interviews. Phase 2 will last about 12 months and will include junior high schools in Liberia. Participating schools will be assigned randomly to provide the adapted HIV prevention curriculum or a general health promotion curriculum. Before starting course modules, students receiving either curriculum will complete questionnaires about their risk-associated sexual behaviors and knowledge about condom use and abstinence. Both curriculums will include eight 1-hour modules delivered weekly over 8 weeks. The HIV prevention curriculum will focus on increasing knowledge about preventing HIV, STDs, and pregnancy; improving condom use skills; increasing confidence in the ability to negotiate safer sex and to use condoms correctly; and lowering the incidence of sexual-risk behavior. The general health promotion curriculum will focus on teaching students healthful behaviors, including eating habits, physical activity, dental hygiene, and avoidance of cigarette smoking and substance abuse. All participants will repeat the initial questionnaires immediately after completing the curriculum and 3, 6, and 9 months after the curriculum ends.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV/STD Prevention, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
866 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participating schools will deliver HIV/STD prevention modules.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participating schools will deliver general health promotion modules.
Intervention Type
Behavioral
Intervention Name(s)
HIV/STD prevention curriculum
Other Intervention Name(s)
Making Proud Choices!
Intervention Description
The curriculum will include eight 1-hour HIV prevention modules administered weekly for 8 weeks. The modules will educate youth about risky sexual behaviors and will provide them with knowledge and skills necessary to reduce their risk of STDs, HIV, and pregnancy by abstaining from sex or using condoms if they choose to have sex. The curriculum is based on cognitive behavioral theories, focus groups, and the researchers' experience working with youth.
Intervention Type
Behavioral
Intervention Name(s)
General health promotion curriculum
Intervention Description
The curriculum will include eight 1-hour general health modules administered weekly for 8 weeks. The curriculum will focus on teaching students healthful behaviors, including eating habits, physical activity, dental hygiene, and avoidance of cigarette smoking and substance abuse.
Primary Outcome Measure Information:
Title
Frequency of unprotected sex
Time Frame
Measured at Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A 6th or 7th grader attending school in Liberia Exclusion Criteria: Not enrolled in the study schools
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen B. Kennedy, MD, MPH
Organizational Affiliation
Pacific Institute for Research and Evaluation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Liberia
City
Monrovia
State/Province
Montserrado County
Country
Liberia

12. IPD Sharing Statement

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A School-Based HIV/STD Prevention Program to Reduce Risky Sexual Behaviors Among Adolescents in Liberia

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