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.: PACTR202208844472053 Date of Approval: 11/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Study title and acronym: INcreasing the upTakE of IPTp-SP throuGh Seasonal MalaRiA ChemoprevenTION channel delivery - INTEGRATION
Official scientific title INCREASING THE UPTAKE OF INTERMITTENT PREVENTIVE TREATMENT USING SULFADOXINE-PYRIMETHAMINE THROUGH SEASONAL MALARIA CHEMOPREVENTION CHANNEL DELIVERY
Brief summary describing the background and objectives of the trial Malaria infection during pregnancy is a major public health problem, with substantial risks for the mother, her fetus and the newborn. Malaria is a notable cause of adverse birth outcomes, including fetal loss, intrauterine growth retardation, and preterm birth. The World Health Organization (WHO) recommends intermittent preventive treatment (IPTp) with sulphadoxine-pyrimethamine (SP) to prevent malaria in pregnancy in areas of moderate-to-high transmission in sub-Saharan Africa. However, IPTp-SP uptake remains unacceptably low. More than two thirds (69%) of pregnant women in sub-Saharan Africa are still not accessing the WHO-recommended three or more doses of IPTp. In contrast, the coverage of Seasonal Malaria Chemoprevention (SMC) among children, a relatively new strategy recommended by the WHO in 2012 for malaria control in Sahelian countries with seasonal malaria transmission such as Mali and Burkina-Faso, is high. Thus, it is hypothesized that IPTp delivery to pregnant women through the SMC channel using door-to-door delivery (DDD) will increase IPTp coverage and have more clinical impact, as the risk of malaria and its burden on birth outcomes increases during rainy season corresponding also to the season of SMC. The primary objective of the INTEGRATION study is to evaluate whether the addition of IPTp-SP to SMC will increase the coverage of IPTp and ANC among pregnant women in Mali and Burkina Faso. This research will also evaluate the acceptability, feasibility, cost and cost effectiveness of the proposed strategy to provide comprehensive data for policy makers to subsequently consider nation-wide roll-out. Because of obvious difference between countries in terms of commodities, human resources costs, per country cost-effectiveness analysis (CEA) will be done in addition to the combined CEA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) INTEGRATION
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 01/06/2022
Actual trial start date 07/06/2022
Anticipated date of last follow up 31/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 1974
Actual target sample size (number of participants)
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 Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 Delivery of IPTp SP through the seasonal malaria chemoprevention channel one (1) dose a month for four (4) months Two-year intervention The intervention will consist of the monthly provision of IPTp-SP through the SMC channel delivery during the four monthly rounds of SMC (from July to October) in the malaria transmission season, annually in two consecutive years. Prior to any SMC round, a list of pregnant women and their household address in each cluster will be obtained from the CHWs and CRs. The CHWs and CRs in charge of the SMC DDD will also conduct proactive case finding while visiting the houses, by asking about the presence of any pregnant women living in the household not already listed. Any women whose last menstrual period occurred more than 6 weeks before the date of the visit or if pregnancy status is unknown or not visible will be encouraged to attend ANC visit before the end of the current SMC cycle. If on subsequent follow-up visits these women confirm they are pregnant, they will be referred to health center using a referral sheet (provided by the trial) for their first ANC visits, where the gestational age will be assessed and the first IPTp-SP dose administered if due. Pregnant women who have been referred to ANC will be followed-up by the CHW during the DDD visit and their ANC card will be checked to see whether a dose of IPTp-SP is due and any dose given by the CHW will be recorded in the mother’s ANC card. If not yet due, they will be followed up again at the eligible gestation. Thus, pregnant women can receive up to 4 doses of IPTp-SP through SMC only, depending on gestation at first CHW visit. Pregnant women will be referred to a health center for any medical condition to receive care or IPTp-SP doses due outside the rainy season (after the annual SMC cycle). The same process will be followed during each of the four SMC rounds of the annual malaria transmission season. Information will be recorded by CHWs on a dedicated (study) IPTp record sheet, the mother’s ANC card and the health center ANC register. Dates will be cross-checked against health centre records of the dates of SP administration during SMC rounds. ANC registers will be consulted so that IPTp doses can be verified by finding the ANC entry in the register. In addition to delivery of IPTp-SP through SMC, women will be asked to continue with their scheduled ANC visits for other essential ANC services and to receive their IPTp-SP doses during the non-malaria transmission season as usual, at the end of the annual SMC cycle. 987
Control Group Delivery of IPTp SP through seasonal malaria chemoprevention channel None (standard care) Four (4) months Women will receive monthly IPTp-SP doses through scheduled ANC visits (standard care) started from ~13 weeks of gestation (if known) or at first fetal movement. This will be based on the new WHO recommendation suggesting 8 ANC contacts. IPTp-SP will not be delivered through SMC channel in the control arm. 987 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women aged 15-49 years in their 2nd or 3rd trimester in a trial facility Women who delivered in the last 12 months Health providers providing ANC services in a trial facility SMC staff and CHWs/CR delivering SMC in the community Guardians of children receiving SMC in the catchment areas of trial facilities Health managers at the facility, district, and national levels in the Ministry of Health Pregnant women participating in the household survey Women not consenting to participate Known pregnant women who are HIV-positive 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 01/06/2022 Liverpool School of Tropical Medicine Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Pembroke Place Liverpool L3 5QA United Kingdom
