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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Malaria in Pregnancy

Intervention / Treatment
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* Other: IPTp delivered by HSAs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women: All pregnant women residing in study catchment area are eligible to receive SP from HSAs, with the exception of HIV positive women. To be included in the women's question portion of the baseline and end line household surveys, women must be between the ages of 16-49 years, have been pregnant/delivered in the previous 12 months, consent to participation, and will be eligible for inclusion in surveys regardless of where the woman gave birth (i.e., whether at home or in facility). All pregnant/recently pregnant women will be included in the cross sectional survey, but the sample size is calculated in order to identify those who have completed pregnancies in the past 12 months. There were be a very short subset of demographic and knowledge questions which will be asked of all households during the baseline and end line surveys, regardless of whether there are any recently pregnant women in the household. Providers: At each facility we will randomly select one ANC provider who has had at least six months of work experience HSA supervisor Health facility in-charge HSAs: • All HSAs working in the study areas will be eligible; we will select at least 36 at random to be participate in interviews and focus groups discussions. 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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>IPTp delivered at antenatal clinic | |
| Experimental: Intervention<br>IPTp delivered by HSAs | Other: IPTp delivered by HSAs<br>* 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.<br>* Other names: community IPTp (cIPTp);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 or more doses of IPTp (IPTp3+) | Proportion of recently pregnant women who received at least 3 doses of IPTp | through study completion, 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPTp doses received | Proportion of women who received 1, 2, or 4 or more dose of IPT | through study completion, 18 months | 
| IPTp doses delivered by ANC | Proportion of doses delivered by the HSA vs at the ANC | through study completion, 18 months | 
| Total ANC visits | proportion of women who made 1, 2, 3, 4, or more ANC visits | through study completion, 18 months | 
| Gestational age at first IPTp | gestational age at the time of first ANC and at 1st dose of IPTp | through study completion, 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malaria, malaria in pregnancy, intermittent preventive treatment in pregnancy (IPTp), community health workers, Sulfadoxine-pyrimethamine (SP)