Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi
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|ClinicalTrials.gov Identifier: NCT03376217|
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malaria in Pregnancy||Other: IPTp delivered by HSAs||Not Applicable|
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, in an effort to boost uptake, the World Health Organization (WHO) updated its policy promoting initiation of IPTp-SP as early as possible during the second trimester and at every scheduled antenatal clinic (ANC) visit thereafter, as long as the visits were at least one month apart. Despite this recommendation, progress has been slow, and no sub-Saharan African country has achieved the 85% coverage target set by the President's Malaria Initiative (PMI). Malawi was the first country to adopt IPTp-SP, and though it had early gains, these have remained stagnant. Coverage of 2 doses of IPTp-SP was 42.9% in 2004 (DHS), 53.8% in 2010 (DHS), and remained only 63% as of 2014 (MIS), despite the fact that >95% of women make 2 or more visits to the ANC, with 44% making four or more visits, and despite the fact that the median gestational age at the first visit is 5.6 months. Clearly, a novel approach to ensure earlier presentation at ANC and increase IPTp delivery is needed to boost coverage to the 85% target. Community delivery of IPTp has been suggested as a means to improve coverage, however, there is concern that this could also lead to reduced antenatal care (ANC) visits. Thus, it is relevant to assess whether there is a benefit of community delivery of IPTp-SP under the current policy advocating IPTp at each ANC visit, whether this approach is feasible, both from the standpoint of service delivery as well as data collection, and ensure that there is no adverse effect on ANC attendance prior to large scale roll-out.
Study Aims Broad objective: 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
Specific objectives Primary objective
- Determine the effect of community-based IPTp delivery by HSAs compared with facility-based IPTp delivery on IPTp coverage (including 1, 2, 3, and 4 doses) and ANC coverage (including 1, 2, 3, and 4 visits) Secondary objectives
- Document the level of service delivery by HSAs
- Assess women's knowledge of HSAs and attitudes about receiving IPTp from a HSA
- Assess the feasibility of scaling-up community delivery of IPTp from the perspective of health facility staff, and HSAs..
- Assess the acceptability of community delivery of IPTp from health facility staff, HSAs, and women.
- Assess the factors which may affect the scale-up of community delivery of IPTp from the perspective of health facility staff, HSAs, and women.
- Assess incremental costs of community-based IPTp delivery compared to HF based IPTp delivery from both provider and household perspectives.
Methodology Study design: 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.
The study will use baseline and end line cross sectional household surveys, midline and post-intervention in-depth interviews with health facility staff and HSAs, pre- and post-intervention in-depth interviews with women, and focus group discussions with HSAs to achieve the objectives.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2744 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Cluster randomized controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||April 30, 2020|
No Intervention: Control
IPTp delivered at antenatal clinic
IPTp delivered by HSAs
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.
Other Name: community IPTp (cIPTp)
- 3 or more doses of IPTp (IPTp3+) [ Time Frame: through study completion, 18 months ]Proportion of recently pregnant women who received at least 3 doses of IPTp
- IPTp doses received [ Time Frame: through study completion, 18 months ]Proportion of women who received 1, 2, or 4 or more dose of IPT
- IPTp doses delivered by ANC [ Time Frame: through study completion, 18 months ]Proportion of doses delivered by the HSA vs at the ANC
- Total ANC visits [ Time Frame: through study completion, 18 months ]proportion of women who made 1, 2, 3, 4, or more ANC visits
- Gestational age at first IPTp [ Time Frame: through study completion, 18 months ]gestational age at the time of first ANC and at 1st dose of IPTp
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): NCT03376217
|Contact: Julie Gutman, MD MScfirstname.lastname@example.org|
|Contact: Jobiba Chinkhumba, MBBS PhDemail@example.com|
|Malaria Alert Center, University of Malawi College of Medicine||Recruiting|
|Contact: Jobiba Chinkhumba, MBBS PhD +011265999775520 firstname.lastname@example.org|
|Principal Investigator: Jobiba Chinkhumba, MBBS PhD|
|Principal Investigator:||Jobiba Chinkhumba, MBBS PhD||Malaria Alert Center, Malawi College of Medicine|
|Principal Investigator:||Julie Gutman, MD MSc||Centers for Disease Control and Prevention|