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.: PACTR201808703097367 Date of Approval: 23/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Using targeted e-voucher and mobile phone technology as a tool in addressing maternal mortality and reproductive health amongst rural poor women in Cameroon
Official scientific title A community, stratified, cluster-randomized control trial, data collectors and statistician blinded, 18-months, parallel-group, superiority study to compare effectiveness of e-vouchers and mobile phone application to standard care amongst rural poor women in Cameroon
Brief summary describing the background and objectives of the trial The trial is a community, stratified, cluster-randomized control trial, data collectors and statistician blinded, 18-months, two arms parallel-group, superiority study to compare effectiveness of e-vouchers and mobile phone application to standard care amongst rural poor women in Cameroon. The study district will be purposefully selected Upon registration into the Pre-Natal Management System(PNMS), pregnant women will be provided 5 e-vouchers: each prenatal visit will automatically redeem one e-voucher and the account of health center credited. Mobile phones will be provided to eligible pregnant women and electronic vouchers that will be redeemed upon antenatal visits and delivery. Each eligible pregnant woman will be assigned 5 vouchers (4 for antenatal visits and one for delivery including 5 transportation vouchers). The voucher will be administered electronically, and the users of the application will communicate their health state with providers using images or direct calls, which on arrival will be sent to appropriate health personnel. The health personnel will receive this information on the computers as well as on their phones as SMS alerts and will react appropriately. Recruitment into the study is prospective, and each participant is followed during the course of their pregnancy until they deliver. Mothers who do not deliver in the hospital are followed-up in the community within one week of delivery by CHWs. The study will run for 18months because it will allow time for the outcome to be measured and enough participants to be enrolled in the study. The proposed interventions (e-vouchers and mobile phone application) are non-invasive and pose no direct adverse effects on participants. Randomizing at the level of health area and the use of e-voucher will help control for contamination because women will not have the opportunity to share, sell, and/or misplaced their vouchers. Every woman is assigned a code to their profile which identifies them upon each vi
Type of trial RCT
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 Prevention
Anticipated trial start date 12/09/2018
Actual trial start date 18/10/2018
Anticipated date of last follow up 31/08/2019
Actual Last follow-up date 31/03/2020
Anticipated target sample size (number of participants) 280
Actual target sample size (number of participants) 140
Recruitment status Completed
Publication URL https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00589-y
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group evoucher and mobile phone application 4 evouchers for four antenatal care visits plus one voucher for delivery. In addition to transportation voucher to cover for all the 4 visits and delivery women are followed from enrollment until they give birth The study is open to women aged 15-49(with the current report of under-age pregnancy of <15years in this area),we anticipate to adjust the age to 12-49 considering that this age group are not only vulnerable but high risk), ≤4months pregnant and fall within the income bracket using a poverty assessment tool. Upon registration into PNMS, pregnant women in the intervention group will be provided a mobile phone and 5 e-vouchers: each prenatal visit will automatically redeem one e-voucher and the account of health center credited. Mobile phones will be provided to eligible pregnant women and electronic vouchers that will be redeemed upon antenatal visits and delivery. Each eligible pregnant woman will be assigned 5 vouchers (4 for antenatal visits and one for delivery including 5 transportation vouchers). The voucher will be administered electronically, and the users of the application will communicate their health state with providers using images or direct calls, which on arrival will be sent to appropriate health personnel. Messages will be both audio and text messages. The health personnel will receive this information on the computers as well as on their phones as SMS alerts and will react appropriately. Recruitment into the study is prospective, and each participant is followed during the course of their pregnancy until they deliver. Mothers who do not deliver in the hospital are followed-up in the community within one week of delivery by CHWs. The study will run for 18months because it will allow time for the outcome to be measured and enough participants to be enrolled in the study. The proposed interventions (e-vouchers and mobile phone application) are non-invasive and pose no direct adverse effects on participants. Randomizing at the level of health area and the use of e-voucher will help control for contamination because women will not have the opportunity to share, sell, and/or misplaced their visits. 2
