Intermittent Preventive Treatment (IPTc) and Home Based Management of Malaria (HMM)in The Gambia
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      Malaria in African countries remains an important cause of mortality and morbidity among
      young children. The global malaria control strategies include prompt treatment with an
      effective antimalarial drug, vector control using ITNs or curtains, indoor residual spraying
      (IRS), and intermittent preventive treatment. However, individually these interventions
      provide only imperfect protection. Thus, there is a need to investigate whether additional
      control measures provide added benefit in reducing mortality and morbidity. Therefore, 1312
      children under 5 years of age living in villages and hamlets near Farafenni, The Gambia,
      which form part of the rural Farafenni Demographic Surveillance system (FDSS) in North Bank
      Region(NBR) were randomly allocated to receive IPTc or placebo from village health workers
      based in primary health care villages. Treatment with a single dose of sulfadoxine
      /pyrimethamine plus three doses of amodiaquine or placebo was given to all study subjects at
      monthly intervals on three occasions during the months of September, October and November. In
      addition, VHWs were trained to administer treatment with coartem to children if they develop
      symptoms compatible with malaria during the malaria transmission season. The primary end
      point was the incidence of clinical attacks of malaria detected during the study.
    

Detailed description: 
      Goals and Objectives

        1. The goal of this project was to determine the degree to which morbidity from malaria can
           be prevented in children who receive intermittent preventive treatment(IPTc) with SP
           plus amodiaquine and home based management of malaria with Coartem by village health
           worker during 2008 malaria transmission season.

        2. The objective of the project was to conduct an individually randomized trial of IPTc in
           children who receive HMM in North Bank Region an area where malaria transmission is
           highly seasonal. This trial will determine whether IPTc adds significant benefit to HMM.

           The study was undertaken in a group of 42 villages and hamlets near Farafenni. The
           villages ranged in size from 46 to 1250 inhabitants. The total population of the rural
           FDSS catchment area was about 17 000 and that of children under 5 years of age was about
           3000. The area has one general hospital, three health centres and two private healthcare
           clinics. There are 18 rural primary health care (PHC) villages in the study area. PHC
           villages, each with a population over 400, have mainly been selected plus, occasionally,
           others located in relatively isolated areas. In all villages, village health workers
           (VHWs) and traditional birth attendants (TBAs) are selected by the Village Development
           Committee (VDC) and given 6 to 8 weeks of training with a standardised curriculum on how
           to treat common conditions such as uncomplicated malaria, ARI, diarrhoeal diseases and
           minor injuries. Thus, VHWs function as primary health care providers for minor illnesses
           and injuries for all ages. In addition, the VHW are expected to work as a
           community-based health educator. TBAs functioned as birth attendants, family planning
           distributors and health educators. Both TBAs and VHWs were expected to refer serious
           cases to the local health facility for management. VHWs and TBAs are supervised by
           Community Health Nurses who oversee circuits of 4 to 10 PHC villages. All rural
           settlements also have a Medical Research Council(MRC) Village Reporter who carries out
           sensitization for MRC activities. The bednet coverage in NBR was estimated to be 50%.
           However, during the study, details of bed net usage by the community were assessed.

           Recruitment and randomization:

           The study was carried in collaboration with the EPI unit of the Department of State for
           Health, National Malaria Control Programme and NBR District Health Team. During the
           preparatory phase of the study, the design and objectives of the study were discussed
           extensively with the NBR District Team and all health care providers working in the
           study area. The study team visited all the villages in the study area to explain the
           objectives of the trial to village elders, opinion leaders, and heads of women's groups,
           village health workers and traditional birth attendants. This was followed by village
           meetings, at which the entire community was invited to participate. During these
           meetings, agreement to participate in the study was obtained from the villagers. In
           addition, parents or guardians of prospective study subjects in the right age group were
           visited at home and they were provided with flyers in English and the appropriate local
           language (Mandinka, Wollof or Fula). Written informed consent was obtained from the
           parent(s) or guardian(s) before a child was enrolled in the study. Enrolled subjects
           were provided with a treatment card stamped with a label carrying their name and study
           number to facilitate identification at each contact.

           Individual randomization was carried out. Study subjects were allocated to receive IPTc
           plus HMM or HMM alone.

