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.: PACTR201903906459874 Date of Approval: 14/03/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Maternal health improvement among fishing communities in Uganda through capacity strengthening of community health workers
Official scientific title Maternal health improvement among fishing communities in Uganda through capacity strengthening of community health workers
Brief summary describing the background and objectives of the trial Background: Uganda is experiencing a critical shortage of skilled health care workers including skilled birth attendants (SBAs), especially in rural hard to reach areas(1). The shortage of SBAs (doctors, nurses, midwives) has contributed to deaths of women, with about 14 women dying daily (maternal mortality ratio of 336 per 100,000 live births) from pregnancy and child birth related complications(2). Task shifting the promotion of maternal health behaviours including aspects of antenatal (ANC) and postnatal care (PNC) to community-based health workers (CHWs) may improve maternal health behaviours in hard to reach fishing communities (FCs) on Lake Victoria(3–5). This study evaluates whether intensified (at least four home visits) involvement of CHWs delivering the Village Health Teams Improving Maternal Health Behaviour (VIMBA) package influences skilled antenatal attendance and births among hard to reach FCs in Kalangala district. The VIMBA package will be implemented among 243 women in the intervention communities. To ascertain the effect of the VIMBA package, 243 women from other control FCs will be receiving standard ANC and PNC. Skilled antenatal attendance and child birth will be determined by comparing these indicators between the communities. Objective: To determine if intensified implementation of the VIMBA package improves maternal health behaviours in the intervention FCs over an 18 months’ period.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) VIMBA
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Community Health Workers providing Maternal Health talks, Blood Pressure measurement, HIV and Anemia testing
Anticipated trial start date 01/01/2018
Actual trial start date 04/01/2018
Anticipated date of last follow up 13/11/2019
Actual Last follow-up date 13/12/2019
Anticipated target sample size (number of participants) 486
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL https://journals.sagepub.com/doi/10.1177/2150132720923101
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 Routine Antenatal and Child Birth Care 18 months Routine Antenatal and Child Birth Care as provided by Health Facilities 243 Dose Comparison
Experimental Group Community Health Worker 18 months Community Health Worker Household visits providing Maternal Health Talks, Blood pressure measurement, HIV and anemia testing 243
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women Pregnant or had a child birth or abortion in the past 6 months Study community resident for at least 3 months Willingness to stay in study community for at least 18 months Willing to be visited by Community Health Worker at home to provide messaging, Blood pressure measurement, HIV and Anemia testing Willing to respond to interviewer administered questionnaires Unwillingness to provide informed consent or assent Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 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 31/10/2017 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6, Kimera Road Kampala 00256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intensified implementation of the VIMBA package improves the following maternal health behaviours by at least 14%, in the intervention communities, over 18 months: 1. Women attended to by a skilled health worker for reasons related to pregnancy at least four times during course of most recent pregnancy 2. Women who got skilled attendance at delivery of the most recent child. 12 and 18 months
Secondary Outcome Unmet need for skilled antenatal care in Jaana, Namisoke, Kitobo, Sserinya, Lulamba and Kachanga communities Baseline
Secondary Outcome Unmet need for a skilled birth attendant at the most recent child birth in Jaana, Namisoke, Kitobo, Sserinya, Lulamba and Kachanga communities Baseline
Secondary Outcome Acceptability of Community Health Worker provided HIV testing and Counselling Baseline and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kachanga Island Kalangala District Kalangala Uganda
Lulamba Island Kalangala District Kalangala Uganda
Sserinya Island Kalangala District Kalangala Uganda
Jaana Island Kalangala District Kalangala Uganda
Namisoke Island Kalangala District Kalangala Uganda
Kitobo Island Kalangala District Kalangala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
International AIDS Vaccine Initiative 125 Broad Street, 9th Floor New York United States of America
USAID D.C. 20523-0016 Washington United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor USAID D.C. 20523-0016 Washington United States of America Funding Agency
Secondary Sponsor International AIDS Vaccine Initiative NY 10004 New York United States of America Research Institution
COLLABORATORS
Name Street address City Postal code Country
Olivier Degomme De Pintelaan 185-UZ P114 Gent Belgium
Noah Kiwanuka New Mulago Hill Road Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ali Ssetaala Ali.Ssetaala@UGent.be 256782863749 Plot 51-59, Nakiwogo Road
City Postal code Country Position/Affiliation
Entebbe Uganda PhD Student
Role Name Email Phone Street address
Scientific Enquiries Olivier Degomme Olivier.Degomme@UGent.be 3293323564 De Pintelaan 185- UZ P 114
City Postal code Country Position/Affiliation
Gent Belgium PhD Supervisor
Role Name Email Phone Street address
Scientific Enquiries Noah Kiwanuka nkiwanuka@gmail.com 256782788036 New Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala Uganda PhD Supervisor
Role Name Email Phone Street address
Public Enquiries Ali Ssetaala Ali.Ssetaala@UGent.be 256782863749 Plot 51-59 Nakiwogo Road
City Postal code Country Position/Affiliation
Entebbe Uganda PhD Student
Role Name Email Phone Street address
Scientific Enquiries Ali Ssetaala Ali.Ssetaala@UGent.be 256782863749 Plot 51-59 Nakiwogo Road
City Postal code Country Position/Affiliation
Entebbe Uganda PhD Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes STATA Dataset Informed Consent Form,Study Protocol October 2020 Authorization request
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 08/03/2019 More meaningful title VIMBA Maternal health improvement among fishing communities in Uganda through capacity strengthening of community health workers
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 13/03/2019 This is a Controlled Trial not randomized as had been previously stated RCT CCT
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 05/10/2020 Completed Closed to recruitment,follow-up continuing Completed
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 05/10/2020 Publication of baseline results https://journals.sagepub.com/doi/10.1177/2150132720923101