NCT03890237

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,500

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Mar 2019Nov 2026

Study Start

First participant enrolled

March 1, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

6.8 years

First QC Date

March 21, 2019

Last Update Submit

April 9, 2025

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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.

    20 months after intervention starts

  • 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.

    20 months after the intervention starts

  • 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.

    20 months after the intervention starts

  • 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

    20 months after the intervention starts

  • 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.

    20 months after the intervention starts

  • 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.

    20 months after the intervention starts

  • 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.

    20 months after the intervention ends

  • 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

    20 months after the intervention ends

  • 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

    20 months after the intervention ends

Study Arms (5)

Control

NO INTERVENTION

Business as usual, no intervention

Her Spaces

EXPERIMENTAL

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

Act With Her

EXPERIMENTAL

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

Act With Her + Asset Transfer

EXPERIMENTAL

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

Act With Her (simple)

EXPERIMENTAL

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

Her SpacesBEHAVIORAL

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

Her Spaces
Act With HerBEHAVIORAL

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).

Act With Her

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.

Act With Her + Asset Transfer

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

Act With Her (simple)

Eligibility Criteria

Age10 Years - 13 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth males and females are eligible for the program, but the specific programming is different for males and females. In Her Spaces arms there is no male specific programming.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Zone 5, Afar Region, Ethiopia

Location

Unknown Facility

South Gondar, Amhara, Ethiopia

Location

Unknown Facility

East Hararghe, Oromiya, Ethiopia

Location

MeSH Terms

Conditions

Adolescent BehaviorCoitus

Interventions

alpha 1-Antichymotrypsin

Condition Hierarchy (Ancestors)

BehaviorSexual Behavior

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesSerpinsPeptidesAmino Acids, Peptides, and ProteinsAcute-Phase ProteinsBlood ProteinsProteinsAlpha-GlobulinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Study participants will not be masked to their assignment, but will not know the full set of treatment and comparison groups, or what those other groups receive. Given cluster level randomization, contamination will be minimized. Enumerators who collect the survey data that forms the basis of the evaluation will not be explicitly told the treatment status of a given Kebele, however, given the community level nature of the intervention it may be possible for them to ascertain whether it is a treatment or control Kebele. Statistical analyses will be done by the investigators who will not be masked to the treatment status of the participants
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The impact evaluation study is a cluster-randomized controlled trial among 175 communities with five study arms: control (no intervention), AWH-E, Her Spaces, AWH- E + asset transfer, and AWH-E without community engagement and systems strengthening.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 21, 2019

First Posted

March 26, 2019

Study Start

March 1, 2019

Primary Completion

December 31, 2025

Study Completion (Estimated)

November 30, 2026

Last Updated

April 10, 2025

Record last verified: 2025-04

Locations