An interventional study of Community distribution of SP for IPTp in Malaria in Pregnancy, sponsored by Jhpiego. Completed at 12 sites in 4 countries. Open to female participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Jhpiego · Not applicable, Interventional, and Prevention
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).
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.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 10,602 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →Jhpiego is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Also known as: C-IPTp-SP
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
Time frame: 1 year
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
Time frame: 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
Time frame: 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
Time frame: 1 year
Early ANC Coverage
Proportion of pregnant women attending the first ANC visit before or at week 14
Time frame: 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
Time frame: 1 year
Plan to share: No — There is no plan to share IPD to other researchers
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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