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Mitigating Adverse Sexual and Reproductive Health Outcomes Among Young Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669913
Recruitment Status : Unknown
Verified September 2018 by Mbarara University of Science and Technology.
Recruitment status was:  Active, not recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborators:
University Ghent
Free University of Brussels
Information provided by (Responsible Party):
Mbarara University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Relationship Problems Specific to Childhood and Adolescence Other: Lessons on comprehensive sexuality education Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A cluster randomized trial where the intervention is structured comprehensive sexuality education lesson packages
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mitigating Adverse Sexual and Reproductive Health Outcomes Through a Comprehensive Primary School Sexuality Education Program in South-Western Uganda
Actual Study Start Date : November 8, 2015
Actual Primary Completion Date : November 30, 2017
Estimated Study Completion Date : December 31, 2018

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



Primary Outcome Measures :
  1. change in sexual health knowledge by 15% from baseline [ Time Frame: one year ]
    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)


Secondary Outcome Measures :
  1. Change in proportion of sexually active adolescents by 10% from baseline [ Time Frame: one year ]
    Change in number of those who are sexually active

  2. Change in gender equitable norm scores by 10% from baseline [ Time Frame: one year ]
    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.

  3. change in body image scores by 10% from baseline [ Time Frame: one year ]
    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

  4. change in self esteem scores by 10% from baseline [ Time Frame: one year ]
    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



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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669913


Sponsors and Collaborators
Mbarara University of Science and Technology
University Ghent
Free University of Brussels
Investigators
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Principal Investigator: Kristien Michielsen, PhD University Ghent
  Study Documents (Full-Text)

Documents provided by Mbarara University of Science and Technology:
Study Protocol  [PDF] November 3, 2016

Publications:
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Responsible Party: Mbarara University of Science and Technology
ClinicalTrials.gov Identifier: NCT03669913    
Other Study ID Numbers: MUST 04/10-15
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be discretely shared with other researchers on request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mbarara University of Science and Technology:
sexuality
education
adolescents