A School-Based HIV/STD Prevention Program to Reduce Risky Sexual Behaviors Among Adolescents in Liberia
| Tracking Information | |||||
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| First Received Date ICMJE | June 13, 2008 | ||||
| Last Updated Date | May 17, 2013 | ||||
| Start Date ICMJE | November 2008 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Frequency of unprotected sex [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00698321 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A School-Based HIV/STD Prevention Program to Reduce Risky Sexual Behaviors Among Adolescents in Liberia | ||||
| Official Title ICMJE | Liberia School-Based HIV/STD Prevention Program | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 866 | ||||
| Completion Date | March 2011 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 13 Years to 15 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Liberia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00698321 | ||||
| Other Study ID Numbers ICMJE | R21 MH082666, R21MH082666, DAHBR 9A-ASPA | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Stephen B. Kennedy, Pacific Institute for Research and Evaluation | ||||
| Study Sponsor ICMJE | Pacific Institute for Research and Evaluation | ||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
| Investigators ICMJE |
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| Information Provided By | Pacific Institute for Research and Evaluation | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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