Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi
Condition: Malaria in Pregnancy
MeSH terms: Malaria
Study type: Interventional

Summary: 
      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: 
      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

        1. 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

        2. Document the level of service delivery by HSAs

        3. Assess women's knowledge of HSAs and attitudes about receiving IPTp from a HSA

        4. Assess the feasibility of scaling-up community delivery of IPTp from the perspective of
           health facility staff, and HSAs..

        5. Assess the acceptability of community delivery of IPTp from health facility staff, HSAs,
           and women.

        6. Assess the factors which may affect the scale-up of community delivery of IPTp from the
           perspective of health facility staff, HSAs, and women.

        7. 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.
    

Intervention name(s): IPTp delivered by HSAs
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): community IPTp (cIPTp)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster randomized controlled trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: malaria; malaria in pregnancy; intermittent preventive treatment in pregnancy (IPTp); community health workers; Sulfadoxine-pyrimethamine (SP)