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

NCT03376217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1447

Last updated 2021-07-26

No results posted yet for this study

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 coverage of three or more IPTp doses compared to IPTp delivery only at antenatal clinics (ANC), while at the same time improve or maintain ANC attendance. This will be a cluster randomized trial, including a total of 20 health facilities (HF) which will be randomly assigned to either the intervention (10) or non-intervention group (10); all HSAs affiliated with a HF will be in the same group.

Conditions

  • Malaria in Pregnancy

Interventions

OTHER

IPTp delivered by HSAs

Pregnant women will have the option to receive IPTp-SP from Health surveillance assistants (HSAs). SP is recommended in Malawi for prevention of malaria during pregnancy, but currently it is only available at antenatal clinics.

Sponsors & Collaborators

  • Centers for Disease Control and Prevention

    collaborator FED

  • Ministry of Health, Malawi

    collaborator OTHER_GOV

  • Peace Corps

    collaborator OTHER

  • Management Sciences for Health

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • Kamuzu University of Health Sciences

    lead OTHER

Principal Investigators

  • Jobiba Chinkhumba, MBBS PhD · Malaria Alert Center, Malawi College of Medicine

  • Julie Gutman, MD MSc · Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2020-08-30
Completion
2020-08-30

Countries

  • Malawi

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03376217 on ClinicalTrials.gov