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Active, not recruitingNCT03890237Updated May 28, 2026

GAGE Act With Her-Ethiopia Evaluation

An interventional study of Her Spaces and Act With Her in Adolescent Behavior and Gender, sponsored by George Washington University. Active, not recruiting at 3 sites in Ethiopia. Open to participants aged 10 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by George Washington University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4,500
Allocation
Randomized
Ages
10 Years to 13 Years
Sex
All
01

Study summary

This study evaluates the impact of Act With Her Ethiopia (AWH-E), a gender transformative multi-level program that aims to improve the lives of young adolescent boys and girls.

Read the detailed description

Unequal gender norms and power dynamics are often driven and reinforced by adolescent girls' male peers, families, communities, and the broader institutional structures that surround them. Without change in gender attitudes and norms at each of these levels, improved outcomes for key transitions are much less likely to be sustained. Efforts to nurture change must also acknowledge that adolescents' opportunities and capabilities are shaped by complex, intersectional forces including ethnicity, caste, religion, and disability, among others. This multi-arm randomized control trial aims to improve the evidence base on effective approaches to improve multi-sectoral outcomes for girls across the following domains from the Gender and Adolescence: Global Evidence (GAGE) framework: education and learning; health, nutrition and sexual and reproductive health; bodily integrity; psychosocial well-being; voice and agency; and economic empowerment.

Specifically, the trial has four goals:

  1. To evaluate the impact of Act With Her in Ethiopia (AWH-E) - a gender-transformative multi-level program - on young adolescent girls' and boys' capabilities (11-13) in the short- and long-run across the six GAGE capability domains using a multi-arm cluster randomized control trial across two regions (Amhara and Oromia).
  2. To compare the impact of AWH-E to a more basic gender-synchronized program (AWH-E without community engagement and systems strengthening), a standalone girls' group program (Her Spaces), and the gender-transformative program with economic support (AWH-E + Asset Transfers) on young adolescent capability achievements and transitions in the short- and longer- terms across two regions (Amhara and Oromia).
  3. To evaluate the impact of AWH-E on young adolescent capability achievements and transitions in the short- and long- term in pastoralist contexts (Afar).
  4. To use mixed-methods research to understand the mechanisms driving the impact, and in particular what works, for whom, and why.
02

Conditions studied

  • Adolescent Behavior
  • Gender

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03

In context

Adolescent Behavior

305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.

This study's enrollment of 4,500 is above the median of 172 across 256 interventional studies indexed under Adolescent Behavior.

Browse Adolescent Behavior studies →

Lead sponsor

George Washington University is the lead sponsor of 192 studies on the registry; 34 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

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

04

Who can participate

Ages eligible
10 Years to 13 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

  • girls and boys 10-13 at time of enrollment in Act With Her Arms
  • girls 11-13 female at time of enrollment in Her Spaces Arm

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,500 participants (actual)

Study arms

  • No intervention
    Control

    Business as usual, no intervention

  • Experimental
    Her Spaces

    Starts in year 1; intervention package with 11-13 year old girls for 10 months; standard parental and community engagement. All programming ends after 10 months.

    Behavioral: Her Spaces

  • Experimental
    Act With Her

    Starts in year 1; core intervention package with 10-13 year old girls and boys for 10 months; 6 dedicated sessions with parents; and community-level system strengthening up to 24 months.

    Behavioral: Act With Her

  • Experimental
    Act With Her + Asset Transfer

    Starts in year 1; core intervention package with 10-13 year old girls and boys for 10 months; asset transfer for girls over 10 months; 6 dedicated sessions with parents; and community-level system strengthening up to 24 months.

    Behavioral: Act With Her + Asset Transfer

  • Experimental
    Act With Her (simple)

    Starts in year 1; core intervention package with 10-13 year old girls and boys for 10 months; 6 dedicated sessions with parents; does not include community-level systems strengthening. All programming ends after 10 months.

    Behavioral: Act With Her (simple)

Interventions

  • BehavioralHer Spaces

    Her Spaces will comprise a set of activities leveraging the Her Spaces curriculum and program model which includes curriculum-based sessions for 11-13 year old girls, with 40 sessions delivered weekly over the course of 10 months

  • BehavioralAct With Her

    Act With Her was designed to facilitate adolescent transitions to adulthood via improvements across the six GAGE domains (education, bodily integrity, health, psychosocial well-being, voice and agency, and economic empowerment). Project activities fall into three main categories: curriculum-based programming with adolescent girls and boys, community transformation, and systems strengthening. Act With Her will work with 10-13 year old girls and boys for 10 months and implement community-level and high-level system strengthening work up to 24 months (in rural and pastoralist areas).

  • BehavioralAct With Her + Asset Transfer

    This arm will implement the Act With Her program described above, using program curricula with 10-13-year-old girls and boys over 10 months and conducting community-level systems strengthening up to 24 months. Additionally, the girls participating in this arm will receive one of three asset transfer options. The packages will be of equal value (115 USD) - one will include school supplies, one will include hygiene supplies, and will be a combination of both. Each adolescent girl will choose which package she would like to receive and will receive components of the package at 3 timepoints over the course of the first 10 months of the project.

