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Randomized evaluation of the Adolescent Girls Empowerment Programme
Last registered on February 16, 2018

Pre-Trial

Trial Information
General Information
Title
Randomized evaluation of the Adolescent Girls Empowerment Programme
RCT ID
AEARCTR-0000983
Initial registration date
December 16, 2015
Last updated
February 16, 2018 9:30 AM EST
Location(s)
Primary Investigator
Affiliation
Population Council
Other Primary Investigator(s)
PI Affiliation
University of Pennslyvania
PI Affiliation
Population Council
PI Affiliation
Population Council
PI Affiliation
Population Council
PI Affiliation
Ministry of Health, Government of the Republic of Zambia
PI Affiliation
Population Council
Additional Trial Information
Status
On going
Start date
2013-07-01
End date
2018-06-30
Secondary IDs
Abstract
Through the Adolescent Girls Empowerment Program (AGEP), the Population Council is implementing a social, health, and economic asset-building program for vulnerable adolescent girls aged 10–19 in Zambia. At its core, the AGEP incorporates a Safe Spaces program, implemented in partnership with YWCA Zambia. At weekly girls’ group meetings, 20 to 30 girls meet with a mentor—a young woman from their community—for short training sessions on a variety of topics as well as a chance to discuss important experiences of the past week. The primary goal of the safe spaces groups is to reduce the social isolation while increasing the assets of adolescent girls. The Safe Spaces groups meet for a period of two years.

Two additional components have been added to the Safe Spaces model for the AGEP program. In the first component, selected girls in the AGEP are assisted in opening bank accounts to manage their money. The Population Council is working in partnership with the National Savings and Credit Bank (NatSave) and Making Cents International to develop the “Girls Dream” Savings Account. The second add-on component of AGEP is a health voucher that will be provided to selected girls in the program. In partnership with the Ministry of Health (MoH) and Mobile Transactions Zambia, the Council is developing a health voucher that will be redeemable for a package of health services at certain public and private health providers, including MoH public facilities. The services covered by the voucher include basic wellness exams as well as age-appropriate sexual and reproductive health services.

In addition to expanding the assets and potential of adolescent girls in Zambia, a principal feature of AGEP is rigorous research and evaluation of program impact. In conjunction with program activities, Council researchers will conduct a four-year impact evaluation of the program using a randomized cluster design. The study will follow participants for the two-year intervention period and for two years after completion of the intervention to assess longer-term impact. Communities where AGEP is being implemented will be randomly assigned one of three different versions of the intervention: (1) the full program (safe spaces, savings accounts, and health vouchers), (2) safe spaces with a health voucher, or (3) safe spaces only. Program participants will be compared with a control group of adolescent girls not participating.

The research and evaluation will assess the impact of AGEP on vulnerable adolescent girls’ longer-term demographic, reproductive, and health outcomes. In addition to survey data, biomarker data will be collected among older participants to measure incidence and prevalence of STIs, specifically Human Immunodeficiency Virus (HIV) and Herpes Simplex Virus 2 (HSV-2). In addition, anemia testing will be conducted among study participants aged 15+ years and their children aged 6−59 months to measure prevalence of anemia. The research will investigate how AGEP changes vulnerable adolescent girls’ lives as they age from 10–19 in 2013 (baseline) to 14–23 in 2017; the study participants will be revisited annually. The adolescent cohort study will include: 1) quantitative structured interviews; 2) in-depth semi-structured interviews; 3) HIV and HSV-2 testing (at three points in time); 4) anemia testing, and 5) assessment of adolescents’ children gross and fine motor skills.
Registration Citation
Citation
Austrian, Karen et al. 2018. "Randomized evaluation of the Adolescent Girls Empowerment Programme." AEA RCT Registry. February 16. https://doi.org/10.1257/rct.983-2.0.
Former Citation
Austrian, Karen et al. 2018. "Randomized evaluation of the Adolescent Girls Empowerment Programme." AEA RCT Registry. February 16. https://www.socialscienceregistry.org/trials/983/history/25888.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
AGEP is being implemented will be randomly assigned one of three different versions of the intervention: (1) the full program (safe spaces, savings accounts, and health vouchers), (2) safe spaces with a health voucher, or (3) safe spaces only.

The core of the safe spaces component, implemented in partnership with YWCA Zambia, is a weekly girls’ group meeting in which 20 to 30 girls get together with a mentor—a young woman from their community—for short training sessions on a variety of topics as well as a chance to discuss the events of the past week. These ongoing, stable group sessions serve two critical functions: 1) they build a platform in which girls meet and can be reached with a variety of interventions and educational topics, and 2) they build social assets, including friendships, trusting relationships, and self-esteem, that have a positive influence on other dimensions of their lives—their livelihood and health. The safe spaces meetings have become an integral part of what girls expect in their lives and can be sustained in the long term via cultural change.

The safe spaces groups are structured in two age cohorts, 10–14 and 15–19, with additional groups for married girls, in order to reach girls with the appropriate programming across the course of adolescence. During their weekly group meetings, girls are trained on a range of health and financial topics, and they have time to simply talk and build strong relationships with other girls in their community.

