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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201906696419769 Date of Approval: 03/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Health systems approach to FGM prevention and care: a multi-country implementation research study
Official scientific title A health systems strengthening approach to prevention of FGM using person-centered communication: implementation research study in Guinea, Somalia and Kenya
Brief summary describing the background and objectives of the trial Female genital mutilation (FGM) is a traditional harmful practice affecting 200 million women and girls globally. Despite the high prevalence of FGM in many settings and elevated risk of health complications among those who have been affected by this harmful practice, health care providers often receive little or no training on how to prevent the practice and manage its complications. As respected members of their communities, health care providers interact regularly with community members, particularly female community members. With additional training, tools, and support they can not only improve the care they provide to women and girls who have complications from FGM, but also they can improve their communication skills to be more effective communicators of FGM prevention messages. There is currently no scientific evidence on effective approaches for FGM prevention within the health sector. To respond to this gap, WHO has developed an intervention package aimed at nurses and midwives providing antenatal care services to offer patient centered communication for FGM prevention. The intervention recognizes that FGM is a social norm and that providers and patients are subject to the same social norms that perpetuate the practice. The aim of this multi-site implementation research project is to implement and test a two-level intervention in antenatal care (ANC) services at the primary health care level in three countries using a cluster randomised trial design. Level one aims to strengthen the health system to respond to FGM by putting in place policies against FGM and delivering materials for the health care providers. Level two aims to build the skills of nurses and midwives to deliver an FGM prevention counseling intervention using a social norms approach.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Female Genital Mutilation - FGM
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/09/2019
Actual trial start date 03/08/2020
Anticipated date of last follow up 31/05/2020
Actual Last follow-up date 30/09/2021
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 163
Recruitment status Completed
Publication URL https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-021-06097-w
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization 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
Control Group Health Systems intervention Cluster randomised design: Month 0: The control group received health system strengthening intervention Month 3: No intervention Introduction of a package of health system strengthening at month 0/baseline and measurement of outcomes at month 6 Health systems intervention occurs at facility level and is comprised of dissemination of WHO FGM guidelines and clinical handbook; implementation of FGM policies; and posting of information, education and communication (IEC) materials at the ANC clinics in primary health settings 90 Dose Comparison
Experimental Group Health systems strengthening intervention package plus person centered communication training Cluster randomised trial design: Month 0: This experimental group will get the health system intervention package Month 3: ANC providers in this experimental group will get the person centered communication skills training Three day training for ANC providers on PCC for FGM prevention at month 3 Person centered communication on FGM prevention training comprised of 6 modules during three day participatory workshop that aims to strengthen the knowledge and skills of nurses and midwives to be active agents of change for the prevention of FGM through increasing their FGM knowledge, reflecting on their FGM values and building skills in person centered communication. Health System package occurs at the facility level with dissemination of WHO FGM guidelines and clinical handbook; implementation of FGM policies; and posting of information, education and communication (IEC) materials within antenatal care (ANC) clinics in primary health care settings 90
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Selection of regions/counties: • FGM prevalence 50% or greater among females 15-49 years • Regions/counties that have over 15 health/MCH centers • Accessibility in terms of security Selection of ANC clinics - unit of randomization: • Facilities that see on average 30 first visit ANC clients are seen per month Selection of ANC providers: • Providers on duty at baseline and anticipated to be present at month 6 visit based on a six-month clinic rotation schedule provided by the clinic manager. Selection of ANC clients: • Women exiting their first ANC consultation of the current pregnancy Not meeting inclusion criteria Refusal to participate Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 65 Year(s) Both
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 06/09/2020 WHO Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
20, Avenue Appia Geneva 1211 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Health facility preparedness to offer FGM prevention and care services - Level 1 primary outcome ANC provider delivery of FGM care services and utilization of level 1 intervention components - Level 1 primary outcome Delivery of “ABCD” steps of PCC by ANC providers measured by responses from their clients - Level 2 primary outcome Month 6
Secondary Outcome ANC providers FGM-related knowledge, attitudes and correct practice as well as communication skills and self-efficacy Month 6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya Ministry of Health ANC clinics Nairobi Kenya
Guinea Ministry of Health ANC clinics Conakry Guinea
Somaliland Ministry of Health ANC clinics Hargeisa Somalia
FUNDING SOURCES
Name of source Street address City Postal code Country
Human Reproduction Programme WHO 20, Avenue Appia Geneva 1211 Switzerland
Government of Norway Bygdoy alle 2 Oslo 0257 Norway
Government of United Kingdom of Great Britain and Northern Ireland King Charles Street London SW1A 2AH United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Human Reproduction Programme WHO 20, Avenue Appia Geneva 1211 Switzerland Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Professor Patrick Muia Ndavi P.O. Box 19676-00202 Nairobi Kenya
Professor Mamadou Balde CERREGUI Conakry Guinea
Mr Ahmed Diriye Data and Research Solutions Hargeisa Somalia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Diriye ahmedmdiriye@yahoo.com +252634165887 N/A
City Postal code Country Position/Affiliation
Somaliland Somalia Manager Data and Research Solutions
Role Name Email Phone Street address
Principal Investigator Mamadou Dioulde Balde baldemddka@gmail.com +224628213340 N/A
City Postal code Country Position/Affiliation
Conakry Guinea Director Centre for Research in Reproductive health in Guinea
Role Name Email Phone Street address
Principal Investigator Patrick Muia Ndavi pmndavi51@gmail.com +254720797586 P.O.Box 19676 -00202 KNH
City Postal code Country Position/Affiliation
Nairobi Kenya Associate Professor of Obstetrics and Gynecology University of Nairobi College Of Health Sciences Kenyatta National Hospital
Role Name Email Phone Street address
Scientific Enquiries Christina Pallitto pallittoc@who.int +41227914745 20, Avenue Appia CH-1211 GENEVA 27
City Postal code Country Position/Affiliation
GENEVA 1211 Switzerland Scientist Reproductive and Research Department WHO Headquarters
Role Name Email Phone Street address
Public Enquiries Christina Pallitto pallittoc@who.int +41227914745 20 Avenue Appia CH-1211 GENEVA 27
City Postal code Country Position/Affiliation
Geneva 1211 Switzerland Scientist Reproductive Health Research Department WHO Headquarters
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results or a link to summary results within the trial registration record will be provided. Study Protocol Within 12 months of the study completion date De-identified dataset will be retained in the WHO HRP electronic archival system. Any use of the de-identified analytic dataset for secondary research purposes will be governed by the WHO data use regulation. Request for data dictionary and for dataset may be sent to pallittoc@who.int
URL Results Available Results Summary Result Posting Date First Journal Publication Date
To be provided later. Yes 26/04/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 26/04/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-021-06097-w
Changes to trial information