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

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ClinicalTrials.gov Identifier: NCT03600844
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Barcelona Institute for Global Health
Information provided by (Responsible Party):
Jhpiego

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).

Condition or disease Intervention/treatment Phase
Malaria in Pregnancy Behavioral: Community distribution of SP for IPTp Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10602 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Districts in high malaria transmission zones were assigned to intervention and comparison areas.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Community Delivery of Malaria Intermittent Preventive Treatment in Pregnancy (C-IPTp) (TIPTOP Project)
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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 Name: 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 Name: C-IPTp-SP




Primary Outcome Measures :
  1. IPTp3 Coverage [ Time Frame: 1 year ]
    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 :
  1. IPTp1 Coverage [ Time Frame: 1 year ]
    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

  2. ANC 4 coverage [ Time Frame: 1 year ]
    • Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics four times

  3. ANC 1 Coverage [ Time Frame: 1 year ]
    Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics at least once

  4. Early ANC Coverage [ Time Frame: 1 year ]
    Proportion of pregnant women attending the first ANC visit before or at week 14

  5. C-IPTp Knowledge [ Time Frame: 1 year ]
    Proportion of women who have had a pregnancy that ended in the past 12 months who know about the IPTp service provided by CHWs



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03600844


Contacts
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Contact: Linda A Fogarty, PhD 4105371873 linda.fogarty@jhpiego.org
Contact: Maya Tholandi, MS 410 537 1981 maya.tholandi@jhpiego.org

Locations
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Congo, The Democratic Republic of the
Kenge District, Community Setting Recruiting
Kenge, Kwango, Congo, The Democratic Republic of the
Bulungu District, Community Setting Recruiting
Bulungu, Kwilu, Congo, The Democratic Republic of the
Madagascar
Mananjary District, Community Setting Recruiting
Mananjary, Fianarantsoa, Madagascar
Toliary District, Community Setting Recruiting
Selected Communities In Toliary District, Fianarantsoa, Madagascar
Mozambique
Meconta District, Community Setting Recruiting
Meconta, Nampula, Mozambique
Nhamatanda District, Community Setting Recruiting
Nhamatanda, Sofala, Mozambique
Nigeria
Ohaukwu District, Community Setting Recruiting
Selected Communities In Ohaukwu District, Ebonyi, Nigeria
Akure South District, Community Setting Recruiting
Selected Communities In Akure South, Ondo, Nigeria
Sponsors and Collaborators
Jhpiego
Barcelona Institute for Global Health
Investigators
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Principal Investigator: Clara Menendez, MD, PhD Barcelona Institute for Global Health

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Responsible Party: Jhpiego
ClinicalTrials.gov Identifier: NCT03600844     History of Changes
Other Study ID Numbers: TIPTOP_HHS_2018
2017-13-TIPTOP ( Other Grant/Funding Number: Unitaid )
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases