ISRCTN ISRCTN77455458
DOI https://doi.org/10.1186/ISRCTN77455458
Secondary identifying numbers AEARCTR-0000962
Submission date
18/12/2015
Registration date
24/12/2015
Last edited
18/01/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Many adolescent girls in Kenya face considerable risks and vulnerabilities that affect their education status, health, and general well-being. They are at high risk of early marriage, teenage pregnancy, early sex, unprotected sex, non-consensual sex and sexually transmitted diseases such as HIV. They also have limited income-earning opportunities, are very likely to be illiterate (not able to read and write) and often experience violence and social isolation. The Adolescent Girls Initiative–Kenya (AGI-K) is a study that tests different combinations of initiatives (packages of interventions) in health, violence prevention, wealth creation and education to see which one of these lead to the biggest improvement in their lives. These interventions will be implemented for two years. This study will compare the impact of four different packages of interventions, including a cost-effectiveness component (testing how expensive they are), in order to assess if and how intervening in early adolescence will impact girls’ life chances.

Who can participate?
Girls aged between 11-14 and living in one of two marginalized areas of Kenya – either the Kibera slums in Nairobi or the Wajir County in Northeastern Kenya.

What does the study involve?
The goal of AGI-K is to test combinations of packages of intervention that cover violence prevention, education, health and wealth creation. The violence prevention intervention involves establishing a committee in the community which includes religious and community leaders, parents, teachers and young men and women. The group members work together to identify key issues that lead to girls being under-valued and at risk of violence. A contract is then developed which includes an action plan to address these issues. The education intervention is a cash transfer scheme where girls are offered a cash payment as long as they have a 80% school attendance record. They also have their fees paid and are given school kits. The health intervention involves girls meeting in groups once a week. Each group has a female mentor that leads discussions on health, life skills and nutrition. The wealth creation intervention involves teaching about finances, and includes the girls opening bank accounts and a small cash incentive to put in practice what they are being taught. Each girl in Kibera is randomly allocated to receiving one of the following four package combinations:
1. Violence prevention
2. Violence prevention and education
3. Violence prevention, education and health
4. Violence prevention, education, health and wealth creation
In Wajir, all the girls within a particular village is randomly allocated to one of the four groups above. Each girl in the study is followed for two years. The effect of the program is assessed using data from surveys.

What are the possible benefits and risks of participating?
Participants may benefit from the interventions. There are no risks involved..

Where is the study run from?
The study is led by Population Council, based in the Nairobi office. Research partners include the African Population and Health Research Centre (APHRC) and Itad. The interventions are run by Save the Children in Wajir and Plan International in Kibera.

When is study starting and how long is it expected to run for?
January 2014 to December 2019

Who is funding the study?
Department for International Development (UK)

Who is the main contact?
1. Dr Karen Austrian (scientific)
kaustrian@popcouncil.org
2. Dr Eunice Muthengi (public)
emuthengi@popcouncil.org

Study website

Contact information

Dr Karen Austrian
Scientific

Population Council
General Accident Insurance HSE
2nd Floor
Nairobi
17643-00500
Kenya

Phone +254202713480
Email kaustrian@popcouncil.org
Dr Eunice Muthengi
Public

Population Council
General Accident Insurance HSE
2nd Floor
Nairobi
17643-00500
Kenya

