Last Updated: 30/10/2018
Assessing the effectiveness of community delivery of Intermittent preventive treatment in pregnancy (IPTp) in Malawi
Objectives
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.
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.
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.
ClinicalTrials.gov Identifier: NCT03376217
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.
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Cluster randomized controlled trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
Combination of Interventions
Drug-based Strategies
Service Delivery
Vulnerable Populations
Dec 2017 — Dec 2020
$409,547
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