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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen B. Kennedy, Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier:
NCT00698321
First received: June 13, 2008
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
HIV Infections
Behavioral: HIV/STD prevention curriculum
Behavioral: General health promotion curriculum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Liberia School-Based HIV/STD Prevention Program

Resource links provided by NLM:


Further study details as provided by Pacific Institute for Research and Evaluation:

Primary Outcome Measures:
  • Frequency of unprotected sex [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Enrollment: 866
Study Start Date: November 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participating schools will deliver HIV/STD prevention modules.
Behavioral: HIV/STD prevention curriculum
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.
Other Name: Making Proud Choices!
Active Comparator: 2
Participating schools will deliver general health promotion modules.
Behavioral: General health promotion curriculum
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.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not enrolled in the study schools
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698321

Locations
Liberia
University of Liberia
Monrovia, Montserrado County, Liberia
Sponsors and Collaborators
Pacific Institute for Research and Evaluation
Investigators
Principal Investigator: Stephen B. Kennedy, MD, MPH Pacific Institute for Research and Evaluation
  More Information

No publications provided

Responsible Party: Stephen B. Kennedy, Principal Investigator, Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier: NCT00698321     History of Changes
Other Study ID Numbers: R21 MH082666, R21MH082666, DAHBR 9A-ASPA
Study First Received: June 13, 2008
Last Updated: May 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Pacific Institute for Research and Evaluation:
HIV/STD Prevention
HIV Seronegativity

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 April 17, 2014