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Objective: To assess whether traditional birth attendants, drug-shop vendors, community reproductive-health workers, or adolescent peer mobilizers could administer intermittent preventive treatment (IPTp) for malaria with sulfadoxine-pyrimethamine to pregnant women. Methods: A non-randomized community trial was implemented in 21 community clusters (intervention) and four clusters where health units provided routine IPTp (control). The primary outcome measures were access and adherence to IPTp, number of malaria episodes, prevalence of anaemia, and birth weight. Numbers of live births, abortions, still births, and maternal and child deaths were secondary endpoints. Findings: 1404 (67.5%) of 2081 with the new delivery system received two doses of sulfadoxine-pyrimethamine versus 281 (39.9%) of 704 with health units (P < 0.0001). The prevalence of malaria episodes decreased from 906 (49.5%) of 1830 to 160 (17.6%) of 909 (P < 0.001) with the new delivery system and from 161 (39.1%) of 412 to 13 (13.1%) of 99 (P < 0.001) with health units. Anaemia was significantly less prevalent in both arms. There was a lower proportion of low birth weight 6.0% with the new delivery system versus 8.3% with health units (P < 0.03). Few abortions and stillbirths were recorded in either arm. Fewer children and women who accessed IPTp with health units died than in the intervention group. Conclusion: The new approaches were associated with early access and increased adherence to IPTp. Health units were, however, more effective in reducing parasitaemia and malaria episodes. We recommend further studies to assess programming modalities linking the new approaches and health units.
The study was done in nine subcounties near the lakeshore region of Mukono district in central Uganda. The background characteristics of the study area have been published elsewhere;13,17 but briefly, the district has a rural population of 88% and is mainly inhabited by Baganda people, the largest tribe in Uganda. The area experiences high temperatures and heavy rainfall from March to May and from October to November. Most areas are endemic for malaria, whereas those on the shores of Lake Victoria are holoendemic and experience high transmission levels.18 The intervention aimed to train community resource people to distribute IPTp. In Uganda, IPTp consists of two therapeutic doses of SP (three tablets of 500 mg sulfadoxine + 25 mg pyrimethamine).3 Nine rural subcounties from the district that were homogenous in terms of geography and cultural attributes were selected. Within each subcounty, at least two parishes were randomly selected. In total, 25 parishes were selected, four tested IPTp at health units (control) while 21 tested IPTp with the new approaches (intervention; Fig. 1). The intervention was not randomized because not all the parishes were uniform in regard to the availability of health units and people available to deliver the treatment. Some parishes had health units providing IPTp; others had both a health unit and people to deliver the treatment while others had only people who referred pregnant women to neighbouring parishes with health units for essential care. The inequitable distribution of health services in the study area and the current health-seeking behaviour influenced the design of the study. Despite this, the populations in the two study arms were comparable in terms of socioeconomic status and other background characteristics (Table 1). Study profile APM, adolescent peer mobilizer; CRHW; community reproductive-health worker; DSV, drug-shop vendor; SP, sulfadoxine-pyrimethamine; TBA, traditional birth attendant. IPTp, intermittent preventive treatment. We targeted all the pregnant women who lived in the study area. One of the key components of the intervention study was a community mobilization and sensitization campaign to ensure that all women received information on the intervention and where to get the SP. Because there was no register of people in this area, the number of pregnant women who accepted the first dose of SP served as the denominator for calculating the proportion of women who received the second dose of SP and other outcome variables. Fifty-one people able to deliver treatment were identified. All these people were trained for one week. The following areas were covered: dangers of malaria in pregnancy; malaria prevention in pregnancy; the benefits of SP and its side-effects; taking blood samples for parasite count and haemoglobin analysis; taking the baby’s weight; and estimating gestational age. Recruitment of pregnant women lasted from May 2003 to February 2005; and those who consented to participate in the study were given SP as directly observed therapy during the second and third trimester as recommended by the policy in Uganda. Pregnant women received iron and folic acid supplementation, deworming, and information on proper nutrition. Those who presented in the first trimester were given an appointment to come back. Exclusion criteria were refusal to give consent to the study and a history of allergy to drugs containing sulphonamide. Data were collected by the community resource people from pregnant women at recruitment, before receiving the second dose of SP and at 36 weeks gestation or at delivery on sociodemographic characteristics, obstetric history, reported malaria illnesses, use of insecticide-treated nets, doses of SP and dates when taken, pregnancy outcomes and deaths. These data were also collected at health units. To have comparable groups, pregnant women who exclusively accessed IPTp (both the first and second dose of SP) with the health units constituted the control group, while pregnant women who exclusively accessed IPTp with the new approaches were the intervention group. Data were entered into EpiInfo version 6.0 (CDC, Atlanta, GA, United States of America), cleaned and transferred to Stata version 8.2 (Stata corp. College Station, TX, USA). Bivariate analyses were done to calculate access and adherence rates to IPTp. The comparison of the effect of the intervention between the new delivery system and health units on access, use of IPTp, maternal health and pregnancy outcomes were calculated with a two-sample proportion test. All estimates with P < 0.05 were considered significant. To assess the effect of SP delivery approaches on maternal-health outcomes, we constructed a logistic regression model while controlling for the effects of age, education, parity and occupation of respondents. The dependent variable was access to the first dose of SP at either the new approaches or health units, while the independent variables were reported number of malaria episodes, parasitaemia, haemoglobin levels at 36 weeks and birth weight. The model fit was assessed for robustness with the log-likelihood ratio test and model estimates were computed at P < 0.001. The study aimed to detect differences in mean haemoglobin of 0.5 g/dl, mean birth weight of 150 g, and a difference of 12% in the proportion of women accessing IPTp between the health units and the new approaches. The minimum sample size required were 310 at each SP distribution outlet; with a study power of 80% and 5% level of significance. To achieve this, 25 parish clusters were selected. On average a parish has a population of approximately 2000 people; therefore the total population was 54 000. With a crude birth rate of 46.9/1000 per year, a total of 3596 pregnant women were expected over a 17-month study period. The number of parish clusters (21 for the new approaches and four for health units) were determined by the sample size required for measuring the primary outcome variables and the rate at which pregnant women would be recruited. For all the analyses, pregnant women accessing IPTp with the new approaches were grouped after calculations showed no significant differences among the different community approaches on all the outcome variables. Self-reported malaria was defined as a febrile illness characterized by feeling hot with headache, joint pains and general weakness. The reference period for self-reported malaria episodes was two weeks before the assessment. Anaemia was defined as haemoglobin concentrations less than 11.0 g/dl. The study was approved by the Danish National Committee for Biomedical Research Ethics and the Uganda National Council of Science and Technology. Verbal consent was obtained from all pregnant women who participated in the study.
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