           IPTc and malaria treatment:

           Study children received their monthly treatment from a VHW based in a PHC village. The
           VWH distributed the trial medication at a central point (usually a health post) during
           the first 10 days of the month during September, October and November. Mothers and
           carers were asked to bring their children to the central point during the morning when
           the VWH was available to distribute the drugs. When a child presented to the central
           point for medication, the VHW identified the study subject using the treatment card held
           by the mother and matched the information on the treatment card with that on his
           register. When he was satisfied that he had correctly identify the study subject, the
           correct dosage of the trial medication was given to the study subject. In non-PHC
           villages, mothers were asked to bring their children to their nearest PHC village to
           receive IPT during the transmission season.

           The first dose of treatment was taken under direct supervision of the VHW and the
           remaining two doses were given to the mother or guardian of the child with clear
           instructions on how to administer the drugs.

           At the end of the malaria transmission season, the total number of complete treatment
           doses each child in the trial had taken was recorded. Compliance was checked on a
           rolling basis throughout the study by assessing the number of correct doses of
           medication received.

           Malaria treatment and morbidity surveillance during the rainy season Passive
           surveillance for malaria was maintained throughout the transmission season. VHW were
           instructed to treat febrile illnesses suggestive of malaria with coartem .
           Parents/guardians were encouraged to take their child to the VHW at any time the child
           became unwell. One field worker was attached to 2-3 village health workers during the
           surveillance period. The role of the field worker was to prepare a thick blood film from
           children scheduled for treatment by the VHW with coartem for subsequent confirmation of
           the diagnosis. VHWs were asked to keep records of children treated for malaria. In
           addition, they were asked to refer children who failed to improve on treatment and those
           with danger signs to the nearest health centre or AFPRC Hospital for further evaluation
           and management.

           Any death of a study child was investigated within a month of death using the
           post-mortem questionnaire technique.

           Cross-sectional survey:

           In December, at the end of the malaria transmission season, a cross-sectional survey of
           all the children enrolled in the study was undertaken in all the villages. Information
           was obtained on demographics, bed net usage, a clinical history was obtained and a
           physical examination performed, including abdominal palpation for splenomegaly and
           measurement of height, weight and axillary body temperature. A finger-prick blood sample
           was obtained from all the children taking part in the cross-sectional survey for
           preparation of blood films, a filter paper sample and determination of the haemoglobin
           level.

           Definitions

           The following definitions were used during the course of the study.

           Clinical malaria. The primary definition of malaria required:

             1. the presence of fever (axillary temperature > 37.5 C) or a history of fever in the
                past 24 hours,

             2. the absence of any other obvious cause of the fever,

             3. the presence of P. falciparum asexual parasitemia above a threshold value of 5,000
                parasites per ul (a threshold shown previously to be of value in differentiating
                symptomatic malaria from other illnesses associated with co-incidental
                parasitemia).

           A secondary definition of malaria required only the presence of P. falciparum
           parasitemia at any density.

           Severe malaria. Severe malaria was defined according to the WHO criteria

           Anemia. Anemia was defined as a haemoglobin(Hb) concentration <11 g/dl, moderate anemia
           as a Hb concentration < 8 g/dL and severe anemia as an Hb concentration < 5 g/dl.

           End-points:

           Primary endpoint :

           Malaria incidence (the number of study subjects seen at the OPD clinic with clinical
           malaria that meet the primary case definitions as indicated above during the
           surveillance period).

           Secondary endpoints :

             1. Malaria incidence (the number of study subjects seen by the VHW with clinical
                malaria that meet the secondary case definitions as indicated above during the
                surveillance period).

             2. the incidence of severe malaria as defined above,

             3. the incidence of anaemia among children seen at a hospital or health centre,

             4. the prevalence of parasitaemia at the end of malaria transmission season
                cross-sectional survey,

             5. the prevalence of anaemia at the end of malaria transmission season cross-sectional
                survey,

           (d) the incidence of all cause hospital admissions,

           (e) the incidence of hospital admissions due to malaria,

           (f) Coverage with IPTc as measured by the following indicators:

             -  the proportion of children who received three IPT courses on schedule;

             -  the proportion of children who received partial or off-schedule IPT courses

             -  the proportion of children with no IPT.
    

Intervention name(s): SP plus amodiaquine; SP placebo plus amodiaquine placebo
Intervention type(s): Drug; Drug
Intervention description(s): SP plus amodiaquine or placebo at monthly interval during September, October and November; monthly treatment with amodiaquine and SP or placebo during September, October and November
Other intervention name(s): Camoquin; Fansidar
Intervention MeSH terms: Amodiaquine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Intermittent Preventive Treatment; Home based management of malaria