An interventional study of IPTp delivered by HSAs in Malaria in Pregnancy, sponsored by Kamuzu University of Health Sciences. Completed at 1 site in Malawi. Open to female participants aged 16 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-26.
Sponsored by Kamuzu University of Health Sciences · Not applicable, Interventional, and Prevention
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.
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
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.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 1,447 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →Kamuzu University of Health Sciences is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pregnant women:
Providers:
HSAs:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: community IPTp (cIPTp)
3 or more doses of IPTp (IPTp3+)
Proportion of recently pregnant women who received at least 3 doses of IPTp
Time frame: through study completion, 18 months
IPTp doses received
Proportion of women who received 1, 2, or 4 or more dose of IPT
Time frame: through study completion, 18 months
IPTp doses delivered by ANC
Proportion of doses delivered by the HSA vs at the ANC
Time frame: through study completion, 18 months
Total ANC visits
proportion of women who made 1, 2, 3, 4, or more ANC visits
Time frame: through study completion, 18 months
Gestational age at first IPTp
gestational age at the time of first ANC and at 1st dose of IPTp
Time frame: through study completion, 18 months
Plan to share: Undecided
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Kamuzu University of Health Sciences