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

Primary Purpose

Malaria in Pregnancy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Community distribution of SP for IPTp
Sponsored by
Jhpiego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria in Pregnancy

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kenge District, Community Setting
  • Bulungu District, Community Setting
  • Community Setting
  • Mananjary District, Community Setting
  • Community Setting
  • Community Setting
  • Meconta District, Community Setting
  • Community Setting
  • Nhamatanda District, Community Setting
  • Community Setting
  • Community Setting
  • Community Setting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phase 1 Intervention

Phase 1 Comparison/Phase 2 Intervention

Arm Description

Phase 1 intervention communities will be offered Community distribution of SP for IPTp in addition to routine ANC IPTp distribution throughout the project.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Early ANC Coverage
Proportion of pregnant women attending the first ANC visit before or at week 14
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

Full Information

First Posted
June 22, 2018
Last Updated
March 29, 2022
Sponsor
Jhpiego
Collaborators
Barcelona Institute for Global Health
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1. Study Identification

Unique Protocol Identification Number
NCT03600844
Brief Title
Evaluating the Effects of Community Delivery of Malaria Intermittent Preventive Treatment on Pregnant Women and Babies
Acronym
TIPTOP
Official Title
Evaluation of Community Delivery of Malaria Intermittent Preventive Treatment in Pregnancy (C-IPTp) (TIPTOP Project)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jhpiego
Collaborators
Barcelona Institute for Global Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria in Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Districts in high malaria transmission zones were assigned to intervention and comparison areas.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10602 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 Intervention
Arm Type
Experimental
Arm Description
Phase 1 intervention communities will be offered Community distribution of SP for IPTp in addition to routine ANC IPTp distribution throughout the project.
Arm Title
Phase 1 Comparison/Phase 2 Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community distribution of SP for IPTp
Other Intervention Name(s)
C-IPTp-SP
Intervention Description
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.
Primary Outcome Measure Information:
Title
IPTp3 Coverage
Description
Proportion of women who had a pregnancy ending in the past 12 months and have received three or more doses of IPTp-SP
Time Frame
1 year
Secondary Outcome Measure Information:
Title
IPTp1 Coverage
Description
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
Time Frame
1 year
Title
ANC 4 coverage
Description
• Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics four times
Time Frame
1 year
Title
ANC 1 Coverage
Description
Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics at least once
Time Frame
1 year
Title
Early ANC Coverage
Description
Proportion of pregnant women attending the first ANC visit before or at week 14
Time Frame
1 year
Title
C-IPTp Knowledge
Description
Proportion of women who have had a pregnancy that ended in the past 12 months who know about the IPTp service provided by CHWs
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clara Menendez, MD, PhD
Organizational Affiliation
Barcelona Institute for Global Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kenge District, Community Setting
City
Kenge
State/Province
Kwango
Country
Congo, The Democratic Republic of the
Facility Name
Bulungu District, Community Setting
City
Bulungu
State/Province
Kwilu
Country
Congo, The Democratic Republic of the
Facility Name
Community Setting
City
Kunda
State/Province
Maniema
Country
Congo, The Democratic Republic of the
Facility Name
Mananjary District, Community Setting
City
Mananjary
State/Province
Fianarantsoa
Country
Madagascar
Facility Name
Community Setting
City
Toliary 2
State/Province
Fianarantsoa
Country
Madagascar
Facility Name
Community Setting
City
Vohipeno
State/Province
Vatovavy-Fitovinany
Country
Madagascar
Facility Name
Meconta District, Community Setting
City
Meconta
State/Province
Nampula
Country
Mozambique
Facility Name
Community Setting
City
Murrupula
State/Province
Nampula
Country
Mozambique
Facility Name
Nhamatanda District, Community Setting
City
Nhamatanda
State/Province
Sofala
Country
Mozambique
Facility Name
Community Setting
City
Ohaukwu District
State/Province
Ebonyi
Country
Nigeria
Facility Name
Community Setting
City
Bosso
State/Province
Niger
Country
Nigeria
Facility Name
Community Setting
City
Akure South
State/Province
Ondo
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD to other researchers
Citations:
PubMed Identifier
33766844
Citation
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.
Results Reference
derived

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

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