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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202108849524454 Date of Registration: 24/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Revive IPTp study
Official scientific title Community directed approaches to promote IPTp self-care for pregnant women in Migori and Kisumu Counties: A quasi-experimental study
Brief summary describing the background and objectives of the trial Background: Malaria infection during pregnancy has a devastating impact on health outcomes for mothers and infants. Uptake of Sulphadoxine-Pyrimethamine (SP) for Intermittent Preventive Treatment in pregnancy (IPTp) is a proven medical intervention for the prevention and management of Malaria in Pregnancy (MiP). Despite Kenya’s adoption of this intervention, uptake of IPTp for MiP has been persistently low. Objectives: (i) To test the feasibility and acceptability of community directed approaches to promote IPTp self-care for pregnant women; (ii) To assess changes in uptake of IPTp-SP among pregnant women following the implementation of the interventions; and (iii) To develop guidelines on scaling up and/or replication of community-based approaches for IPTp across the 14 Malaria endemic counties in Kenya.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 01/11/2021
Actual trial start date
Anticipated date of last follow up 30/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 4080
Actual target sample size (number of participants)
Recruitment status Not yet 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community directed approaches to promote IPTp selfcare for pregnant women Continuous 2 years Population Council in collaboration with KMET and County Health Management Teams (CHMT) will implement a combination of IPTp delivery models that promote self-care i.e. (a) Recruit and deploy newly graduated community nurses and midwives who will work in partnership with community health volunteers (CHVs) to sensitize and educate pregnant women on the importance of IPTp and distribute SP; (b) Foster SP availability and visibility in private outlets by promoting the provision of SP in IPTp by local private pharmacy providers; and, (c) Promote self-care of IPTp through mobile-phone messaging and local radio educational programmes to provide information on the prevention of MiP using IPTp, how to access IPTp and the recommended dosage. 76250
Control Group Standard outreach services Continuous 2 years Pregnant women in the control sub-counties will receive the standard outreach services provided by the sub-county health management teams 76250 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women Pregnant women who are HIV positive Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 13 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 04/12/2020 Amref Africa Ethics and Review Committee
Ethics Committee Address
Street address City Postal code Country
Off Langata Road, P.O. Box 30125-00100, Nairobi, Kenya Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of women who received 3 or more doses of Sulphadoxine Pyrimethamine for prevention of malaria during pregnancy Baseline and endline
Secondary Outcome Proportion of women who are knowledgeable about malaria prevention approaches during pregnancy Baseline and endline
Secondary Outcome Proportion of women who attended 4 or more ANC visits Baseline and endline
Secondary Outcome Proportion of women who received ANC from a skilled provider Baseline and endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kisumu Medical Education Trust Tom Mboya Estate, Along Kondele-Nyawita By-pass, off Kisumu Kakamega Road P.O. Box 6805-40103 Kisumu, Kenya Kisumu 40103 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP P.O. Box 93015 2509 AA The Hague, The Netherlands The Hague Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor European Union Rue de la Loi 175, 1000 Bruxelles, Belgium Bruxelles 1000 Belgium Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Kisumu Medical and Education Trust Tom Mboya Estate, Along Kondele-Nyawita By-pass, off Kisumu Kakamega Road P.O. Box 6805-40103 Kisumu, Kenya Kisumu 40103 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dennis Matanda matandajd@gmail.com +254715441788 Rose Avenue, P.O. Box 17643-00500
City Postal code Country Position/Affiliation
Nairobi 00500 Kenya Senior Program Officer
Role Name Email Phone Street address
Public Enquiries Esther Lwanga elwanga@popcouncil.org +254721501338 Rose Avenue, P.O. Box 17643-00500
City Postal code Country Position/Affiliation
Nairobi 00500 Kenya Research Associate
Role Name Email Phone Street address
Scientific Enquiries Wilson Liambila wliambila@popcouncil.org +254733542384 Rose Avenue, P.O. Box 17643-00500
City Postal code Country Position/Affiliation
Nairobi 00500 Kenya Research Associate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Dissemination strategies will include publication of study findings through fact sheets, evidence briefs, journal articles, workshop events, meetings, and conferences. Anonymized data will be made available through the Population Council data repository. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years Data will be made available to the public and researchers upon request/application to the Population Council
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