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.: PACTR202105496495690 Date of Approval: 06/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Family planning strategy for adolescents and youth through innovative access to Emergency Contraception in Kenya: A randomised controlled trial Protocol
Official scientific title Family planning strategy for adolescents and youth through innovative access to Emergency Contraception in Kenya: A randomised controlled trial Protocol
Brief summary describing the background and objectives of the trial Access to modern family planning methods can be effective in reducing unintended pregnancies, which is a public health concern globally. Births following unintended pregnancies are associated with adverse social and health outcomes for the mother and challenges for the child's growth and development. Most unintended pregnancies occur among adolescents and young women, who have a high level of unmet modern contraceptive needs. In Kenya, unmet needs for modern contraceptives remain high, additionally the use of emergency contraceptive pills remains low. Emergency Contraceptive pills (ECPs) are a highly effective option for women who wish to prevent pregnancy after unprotected sexual intercourse or contraceptive failure or accidents. This paper presents a study protocol for an innovative program that involves theincluding development and deployment of a mobile phone app called “MaOptions”. The MaOptions mobile app that aims to increase uptake of emergency contraceptives in Kenya by eliminating the financial limitations, and confidentiality barriers to access. Objectives: The study will test whetherif eliminating the financial limitations and confidentiality barriers to access can results in increased uptake of ECPs, hence, reducing unwanted pregnancies. The program will also assess users of the MaOptions App's on their change in knowledge and practices in usage of ECPs, and in Sexual Reproductive Health (SRH) in general.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Prevention
Anticipated trial start date 01/04/2021
Actual trial start date
Anticipated date of last follow up 01/04/2022
Actual Last follow-up date 31/03/2022
Anticipated target sample size (number of participants) 452
Actual target sample size (number of participants) 452
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Facilitated and confidential access to Emergency contraceptives N/A 6 months Participants in the intervention will receive a mobile app (MaOptions) with a dial-in/SMS feature where those in need of Emergency contraceptives will dial or text requesting for EC. The text will be sent to a partner trained private pharmacist who will package the EC in using plain packaging to conceal the content. A trained rider will deliver the package to the girls' location of choice. 226
Control Group Control N/A 6 months Participants in the control group will have the MaOptions app with comprehensive content on sexual reproductive health including the different types of contraceptives, HIV/AIDS and STIs. However, they will not have the ability to request emergency contraceptives and will not be facilitated to receive them for free. 226 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Young women and adolescent girls residing in Bungoma County. • Should be aged between 18 -30 years. • Sexually active (Self-reported). • Access to an internet-enabled Android smartphone or tablet. • Literate with the ability to read in the English language • Refusal to provide informed consent. • Not in possession of internet-enabled Android smartphone device. • Those using any long-term family planning method. • Less than 18 years old • Not sexually active Adult: 19 Year-44 Year 18 Year(s) 35 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 05/06/2020 Moi University MTRH Institutional Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O BOX, 3, Eldoret Eldoret 30100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The increase in uptake of ECPs measured by the proportion change in ECPs uses six months before the project and six months during the project. An increase in knowledge on ECPs measured by the proportion change in knowledge on ECPs before and after the project will be the primary study outcomes. Baseline and and endline.
Secondary Outcome The secondary outcomes are changes in participant’s knowledge of SRH and sexual behaviours at month six. 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sentum Scientific 1796, Upper Hill Nairobi 00200 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada 661 University Avenue, Suite 1720 Toronto ON M5G 1M Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sentum Scientific 1796, City Square Nairobi 00200 Kenya Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mary Nangukhula marynangukhula@gmail.com +25422843069 1796 City Square
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Researcher Sentum Scientific
Role Name Email Phone Street address
Public Enquiries Michael Omulayi mikeomuch@gmail.com +254729502336 1796
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Project Manager
Role Name Email Phone Street address
Scientific Enquiries Protus Musotsi protusmusotsi@gmail.com +254706179830 251
City Postal code Country Position/Affiliation
Mumias 50102 Kenya Researcher Sentum Scientific
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data on knowledge attitude and practices on Emergency contraceptives and Sexual Reproductive health and the uptake of emergency contraceptives will be collected. Besides participants, MaOptions app usage data will also be collected. The data will be available in both CSV and .sav file formats. Informed Consent Form,Study Protocol The raw data will be cleaned, anonymized and made freely within 6 months after the end of the project. The anonymized participant's raw data will be available open access at the end of the study and can be accessed from the study principal investigator upon request. The results will be published in an open-access journal at the end of the project.
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