Adolescent Transition West Africa

NCT05396664 | Completed

• 1 other identifier: 111111
• Study Type: interventional
• Target: 4,300
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Adolescent Development

Outcome Measures

Primary Outcomes (19)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

ATWA BEHAVIORAL

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).

Intervention

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead
• Save the Children Netherlands: collaborator
• GRADE Africa: collaborator

Study Sites (3)

Save the Children, Burkina Faso

Ouagadougou, Burkina Faso

Location

Save the Children, Mali

Bamako, Mali

Location

Save the Children, Niger

Niamey, Niger

Location

Study Officials

• Jay Silverman, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: May 31, 2022
• Study Start: December 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NI (1); BU (1); MA (1)