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.: PACTR202002812123868 Date of Approval: 25/02/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of implementing the timed and targeted counselling (ttC) model on pregnancy outcome and Newborn survival in rural Uganda. A Quaisi experimental study in Hoima and Mansidi district
Official scientific title Effect of implementing the timed and targeted counselling (ttC) model on pregnancy outcome and Newborn survival in rural Uganda. A Quaisi experimental study in Hoima and Mansidi district
Brief summary describing the background and objectives of the trial It’s been evident that Uganda unfortunately failed to hit the reduction of maternal motility Millennium development gaol target presenting a 307 deaths per 100,000 live births. With a 37% contribution to under one-year death, strategies geared towards reduction of Newborn death shall be essential, including community based newborn care as a component of the essential Newborn care package. Timed and targeted counselling (ttC) a CHW approach of extending primary health care counselling to the household level, built around evidence-based, cost effective key interventions for pregnant women and children under two aimed at the significant reduction of maternal, infant and young child morbidity and mortality is one of those interventions that can respond to Uganda’s slow achievements. The purpose of this study will be to determine the effect of ttC on pregnancy outcomes and Newborn survival in Rural Uganda focusing on uptake of timely Goal Oriented ANC, hygienic birthing practices, essential new-born care practices, fostering positive male involvement in Pregnancy and New Born care, appropriate pregnancy weight gain and appropriate birth weight The Study is a longitudinal Quaisi experimental design following a Non-equivalent Groups Design. The implementation area for ttC is in Hoima District and the comparison area is Masindi District that neighbours Hioma on the Ugandan map. Mothers (1,283) who have gone through pregnancy and have children above 6 weeks will provide data for the end line survey. A household questionnaire has been developed and translated into the local languages for this purpose. Informed consent shall be sought from all participants before being included in the study. Data will be entered into SPSS and analysis of variables shall be done for Multivariate, Bivariate and Univariate depending on variable requirements.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) ttC
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 01/11/2018
Actual trial start date 01/11/2018
Anticipated date of last follow up 31/01/2022
Actual Last follow-up date 31/01/2022
Anticipated target sample size (number of participants) 1283
Actual target sample size (number of participants) 1283
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
730 Makerere University Schoo of Public Health Higher Degree, Research and Ethics Committee
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 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
Experimental Group Implementation of the timed and targeted counseling model for Behavioral change in MNCH A household that has a pregnant mother is visited 4 times during pregnancy at that exact time when the pregnant mother is supposed to have gone for ANC, then visited on day one of childbirth, day 3 and day 7 plus 6 weeks after delivery for vaccination support by the CHW. Messaging and counseling support is offered for other behaviors that the pregnant mother should practice one year Timed and Targeted counselling (ttC) is a package of key Maternal Newborn and Child Health (MNCH) messages and actions that are disseminated and passed on to pregnant and breastfeeding mothers to cause sustainable behavioral change at specific timelines in the 1,000 days. The strategy also targets key decision makers and those who influence decisions in households during home visits. The approach addresses integrated health and nutrition needs of the target groups, barriers and negotiation agreement with households. 642
Control Group CHW Normal Ugandan strategy implementation The CHW visits the Household with a pregnant mother according to the normal household visit schedule. The Visits are not that targeted with key messages and behaviors 12 months The Uganda Strategy and Operational Guidelines for the implementation of the VHT at the household level promotes that VHT are people chosen by their own community to promote the health and wellbeing of all village members. The coverage of each VHT is at least 30 household. The strategy clearly emphasizes that VHT is a way for all Ugandans, their families and neighbours to improve their health. By taking action at home in the way Ugandans live and care for themselves and families. The purpose and Profile of the VHT in Uganda includes the mobilization of village members for health activities mainly organised by the Health centres in the area, keeping village health records up to date, making monthly village health reports and meetings to the village members to provide an update on the current health status for that particular village. The VHT promotes health to prevent disease, reports village sickness to health workers and does period check for danger signs in village members who are sick. The MoH anticipated that the implementation of the VHT strategy in a given geographical location would involve the immediate referral of village members who are sick or are supposed to go for health care (e.g., immunization and antenatal care) to health workers. The VHT also help in the treatment of simple illness at home, assist some village members take medicines as prescribed (Daily Observed Treatment: DOT) and focus on MNCH services effecting behavioural change. 642 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Pregnant Women registered by the CHWs 2. Have stayed in the project sites throughout pregnancy and childbirth 3. For the end of study results, the mother must have either an ANC card with a CHC or have a mother-child passport Those mother-baby pairs that have not been in the project site though out the pregnancy period. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,New born: 0 Day-1 Month 13 Year(s) 50 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 02/02/2020 College of health Sciences School of Public health Higher Degree Research and Ethics Committtee.
Ethics Committee Address
Street address City Postal code Country
Mulago Complex kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Uptake of timely Goal Oriented ANC with a focus on the recommended 4 visits 2. The recommended hygienic birthing practices 3. Improved essential new-born care practices (ENC) during the newborn period 4. Fostering positive male involvement in Pregnancy and New Born care Mid term, focusing on the intervention area, behavioral
Secondary Outcome 5. Appropriate pregnancy weight gain by end of Pregnancy. 6. Appropriate birth weight End of study period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hoima District Albertine Region Hoima Uganda
Masindi District Albertine region Masindi Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Maastricht University 6229 ER Maastricht Maastricht Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Alex Mokori UNICEF Uganda Kampala Uganda Individual
Primary Sponsor Dr. Jessica Gubbles Maastricht University Maastricht Netherlands University
Primary Sponsor Dr. Gerards Sanne Maastricht University Maastricht Netherlands University
Secondary Sponsor Prof.Stef Kremers Maastricht University Maastricht Netherlands University
COLLABORATORS
Name Street address City Postal code Country
World Vision Uganda 13B Nakasero kampala Uganda
Benon Musasizi Options Consultancy Services kampala Uganda
Nathan Isabirye Makerere University Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Benon Musasizi musasizi.benon1@gmail.com 256751762466 Kiti
City Postal code Country Position/Affiliation
kampala Uganda Makerere University encourages that PIs be either staff or affiliates to the institution. That is why Benon was brought on board.
Role Name Email Phone Street address
Principal Investigator Geoffrey Babughirana gbabughirana@gmail.com 256706356376 kulambiro
City Postal code Country Position/Affiliation
Kampala Uganda The PhD student the one managing the study and conception of the study
Role Name Email Phone Street address
Scientific Enquiries Nathan Isabirye isabirye.nathan@yahoo.com 256782836002 School of Public Health
City Postal code Country Position/Affiliation
kampala Uganda Makerere University
Role Name Email Phone Street address
Public Enquiries Emmanuel Busajja ebussaja@gmail.com 256704307374 Mulago Hospital
City Postal code Country Position/Affiliation
kampala Uganda Mulago Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Using the CHW register, data collected, and also through the tool for the end line. The consent shall be acquired from the participants. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol one year after interventions Through paper pubblications
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