Adolescent Girls Initiative - Kenya
| ISRCTN | ISRCTN18226614 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18226614 |
- Submission date
- 13/06/2023
- Registration date
- 20/06/2023
- Last edited
- 20/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This research involves an evaluation of modified versions of the Adolescent Girls Initiative – Kenya intervention packages in Wajir County. The initial study showed the successful impact of the intervention on increasing school enrollment and delaying marriage among originally out-of-school girls in Wajir County. The County Government of Wajir has indicated their interest in and commitment to scaling up the intervention. Population Council Kenya has received funding from the Children’s Investment Fund Foundation (CIFF) to test three versions of the original intervention to identify an optimized model and prepare the county government systems for implementation.
Who can participate?
Girls aged between 11 and 14 years old who are out of school and reside within selected study sites
What does the study involve?
The evaluation will test three packages of interventions. All packages will include community-level conversations addressing inequitable gender norms and barriers to girls’ education, weekly group meetings for girls ages 11-14 that cover a range of health, life skills and financial literacy topics and a government-run school feeding program. One package will have only these three components. The second package will add in-kind individual and community-level incentives conditioned on meeting school enrollment targets. The third package will add a household-level cash transfer conditioned on girls’ school enrollment. Throughout, the focus of the intervention design will be on a model that is feasible for implementation by the county government both vis-à-vis delivery channels and cost.
The study will take place in 33 villages in Wajir County located in the mainly rural, semi-arid region of Northern Kenya, and inhabited by a mainly pastoralist, Muslim population of Somali origin. Eleven villages will be randomized to each study arm. Data collection activities will include a household listing, baseline and endline surveys, qualitative interviews and comprehensive monitoring of group attendance and school enrollment.
What are the possible benefits and risks of participating?
Possible benefits include increasing school enrolment for girls. The evidence generated will also assist to establish and improve adolescent programs in Wajir and other settings with low school enrolment, early marriage and early pregnancy for girls.
There are two main risks: 1. The security situation in Wajir may deteriorate and delay data collection; and 2. The national elections in 2022 may create political instability.
The research team will address the first risk by liaising with Save the Children’s security team who will inform the research team where there have been flare-ups of clan conflict or terrorism threats from Al-Shabab. The team will remain flexible in their movement plans and relocate to different villages when necessary and wait for the insecurity to die down before revisiting the previously unreachable area.
To address the second risk, the research team will remain apolitical and focus engagement on technical members of the government where possible. Save the Children will continue to engage new political stakeholders after the elections.
The research team have also put in place a sustainability mechanism through the design of the intervention and the involvement of the MoH staff in the implementation and monitoring of the program to ensure a successful handover of the program. Alongside the program will be an effort to ensure that there is an enabling policy and legal framework for the scale-up of AGI-K. This will start with a Political Economy Analysis (PEA) that will identify the key strengths and gaps in the policy landscape in Wajir County. After the PEA, the project team will support the necessary processes to ensure that by the end of the grant period, there is a more favorable policy and legal environment to support the next phase of scaling up AGI-K in Wajir. For example, this includes the passing of the Community Health Services Bill so that CHVs can be included on the county payroll, as well as the County Integrated Development Plan, the Annual Development Plan and the budgets.
Where is the study run from?
Population Council Kenya and USA
When is the study starting and how long is it expected to run for?
November 2021 to October 2023
Who is funding the study?
1. Children's Investment Fund Foundation (UK)
2. Wajir County Government (Kenya)
3. Save the Children (UK)
Who is the main contact?
