Clinical trial NCT03600844: Evaluating the Effects of Community Delivery of Malaria Intermittent Preventive Treatment on Pregnant Women and Babies
Official title: Evaluation of Community Delivery of Malaria Intermittent Preventive Treatment in Pregnancy (C-IPTp) (TIPTOP Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria in Pregnancy
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: Barcelona Institute for Global Health
First posted: 2018-07-26
Enrollment: 10602
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Districts in high malaria transmission zones were assigned to intervention and comparison areas.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: IPTp3 Coverage
timeFrame: 1 year
Secondary outcomes:
measure: IPTp1 Coverage
timeFrame: 1 year
measure: ANC 4 coverage
timeFrame: 1 year
measure: ANC 1 Coverage
timeFrame: 1 year
measure: Early ANC Coverage
timeFrame: 1 year
measure: C-IPTp Knowledge
timeFrame: 1 year
Other outcomes:
Locations:
city: Kenge
country: Congo, The Democratic Republic of the
facility: Kenge District, Community Setting
state: Kwango
city: Bulungu
country: Congo, The Democratic Republic of the
facility: Bulungu District, Community Setting
state: Kwilu
city: Kunda
country: Congo, The Democratic Republic of the
facility: Community Setting
state: Maniema
city: Mananjary
country: Madagascar
facility: Mananjary District, Community Setting
state: Fianarantsoa
city: Toliary 2
country: Madagascar
facility: Community Setting
state: Fianarantsoa
city: Vohipeno
country: Madagascar
facility: Community Setting
state: Vatovavy-Fitovinany
city: Meconta
country: Mozambique
facility: Meconta District, Community Setting
state: Nampula
city: Murrupula
country: Mozambique
facility: Community Setting
state: Nampula
city: Nhamatanda
country: Mozambique
facility: Nhamatanda District, Community Setting
state: Sofala
city: Ohaukwu District
country: Nigeria
facility: Community Setting
state: Ebonyi
city: Bosso
country: Nigeria
facility: Community Setting
state: Niger
city: Akure South
country: Nigeria
facility: Community Setting
state: Ondo
Study officials:
affiliation: Barcelona Institute for Global Health
name: Clara Menendez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pons-Duran C, Llach M, Sanz S, Ramirez M, Mendez S, Roman E, Tholandi M, Pagnoni F, Menendez C, Gonzalez R. Community delivery of malaria intermittent preventive treatment in pregnancy: protocol of a quasi-experimental evaluation through multistage cluster sampling household surveys in four sub-Saharan African countries. BMJ Open. 2021 Mar 25;11(3):e044680. doi: 10.1136/bmjopen-2020-044680.