ClinicalTrials.gg
CompletedNCT05396664ATWAUpdated Sep 27, 2024

Adolescent Transition West Africa

An interventional study of ATWA in Adolescent Development, sponsored by University of California, San Diego. Completed at 3 sites in 3 countries. Open to participants aged 10 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-27.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
4,300
Allocation
Randomized
Ages
10 Years to 19 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Adolescent Development
03

In context

Lead sponsor

University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Enrolled in primary or secondary school
  • Participating in community group (Niger only)
  • Aged 10 to 19

Exclusion criteria

Exclusion Criteria:

  • Not enrolled in school (Mali and Burkina Faso)
  • Younger than age 10
  • Older than age 19
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,300 participants (actual)

Study arms

  • 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.

    Behavioral: ATWA

  • 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.

Interventions

  • BehavioralATWA

    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).

06

What researchers measure

Primary outcomes

  1. Impact Indicator 1. Decrease in adolescent birth rate

    The average number of births to female respondents ages 15-19

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  2. 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

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  3. 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

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  4. 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'

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  5. 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.

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  6. Outcome 1.1.

    Proportion of adolescents who respond yes to planning to use modern contraception in the future, disaggregated by method

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  7. Outcome 1.2.

    Proportion of sexually active adolescents reporting using a condom at last sex

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  8. 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

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  9. 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

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  10. Outcome 1.5.

    Average number of modern contraceptive methods known among women 10-14 and 15-19 years old

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  11. 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

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  12. 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

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  13. Outcome 1.8.

    Proportion of adolescents with comprehensive knowledge of HIV prevention, assessed using a composite indicator of 6 questions on HIV prevention

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  14. 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

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  15. 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))

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  16. 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)

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  17. Output 1.2.1.

    Proportion of girls and boys that can correctly answer a basic set of four yes/no questions about menstruation

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  18. Output 1.2.2.

    Proportion of girls that can answer a set of five questions correctly about how to hygienically manage menses

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

  19. 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

    Time frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

07

Study locations

3 sites
  • Save the Children, Burkina Faso
    Ouagadougou, Burkina Faso
  • Save the Children, Mali
    Bamako, Mali
  • Save the Children, Niger
    Niamey, Niger
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05396664
Collaborators
Save the Children Netherlands, GRADE Africa
Responsible party
Jay G. Silverman, PhD (Professor, University of California, San Diego) — Principal investigator
First posted
May 31, 2022
Start date
Dec 1, 2021
Primary completion
Jun 1, 2023
Completion
Dec 1, 2023
Last update
Sep 27, 2024

Study contacts

Jay Silverman, PhD
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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