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.: PACTR202105818874512 Date of Approval: 21/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A study to assess the effect of a text message intervention using mobile phones to promote clinical antenatal uptake and institutional deliveries among young expectant women in Kwale County, Kenya.
Official scientific title The Effect of mHealth Integration on the Health Outcomes of Expectant Adolescents and Young Mothers – A Quasi-Experimental Study in Kwale County, Kenya
Brief summary describing the background and objectives of the trial Poor referral channels and lack of knowledge on the importance of ANC often impede expectant young women from attending antenatal clinics. The ubiquity of mobile phones offers the potential to improve ANC knowledge through prompt educational and reminder messages when integrated into existing antenatal care systems. The main objective of this study is to determine whether mHealth intervention integrated into an existing ANC delivery system improves the health outcomes among adolescents and young mothers aged 24 and below in Kwale County, Kenya. Study method This is a quasi-experimental trial with two arms, one arm of the study will be exposed to the mHealth intervention while the other arm will not. Four public health facilities will be randomly selected from a list of health facilities stratified by number of expectant young women. Public health facilities in Kwale County with more than 200 young women who presented with pregnancies in 2018 will be used as a proxy for hospital’s teenage pregnancies’ burden. This will then be followed by random assignment of health facilities to either the intervention or control arm within the established strata (>200 young women who presented with pregnancies in 2018). Random selection of study participants meeting the eligibility criteria in the four selected facilities will then follow. Each selected facility will have one arm either intervention or control. Pushed text messages in the form of Short Messages Service (SMS) will be sent to intervention participants from the mHealth platform. To complement health information given to expectant young women according to their gestational age, text messages will be tailored and staggered according to gestational ages of intervention study participants. After the trial, the researcher with the help of the health care providers from the four health centers will extract relevant quantitative data from the Ministry of Health’s registers for analysis.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2020
Actual trial start date 01/10/2020
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date 30/09/2021
Anticipated target sample size (number of participants) 856
Actual target sample size (number of participants) 856
Recruitment status 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
Parallel: different groups receive different interventions at same time during study Non-randomised 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 mHealth text messages using mobile phones This group will not receive the mHealth intervention but will be offered standard antenatal care in line with the Reproductive, Maternal, Neonatal Child and Adolescent Health (RMNCAH) national guidelines which include four or more antenatal care visits, intermittent preventive treatment for pregnant women, tetanus toxoid vaccine, prevention of mother to child transmission of HIV and skilled attendance at delivery The intervention will end when the last enrolled participant gets her last set of messages at week 38 or if she gives birth prior to her 38th week of pregnancy projected to be six months’ post-intervention period. The control group will not receive any intervention apart from the standard antenatal care. 428 Active-Treatment of Control Group
Experimental Group mHealth text messages using mobile phones One message per month will be sent in the first trimester, two messages per month in the second trimester and then messages will intensify to one per week from week 27 until delivery. The intervention will end when the last enrolled participant gets her last set of messages at week 38 or if she gives birth prior to her 38th week of pregnancy projected to be six months’ post-intervention period. Pushed text messages in the form of Short Messages Service (SMS) will be sent to intervention participants from the mHealth platform. To complement health information given to expectant young women according to their gestational age, text messages will be tailored and staggered according to gestational ages of intervention study participants. All intervention participants will receive a welcome message regardless of their gestational age. Prompt reminders and educational text messages will be sent between 24 and 48 hours prior to the scheduled appointment. Additionally, for the intervention participants, communication will be both unidirectional and bidirectional with the initial contact coming from the integrated mHealth system. Process monitoring will be done throughout the intervention period to ensure there is implementation fidelity and systemic functionality as envisioned by the study. In line with the new WHO recommendations of increased antenatal contacts to at least eight, one contact in the first trimester, two contacts in the second trimester and five contacts in the third trimester, the frequency of the messages sent to intervention participants will follow a similar pattern. One message per month will be sent in the first trimester, two messages per month in the second trimester and then messages will intensify to one per week from week 27 until delivery. 428
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Expectant young women aged 24 years and below residing within the study setting • Expectant young women with a gestational age not exceeding 24 weeks • Expectant young women with uneventful first and second trimesters • Have their own mobile phone at the time of recruitment • Can read and write either English and/or Swahili • Consenting eligible participants Expectant young women presenting with complications including hyperemesis gravidarum, placenta Previa, gestational hypertension, gestational diabetes mellitus, preeclampsia and iron deficiency anaemia. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 13 Year(s) 24 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 06/05/2020 Noguchi Memorial Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
University of Ghana, P.O Box LG 581, Legon, Accra Ghana Accra LG 581 Ghana
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 21/07/2020 Kenyatta National Hospital University of Nairobi Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
Kenyatta National Hospital P.O Box 30197 Nairobi Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Percentage of women Adhering to ANC appointments • Percentage of women with increased antenatal contacts to four or more After delivery
Secondary Outcome • Percentage of women delivering at health facilities under skilled birth attendants • Percentage of women with Infant born with normal birthweights After delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kwale County Public Health Facilities Kwale County Kwale Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
World Health Organization HRP Alliance for Research Capacity Strengthening through the University of Ghana School of Public Health University of Ghana, School of Public Health Accra LG 13 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor World Health Organization HRP Alliance for Research Capacity Strengthening Avenue Appia 20 1211 Geneva 27 Switzerland Geneva 1211 Switzerland Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof. Kwasi Torpey University of Ghana, School of Public Health Accra LG 13 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jefferson Mwaisaka jeffmwaisaka@gmail.com +254723206132 97513 Mombasa Kenya
City Postal code Country Position/Affiliation
Mombasa 80112 Kenya Doctoral Candidate
Role Name Email Phone Street address
Public Enquiries Jefferson Mwaisaka jeffmwaisaka@gmail.com +254723206132 97513 Mombasa Kenya
City Postal code Country Position/Affiliation
Mombasa 80112 Kenya Doctoral Candidate
Role Name Email Phone Street address
Scientific Enquiries Jefferson Mwaisaka jeffmwaisaka@gmail.com +254723206132 97513 Mombasa Kenya
City Postal code Country Position/Affiliation
Mombasa 80112 Kenya Doctoral Candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants' data will be available including data dictionaries. Also, all of the individual participants' data collected during the trial will be shared after de-identification. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, no end date Researchers and investigators whose proposed use of the data has been approved by an independent review committee for any type of analysis. Data will be available at the UGSpace, the institutional repository of the University of Ghana or by mail addressed to jeffmwaisaka@gmail.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://ugspace.ug.edu.gh/ 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