Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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3 October 2023 |
Main ID: |
ISRCTN10894523 |
Date of registration:
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22/08/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Evaluation of the Nia Project
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Scientific title:
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Identify the effect of menstrual health management interventions on girls’ well-being and education in Kilifi County |
Date of first enrolment:
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22/02/2017 |
Target sample size:
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3500 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN10894523 |
Study type:
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Interventional |
Study design:
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Cluster randomized controlled trial (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Karen
Austrian |
Address:
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Population Council
Avenue 5, 3rd Floor
Rose Avenue
PO Box 17643 - 00500
Nairobi
Kenya |
Telephone:
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+254 (0)205 134 700 |
Email:
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kaustrian@popcouncil.org |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Girls enrolled in class 7 in 140 project schools
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Adolescent reproductive health Pregnancy and Childbirth
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Intervention(s)
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The Nia Project interventions are implemented by ZanaAfrica. Girls enrolled in Class 7 at the start of the 2017 school year are the beneficiaries, receiving interventions over a period of 5 school terms, from May 2017 to December 2018. Before program implementation, a total of 140 schools in three rural Kilifi sub-counties (Magarini, Kaloleni and Ganze) were stratified by sub-county and randomly assigned to one of the following four study arms: 1. Control group 2. Sanitary pad distribution 3. Reproductive health education 4. Sanitary pad distribution + reproductive health education
Sanitary Pads For the Nia Project, each girl receives one packet of 10 ZanaAfrica’s Nia Teen brand disposable sanitary pads each month, for the entire project period. Project beneficiaries also receive two pairs of underwear at the start of the intervention, and an additional pair at the start of each subsequent term.
Reproductive Health Education The Nia Project reproductive health education intervention is comprised of facilitated health education sessions (FHE) and a health magazine developed by ZanaAfrica. Nia Yetu, the curriculum for the FHE sessions, was developed by ZanaAfrica (2017) with many elements adapted from the Tuko Pamoja: Adolescent Reproductive Health and Life Skills Curriculum developed by PATH and Population Council as part of the Kenya Adolescent Reproductive Health Program (KARP). The 25-session curriculum is delivered by trained facilitators during bi-monthly girls-only health clubs held during time allocated for extra-curricular activities in school for the duration of the project period. ZanaAfrica’s health magazine, Nia Teen, is distributed at the start of each term for the five-term period. Each issue corresponds directly to the topics covered in the Nia Yetu cu
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Primary Outcome(s)
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1. School attendance, assessed daily by staff members for a period of 4 weeks per term, starting in September 2017 through December 2018. 2. School participation/engagement, assessed using survey data at baseline in the first quarter of 2017 and after the intervention period in the first quarter of 2019 3. Sexual and reproductive health and rights (SRHR) knowledge, attitudes and norms, assessed using survey data at baseline in the first quarter of 2017 and after the intervention period in the first quarter of 2019
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Secondary Outcome(s)
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1. School retention and performance 2. Timing of pregnancy and birth 3. Timing of sex and sexual behavior Assessed using survey data at baseline in the first quarter of 2017 and after the intervention period in the first quarter of 2019
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Source(s) of Monetary Support
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Bill and Melinda Gates Foundation
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; 1. Population Council Institutional Review Board, 06/10/2016, ref: 788
2. AMREF Ethical and Scientific Review Committee, 08/11/2016, ref: P292/2016
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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31/08/2019 |
URL:
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