Different Approaches for Delivery of IPT in Pregnancy in Burkina Faso
Condition: Malaria Parasitaemia; Birth Weight; Anaemia
MeSH terms: Parasitemia; Birth Weight
Study type: Interventional

Summary: 
      IPT/SP was adopted in 2005 by The Ministry of Health (MoH) of Burkina Faso to replace
      chemoprophylaxis with CQ in pregnancy. The new strategy is being implemented but no delivery
      approach was defined and presumably IPT/SP will only be delivered to pregnant women
      presenting at ANC visits. It would be of extreme importance to ensure a better coverage and
      higher compliance to make the new strategy effective. In order to obtain a more efficient
      IPT/SP programme with a good level of compliance and coverage, several delivery approaches
      beside ANC should be explored.

      The study site will be in Pissy health district covering both peri-urban Ouagadougou city and
      rural areas. Participants include pregnant women irrespective of gravidity residing in the
      study area.

      The study is a prospective comparative study of 3 different approaches of delivering IPT/SP
      in the catchment areas of rural health facilities. The approaches will be the following:

        1. Passive health centre based delivery approach (PHC). IPT/SP will be delivered to
           pregnant women presenting to the health centre for ANC visits.

        2. Joint, with an advanced strategies delivery approach (JAS). In addition to passive
           delivery at health centres, the pregnant women will be reached during preventive
           activities the health staff carry out regularly in villages, such as immunization,
           health promotion, and even ANC visits.

        3. Community based distribution delivery approach (CBD). In addition to passive delivery at
           health centres, the pregnant women will be reached by traditional birth attendants
           (TBAs) or representatives of village women's associations (RWAs). Each approach will be
           implemented in a zone constituted by the catchment area of a number of health centres to
           achieve the required sample size. The zones will be randomly assigned to a delivery
           approach. The main outcomes to be measured are: a) the coverage of IPT, b) compliance,
           c) infection prevalence, d) Hb level, e) difficulties and constraints of each approach,
           f) the acceptability to population and health staff and g) the performance of each
           approach to deliver IPT /SP. to be able to identify a significant increase in coverage
           of 10%, each group should be composed of n = 3841 pregnant women.

      Cross sectional surveys will be carried out at the beginning, during and at the end of the
      study period. The study will be carried out over 24 months from June 2007.
    

Detailed description: 
      Pregnant women are more susceptible to malaria than non-pregnant women, in particular during
      the first pregnancies. Malaria infection in pregnant women may cause anaemia, illness and
      abortion or stillbirth. It may also cause low birth weight through placental infection. In
      Africa the burden of malaria in pregnancy is highest in remote rural areas. IPT with
      sulphadoxine - pyrimethamine (SP) has been demonstrated to be effective in preventing
      pregnancy related malaria (anaemia, clinical cases and placenta infection), and to be
      beneficial to both babies and pregnant women, and increasing ANC attendance. In many Sub -
      Saharan African countries, IPT / SP is being adopted to replace chloroquine (CQ) as
      chemoprophylaxis was shown to be no longer efficacious. IPT/SP was adopted in 2005 by The
      Ministry of Health (MoH) of Burkina Faso to replace chemoprophylaxis with CQ. The new
      strategy is being implemented but no delivery approach was defined and presumably IPT/SP will
      only be delivered to pregnant women presenting at ANC visits. Although the expected
      compliance should be better than for the previous CQ weekly regime, it would be of importance
      to ensure a better coverage and higher compliance to make the new strategy effective.
      Therefore, in order to obtain a more efficient IPT / SP programme with a good level of
      compliance and coverage, several delivery approaches beside use of ANC alone will be
      explored. It is hypothesized that the IPT strategy using SP will be as inefficient as
      chemoprophylaxis with CQ if an effective delivery approach is not used.

      General Objective: to assess different IPT/SP delivery approaches in rural Burkina Faso with
      the aim of improving coverage and compliance among pregnant women.

      Specific objectives:

        -  To implement three approaches of IPT/SP delivery to pregnant women based on health
           centre distribution, and in addition community based distribution either by health
           services or by community members;

        -  To compare the effects of the approaches on compliance to and coverage of IPT / SP and
           their feasibility.

      Material & Methods

      The research will be implemented in Burkina Faso. Malaria is endemic with seasonal
      transmission and is responsible for considerable ill health among pregnant women. The study
      site will be situated in the rural area of the Pissy health district which covers both the
      western peri-urban zone of Ouagadougou city and adjacent rural areas. There are a total of 25
      health facilities in the district (both rural and urban) and a reference hospital at
      Ouagadougou. In 2004 the population of the district was approx. 542000 inhabitants. The
      estimated number of pregnancies was 27000. There is generally low attendance for antenatal
      care (ANC) and 15% of babies are born with LBW. In a study carried out in the Boromo rural
      district, only 51% of pregnant women had 2 ANC visits before delivery (Coulibaly, personal
      communication). HIV infection prevalence was found around 4% for the whole country (MoH,
      2005) and there is no indication that it is different for the Pissy district catchment area.