Phone +254202713480
Email emuthengi@popcouncil.org

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEstablish the combination of multi-sectoral interventions with the greatest impact on the reproductive health of young adolescent girls in Wajir County and Nairobi Slums.
Study acronymAGI-K
Study objectivesTo determine the incremental effect produced by layering multi-sectoral interventions to improve the reproductive health of adolescent girls in marginalized communities.
Ethics approval(s)1. Population Council Institutional Review Board, 10/09/2014, ref: 661
2. AMREF Ethical and Scientific Review Committee, 19/11/2014, ref: P143/2014
Health condition(s) or problem(s) studiedAdolescent reproductive health
InterventionThe goal of the Adolescent Girls Initiative (AGI-K) is to test multi-sectoral packages of interventions in four sectors: violence prevention, education, health and wealth creation. The violence-prevention intervention is a community-level intervention that uses the community dialogues and contracts strategy based on the UNDP/Concern Worldwide model. The education intervention is a conditional cash transfer (CCT) based on 80% attendance over the course of a term. The health intervention will follow the Council’s Safe Spaces model in which girls meet in groups once a week under the guidance of a female mentor from the community. The wealth-creation intervention is composed of financial education, which is delivered during Safe Spaces meetings, as well as savings through individual bank accounts (Nairobi) or home banks (Wajir) and a small savings incentives. Using a randomized controlled trial design, researchers will conduct a rigorous impact evaluation of the program. Randomization to intervention packages is at the individual level in Kibera and at the
village level in Wajir. The following packages of interventions will be tested:
1. Violence prevention
2. Violence prevention and education
3. Violence prevention, education and health
4. Violence prevention, education, health and wealth creation
The study will follow girls for the two-year intervention period and for two years after completion of the intervention. Using both quantitative and qualitative methods, the program evaluation will examine the impact of the intervention packages while identifying the causal mechanisms driving that impact. Surveys will cover a wide range of topics, including education history, self-esteem, social networks, attitudes and behaviors related to gender, work and savings activity, nutrition status, literacy and numeracy skills, cognitive function, sexual and reproductive health knowledge, marriage history, and sexual behavior.
Intervention typeBehavioural
Primary outcome measure1. Increased age at first birth
2. Increased age at first sex
3. Increased age at first marriage

All outcomes to be assessed after 2 years (from the time of the baseline survey) and then again after 4 years using survey data.
Secondary outcome measures1. Violence Prevention: Decreased experience of gender-based violence and improved gender norms related to violence
2. Education: Increased mean grade of schooling and increased rate of primary school completion
3. Health: Increased knowledge on sexual and reproductive health and improved decision-making skills
4. Wealth creation: Increased knowledge on financial education, increased saving and increased participation in income generating activities

All assessed after 2 years and again after 4 years using survey data.
Overall study start date20/01/2014
Completion date31/12/2019

Eligibility

Participant type(s)Other
Age groupChild
Lower age limit11 Years
Upper age limit14 Years
SexFemale
Target number of participantsFor the Nairobi sub-study the target is 2,400 girls in intervention site and 600 girls in the external control site. For the Wajir sub-study the target is a total of 2,160 girls with 80 clusters and 27 girls per cluster.
Total final enrolment4537
Key inclusion criteria1. Girls aged between 11 and 14 years
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 criteria1. 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 enrolment24/02/2015
Date of final enrolment02/06/2015

Locations

Countries of recruitment

  • Kenya

Study participating centres

Population Council, Nairobi Office
Ralph Bunche Rd
Nairobi City
P.O. Box 17643-00500
Kenya
African Population and Health Research Center
Manga Cl
Nairobi
P.O. Box 10787-00100
Kenya

Sponsor information

Population Council
Research organisation

General Accident Insurance HSE
2nd Floor
Nairobi
P.O. Box 17643-00500
Kenya

Website http://www.popcouncil.org/
ROR logo "ROR" https://ror.org/03zjj0p70

Funders

Funder type

Government

Department for International Development
Government organisation / National government
Alternative name(s)
Department for International Development, UK, DFID
Location
United Kingdom

Results and Publications

Intention to publish date30/06/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planWe plan to publish the study protocol in 2016
IPD sharing planNot expected to be made available

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/03/2016 12/01/2021 Yes No
Results article 24/11/2021 26/11/2021 Yes No
Results article 07/02/2022 08/02/2022 Yes No
Results article longer term (after 4 years) effects 13/02/2022 18/01/2024 Yes No

Editorial Notes

19/01/2024: Publication reference added.
08/02/2022: Publication reference added.
26/11/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
12/01/2021: Publication reference added.