Dr Karen Austrian, kaustrian@popcouncil.org
Contact information
Principal Investigator
One Dag Hammarskjold Plaza
New York
10017
United States of America
 ORCID ID |
0000-0001-5464-7908 |
|---|---|
| Phone | +254202713480 |
| kaustrian@popcouncil.org |
Scientific
Population Council
Avenue 5 Building, Rose Avenue
3rd Floor
Nairobi
17643-00500
Kenya
| ORCID ID |
0000-0001-7503-9565 |
|---|---|
| Phone | +254721617455 |
| emuluve@popcouncil.org |
Public
Population Council
Avenue 5 Building, Rose Avenue
3rd Floor
Nairobi
17643-00500
Kenya
| Phone | +254721617455 |
|---|---|
| emuluve@popcouncil.org |
Study information
| Study design | Cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | 43790_PIS_v4_31May 2019.pdf |
| Scientific title | Testing the optimized Adolescent Girls Initiative -Kenya models for scale-up in Wajir County, Kenya |
| Study acronym | AGI-K |
| Study objectives | We hypothesize that the study arm that includes the community conversations, girl’s empowerment groups and conditional cash transfers will be the most effective on increasing school enrolment and attaining more equitable gender attitudes outcomes. We also hypothesize that the arm with the in-kind incentives will be more effective than the arm with only the community conversation groups and the girl’s empowerment groups. |
| Ethics approval(s) |
1. Approved 07/02/2022, Population Council Institutional Review Board (One Dag Hammarskjold Plaza, New York, NY 10017, United States of America; +1 212-339-0500; development@popcouncil.org), ref: 993 2. Approved 07/04/2022, AMREF Ethics and Scientific Review Committee (ESRC) (P.O. Box 30125, Nairobi, 00100, Kenya; +254 20 699 4000; esrc.kenya@amref.org), ref: ESRC P1165/2022 |
| Health condition(s) or problem(s) studied | Education status |
| Intervention | The evaluation will test three packages of interventions. All packages will include community-level conversations addressing inequitable gender norms and barriers to girls’ education, and weekly group meetings for girls ages 11-14 that cover a range of health, life skills and financial literacy topics. One package will have only these three components. The second package will add in-kind individual and community-level incentives conditioned on meeting school enrollment targets. The third package will add a household-level cash transfer conditioned on girls’ school enrollment. Throughout, the focus of the intervention design will be on a model that is feasible for implementation by the county government both vis-à-vis delivery channels and cost. The intervention will start at the end of April 2022 with the start of the 2022 school year and end in April 2023 during the first term of the 2023 school year. Community Conversation Groups: These are community-based groups composed of community members and leaders and they are run through existing government-led community health unit structures. The groups will be taken through a facilitated process to identify key issues in the community that lead to the undervaluing of girls, inequitable gender norms, early marriage and the perpetuating of violence against girls and women. The meetings will be facilitated once a month by Community Health Assistants (CHAs) with support from Community Health Volunteers (CHVs). Girls’ Safe Spaces Groups: The girls´ groups will be facilitated by CHVs. This intervention component will follow the Council’s safe spaces model in which girls will meet in groups once a week under the guidance of a female mentor from that community. The groups will follow a structured curriculum but also allow time for open discussion. The curricula will include topics on financial literacy, hygiene, nutrition, sexual and reproductive health, communication/negotiation skills, gender norms, sexual and gender-based violence, female genital mutilation/cutting (FGM/C), early marriage, leadership skills and relationships. The curriculum will be adapted from the original AGI-K curriculum used in Wajir based on what was accepted and impactful from the original RCT. Education Conditional Transfers: We will be testing two types of transfers – one that employs a cash transfer approach and one that employs an in-kind approach. Cash: All payments will be conditioned on girls being enrolled in school. Enrollment will be verified during the second month of each term and payments made by the end of that month. Household heads that had an out-of-school girl in study arms 2 and 3 aged 11-14 at the start of the intervention period will receive a one-time payment of 4500/ (~US$ 41). In addition, household heads of all study arm 3 girls aged 11-14, regardless of baseline school status, will receive 1500/ (~$13.50) each term thereafter (total of four payments). Cash transfers will be paid via Mpesa to the household head determined at the time of registration. If the household has more than one girl between the ages of 11-14, they will all be eligible for their cash transfer. In-Kind: A community-level enrollment target will be set at 10 percentage points above baseline enrollment. If the community meets the enrollment target at the end of the program, an in-kind project will be given that values a maximum of KES 1,000,000 (e.g., building classrooms or latrines at the school) which will be implemented and monitored by the community conversation group members. For both cash and in-kind incentives, out-of-school and in-school girls are included to avoid a disincentive for families that have a girl in school. The additional incentive to out-of-school girls is one-time only and addresses the real and perceived costs of enrollment. Ten villages will be randomly assigned to each study arm for a total of 30 villages. To minimize the chances of having imbalances across arms, the 30 villages will be sorted by the proportion of girls aged 11-14 who are out of school and divided into two groups of 15 villages each. Within each group, five villages will be randomly assigned to each study arm. The randomization will take place publicly with eligible village leaders in attendance and each drawing the randomization assignment to minimize discontent and increase acceptance of the randomization results. Due to the vast geographical nature of Wajir County, the villages are quite far from one another, therefore there is little risk