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 03/03/2022 Comite d Ethique pour la Recherche en Sante Publique
Ethics Committee Address
Street address City Postal code Country
Ministere de la Sante Building Lamizana Ouagadougou Ouagadougou BP 7009 Burkina Faso
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 13/04/2022 Comite d Ethique de la Faculte de Medecine de Pharmacie et d Odonto Stomatologie
Ethics Committee Address
Street address City Postal code Country
FMOS Bamako 1805 Mali
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of women who delivered within the last 12 months who received at least 3 doses of IPTp-SP during pregnancy. Baseline and endline
Secondary Outcome Proportion of recently pregnant women who received 0, 1, 2 doses of IPTp-SP during their last pregnancy Proportion of recently pregnant women who attended 1, 2, 3, 4, 5, 6, 7, and 8 antenatal visits (or contacts) during their last pregnancy Baseline and endline
Secondary Outcome Proportion of children reached by SMC Baseline and endline
Secondary Outcome Proportion of women who attended ANC after the first trimester and were eligible for IPTp, but who did not receive SP Endline
Secondary Outcome Proportion of doses of IPTp-SP given by Directly Observed Therapy (DOT) Baseline and endline
Secondary Outcome Mean gestational age at first ANC visit and at first IPTp-SP administration Baseline and endline
Secondary Outcome Incidence of malaria in children and pregnant women and incidence of birth outcomes at delivery (health center records). Throughout the study
Secondary Outcome Marginal economic cost per woman receiving correct number of doses of IPTp-SP in the intervention, versus control arm. Midline
Secondary Outcome Marginal economic cost per DALY averted in intervention, versus control arm. Midline and endline
Secondary Outcome Acceptability and feasibility of ANC + SMC combined delivery of IPTp-SP compared to standard care (ANC) among health providers. Baseline and endline
Secondary Outcome Acceptability of ANC + SMC combined delivery of IPTp-SP compared to standard care (ANC) among pregnant women. Endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kangaba district Kangaba Kangaba Mali
Bousse district Bousse Bousse Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
The European and Developing Countries Clinical Trials Partnership 2509 AA The Hague 93015 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Sciences Techniques and Technologies of Bamako Hamdalaye ACI 2000 Bamako 423 Mali University
COLLABORATORS
Name Street address City Postal code Country
Halidou Tinto Nanoro Nanoro Burkina Faso
Jenny Hill Pembroke Place Liverpool L3 5QA United Kingdom
Valerie Briand 146 Rue Leo Saignat Bordeaux 33076 France
Eve Worall Pembroke Place Liverpool L3 5QA United Kingdom
Dario Scaramuzzi Maglie Apulia Italy
Kassoum Kayentao Point G Bamako Mali
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kassoum Kayentao kayentao@icermali.org +22376460173 Point G
City Postal code Country Position/Affiliation
Bamako Mali The International Center for Excellence in Research
Role Name Email Phone Street address
Scientific Enquiries Jenny Hill jenny.hill@lstmed.ac.uk +447732161353 Pembroke Place
City Postal code Country Position/Affiliation
Liverpool United Kingdom Liverpool School of Tropical Medicine
Role Name Email Phone Street address
Public Enquiries Kadiatou Koita kadiatou.koita@lstmed.ac.uk +4084497773 Point G
City Postal code Country Position/Affiliation
Bamako Mali Liverpool School of Tropical Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The investigators will ensure that all personal data collected during the study are appropriately protected. The collection of personal information will be restricted to meet the objectives of the project, and only data relevant to the execution of the project and interpretation of data will be collected. Data will be kept for a minimal time period stipulated by national or international law. All personal data collected during the study will be kept confidential. The involved research institutes' Standard of Operating Procedures on the management of personal data will be followed throughout the study. All data will be pseudo-anonymized using the trial ID number, and date of birth. Other identifiers such as name and address will not be stored electronically. All paper-based source documents will be treated as confidential and kept in lockable cabinets in lockable rooms with access limited to approved staff as recorded on the Trial Delegation Log. All staff will receive formal Good Clinical Practice (GCP) training before study initiation and retraining afterward. Only the participant’s anonymous study ID will be captured in the database. None of the results will be published with personal identifiers. At the end of the project, all personal information will be destroyed. All personalized data forms signed informed consent forms and other personalized information will be kept under lock and key and available only to the project coordinator, principal investigators, and data managers. Information stored in electronic databases will be protected by unique usernames and passwords, available only to appropriate authorized personnel. Data entry will be checked independently on-site by the nurse/research clinician and by the local PI to ensure accuracy. Data with personal identifiers will not be transferred outside the country. Informed Consent Form,Statistical Analysis Plan,Study Protocol All study documents are provided by the Sponsor (USTTB) in confidence to the investigators and his/her appointed staff. Data will be shared with outside entities only after publication of results. None of this material may be disclosed to any party not directly involved in the study without written permission from the sponsor.
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