NCT04250428

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

January 29, 2020

Last Update Submit

February 1, 2020

Conditions

Antenatal Care

Keywords

antenatal iron and folic acid supplementationmalaria chemoprophylaxismaternal and child healthRandomized controlled trialHealth and demographic surveillance siteCost-effectiveness

Outcome Measures

Primary Outcomes (2)

  • Percentage of participants with a concentration of hemoglobin less than 11g/dL after delivery

    Hemoglobin levels obtained assessed using HEMOCUE devices

    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

  • Percentage of participants tested positive for malaria

    Malaria infection will be tested using standard Rapid Diagnostic Tests (RDTs).

    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

Study Arms (3)

Control

NO INTERVENTION

Women in the control arm will have (standard) access to antenatal care.

Demand intervention

EXPERIMENTAL

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

Supply intervention

EXPERIMENTAL

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

Interventions

Demand interventionBEHAVIORAL

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).

Also known as: information intervention
Demand intervention
Supply interventionBEHAVIORAL

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.

Also known as: Home delivery of supplements
Supply intervention

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • Christian P, Shrestha J, LeClerq SC, Khatry SK, Jiang T, Wagner T, Katz J, West KP Jr. Supplementation with micronutrients in addition to iron and folic acid does not further improve the hematologic status of pregnant women in rural Nepal. J Nutr. 2003 Nov;133(11):3492-8. doi: 10.1093/jn/133.11.3492.

    PMID: 14608063BACKGROUND

  • Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.

    PMID: 23746772BACKGROUND

  • Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost? Lancet. 2013 Aug 3;382(9890):452-477. doi: 10.1016/S0140-6736(13)60996-4. Epub 2013 Jun 6.

    PMID: 23746776BACKGROUND

  • Sharma JB, Jain S, Mallika V, Singh T, Kumar A, Arora R, Murthy NS. A prospective, partially randomized study of pregnancy outcomes and hematologic responses to oral and intramuscular iron treatment in moderately anemic pregnant women. Am J Clin Nutr. 2004 Jan;79(1):116-22. doi: 10.1093/ajcn/79.1.116.

    PMID: 14684407BACKGROUND

  • Trowbridge F, Martorell R. Summary and recommendations. J Nutr. 2002 Apr;132(4 Suppl):875S-9S. doi: 10.1093/jn/132.4.875S.

    PMID: 11925502BACKGROUND

  • Brady J, Ho K, Kelley E, Clancy CM. AHRQs National Healthcare Quality and Disparities reports: an ever-expanding road map for improvement. Health Serv Res. 2007 Jun;42(3 Pt 1):xi-xxi. doi: 10.1111/j.1475-6773.2007.00736.x. No abstract available.

    PMID: 17489895BACKGROUND

  • Ensor T, Cooper S. Overcoming barriers to health service access: influencing the demand side. Health Policy Plan. 2004 Mar;19(2):69-79. doi: 10.1093/heapol/czh009.

    PMID: 14982885BACKGROUND

  • Ensor T, Dave-Sen P, Ali L, Hossain A, Begum SA, Moral H. Do essential service packages benefit the poor? Preliminary evidence from Bangladesh. Health Policy Plan. 2002 Sep;17(3):247-56. doi: 10.1093/heapol/17.3.247.

    PMID: 12135990BACKGROUND

  • Deardorff KV, Rubin Means A, Asbjornsdottir KH, Walson J. Strategies to improve treatment coverage in community-based public health programs: A systematic review of the literature. PLoS Negl Trop Dis. 2018 Feb 8;12(2):e0006211. doi: 10.1371/journal.pntd.0006211. eCollection 2018 Feb.

    PMID: 29420534BACKGROUND

  • Oyo-Ita A, Wiysonge CS, Oringanje C, Nwachukwu CE, Oduwole O, Meremikwu MM. Interventions for improving coverage of childhood immunisation in low- and middle-income countries. Cochrane Database Syst Rev. 2016 Jul 10;7(7):CD008145. doi: 10.1002/14651858.CD008145.pub3.

    PMID: 27394698BACKGROUND

  • Bellows NM, Bellows BW, Warren C. Systematic Review: the use of vouchers for reproductive health services in developing countries: systematic review. Trop Med Int Health. 2011 Jan;16(1):84-96. doi: 10.1111/j.1365-3156.2010.02667.x. Epub 2010 Nov 2.

    PMID: 21044235BACKGROUND

  • Mbuagbaw L, Medley N, Darzi AJ, Richardson M, Habiba Garga K, Ongolo-Zogo P. Health system and community level interventions for improving antenatal care coverage and health outcomes. Cochrane Database Syst Rev. 2015 Dec 1;2015(12):CD010994. doi: 10.1002/14651858.CD010994.pub2.

    PMID: 26621223BACKGROUND

  • Kone S, Baikoro N, N'Guessan Y, Jaeger FN, Silue KD, Furst T, Hurlimann E, Ouattara M, Seka MC, N'Guessan NA, Esso EL, Zouzou F, Boti LI, Gonety PT, Adiossan LG, Dao D, Tschannen AB, von Stamm T, Bonfoh B, Tanner M, Utzinger J, N'Goran EK. Health & Demographic Surveillance System Profile: The Taabo Health and Demographic Surveillance System, Cote d'Ivoire. Int J Epidemiol. 2015 Feb;44(1):87-97. doi: 10.1093/ije/dyu221. Epub 2014 Nov 29.

    PMID: 25433704BACKGROUND

  • Furst T, Silue KD, Ouattara M, N'Goran DN, Adiossan LG, N'Guessan Y, Zouzou F, Kone S, N'Goran EK, Utzinger J. Schistosomiasis, soil-transmitted helminthiasis, and sociodemographic factors influence quality of life of adults in Cote d'Ivoire. PLoS Negl Trop Dis. 2012;6(10):e1855. doi: 10.1371/journal.pntd.0001855. Epub 2012 Oct 4.

    PMID: 23056662BACKGROUND

  • Kone S, Furst T, Jaeger FN, Esso EL, Baikoro N, Kouadio KA, Adiossan LG, Zouzou F, Boti LI, Tanner M, Utzinger J, Bonfoh B, Dao D, N'Goran EK. Causes of death in the Taabo health and demographic surveillance system, Cote d'Ivoire, from 2009 to 2011. Glob Health Action. 2015 May 8;8:27271. doi: 10.3402/gha.v8.27271. eCollection 2015.

    PMID: 25959772BACKGROUND

  • Kone S, Probst-Hensch N, Dao D, Utzinger J, Fink G. Improving coverage of antenatal iron and folic acid supplementation and malaria prophylaxis through targeted information and home deliveries in Cote d'Ivoire: a cluster randomised controlled trial. BMJ Glob Health. 2023 Apr;8(4):e010934. doi: 10.1136/bmjgh-2022-010934.

    PMID: 37076197DERIVED

  • Kone S, Utzinger J, Probst-Hensch N, Dao D, Fink G. Study protocol of a cluster randomized controlled trial of strategies to increase antenatal iron and folic acid supplementation and malaria prophylaxis in rural south-central Cote d'Ivoire. BMC Public Health. 2020 Oct 27;20(1):1609. doi: 10.1186/s12889-020-09626-0.

    PMID: 33109138DERIVED

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is designed as a 3-arm parallel trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2020

First Posted

January 31, 2020

Study Start

February 1, 2020

Primary Completion

May 1, 2021

Study Completion

December 1, 2021

Last Updated

February 5, 2020

Record last verified: 2020-02