Adolescent Transition West Africa

Adolescent Development Clinical Trial

— ATWA  

Official title:

Adolescent Transition West Africa: An Outcome Evaluation of a Gender and Sexual and Reproductive Health and Rights Intervention in Mali, Burkina Faso, and Niger

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396664
• Other study ID #: 111111
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2022
• Source: University of California, San Diego
• Contact: Kathryn M Barker, ScD
• Phone: 919-360-3951
• Email: k1barker[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Development

Intervention

Behavioral:
• ATWA
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).

Locations

Country	Name	City	State
Burkina Faso	Save the Children, Burkina Faso	Ouagadougou
Mali	Save the Children, Mali	Bamako
Niger	Save the Children, Niger	Niamey

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	GRADE Africa, Save the Children Netherlands

Countries where clinical trial is conducted

Burkina Faso,  Mali,  Niger, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact Indicator 1. Decrease in adolescent birth rate	The average number of births to female respondents ages 15-19	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Impact 2. Decrease in proportion of adolescents who have ever been pregnant or caused a pregnancy	The percent of adolescent females who have ever been pregnant + the percent of adolescent males who have ever caused a pregnancy	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Impact 3. Increase in need for family planning satisfied with modern contraception	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	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Impact 4. Increase in adolescent modern contraceptive prevalence rate	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'	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Impact 5. Decrease in proportion of adolescents married	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
Primary	Outcome 1.1.	Proportion of adolescents who respond yes to planning to use modern contraception in the future, disaggregated by method	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Outcome 1.2.	Proportion of sexually active adolescents reporting using a condom at last sex	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Outcome 1.3.	Proportion of sexually active unmarried adolescents who respond yes to having used a condom every time they had sex in the last 6 months	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Outcome 1.4.	Proportion of adolescents with significant increase from baseline to end-line in average score on a 6-item gender equitable attitude scale	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Outcome 1.5.	Average number of modern contraceptive methods known among women 10-14 and 15-19 years old	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Outcome 1.6.	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	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Outcome 1.7.	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	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Outcome 1.8.	Proportion of adolescents with comprehensive knowledge of HIV prevention, assessed using a composite indicator of 6 questions on HIV prevention	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Outcome 1.9.	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	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Outcome 1.10.	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))	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Outcome 1.11.	Proportion of girls who report hygienically washing and drying reusable menstrual cloth (denominator = number of girls who washed and reused menstrual materials)	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Output 1.2.1.	Proportion of girls and boys that can correctly answer a basic set of four yes/no questions about menstruation	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Output 1.2.2.	Proportion of girls that can answer a set of five questions correctly about how to hygienically manage menses	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Primary	Output 1.2.3.	Proportion of girls and boys that answer a question correctly regarding that menstruation is a normal biological function of the female body	Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023