Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202208731662190 Date of Registration: 22/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Tracking the Girls in Crisis
Official scientific title Effectiveness of the Alternative Rites of Passage Model in Reducing Female Genital Mutilation/Cutting, Teenage Pregnancies, and Child, Early and Forced Marriages: A stepped-wedge cluster randomised controlled trial in Kajiado and Narok Counties, Kenya
Brief summary describing the background and objectives of the trial Amref Health Africa (Amref) has over a decade implemented community focused interventions addressing harmful traditional practices that negatively affect girls. One of the interventions is the Alternative Rites of Passage (ARP) model that was initiated in 2009 and to date about 20,000 girls have been supported by their communities to denounce FGM/C and graduate into ‘maturity’ through ARP. While this intervention has been implemented for decades, there is limited evidence on its effectiveness in ending FGM/C. In order to ascertain effectiveness of this intervention, Amref has developed a digital tracking tool to follow up girls who have and haven’t gone through the ARP. The main objective of the study is to assess the effectiveness of the ARP model on FGMC, educational attainment, early marriages and teenage pregnancies among adolescent girls and young women in Narok and Kajiado County, Kenya.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Female Genital Mutilation/Cutting
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 05/09/2022
Actual trial start date
Anticipated date of last follow up 29/08/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 604
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Alternative Rites of Passage 6 months The Alternative Rites of Passage (ARP) Model is a community-led cultural alternative to FGM/C that retains cultural rituals and ceremonies in the transition to womanhood, whilst replacing the harmful ‘cut’ by sexual and reproductive health rights education and the promotion of girls’ education. This process begins through structured community entry and intergenerational community dialogues with various community members including men and boys who are actively engaged in addressing norms, attitudes and behaviors underlying FGM/C and other forms of sexual and grievous bodily harm and harmful practices, like child and early marriage. After this initial engagement with the whole community and buy in to the alternative process, the real initiation process with the girls begins. This follows the tripartite sequence of separation, transition and assumption. Firstly, the girls undergo a separation process whereby they are taken into seclusion, a safe space within the community, where they will reside during this whole process. The transition process also takes place which involves training of girls on a variety of topics including sexual and reproductive health, the dangers of female genital mutilation (FGM), early marriage, teenage pregnancy, life skills and gender issues, self-esteem, life skills and children’s rights. It culminates in a graduation which takes the original traditional format that involves the girls, parents, women leaders, elders and other community leaders and assumption of the new initiates role that forms the focal points of the intervention. 302
Control Group Alternative Rites of Passage 6 months Since the study will adopt a stepped-wedge cluster randomized controlled trial design to assess the effectiveness of ARP model on FGM/C prevalence, teenage pregnancy, child and early forced marriage and education attainment, the design will involve random and sequential crossover of clusters from control to intervention until all clusters are exposed. We expect that the control sites will continue receiving the usual behavior change communication initiatives implemented by various non-governmental organizations and implementation of the anti-FGM law by the government. 302 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Girls aged 10-18 years Girls who have not undergone FGM/C Girls who have not been pregnant and are not married at the time of recruitment Girls who are currently in school at the point of enrollment for the study Girls who do not consent to be part of the study Minors who do not assent to be part of the study Minors whose parents do not consent to be part of the study Adolescent: 13 Year(s)-17 Year(s) 10 Year(s) 18 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/05/2022 Amref Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
Amref Health Africa, P.O. Box 30125, 00100, Wilson Airport Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of FGM/C - Number of new cases of FGM/C within the cohort 2
Secondary Outcome Incidence of teenage pregnancies: Number of new cases of teenage pregnancies within the cohort 2
Secondary Outcome Incidence of early child marriages: Number of new cases of early child marriages within the cohort 2
Secondary Outcome Educational attainment: Number of cases who complete classes, school drop outs, transition to higher learning 2
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ARP database Amref Health Africa, P.O. Box 30125, 00100, Wilson Airport Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Amref Health Africa in the Netherlands Amref Health Africa P.O.Box 30125, 00100, Wilson Airport Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amref Health Africa Amref Health Africa, P.O.Box 30125, 00100, Wilson Airport Nairobi 00100 Kenya Non-Governmental Organization
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator David Kawai David.Kawai@amref.org +254721619872 Amref Health Africa, P.O.Box 30125, 00100, Wilson Airport
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Project Manager
Role Name Email Phone Street address
Public Enquiries Yvonne Opanga Yvonne.Opanga@amref.org +254795746777 Amref Health Africa, P.O.Box 30125, 00100, Wilson Airport
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Project Officer
Role Name Email Phone Street address
Scientific Enquiries Tammary Esho Tammary.Esho@amref.org +254722319369 Amref Health Africa, P.O.Box 30125, 00100, Wilson Airport
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Deputy Vice Chancellor Amref University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The datasets used and/or analyzed during the current study will be available upon request from the corresponding author. Study findings will be shared publicly using various platforms including Amref Health Africa organization website and publications in peer reviewed journals. Study Protocol 1 year The datasets used and/or analyzed during the current study are available to be public on reasonable request through application to the principal investigator.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information