Control Group standard care women are followed from enrollment until they give birth Standard care: This group is business as usual (standard practice). Women pay for their transportation to antenatal clinics, antenatal care services, and delivery through out-of-pocket. In addition, no mobile phones will be distributed to this group so they will not have access to mobile family planning and GIS feature and those who may own mobile phones will be unable to download the app during the pilot study. 2 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Women aged 12-49 years, ≤4months pregnant • Residence in the study area during the entire pregnancy • Provision of informed consent for study participation • Meet income bracket as defined by the tool that will be employed in the study • Above income bracket as defined in the study • Pregnancy above four months • Refused to provide informed consent Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 49 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 28/04/2018 Regional Hospital Institutional Review Board IRB
Ethics Committee Address
Street address City Postal code Country
Regional Hospital Bamenda, P.O.Box 818 Bamenda 00818 Cameroon
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 31/07/2018 University of Ottawa Office of Research Ethics and Integrity
Ethics Committee Address
Street address City Postal code Country
550 Cumberland street Rm 154 Ottawa Ontario K1N 6N5 Ottawa 0088 Canada
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the number of antenatal care and the number of skilled birth delivery attended. Baseline, Midline, Endline
Secondary Outcome awareness on family planning and methods after the introduction of mobile family planning in the intervention versus control group. number of maternal death during this period Baseline, Midline, Endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bali District health area North west Region Bali district health service Bali rural area Cameroon
Ndop district health area Ndop district health service North West Region Ndop rural area Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada and Global Affairs Canada which is funded by the Government of Canada Mars Center West Tower, 661 University Avenue, suite 1720, Toronto On, M5G 1M1 Toronto Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Ottawa 451 Smyth , Ottawa, ON, K1H 8M5, Canada Ottawa 0011 Canada University
COLLABORATORS
Name Street address City Postal code Country
Effective Basic Services Africa eBASE Cameroon P.O.Box 5175 Nkwen Bridge, Ndamukong Street, NWR, Bamenda Bamenda Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Miriam Nkangu mngui058@uottawa.ca 5145687566 451 Smyth Road K1H 8M5
City Postal code Country Position/Affiliation
Ottawa Canada PhD Candidate University of Ottawa
Role Name Email Phone Street address
Scientific Enquiries Sanni Yaya sanni.yaya@uottawa.ca 6135625800 120 University Private
City Postal code Country Position/Affiliation
Ottawa Canada Professor
Role Name Email Phone Street address
Principal Investigator Sanni Yaya sanni.yaya@uottawa.ca 16135625800 120 University Private Social Sciences Building Ottawa, Ontario, Canada K1N 6N5
City Postal code Country Position/Affiliation
Ottawa Canada Professor University of Ottawa Canada
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Intended use of Data Data generated during this study will permit University of Ottawa to determine how e-voucher and mobile phone application can better contribute to increasing access and utilization of RMNCH amongst rural poor women at district level. The final data will be available to Grand Challenges Canada, University of Ottawa and the Cameroon ministry of health to assist in decision making. Constraints on use of Data eBASE shall not share any data regarding the abovementioned project with any third party without a written permission of the investigators involved (University of Ottawa). Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The period shall be in effect from, April 1, 2018 until terminated in writing by either organization, October 2019. Data Security and Protection of Privacy The transfer of any data and information will strictly follow legal rules and personally identifiable data shall be kept strictly confidential. eBASE Africa, Cameroon and participating district health centers shall abide to the following: 1. Data obtained in the study will be protected and will strictly follow legal rules established by University of Ottawa. 2. All personally identifiable data shall be kept confidential in an anonymous form on papers or electronically at eBASE in Cameroon, participating health districts and Project leads. If necessary, the anonymous data sets maybe forwarded also to GCC. 3. No data report containing personally identifiable information will be transferred by email. All data reports containing personally identifiable information shall be conveyed via secured FTP site and physical media (Hard drive, DVD, CD, Flash or USB drives). All files will be password protected. 4. Data will be used for no other purpose than to meet the objectives of the research study specified in the project. 5. Data from this study can be published as long as personally identifiable information are kept confidential. Responsibility for Improper Disclosure of Personally Identifiable Information The party responsible for misuse or improper disclosure of personally identifiable information shall be solely responsible for the damages caused.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 23/09/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 23/09/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information