Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2021
• Main ID: NCT03376217
• Date of registration: 06/12/2017
• Prospective Registration: No
• Primary sponsor: University of Malawi College of Medicine
• Public title: Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi
• Scientific title: Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi
• Date of first enrolment: December 1, 2017
• Target sample size: 1447
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03376217
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Malawi

Contacts

• Name: Jobiba Chinkhumba, MBBS PhD
• Affiliation: Malaria Alert Center, Malawi College of Medicine

• Name: Julie Gutman, MD MSc
• Affiliation: Centers for Disease Control and Prevention

Key inclusion & exclusion criteria

Inclusion Criteria:

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 Criteria:

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.



Age minimum: 16 Years
Age maximum: 49 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Malaria in Pregnancy

Intervention(s)

Other: IPTp delivered by HSAs

Primary Outcome(s)

3 or more doses of IPTp (IPTp3+) [Time Frame: through study completion, 18 months]

Secondary Outcome(s)

IPTp doses received [Time Frame: through study completion, 18 months]

Total ANC visits [Time Frame: through study completion, 18 months]

Gestational age at first IPTp [Time Frame: through study completion, 18 months]

IPTp doses delivered by ANC [Time Frame: through study completion, 18 months]

Secondary ID(s)

P.08/17/2232

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

United States Agency for International Development (USAID)

Ministry of Health, Malawi

Management Sciences for Health

Peace Corps

Centers for Disease Control and Prevention