- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05396664
Adolescent Transition West Africa (ATWA)
September 25, 2024 updated by: Jay G. Silverman, PhD, University of California, San Diego
Adolescent Transition West Africa: An Outcome Evaluation of a Gender and Sexual and Reproductive Health and Rights Intervention in Mali, Burkina Faso, and Niger
This trial will serve as an outcome evaluation of 'Adolescent Transition in West Africa' (ATWA), a school-based program in Mali, Burkina Faso, and Niger for adolescents ages 10-19.
The overall objectives of the project are as follows: Impact: Improved sexual and reproductive health and rights of 472,180 adolescents.
Outcome 1: Improved sexual and reproductive health and rights and gender equality knowledge, intent, and behaviors among 472,180 adolescents.
Outcome 2: 500 health facilities offer quality adolescent responsive SRH services that are used by adolescent girls and boys.
To evaluate program impact, an external evaluation will be conducted.
A pre/post cross-sectional evaluation design will be used across two evaluation years.
Study Overview
Study Type
Interventional
Enrollment (Actual)
4300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ouagadougou, Burkina Faso
- Save the Children, Burkina Faso
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Bamako, Mali
- Save the Children, Mali
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Niamey, Niger
- Save the Children, Niger
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Enrolled in primary or secondary school
- Participating in community group (Niger only)
- Aged 10 to 19
Exclusion Criteria:
- Not enrolled in school (Mali and Burkina Faso)
- Younger than age 10
- Older than age 19
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention
The ATWA LSE program will be implemented following a joint curricula development process with approval from the government in each of the three countries.
The 'dose' of the intervention are once-weekly hour-long sessions for both in-school adolescents (session facilitated by teachers) and out-of-school adolescents (sessions facilitated by community leaders) over the course of the academic year (roughly 9 months), or roughly 30 sessions of exposure to the in-depth LSE curriculum.
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The Adolescent Transition in West Africa (ATWA) program is an in-school (Niger, Mali, Burkina Faso) and out-of-school (Niger and Mali) educational intervention implemented by local staff members at Save the Children, local community members, and teachers.
ATWA provides internationally-recognized life skills education (LSE) to adolescents ages 10-19 years, and seeks to improve adolescents' knowledge and behaviors regarding sexual and reproductive health and rights.
Outcome indicators to assess knowledge, behavior and attitudes of adolescents will vary by adolescent demographics as well as by country context, as based on the final set of curriculum deemed appropriate by the respective Ministries of Education (MOE).
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No Intervention: Control
Control groups are comprised of adolescents (10-19) attending schools where the ATWA Life Skills Education (LSE) program has not been implemented, as well as out-of-school adolescents (10-19) who have not received the ATWA LSE program in their communities.
Control groups receive "standard of care" educational opportunities.
"Standard of care" in the case of this trial translate to the provision of standard Ministry of Education-sanctioned sexuality education, as already available in the adolescents' schools and communities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Impact Indicator 1. Decrease in adolescent birth rate
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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The average number of births to female respondents ages 15-19
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Impact 2. Decrease in proportion of adolescents who have ever been pregnant or caused a pregnancy
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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The percent of adolescent females who have ever been pregnant + the percent of adolescent males who have ever caused a pregnancy
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Impact 3. Increase in need for family planning satisfied with modern contraception
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Indicator definition 3A: Percentage of [sexually active] adolescents age 15-19 years currently married or in union who have their need for family planning satisfied with modern contraceptive methods Indicator definition 3B: Percentage of female adolescents (15-19) who are sexually active and who have their need for contraception satisfied with modern methods
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Impact 4. Increase in adolescent modern contraceptive prevalence rate
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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The percent of sexually active adolescents (15-19) who are currently using (or whose partner is using) a modern contraceptive method.
"Currently" is defined as 'at last sex'
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Impact 5. Decrease in proportion of adolescents married
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Indicator definition 5A: Percentage of women 10-19 years old living with spouse before age 18. Indicator definition 5B: Percentage of women 10-19 years old living with spouse before age 15. |
Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Outcome 1.1.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Proportion of adolescents who respond yes to planning to use modern contraception in the future, disaggregated by method
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Outcome 1.2.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Proportion of sexually active adolescents reporting using a condom at last sex
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Outcome 1.3.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Proportion of sexually active unmarried adolescents who respond yes to having used a condom every time they had sex in the last 6 months
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Outcome 1.4.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Proportion of adolescents with significant increase from baseline to end-line in average score on a 6-item gender equitable attitude scale
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Outcome 1.5.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Average number of modern contraceptive methods known among women 10-14 and 15-19 years old
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Outcome 1.6.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Proportion of adolescents with correct knowledge about body changes during puberty, the menstrual cycle, fertility and conception, pregnancy risk and prevention, as assessed via a 9-item composite indicator
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Outcome 1.7.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Proportion of adolescents with correct knowledge about STI risk and prevention and treatment, assessed using a composite indicator of 4 questions on STI prevention and treatment
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Outcome 1.8.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Proportion of adolescents with comprehensive knowledge of HIV prevention, assessed using a composite indicator of 6 questions on HIV prevention
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Outcome 1.9.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Proportion of adolescents with knowledge of where to seek SRH services, including where to get tested for HIV, where to get condoms, and where to get contraceptives
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Outcome 1.10.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Proportion of girls who report properly disposing of absorbent materials (sanitary napkins or menstrual cloth) (denominator = the total number of girls who use absorbent materials (sanitary napkins or menstrual cloth))
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Outcome 1.11.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Proportion of girls who report hygienically washing and drying reusable menstrual cloth (denominator = number of girls who washed and reused menstrual materials)
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Output 1.2.1.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Proportion of girls and boys that can correctly answer a basic set of four yes/no questions about menstruation
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Output 1.2.2.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Proportion of girls that can answer a set of five questions correctly about how to hygienically manage menses
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Output 1.2.3.
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Proportion of girls and boys that answer a question correctly regarding that menstruation is a normal biological function of the female body
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Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jay Silverman, PhD, University of California, San Diego
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
December 1, 2023
Study Registration Dates
First Submitted
January 19, 2022
First Submitted That Met QC Criteria
May 24, 2022
First Posted (Actual)
May 31, 2022
Study Record Updates
Last Update Posted (Actual)
September 27, 2024
Last Update Submitted That Met QC Criteria
September 25, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 111111 (Other Grant/Funding Number: FUZEhub)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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