Study area
This study was carried out in Bushenyi District, Uganda (Figure 1). The district has eleven (11) Sub-counties; 76 parishes and 529 villages. The district is located approximately 380 kilometers from the capital city, Kampala. It lies on latitude: 0° 29' 27.6" (0.491°) South, longitude: 30° 10' 58.8" (30.183°) East. The district has a total land of 3,949 square kilometers and it lies between 910 and 2,500 meters above the sea level. It is hilly with forest and swampy vegetation and is characterized by seasonal water bodies, net-works of streams, stagnant pools, over filled blocked gutters and drainages. The region experiences three wet seasons (April-May, August-September, and November-December) and one dry season (January and February); the temperatures are about 25°C-37°C no wonder the major economic activity of this community is agriculture. The communities reside mainly in semi-permanent and mud-thatched houses. It has over grown bushes and fields of bananas around residential homes which favors the survival and multiplication of mosquitoes. The land under cultivation consists of 2,215 square kilometers and wetlands covers 183 square kilometers.
This study was conducted at the four selected health centers, namely; Kampala International University teaching hospital, Ishaka Adventist hospital, Kyamuhunga health centre and Kyeizooba health Centre. The study area has an entomological inoculation rate (EIR) of 100 per annum [14] and Anopheles gambiae and Anopheles funestus are the main malaria vectors in the region. The control methods which have been scaled up by the government in this region to prevent malaria infection include proper case management with antimalaria drugs such as ACTs, intermittent prophylaxis during pregnancy (IPTp), use of mosquito nets and indoor residual spraying (IRS) [15].
Study Design and study population
This was a descriptive cross-sectional study carried out to assess the influence of malaria intervention practices on in-vivo Artemether- Lumefantrine (AL) treatment outcomes in Bushenyi district, Uganda. The investigative methods included questionnaire, laboratory and clinical evaluations. The study participants were recruited from the health facility regardless of the age specifications.
Inclusion criteria
All participants were out-patients who were presenting with signs of uncomplicated malaria to the clinician in-charge; those who had resided in Bushenyi district for at least the last six months prior to the commencement of the study, those who confirmed that they were able to comply with the stipulated follow-up visits, and those without severe malnutrition as per the 2015 WHO guidelines.
Exclusion criteria
Those who declined to consent to the study, nomadic patients, intolerant to oral treatment according to modified WHO 2010 criteria, hypersensitivity or allergy to ACTs, Febrile conditions due to other malaria, and those under medications which may have interfered with pharmacokinetics of anti-malarial drugs and those with severe malaria as per the WHO guidelines were excluded.
Study setting
All adult patients signed the informed consent form and parents or guardians signed the informed consent on behalf of the patients below 18 years. Out of the 283 participants recruited to this study, 194 completed the follow up schedules while 89 were withdrawn from the study because they did not adhere to the follow up visits in the first three days.
Questionnaires
The study was conducted by using pre-tested administered questionnaires which were used to determine the demographic patterns and effects of malaria intervention programs used by the participants to prevent malaria infection. The questionnaires were developed from the demographic health survey (DHS). This was adapted to reflect the population and health issues relevant to malaria infection in Uganda [17]. The questionnaire was pretested to verify for clarity and administerbility. Consequently, questionnaires were translated to the two most common local languages of Luganda and Runyankole. Information on the following independent variables was collected; socio-demographic parameters (age, sex, number of members in each household, educational level of patient or household head, protective facilities from mosquito bite, symptoms of malaria experienced, frequency of taking anti- malarial drugs, misuse of ant malarial agents, prescription of drugs, hospital visit for fever management, pattern of febrile illness, dwelling unit long-lasting insecticidal nets (LLIN) use, indoor residual spraying (IRS) in the household and intermittent preventive treatment of pregnant women (IPTp) intake were determined [18]. Every participant was allocated a unique recognition code at the time of the questionnaire administration. The names of respondents and households were kept as total confidential information and were not to be used in the presentation of results or available to anybody.
Determination of malaria treatment outcomes
The Plasmodium falciparum positive participants were treated with Artemether-Lumefantrine (AL) drug and monitored at day 0, 1, 2 3,7,14 and day 28. The efficacy of the Artemether-Lumefantrine (AL) treatment was assessed as previously described [19] by evaluating clinical and parasitological outcomes as per the WHO in-vivo clinical and parasitological classification criteria for areas of intense malaria transmission [20] which classifies the response as adequate clinical and parasitological response (ACPR) if there is no treatment failure, late parasitological failure (LPF) if P. falciparum parasitemia occurs between 4 and 28 days without fever, late clinical failure (LCF) if P. falciparum parasitemia occurs between 4 and 28 days with fever and finally as early treatment failure (ETF) if there is development of severe symptoms, or insufficient parasitological response by day three.
Data analysis
Data was entered in excel spread sheet 2007, by considering different parameters against the study participants. Data retrieved was analyzed using statistical package for social sciences (SPSS version 10 windows). Descriptive statistics was done using tables showing frequencies and percentage distributions. Factors that were statistically significant (p ≤0.05) at bivariate analysis were included in the multivariate analysis. The model was checked for best fit of data and then used to compute adjusted odds ratios of factors that were associated with malaria treatment outcomes. Statistical significance was considered at 95% level of confidence. Interaction and confounding factors were assessed, and values of p ≤ 0.05 were regarded as statistically significant relationships.