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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03600844
Acronym
TIPTOP
Enrollment
10602
Registered
2018-07-26
Start date
2018-04-02
Completion date
2021-10-31
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria in Pregnancy

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.

Interventions

BEHAVIORALCommunity 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.

Sponsors

Barcelona Institute for Global Health
CollaboratorOTHER
Jhpiego
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Districts in high malaria transmission zones were assigned to intervention and comparison areas.

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
IPTp3 Coverage1 yearProportion of women who had a pregnancy ending in the past 12 months and have received three or more doses of IPTp-SP

Secondary

MeasureTime frameDescription
IPTp1 Coverage1 yearProportion 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 coverage1 year• Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics four times
ANC 1 Coverage1 yearProportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics at least once
Early ANC Coverage1 yearProportion of pregnant women attending the first ANC visit before or at week 14
C-IPTp Knowledge1 yearProportion of women who have had a pregnancy that ended in the past 12 months who know about the IPTp service provided by CHWs

Countries

Democratic Republic of the Congo, Madagascar, Mozambique, Nigeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026