Mitigating Adverse Sexual and Reproductive Health Outcomes Among Young Adolescents

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

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

Study Overview

• Status: Unknown
• Conditions: Relationship Problems Specific to Childhood and Adolescence
• Intervention / Treatment: Other: Lessons on comprehensive sexuality education

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

• Study Type: Interventional
• Enrollment (Anticipated): 1100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Provision of 11 standardized lessons on comprehensive sexuality education based on international guidance on sexuality education by UNESCO
No Intervention: Control arm; 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?

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

Collaborators and Investigators

• Sponsor: Mbarara University of Science and Technology
• Collaborators: University Ghent; Free University of Brussels
• Investigators: Principal Investigator: Kristien Michielsen, PhD, University Ghent

Publications and helpful links

General Publications

• Rosenberg M. Rosenberg self-esteem scale (RSE). Acceptance and commitment therapy. Measures package. 1965;61:52.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2015
• Primary Completion (Actual): November 30, 2017
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: adolescents; education; sexuality
• Other Study ID Numbers: MUST 04/10-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be discretely shared with other researchers on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No