The Population Council worked in partnership with the National Savings and Credit Bank (NatSave) and Making Cents International to develop the Girls Dream Savings Account that AGEP participants are able to open. The NatSave account has a very low minimum opening balance, and any amount can be deposited or withdrawn with no fee. While girls are able to make deposits on their own, in order to adapt to the Zambian legal minimum age of 18 for opening accounts, girls select a cosignatory—a woman aged 18 or older—to assist with account opening and withdrawals. This financial mentor can be the girl’s mother, however the participant has the option to choose another female in her life who she trusts (i.e., older sister, teacher, aunt, neighbor).

In partnership with the Ministry of Community Development, Mother Child Health (MCDMCH) and InSTEDD, the Council is developing an e-Health Voucher that AGEP participants can redeem for a package of health services at contracted public and private health providers. The services covered by the voucher include basic wellness exams as well as age-appropriate sexual and reproductive health services. Service providers use text messages to interact with a web-based system that logs and issues authorization for the services in real-time. The Council trains providers at participating clinics in the provision of adolescent-friendly health services and conducts ongoing monitoring and quality-assurance visits at participating clinics. Providers are reimbursed per service provided based on pre-approved rates.
Intervention Start Date
2013-08-01
Intervention End Date
2016-03-31
Primary Outcomes
Primary Outcomes (end points)
Sexual initiation
Early marriage
First birth
Grade 7 and 9 attainment
Use of modern contraception
HIV prevalence
HSV02 prevalence
Primary Outcomes (explanation)
% of girls who have ever had sex
% of girls who are married
% of girls who have ever given birth
% of girls Completed grade 7 & grade 9
% Ever used modern contraception
% HIV prevalence
% HSV-2 prevalence
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
AGEP is a randomized cluster trail of one of three different versions of the intervention: (1) the full program (safe spaces, savings accounts, and health vouchers), (2) safe spaces with a health voucher, or (3) safe spaces only. A fourth control arm is also included.
Experimental Design Details
The study will follow participants for the two-year intervention period and for two years after completion of the intervention to assess longer-term impact. Communities where AGEP is being implemented will be randomly assigned one of three different versions of the intervention: (1) the full program (safe spaces, savings accounts, and health vouchers), (2) safe spaces with a health voucher, or (3) safe spaces only. Program participants will be compared with a control group of adolescent girls not participating.
Randomization Method
Computer random number at first stage
Public lottery at second stage
Randomization Unit
The AGEP operates in ten master sites clustered around health service sites that allow concentrated implementation within them. A two stage randomization process was developed for selection. In the first stage of randomization, a sampling frame containing matched binary or triplets of public health clinics that are proximal to each other will be generated for districts in the selected AGEP provinces. For a matched pair or triplet of health clinics to be included, it must also be within a reasonable distance to a NatSave branch. For rural areas, a fixed distance (15 kilometers) catchment area will be defined around the selected health centers to obtain a sufficient number of clusters for sampling. The health center groupings will be sampled randomly, proportional to catchment population size. It is believed that this randomization and sampling strategy will obtain a representative sample of the population in these provinces and eligible adolescent girls to achieve a reasonable degree of external validity.

The second stage of randomization will assign CSAs (“communities”) within master sites to control or experimental arms. The sampling frame will be defined by and contain approximately 20 to 40 census supervisory areas (CSAs) within each master site, with each CSA containing two to five contiguous statistical enumeration areas (SEAs). In urban areas, a similar number of catchment area CSAs will be enumerated, although no distance criteria is needed as there are sufficient numbers of CSAs in close proximity from which to select due to population density. Across the ten master program areas it is expected that there will be anywhere from 250 to 400 CSAs forming the sampling frame for this level of randomization. This amounts to approximately 25 to 40 CSAs from which to randomly draw and assign in each master site. In the four-arm RCD, approximately 12 CSAs will be selected for AGEP and four for the control arm. This will leave anywhere from 4 to 24 CSAs per site not participating in either the program or research. an additional four ‘external’ control CSAs will be selected for the urban study sites. A sufficient number of girls will be recruited to obtain the participation of approximately 1,000 girls for each master site at baseline.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
120 intervention census enumeration areas
40 internal control census enumeration areas
20 external control census enumerator areas
Sample size: planned number of observations
minimum of 4897 at baseline
Sample size (or number of clusters) by treatment arms
approximately 27 girls per AGEP cluster
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
The number of clusters and sample size of adolescent girls needed for the RCD is determined by estimates of minimally detectable effect sizes for the representative set of impact indicators given a statistical power (.80), alpha (.05), intra-class correlation, and effect size variability. Estimates indicate that 40 communities per arm of the study are required with a minimum of 25 girls per cluster at baseline. Thus, a four-arm study (control and three experimental or program arms) require implementing AGEP in 120 communities and conducting the research in 160 communities. Estimates of cluster number and sample sizes were conducted for different baseline age groups (10-14, 10-16 and 10-19) and scenarios for the number of study arms. Optimal Design Software Version 3.0 for a multi-site randomized trial was used to generate cluster number and sample sizes requirements for the AGEP design.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
University of Zambia, Biomedical Research Ethics Committee
IRB Approval Date
2013-04-12
IRB Approval Number
008-11-12
IRB Name
Population Council Institutional Review Board
IRB Approval Date
2012-01-15
IRB Approval Number
581
Analysis Plan

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Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers