Clinical trial NCT03669913: Mitigating Adverse Sexual and Reproductive Health Outcomes Among Young Adolescents
Official title: Mitigating Adverse Sexual and Reproductive Health Outcomes Through a Comprehensive Primary School Sexuality Education Program in South-Western Uganda
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Relationship Problems Specific to Childhood and Adolescence
Keywords: sexuality
education
adolescents
Lead sponsor: Mbarara University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Free University of Brussels
First posted: 2018-09-13
Enrollment: 1100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster randomized trial where the intervention is structured comprehensive sexuality education lesson packages
Primary purpose: PREVENTION

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: change in sexual health knowledge by 15% from baseline
timeFrame: one year
Secondary outcomes:
measure: Change in proportion of sexually active adolescents by 10% from baseline
timeFrame: one year
measure: Change in gender equitable norm scores by 10% from baseline
timeFrame: one year
measure: change in body image scores by 10% from baseline
timeFrame: one year
measure: change in self esteem scores by 10% from baseline
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: University Ghent
name: Kristien Michielsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenberg M. Rosenberg self-esteem scale (RSE). Acceptance and commitment therapy. Measures package. 1965;61:52.
citation: Cash TF, Fleming EC, Alindogan J, Steadman L, Whitehead A. Beyond body image as a trait: the development and validation of the Body Image States Scale. Eat Disord. 2002 Summer;10(2):103-13. doi: 10.1080/10640260290081678.
citation: Galambos NL, Petersen AC, Richards M, Gitelson IB. The Attitudes Toward Women Scale for Adolescents (AWSA): A study of reliability and validity. Sex roles. 1985;13(5):343-356.
citation: Kemigisha E, Nyakato VN, Bruce K, Ndaruhutse Ruzaaza G, Mlahagwa W, Ninsiima AB, Coene G, Leye E, Michielsen K. Adolescents' Sexual Wellbeing in Southwestern Uganda: A Cross-Sectional Assessment of Body Image, Self-Esteem and Gender Equitable Norms. Int J Environ Res Public Health. 2018 Feb 22;15(2):372. doi: 10.3390/ijerph15020372.