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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Impact Indicator 1. Decrease in adolescent birth rate
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
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
Time Frame: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Save the Children Netherlands
GRADE Africa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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