Skip to main content
OpenTrials
Completed

NCT Number: NCT03600844

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kenge District, Community Setting, Kenge, Kwango, Democratic Republic of the Congo

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community distribution of SP for IPTp

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jhpiego

Other

Collaborators

  • Barcelona Institute for Global Health

Registry information

Official study title

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

Acronym: TIPTOP

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 26, 2018
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.