Adolescent DevelopmentATWANCT05396664
Adolescent Transition West Africa
A study testing ATWA in people with Adolescent Development, run by University of California, San Diego at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Development
- What is being tested?
- ATWA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,300 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Dec 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Enrolled in primary or secondary school
- Participating in community group (Niger only)
- Aged 10 to 19
Who cannot join
- Not enrolled in school (Mali and Burkina Faso)
- Younger than age 10
- Older than age 19
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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
- Being tested
- ATWA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATWABehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact Indicator 1. Decrease in adolescent birth rate
The average number of births to female respondents ages 15-19
Measured: 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
Measured: 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
Measured: 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'
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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))
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Year 1 Evaluation: September 2021 - May 2022; Year 2 Evaluation: September 2022 - May 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Dec 2021
- Primary completion1 Jun 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Save the Children Netherlands, GRADE Africa
- Responsible party
- Principal investigator, Jay G. Silverman, PhD, University of California, San Diego
- Investigators
- Jay Silverman, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396664
- Sponsor's protocol ID
- 111111
- Acronym
- ATWA
- Status last verified
- Sep 2024
- First submitted
- 19 Jan 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05396664
- Acronym / sponsor ID
- ATWA / 111111
- Conditions
- Adolescent Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,300 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Save the Children Netherlands, GRADE Africa
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ATWAThe 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. |
| 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Enrolled in primary or secondary school
- Participating in community group (Niger only)
- Aged 10 to 19
Key exclusion criteria (3 listed)
- Not enrolled in school (Mali and Burkina Faso)
- Younger than age 10
- Older than age 19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATWAThe 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). | Behavioural | Intervention |
Primary outcome
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
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
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
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'
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.
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
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
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
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
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
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
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
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
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
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))
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)
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Silverman, PhD principal investigator
University of California, San Diego
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATWA in people with Adolescent Development, run by University of California, San Diego at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Burkina Faso, Mali, Niger. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.