      The study participants will include pregnant women irrespective of gravidity residing in the
      study area and reachable by the approach that is applied in the zone.

      It is a prospective comparative study of 3 different approaches of delivering IPT / SP in the
      catchment areas of rural health facilities. The approaches will be the following:

        1. Passive health centre based delivery approach (PHC). IPT/SP will be delivered to all
           pregnant women presenting to the health centre either for ANC visit or for care seeking
           consultation. Drugs will be administered as a directly observed treatment (DOT). Some
           collation may be given to women as some of them refuse to take drugs because they have
           not eaten before. This approach, which is the most likely to be applied by the MOH, will
           serve as the control one.

        2. Joint methods, with an advanced strategies delivery approach (JAS). In addition to
           passive delivery at health centres, the pregnant women will be reached during preventive
           activities the health staff carry out regularly in villages, such as immunization,
           health promotion, and even ANC visits. The women will be asked to present to the health
           staff for treatment and IPT/SP administered as DOT.

        3. Community based distribution delivery approach (CBD). In addition to passive delivery at
           health centres, the pregnant women will be reached by traditional birth attendants
           (TBAs) or representatives of village women's associations (RWAs). The IPT/SP is then
           delivered also as DOT.

      The two community - directed approaches will be further developed through workshops with
      health staff, communities, and resource persons to adapt them to the local situation. Each
      approach will be implemented in a zone constituted by the catchment area of a number of
      health centres to cover the required sample size. The zones will be selected in order to
      avoid contamination between them and randomly assigned to a delivery approach. The main
      outcomes to be measured are: a) the coverage of IPT (proportion of pregnant women who are
      administered the treatment), b) the compliance (number of administered doses per pregnant
      woman), c) the infection prevalence, d) the Hb rate, e) the most relevant difficulties and
      constraints to each approach, f) the acceptability to population and health staff and g) the
      performance of each approach to deliver IPT /SP. The sample size is calculated to measure a
      difference between groups of 10% in IPT administration coverage. Assuming we require 80%
      power (zβ = 0.84) of detecting a significant difference (P<0.05; zα/2 =1.96) if the
      intervention increases coverage by 10%, each group should be composed of n = 3841 pregnant
      women. Assuming a design effect of 1.5, n = 5762 women. The 3 geographical zones will be
      defined to each cover 5800 expected pregnancies.

      Cross sectional surveys will be carried out at the beginning, during and at the end of the
      study period. The first will aim to ensure the study zones are comparable regarding the
      outcomes a) b) c) and d) and later on for comparison between zones. Furthermore, SP will be
      measured in urine using dipsticks for compliance measurement. An anthropological component
      will assess part of main outcomes e) and f) in health staff, communities, and pregnant women.
      Questionnaires, focus group discussions (FGD) and in-depth interviews (IDI) will be used for
      cross-sectional survey data collection. Data about pregnancy and IPT will be recorded from
      personal ANC book to be credible. The sample sizes will be calculated to be representative of
      the populations of different villages and zones.

      Data on IPT / SP delivery will be also collected from records hold by health centre and TBAs
      / RWAs to measure main outcome e). Specific records different from the health centre's own
      records will be opened at each IPT/SP delivery site, including TBAs / RWAs, to register
      information on treated pregnant women. The information will be personal data (name, age,
      village, marital status, and profession), data on the current and previous pregnancies (rank
      of pregnancy, children, ANC visits, drugs given) and medical history (previous adverse
      reactions to drugs, fever, and malaria attacks), and the administered IPT/SP doses. As usual,
      the IPT / SP treatment received will be recorded in the women's personal ANC book as proof
      for further use, including the cross sectional surveys.

      Quantitative data will be regularly entered with Epi Info software and analysed using Stata
      version 9. Qualitative data will be processed and reports produced. Proportions will be
      compared by ANOVA and means by student t test.

      Training sessions will be organized for caregivers to harmonize IPT administration (as it is
      not yet in practice in Burkina Faso) and study implementation in each study zone. The PI will
      undertake monthly supervision in each zone. During the preparation phase, more information
      will be gathered to better understand the health district and centres organization and
      functioning system regarding ANC and malaria prevention.

      Study period The study will be carried out over 24 months from June 2007.
    

Intervention name(s): delivery approaches of malaria intermittent preventive treatment in pregnancy
Intervention type(s): Other
Intervention description(s): Health centre based delivery approach (PHC). IPT/SP will be delivered to pregnant women presenting to the health centre for ANC visit.
Joint with advanced strategies delivery approach (JAS). In addition to passive delivery at health centres, the pregnant women will be reached during preventive activities the health staff carry out regularly in villages Community based distribution delivery approach (CBD). In addition to passive delivery at health centres, the pregnant women will be reached by traditional birth attendants (TBAs) or representatives of village women's associations (RWAs).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention