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.: PACTR201805003259293 Date of Approval: 28/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mobile-based Adolescent Sexo-reproductive Health Scheme
Official scientific title Determinants of ¨Sexo-Reproductive¨ Health needs of adolescent girls in the Kumbo West Health District; North west Region of Cameroon
Brief summary describing the background and objectives of the trial Background Adolescence is a decisive age for boys and girls around the world. What transpires during an adolescent¿s years shapes the direction of his/her life and that of her family. For many girls in developing countries, the mere onset of puberty that occurs during adolescence marks a time of heightened vulnerability¿to early pregnancy, HIV, leaving school, child marriage, sexual exploitation, coercion and violence. Mobile-based Adolescent sexo-reproductive health scheme-MASHS is an education intervention tool in other words, a predictive model that has been developed by the research team to provide adolescents with a sustainable or long-term mobile based Reproductive Health Scheme that will basically involve the provision of accurate and persuasive information on how adolescents can meet their sexual and reproductive health needs. This educational intervention shall involve the use of a unique SMS update portal named MASHS, which shall consist of the main operator and the beneficiary who shall be in possession or have access to a mobile phone. The operator, who is the study principal investigator (PI) shall generate the content of the message based on the variables of a study questionnaire on adolescent sexual and reproductive health. When sending these messages, we shall take into consideration the audience and make sure the messages are clear and understandable to the beneficiary. During the start intervention, MASHS will be explained to the families of participants such that they will be expecting three to five messages from the principal investigator per week for a period of six months. Objectives -Reduce the vulnerability of adolescents to the risk of; early pregnancy and its complications, acquiring HIV/AIDS, leaving school, child marriage, sexual exploitation, coercion and violence -Improve the knowledge of adolescent girls on contraceptive use. -Improve sexo-reproductive health dialogue between adolescents and their peers, parents and guardians.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MASHS
Disease(s) or condition(s) being studied Infections and Infestations,Sexually Transmisible Diseases
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Education /Training
Anticipated trial start date 28/04/2018
Actual trial start date 01/05/2018
Anticipated date of last follow up 31/10/2018
Actual Last follow-up date 01/11/2018
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 384
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation such as age, community of residence 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 MASHS sms for three to five times a week 6months Educationa via the use of a unique SMS update portal named MASHS 200
Control Group No MASHS Not Applicable 6 months No MASHS 200 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A participant of this study, should be a resident of the community selected for the study. Acceptance to participate in the study after informed assent/consent. Participants of the study shall be adolescent girls between 10-19 years of age. Individuals who refuse to participate in the study after consent shall be automatically excluded 10 Year(s) 19 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
No 07/03/2018 Faculty of Health Sciences Institutional Review Board, University of Buea
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, Molyko, Buea Buea 63 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Improved behaviour and attitudes towards sexo-reproductive health. After six months
Primary Outcome Improved Knowledge and practices After three months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kumbo District Health service Tobin Kumbo 237 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Frankline S. Wirsiy Molyko Buea 63 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Frankline S. Wirsiy Molyko Buea 63 Cameroon University
COLLABORATORS
Name Street address City Postal code Country
Kah Emmanuel Muea Buea 63 Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Frankline Wirsiy wirsiysevid2000@yahoo.com 675 25 25 71 Molyko
City Postal code Country Position/Affiliation
Buea 63 Cameroon Ph.D. Candidate in Public Health
Role Name Email Phone Street address
Public Enquiries Lukong Leslie leslielukong@gmail.com 676306847 Molyko
City Postal code Country Position/Affiliation
Buea 63 Cameroon Information Service Provider
Role Name Email Phone Street address
Scientific Enquiries Nsagha Dickson dsnsagha@gmail.com +237 677499429 Molyko Buea
City Postal code Country Position/Affiliation
Buea 63 Cameroon Associate Professor of Public Health Epidemiology
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information