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

Malaria in Pregnancy Clinical Trial

— TIPTOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600844
• Other study ID #: TIPTOP_HHS_2018
• Secondary ID: 2017-13-TIPTOP
• Status: Completed
• Phase: N/A
• Start date: April 2, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: March 2022
• Source: Jhpiego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10602
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Malaria
• Malaria in Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Bulungu District, Community Setting	Bulungu	Kwilu
Congo, The Democratic Republic of the	Kenge District, Community Setting	Kenge	Kwango
Congo, The Democratic Republic of the	Community Setting	Kunda	Maniema
Madagascar	Mananjary District, Community Setting	Mananjary	Fianarantsoa
Madagascar	Community Setting	Toliary 2	Fianarantsoa
Madagascar	Community Setting	Vohipeno	Vatovavy-Fitovinany
Mozambique	Meconta District, Community Setting	Meconta	Nampula
Mozambique	Community Setting	Murrupula	Nampula
Mozambique	Nhamatanda District, Community Setting	Nhamatanda	Sofala
Nigeria	Community Setting	Akure South	Ondo
Nigeria	Community Setting	Bosso	Niger
Nigeria	Community Setting	Ohaukwu District	Ebonyi

Sponsors (2)

Lead Sponsor	Collaborator
Jhpiego	Barcelona Institute for Global Health

Countries where clinical trial is conducted

Congo, The Democratic Republic of the,  Madagascar,  Mozambique,  Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	Early ANC Coverage	Proportion of pregnant women attending the first ANC visit before or at week 14	1 year
Secondary	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	1 year