Status:
COMPLETED
Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi
Lead Sponsor:
Kamuzu University of Health Sciences
Collaborating Sponsors:
Centers for Disease Control and Prevention
Ministry of Health, Malawi
Conditions:
Malaria in Pregnancy
Eligibility:
FEMALE
16-49 years
Phase:
NA
Brief Summary
The overall aim of the study is to learn whether utilization of Health Surveillance Assistants (HSAs) for delivery of intermittent preventive treatment of malaria in pregnant women (IPTp) can increase...
Detailed Description
Project Background WHO recommends the use of intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) to prevent the adverse effects of malaria in pregnancy. In 2012, ...
Eligibility Criteria
Inclusion
- Pregnant women:
- All pregnant women residing in study catchment area are eligible to receive SP from HSAs, with the exception of HIV positive women.
- To be included in the women's question portion of the baseline and end line household surveys, women must be between the ages of 16-49 years, have been pregnant/delivered in the previous 12 months, consent to participation, and will be eligible for inclusion in surveys regardless of where the woman gave birth (i.e., whether at home or in facility). All pregnant/recently pregnant women will be included in the cross sectional survey, but the sample size is calculated in order to identify those who have completed pregnancies in the past 12 months. There were be a very short subset of demographic and knowledge questions which will be asked of all households during the baseline and end line surveys, regardless of whether there are any recently pregnant women in the household.
- Providers:
- At each facility we will randomly select one ANC provider who has had at least six months of work experience
- HSA supervisor
- Health facility in-charge
- HSAs:
- • All HSAs working in the study areas will be eligible; we will select at least 36 at random to be participate in interviews and focus groups discussions.
Exclusion
- Pregnant women: Women who experienced a delivery in the past 12 months, but are \<16 or \>49 years will be excluded. Those who last delivered a child over twelve months ago will be excluded from survey questions specific to recently pregnant women, but may answer questions related to community perception or general demographics. For qualitative research, the same criteria will be used.
- Health facility providers: Those who have been working in the health service for less than six months will not be interviewed due to low levels of relevant experience or exposure to the intervention.
- HSAs: All HSAs are eligible to participate.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2020
Estimated Enrollment :
1447 Patients enrolled
Trial Details
Trial ID
NCT03376217
Start Date
December 1 2017
End Date
August 30 2020
Last Update
July 26 2021
Active Locations (1)
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1
Malaria Alert Center, University of Malawi College of Medicine
Liwonde, Malawi