Mitigating Adverse Sexual and Reproductive Health Outcomes Among Young Adolescents

Study Overview
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Brief Summary
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This study evaluates the effectiveness of comprehensive sexuality education (CSE) among young adolescents (10-14 years) in schools. A total of 33 schools will participate in the trial with 15 intervention arm that will receive CSE education and 18 in the control arm, Intervention will go on for one year

Detailed Description
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The International Technical Guidance on Sexuality Education (ITGSE) defines CSE as an age-appropriate, culturally relevant approach to teaching about sexuality and relationships by providing scientifically accurate, realistic, non-judgmental information and CSE improves sexual and reproductive health outcomes of young people by delaying sexual debut, promoting condom use and increasing sexual health knowledge, however, most of these outcomes have been reported in older adolescents and there is limited evidence for effectiveness of CSE among young adolescents The study aims at improving adolescent sexual and reproductive health of young adolescents through CSE that is led by interdisciplinary university students' team in an environment where no consistent or regulated sexual and reproductive health education program currently exists

Official Title
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Mitigating Adverse Sexual and Reproductive Health Outcomes Through a Comprehensive Primary School Sexuality Education Program in South-Western Uganda

Conditions
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Relationship Problems Specific to Childhood and Adolescence

Intervention / Treatment
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* Other: Lessons on comprehensive sexuality education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adolescent 10-14 years in primary school Adolescent in primary 5 or 6 of education in Uganda Written consent/assent to participate Exclusion Criteria: Below 10 years or above 14 years at baseline No consent obtained

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A cluster randomized trial where the intervention is structured comprehensive sexuality education lesson packages
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention arm will receive a pre evaluation survey, 11 lessons on CSE sequentially in a period of one year and a post evaluation survey | Other: Lessons on comprehensive sexuality education<br>* Provision of 11 standardized lessons on comprehensive sexuality education based on international guidance on sexuality education by UNESCO<br>|
| No Intervention: Control arm<br>This is a control arm that receives no intervention but will have and pre and post evaluation in one year | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in sexual health knowledge by 15% from baseline | change in sexual health knowledge(HIV, STI, contraception and puberty knowledge) using an itemized questionnaire developed for the study. The estimated knowlege score will be 25 . Individual items include on knowledge of puberty, HIV/STIs and pregnancy prevention. This includes knowledge on how HIV/AIDS can be acquired (score 0-4), types of common Sexually Transmitted Infections (score 0-4), knowledge of pubertal changes in boys (score 0-6.) and in girls (score 0-7), and knowledge about ways to prevent pregnancy (score 0-4) | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in proportion of sexually active adolescents by 10% from baseline | Change in number of those who are sexually active | one year | 
| Change in gender equitable norm scores by 10% from baseline | Adolescents to adopt a more gender equitable norm attitude. Gender equitable norms scale will be developed on a 4 likert point scale and total scores will range from 0 to 44. The higher the score, the higher the tendency to have gender equitable norms. The score consists of 11 items. Six of these items were adapted from the Attitudes towards Women Scale for Adolescents (AWSA) by Galambos NL et al., 1985 while 5 items were developed to suit the respondents' age and the Ugandan context. | one year | 
| change in body image scores by 10% from baseline | Adolescents develop a more positive attitude in appreciation of their body size or shape.The items for this scale were adapted from the Body Image States Scale (BISS-6) by Cash TF et al, 2002 but transformed to a 5 point likert scale including a neutral point for ease of use among respondents. The total expected score was 24 and the higher the score the better the body image | one year | 
| change in self esteem scores by 10% from baseline | Adolescent develop confidence in themselves and their abilities. Self esteem score used was developed by Rosenberg M et al., 1965. The total expected score for the 10 items was 40. The higher the score the better the self esteem | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sexuality, education, adolescents