  • BehavioralAct With Her (simple)

    This arm will implement the Act With Her curricula described above with 10-13 year old girls and boys over 10 months. The adolescent groups will follow the same model (near-peer, same-sex mentors, 40 weekly meetings for girls, 18 meetings for boys, 4 of which are joint sessions for boys and girls, 6 sessions for parents), but will not include community-level systems strengthening activities

06

What researchers measure

Primary outcomes

  1. Standardized Index of Education and Learning (girls)

    Standardized index of education and learning at the individual level. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. The index is comprised of four components: indicator for enrolled in school (at time in survey, or if school not in session at survey, at time of most recent session), share of school days attended (past two weeks; among those enrolled), indicator for did not miss more than one week of school at one time (past 12 months; among those enrolled), aspires for secondary degree or higher. The construction of the index, and a detailed description of its components is described in the protocol.

    Time frame: 20 months after intervention starts

  2. Standardized index of Bodily Integrity (girls)

    Standardized index of bodily integrity at the individual level. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. The index is comprised of six indicators: peer violence scale (past 12 months, inverse), indicator for did not experience peer violence (past 12 months), indicator for did not perpetrate peer violence (past 12 months), indicator for did not experience violence or witness violence against female caregiver in the household (past 12 months), indicator for did not experience sexual violence (past 12 months), ideal age of marriage. The construction of the index, and a detailed description of its components is described in the protocol.

    Time frame: 20 months after the intervention starts

  3. Standardized Index of Health, Nutrition, and Sexual and Reproductive Health (girls)

    Standardized index of bodily integrity at the individual level. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. The index is comprised of five components: indicator for self-reported health very good or good, proportion of meals yesterday with meat/chicken/fish/egg, indicator if ever hungry because not enough food (past four weeks), indicator for normal activities not affected during menstruation (among those who have reached menarche), index of improved menstrual hygiene practices (among those who have reached menarche), ideal age of first child (among childless). The construction of the index, and a detailed description of its components is described in the protocol.

    Time frame: 20 months after the intervention starts

  4. Standardized Index of Psychosocial Well-Being (girls)

    Standardized index of bodily integrity at the individual level. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. The index is composed of three components. Rosenberg Self Esteem Scale score, General Health Questionnaire-12 (GHQ-12; measure of psychosocial distress; inverse) score, Child and Youth Resilience Scale score. The construction of the index, and a detailed description of its components is described in the protocol

    Time frame: 20 months after the intervention starts

  5. Standardized Index of Voice and Agency (girls)

    Standardized index of voice and agency. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. The index is composed of five components: index of participation in decision making (school, family; standardized separately for in school and out of school), index of comfort discussing issues, index of voice, index of mobility, index of collective action. The construction of the index, and a detailed description of its components is described in the protocol.

    Time frame: 20 months after the intervention starts

  6. Standardized Index of Economic Empowerment (girls)

    Standardized index of economic empowerment. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. Index is comprised of five components: indicator for any control of money (past 12 months), indicator for any savings for the future, indicator for aspires to be employed in skilled or professional work when adult, aspires to have employment or a business when adult, proportion of time yesterday in leisure and school (including travel to and from, and studying). The construction of the index, and a detailed description of its components is described in the protocol.

    Time frame: 20 months after the intervention starts

  7. Standardized Index of Cross-Cutting Gender Issues (girls)

    Standardized index of cross-cutting gender issues. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. Index is comprised of six components: index of gender equitable attitudes, index of gender consciousness, index of trusted friends (supportive social network), indicator for supportive adult, knowledge index, index of access to health services. The construction of the index, and a detailed description of its components is described in the protocol.

    Time frame: 20 months after the intervention ends

  8. Standardized Index of Cross-Cutting Gender Issues (boys)

    Standardized index of cross-cutting issues for boys. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. Index of composed of 9 components: index of gender equitable attitudes, index of gender consciousness, index of gender equitable behaviors, indicator for not perpetrating peer violence, peer violence index (inverse), indicator for not being a victim of peer violence, General Health Questionare-12 (GHQ-12; measure of mental health, inverse) score, indicator for supportive adult, knowledge index. The construction of the index, and a detailed description of its components is described in the protocol

    Time frame: 20 months after the intervention ends

  9. Standardized Index of Cross-cutting Gender Issues (primary female caregivers of girls)

    Standardized index of cross-cutting issues for primary female caregivers of girls. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. Index consists of 8 components: aspiration for adolescent's education, expected age of marriage for adolescent, aspiration for adolescent to work in skilled or professional employment as an adult, aspiration for adolescent to be employed or own a business as an adult, index of support for education, indicator for did not cut back food same for boys and girls (past 4 weeks), index of gender consciousness, index of gender attitudes. The construction of the index, and a detailed description of its components is described in the protocol

    Time frame: 20 months after the intervention ends

07

Study locations

3 sites
  • Zone 5, Afar Region, Ethiopia
  • South Gondar, Amhara, Ethiopia
  • East Hararghe, Oromiya, Ethiopia
08

References and documents

Individual participant data

Plan to share: Undecided — Deidentified data will be made public through the UK data archive per DfID funding requirements.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2019 to primary completion in Dec 2025, 81 months.

Of 195 non-industry interventional studies with no phase under Adolescent Behavior, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's 81 months is above that.

Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 8 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 21, 2019
First posted
Mar 26, 2019
StartActual
Mar 1, 2019
Primary completionActual
Dec 31, 2025
CompletionEst.
Nov 30, 2026
Last update
May 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03890237
Collaborators
Overseas Development Institute, Addis Ababa University, University of Oklahoma, Pathfinder International, Care International, Department for International Development, United Kingdom, Bill and Melinda Gates Foundation
Responsible party
Sarah Baird (Associate Professor, George Washington University) — Principal investigator
First posted
Mar 26, 2019
Start date
Mar 1, 2019
Primary completion
Dec 31, 2025
Completion
Nov 30, 2026 (estimated)
Last update
May 28, 2026

Oversight

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

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