A New Approach to Deliver Malaria Preventions to Pregnant Women at a Community Level in Uganda
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|ClinicalTrials.gov Identifier: NCT00118027|
Recruitment Status : Completed
First Posted : July 11, 2005
Last Update Posted : January 12, 2017
Background: Malaria is the leading cause of morbidity and mortality among pregnant women in Uganda. Although effective tools for prevention and control of malaria exist, their delivery presents a problem. Intermittent presumptive treatment (IPT) with sulfadoxine-pyrimethamine (SP) is effective, yet >60% of women in Uganda do not get it as < 40%, attend antenatal care. Effective ways of delivering IPT with SP to pregnant women at a community level need to be developed. This study assessed whether community based resource persons like traditional birth attendants (TBAs), community reproductive health workers (CRHWs), adolescent peer mobilizers (APMs) and drug-shop owners (DSV) can distribute IPT with SP to pregnant women.
Objectives: The objectives of this study were:
- To assess community based approaches for delivering malaria prevention to pregnant women in Uganda;
- To assess community perceptions, beliefs and practices associated with malaria treatment and prevention in pregnancy;
- To assess whether community based resource persons can deliver IPT to pregnant women and reach those most at risk;
- To assess the impact of IPT on anaemia and pregnancy outcome;
- To estimate cost-effectiveness of the approaches and assess the acceptability and sustainability of the approaches.
Methods: The study was conducted in 5 sub-counties of the Mukono district, situated on the shores of L. Victoria in Central Uganda. The district is hyper-endemic for malaria. 25 parishes with a total population of 75,000 people were used to test the new approaches. Phase 1 obtained qualitative data on community perceptions, beliefs and practices associated with malaria prevention in pregnancy. Phase 2 was an intervention study that assessed distribution of IPT to pregnant women by TBAs, CRHWs, APMs and DSVs compared with health units. Pregnant women of all parities were enrolled. Key resource persons in each parish were identified to sensitise the communities on the intervention. Data was collected regarding: timing of the first dose of SP, proportion of women who complete two doses of SP, birth weight of babies, proportion of low birth-weight babies, and proportion of adolescent pregnancies. The third phase of the study evaluated the sustainability of the approaches.
Work Plan: The first phase of the study took two months. The second phase took 14-16 months. Data analysis was expected to take 12 months.
|Condition or disease||Intervention/treatment||Phase|
|Malaria Pregnancy Anemia||Drug: sulphadoxine-pyrimethamine intermittent preventive treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||2150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A New Approach to Deliver Malaria Preventions to Pregnant Women at a Community Level in Uganda|
|Study Start Date :||May 2003|
|Actual Study Completion Date :||June 2007|
- Timing of the first dose of SP.
- Proportion of women who complete two doses of SP.
- Birth weight of babies.
- Proportion of low birth-weight babies.
- Maternal haemoglobin and malaria parasite counts.
- Proportion of adolescent pregnancies participating in the study.
- Proportion of pregnant women who agree to take part in the study.
- Proportion of scheduled visits completed by each delivery approach.
- The costs per low birth weight of babies avoided.
- The costs per anaemic pregnant woman avoided.
- Mothers' perceptions on the four different SP delivery outlets
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118027
|Mukono, Central Uganda, Uganda, P.O Box 7272|
|Principal Investigator:||Anthony K Mbonye, MpH||Ministry of Health, Uganda|