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.: PACTR202204774993198 Date of Approval: 14/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title LEVERAGING MOBILE PHONE-BASED TECHNOLOGIES TO PROVIDE ON-DEMAND ADOLESCENT SEXUAL REPRODUCTIVE HEALTH INFORMATION IN A RESOURCE LIMITED SETTING: KIBRA, NAIROBI COUNTY
Official scientific title LEVERAGING MOBILE PHONE-BASED TECHNOLOGIES TO PROVIDE ON-DEMAND ADOLESCENT SEXUAL REPRODUCTIVE HEALTH INFORMATION IN A RESOURCE LIMITED SETTING: KIBRA, NAIROBI COUNTY
Brief summary describing the background and objectives of the trial We aimed to field-test through mobile application a randomized clinical trial (RCT) to evaluate the system’s ability to: i) offer on-demand ASRH information in a discreet, confidential, anonymous, novel, convenient and accessible manner, and ii) influence adolescent’s knowledge, attitudes and practice on ASRH awareness.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Reproductive health awareness
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2019
Actual trial start date 16/10/2019
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 31/01/2020
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Accessing mobile app 3-month period A Randomized Clinical Trial evaluated the prototypes ability to i) offer on-demand Adolescent Sexual Reproductive Health information in a discreet, confidential, anonymous, novel, convenient and accessible manner, and ii) influence adolescent’s knowledge, attitudes and practice on ASRH awareness. 146
Control Group Control group 3-month period No intervention was offered to this group. The adolescents were assumed to continue accessing sexual reproductive health information form their current sources including parent, healthcare providers, social media and their peers. 154 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Must have lived in the study location for at least 3 months. 2) Willing to take part in the prototype pilot. 3) If 15 – 17 years, accompanied by a Parent or Guardian for consent procedures to be administered. 4) For 15 – 17 year olds, accepts assent procedures to be administered 5) For 18 years and above, accepts informed participant consent procedures to be administered. 1) Has not lived in the study location for at least 3 months. 2) Not willing to take part in the prototype pilot. 3) If 15 – 17 years, not accompanied by a Parent or Guardian for consent procedures to be administered. 4) For 15 – 17 year olds, refuses assent procedures to be administered 5) For 18 years and above, refuses informed participant consent procedures to be administered. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 19 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 21/03/2019 Kenyatta National Hospital University of Nairobi Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
Off Hospital Road Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Evaluate the system’s ability to: i) offer on-demand Adolescent Sexual Reproductive Health information in a discreet, confidential, anonymous, novel, convenient and accessible manner, and ii) influence adolescent’s knowledge, attitudes and practice on Adolescent Sexual Reproductive Health awareness 3-month follow-up visit
Secondary Outcome To evaluate the secondary outcomes, Mobile Application Rating Scale was used to collect descriptive and technical information about the application’s functionality. A mobile phone technology-based user experience questionnaire was also administered. 3-month follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AIC Church Kibera Off Kibera Drive Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Paul Macharia Off Kabiria Road Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Paul Macharia Off Kabiria road Nairobi 00100 Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
Antoni Navarro Rambla del Poblenou, 156 08018 Barcelona Spain
Irene Inwani Off Hospital Road Nairobi 00202 Kenya
Ruth Nduati Off Hospital road Nairobi Kenya
Carme Carrion Ribas Rambla del Poblenou, 156 Barcelona 08018 Spain
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paul Macharia paulmachariah@gmail.com +254722866753 Off Kabiria road
City Postal code Country Position/Affiliation
Nairobi Kenya PhD Student
Role Name Email Phone Street address
Scientific Enquiries Antoni Navarro aperezn@uoc.edu +34619963691 Rambla del Poblenou, 156
City Postal code Country Position/Affiliation
Barcelona 08018 Spain PhD Supervisor
Role Name Email Phone Street address
Public Enquiries Carme Ribas mcarrionr@uoc.edu +34630983328 Rambla del Poblenou, 156
City Postal code Country Position/Affiliation
Barcelona 08018 Spain PhD Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymous participant identification numbers were used for all participants. All datasets have no link to the study participants. Data can be availed to other reseearchers on request. Informed Consent Form,Statistical Analysis Plan,Study Protocol upto 5 years after study completion The data will be availed in CSV format
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 06/04/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 06/04/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information