Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Strategies to Increase Antenatal Iron and Folic Acid Supplementation and Malaria Prophylaxis (AIFASMaP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250428
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Swiss Tropical & Public Health Institute
Information provided by (Responsible Party):
Siaka Kone, Centre Suisse de Recherches Scientifiques en Cote d'Ivoire

Brief Summary:
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 Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Folic acid

Arm Intervention/treatment
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 :
  1. 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

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women in the first trimester of their pregnancy, living in the HDSS with an age greater than or equal to 15 years.
  • Be registered as a member in the HDSS of Taabo
  • Willing to provide one drop of blood for hemoglobin assessment and the rapid diagnostic malaria test.
  • Written informed consent
  • Under 18 years with permission of legal representative

Exclusion Criteria:

  • No written informed consent
  • Under 18 years pregnant women without permission of legal representative
  • Not registered as a member of the HDSS of Taabo
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Siaka Kone, Principal Investigator, Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
ClinicalTrials.gov Identifier: NCT04250428    
Other Study ID Numbers: TSS01021920
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Siaka Kone, Centre Suisse de Recherches Scientifiques en Cote d'Ivoire:
antenatal iron and folic acid supplementation
malaria chemoprophylaxis
maternal and child health
Randomized controlled trial
Health and demographic surveillance site
Cost-effectiveness
Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Protozoan Infections
Parasitic Diseases