Evaluating the Effects of Community Delivery of Malaria Intermittent Preventive Treatment on Pregnant Women and Babies (TIPTOP)

Evaluation of Community Delivery of Malaria Intermittent Preventive Treatment in Pregnancy (C-IPTp) (TIPTOP Project)

This study evaluates the effectiveness of community delivery of sulfadoxine-pyrimetamine (SP) for intermittent preventive treatment of malaria in pregnancy (IPTp) in increasing the coverage of IPTp among pregnant women in selected districts in Democratic Republic of Congo (DRC), Madagascar, Mozambique and Nigeria, compared to comparison districts where SP for IPTp is distributed as usual in facilities through routine antenatal care (ANC).

Study Overview

• Status: Completed
• Conditions: Malaria in Pregnancy
• Intervention / Treatment: Behavioral: Community distribution of SP for IPTp

Detailed Description

The specific objectives of this study are to determine the change in the following indicators during the course of the TIPTOP project: 1) Proportion of women who have had a pregnancy that ended in the past 12 months and have received 1 or more, 2 or more and 3 or more doses of IPTp-SP; proportion of women with pregnancy in the past 12 months who attended ANC clinics at least once, and who attended at least four times; proportion of pregnant women attending the first ANC visit before or at week 14; proportion of women who have had a pregnancy that ended in the past 12 months who know about the IPTp service provided by CHWs; and acceptability of C-IPTp for community delivery of IPTp (note: results will be disaggregated by provider type, age, gravidity and distance from facility). To assess these changes, the study will implement structured household surveys targeting potential beneficiaries of the project (pregnant women) in the intervention and comparison areas, implemented at three time points: baseline, mid- and end-points. In each country an initial implementation area (Phase I) and two expansion areas (Phase II) have been selected for the project. This study will establish if community deliver of IPTp is effective and feasible and whether it influences antenatal care service coverage rates. It is expected that the study will provide information to scale up the approach the 4 study countries for the prevention of malaria in pregnancy. This information is also meant to inform global guidelines on community IPTp delivery and may also be used by other countries.

• Study Type: Interventional
• Enrollment (Actual): 10602
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Congo, The Democratic Republic of the
  • Kwango
    • Kenge, Kwango, Congo, The Democratic Republic of the
      • Kenge District, Community Setting
  • Kwilu
    • Bulungu, Kwilu, Congo, The Democratic Republic of the
      • Bulungu District, Community Setting
  • Maniema
    • Kunda, Maniema, Congo, The Democratic Republic of the
      • Community Setting
• Madagascar
  • Fianarantsoa
    • Mananjary, Fianarantsoa, Madagascar
      • Mananjary District, Community Setting
    • Toliary 2, Fianarantsoa, Madagascar
      • Community Setting
  • Vatovavy-Fitovinany
    • Vohipeno, Vatovavy-Fitovinany, Madagascar
      • Community Setting
• Mozambique
  • Nampula
    • Meconta, Nampula, Mozambique
      • Meconta District, Community Setting
    • Murrupula, Nampula, Mozambique
      • Community Setting
  • Sofala
    • Nhamatanda, Sofala, Mozambique
      • Nhamatanda District, Community Setting
• Nigeria
  • Ebonyi
    • Ohaukwu District, Ebonyi, Nigeria
      • Community Setting
  • Niger
    • Bosso, Niger, Nigeria
      • Community Setting
  • Ondo
    • Akure South, Ondo, Nigeria
      • Community Setting

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women who had a pregnancy that ended in the 12 months preceding the survey
• Being resident in the study area during for at least 4 months before the end of the pregnancy
• Willing to participate in the household survey (signing informed consent/assent, in line with country guidelines)

Exclusion Criteria:

• Anyone considered to be a minor in their country.
• Not willing to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Phase 1 Intervention; Phase 1 intervention communities will be offered Community distribution of SP for IPTp in addition to routine ANC IPTp distribution throughout the project.	Behavioral: Community distribution of SP for IPTp; SP is distributed to eligible pregnant women by trained Community Health Workers (CHWs) at community level. Demand creation activities are implemented within the community as well.; Other Names: C-IPTp-SP
ACTIVE_COMPARATOR: Phase 1 Comparison/Phase 2 Intervention; During Phase 1 (intervention months 1 through 12), these communities will be offered only usual treatment--SP for IPTp at in facilities during routine ANC. During Phase 2 (intervention month 13 through the end of the project), these communities will be offered Community distribution of SP for IPTp, in addition to routine ANC IPTp distribution.	Behavioral: Community distribution of SP for IPTp; SP is distributed to eligible pregnant women by trained Community Health Workers (CHWs) at community level. Demand creation activities are implemented within the community as well.; Other Names: C-IPTp-SP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPTp3 Coverage	Proportion of women who had a pregnancy ending in the past 12 months and have received three or more doses of IPTp-SP	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPTp1 Coverage	Proportion of women who have had a pregnancy that ended in the past 12 months and have received one or more doses of IPTp-SP	1 year
ANC 4 coverage	• Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics four times	1 year
ANC 1 Coverage	Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics at least once	1 year
Early ANC Coverage	Proportion of pregnant women attending the first ANC visit before or at week 14	1 year
C-IPTp Knowledge	Proportion of women who have had a pregnancy that ended in the past 12 months who know about the IPTp service provided by CHWs	1 year

Collaborators and Investigators

• Sponsor: Jhpiego
• Collaborators: Barcelona Institute for Global Health

Publications and helpful links

General Publications

• Pons-Duran C, Llach M, Sanz S, Ramirez M, Mendez S, Roman E, Tholandi M, Pagnoni F, Menendez C, Gonzalez R. Community delivery of malaria intermittent preventive treatment in pregnancy: protocol of a quasi-experimental evaluation through multistage cluster sampling household surveys in four sub-Saharan African countries. BMJ Open. 2021 Mar 25;11(3):e044680. doi: 10.1136/bmjopen-2020-044680.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2018
• Primary Completion (ACTUAL): October 31, 2021
• Study Completion (ACTUAL): October 31, 2021

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: TIPTOP_HHS_2018; 2017-13-TIPTOP (OTHER_GRANT: Unitaid)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No