Strategies to Increase Antenatal Iron and Folic Acid Supplementation and Malaria Prophylaxis (AIFASMaP)
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|ClinicalTrials.gov Identifier: NCT04250428|
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : February 5, 2020
Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Swiss Tropical & Public Health Institute
Information provided by (Responsible Party):
Siaka Kone, Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Pregnancy increases the risk of malaria and nutritional deficiency. Despite some progress in ANC access over the past years, coverage of antenatal iron and folic acid supplementation (AIFAS) and intermittent preventive treatment of malaria in pregnancy (IPTp) remains low in many countries. The main objective of this research project is to identify the most effective ways to increase AIFAS and IPTp in low-income settings. We will assess the relative effectiveness of two strategies: the provision of information on the importance of AIFAS and IPTp for pregnant women (Intervention Arm I - demand side intervention), and the direct delivering of supplements and malaria drugs to women's homes (Intervention Arm 2 - supply side intervention). The two strategies will be tested through a small-randomized experiment with 720 pregnant women in the Taabo Health and Demographic Surveillance Site located in South-central Côte d'Ivoire. The primary outcome variable for the pilot study will be post-partum anemia and malaria infections. Secondary outcomes will be AIFAS and IPTp coverage as well as miscarriages, stillbirths and low birth weight deliveries as adverse birth outcomes.
|Condition or disease||Intervention/treatment||Phase|
|Antenatal Care||Behavioral: Demand intervention Behavioral: Supply intervention||Not Applicable|
Show detailed description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||720 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study is designed as a 3-arm parallel trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Given the in-person nature pf both interventions, masking of subjects will not be possible. Interviewers conducting the final assessment will however be blinded to the treatment condition.|
|Official Title:||Strategies to Increase Antenatal Iron and Folic Acid Supplementation and Malaria Prophylaxis in Rural South-central Côte d'Ivoire: Study Protocol of a Cluster Randomised Controlled Trial|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||December 2021|
No Intervention: Control
Women in the control arm will have (standard) access to antenatal care.
Experimental: Demand intervention
Women in this arm will receive a home visit by a study nurse at the beginning of their pregnancy that will inform them regarding the importance of iron and folic acid supplementation as well as malaria prophylaxis.
Behavioral: Demand intervention
Women in the "demand intervention" arm will receive a home visit by a study nurse who will highlight the importance of supplementation and prophyllaxis to women. During this session, women will also be informed regarding side effects and the ideal timing of supplementation (after meals).
Other Name: information intervention
Experimental: Supply intervention
Women in this arm will get a monthly visit by study nurses. Women who did not obtain supplements or malaria prophyllaxis through routine antenatal care services will be directly provided with the supplements and malaria drugs by the study nurse.
Behavioral: Supply intervention
In order to directly test the importance of access barriers, we will deliver supplements as well as malaria chemo- prophyllaxis directly to women through home visits by study nurses.
Other Name: Home delivery of supplements
Primary Outcome Measures :
- Percentage of participants with a concentration of hemoglobin less than 11g/dL after delivery [ Time Frame: Each mother will be enrolled in the study for approximately six months from the end of the first trimester to the endline survey conducted shortly after delivery. We will assess hemoglobin levels within the first two weeks after delivery ]Hemoglobin levels obtained assessed using HEMOCUE devices
- Percentage of participants tested positive for malaria [ Time Frame: Each mother will be enrolled in the study for approximately six months from the end of the first trimester to the endline survey conducted shortly after delivery. We will assess malaria infection within the first two weeks after delivery ]Malaria infection will be tested using standard Rapid Diagnostic Tests (RDTs).
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