of contamination between study villages. The process for village selection started with a list of all villages in which there was a primary school in Wajir (n=271). Then, 218 villages without a functional Community Unit were excluded. Next, based on 2021 school enrollment figures provided by the Ministry of Education, 15 schools were eliminated as girls made up 47% or higher of the students enrolled in upper primary school. Other villages were removed for security reasons, due to not having a CHA or being very large/peri-urban. Given the available number of villages for implementation based on a combination of the exclusion criteria and the budget, minimum detectable effects were calculated for the key outcome – school enrollment – as well as literacy and numeracy, both for the total sample, as well as the sample segmented by schooling status. The calculations were based on data from the original AGI-K RCT. Based on the calculations, it was determined that a 33.5 percentage point difference in school enrollment between arms could be detected at a 5% level if we included 30 villages. Given that a 41.9 percentage point difference was achieved in the original RCT, this was deemed to be acceptable, and a sample of 30 villages with 40 respondents was finalized at baseline for each village. The baseline survey sample will be drawn from the HH Listing data. 40 girls per village will be randomly selected and interviewed – 20 in-school girls and 20 out-of-school girls. The team have oversampled out-of-school girls because it is anticipated that the bulk of the effect will be on out-of-school girls, and they want to ensure enough power to detect those effects. Sample weights will be generated so that the combined in and out-of-school samples are representative of the villages. |
| Intervention type | Behavioural |
| Primary outcome measure | School enrollment measured using a self-reported school enrollment constructed from responses to “Did you attend school at any time during the [xxxx] school year?” at baseline for the school year 2021 and at endline for the school years 2022 and 2023 |
| Secondary outcome measures | The following gender attitudes are assessed at baseline (school year 2022) and endline (school year 2023): 1. Gender attitudes regarding education measured using the following four agree/disagree items: (1) “It is as important for girls to complete secondary school as it is for boys”; (2) “When a family cannot afford to send all children to school, it is better to send boys than girls”; (3) “A 16-year old girl should get married when she finds an appropriate partner, even if she is still in school”; and (4) “Girls are as intelligent as boys”. 2. Gender attitudes regarding girl's and boy's behaviours measured using a subset of items : (1) Girls should avoid playing sports with boys because they get hurt easily 2) Boys should be raised tough so they can overcome any difficulty in life 3) Girls should avoid raising their voice to be ladylike. 4) Boys should always defend themselves even if it means fighting. 5) Girls are expected to be humble. 6) Girls should always fight back if boys try to take advantage of them. 7) Girls need their parent's protection more than boys. 8) Boys should be able to show their feelings without fear of being teased. 9) Boys who behave like girls are considered weak. 10) It's important for boys to show they are tough. 3. Gender attitudes regarding marriage measured using a subset of items: 1) When a husband and wife disagree about the number of children to have, the husband's opinion matters more. 2) A wife should be able to refuse her husband's sex. 3) It is OK for a man to cook for his family. 4) Polygamous marriages are part of your culture, so they should continue. 5) It is better if a family arranges a girl’s marriage than her choosing herself. 6) If a man doesn’t hit his wife, it means he doesn’t love her. 7) It is a man’s right to have sex with his wife whenever he wants. 8) If a young woman in this community were age 25 and unmarried, people would respect her. 9) A wife should have primary responsibility for taking care of the home and children. 10) For a couple that does not want more children, it is solely the woman's responsibility to avoid getting pregnant. 11) A woman should not tolerate violence to keep her family together. |
| Overall study start date | 30/11/2021 |
| Completion date | 31/10/2023 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 14 Years |
| Sex | Female |
| Target number of participants | The target is a total of 1200 girls with 30 clusters and 40 girls per cluster |
| Total final enrolment | 1107 |
| Key inclusion criteria | 1. Girls aged between 11 and 14 years old 2. Residing within selected study sites 3. Not in boarding school at the time of the listing and/or at the time of the baseline survey |
| Key exclusion criteria | 1. Girls who were in boarding school at the time of enrollment 2. Girls who were no longer residing in the study site at the time of enrollment |
| Date of first enrolment | 04/04/2022 |
| Date of final enrolment | 27/04/2022 |
Locations
Countries of recruitment
- Kenya
Study participating centre
P.O. Box 17643-00500
Nairobi City
00500
Kenya
Sponsor information
Research organisation
Population Council - Kenya
Avenue 5 Building
Rose Avenue
P.O. Box 17643
Nairobi
00500
Kenya
| Phone | +254 20 5134731 |
|---|---|
| Info-Nairobi@popcouncil.org | |
| Website | http://www.popcouncil.org/ |
"ROR" |
https://ror.org/03zjj0p70 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- CIFF
- Location
- United Kingdom
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | Within one year of data collection, de-identified quantitative survey datasets generated during and/or analysed during the current study will be made publicly available via the Adolescent Data Hub repository, https://adh.popcouncil.org/. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Consent Form (Age of Majority) version 4 |
31/05/2019 | 20/06/2023 | No | Yes |
| Protocol file | 11/01/2022 | 20/06/2023 | No | No |
Additional files
- 43790_Protocol_11Jan2022.pdf
- 43790_PIS_v4_31May 2019.pdf
- Consent Form (Age of Majority)
Editorial Notes
20/06/2023: Trials' existence confirmed by Amref Health Africa in Kenya Ethics and Scientific Review Committee (ESRC) (KENYA).
