Design
A pre-post-test intervention study without a control group using mixed approaches was used to understand the impact of the community health education training in improving patients’ adherence to ACT. To establish the impact of such an intervention, participants were assessed prior to the intervention to determine the baseline knowledge, their adherence level and factors influencing their adherence to ACT before the training in a longitudinal study [15]. The Analysis, Design, Development and Implementation (ADDIE) model was adopted at the intervention phase. Then, a post-test longitudinal study to determine if the intervention improved community knowledge and adherence to malaria ACT treatment. Pre-test data was collected in March and April 2023, education intervention carried out in May 2023, and post-test data collected in February and March 2024.
Study area
The study was conducted in Kamuli District, Uganda. The district is rural and malaria transmission occurs throughout with a mean prevalence of 24.2% (Fig. 1) climaxing after March/April and August/November rains. The study focused on public health facilities as they manage more patients compared to private facilities [25, 26], and from health facility level III and above in line with the national implementation of the test and treat policy [27]. The district is served by one public hospital, two Health Centre (HC) IV’s, and 12 HC III’s. The community education trainings were based at all public health facilities lasting two days at each facility, and one day at 27 parishes within the community.
Sample
Study population and eligibility criteria
The study population were patients diagnosed at outpatient departments (OPD) at public healthcare facilities. The eligibility criteria at pre-test and post-test did not change and these have been reported elsewhere [15]. Facility administrators were also enrolled as key informants.
Sample size
The study was powered to determine the impact of the community education training on patients’ adherence to malaria ACT in Kamuli District, Uganda. The study enrolled a total of 2,532 participants with equal numbers (1,266) each time. The quantitative sample size was calculated based on the formula n = Z2 * P(1-P)/e2 [28], assuming a 95% CI, allowable error of 5% and a 46.5% patients’ adherence level to ACT [9]. The final sample size was calculated as follows: n = (1.962 * 0.465 * 0.535)/0.052, n = 383. We also considered a loss to follow up of 10% and design effect of three arms (n = 10% * 383 * 3, n = 1266 participants). However, at all times, the no follow-up arm was not studied as it masked the intention to follow-up, and these were removed from the final analysis and hence the final minimum sample size analyzed was N = 1,688.
Thirty key informants were enrolled into the study based on the concept of information power [29].
Sampling and data collection procedures
The pre-test and post-test procedures were same, and these have been detailed somewhere else [15]. The key informants were purposely and appointments scheduled to enroll them into the study.
Data collection strategy
Stage I: Baseline stage
At the baseline stage, a longitudinal study was done to understand the level of patients’ adherence to ACT treatment and the influencing factors. This relied on ex-post facto information. Baseline data was collected in the months of March and April 2023. This helped in the designing, tailoring and refining of the community health education intervention.
Stage II: Health Education Intervention programme
Education interventions are useful in improving patients’ knowledge, and subsequently their adherence to ACT treatment. If one is properly educated on proper use of ACT treatment, common misconceptions may be dispelled, and behavior may subsequently be improved. The “ADDIE” instructional model [30], was adopted, and it has five steps:
![](https://myfiles.space/user_files/127393_c7e80a1c9bb65875/127393_custom_files/img1713413496.png)
The model is based on analysis of patients’ needs, design of appropriate training intervention, development of materials for instruction, conduct of the training, and evaluation of the patients’ progress.
Before the start of the implementation of the intervention, baseline data was collected, synthesized and interpreted [15], to aid development of the community health education intervention. The developed training tool was revised rigorously under the guidance of the supervisors and pre-tested to ensure its suitability. The training tools were continuously revised during the project. The education training tool was based on the following national manuals [4, 31, 32], and international standards [3, 6, 18, 33–37]. The malaria education manual consisted of four modules; (1) Uganda national malaria policy (policy goal, objectives and elements), (2) parasitology and entomology (causes, transmission, distribution, life cycle, vector habitation, and malaria prevention and control), (3) clinical features (clinical features of malaria, common signs and symptoms of uncomplicated and complicated malaria, and (4) malaria management [treatment using ACT - important instructions to follow when taking ACT, what to do if you take more medicines than you should and what to do if you forget to take the medicine, things you need to know before use of ACT, possible side effects of ACT, medicine storage, myths about malaria, advantages of completing treatment and disadvantages of non-completion, things to do and never to do at home and role of healthcare workers (HCW)]. The tool was revised rigorously under the guidance of supervisors and practicing professionals before its final adoption. The community education intervention was conducted for one month (May 2023). There was a time lag of nine months before post-test data was collected to ensure that what was taught in the intervention was not forgotten by the community members, community members are practicing what they had learnt, and diffusion of the innovation had taken place [19, 38]. This enabled in the assessment of the impact of the education intervention in this study.
The trainings were conducted through the following channels; (1) at the outpatient departments of the 42 public health facilities within Kamuli district for two days targeting patients seeking services at these facilities on pre-announced days – lasting 30 minutes (15–20 minutes for presentation and 10–15 minutes for question and answer sessions, (2) 27 parish community trainings each training lasting 1 hour (40 presentation and 20 minutes question and answer session) on pre-communicated days using the village health teams (VHT) model [18, 19, 39], and (3) facility-based training/mentorship of HCW at the 42 public health facilities lasting one hour (45 training and 15 minutes question and answer) (Additional file 1). The customized guide was shared with the participants during such engagements for continual referral after training. The community education trainings were done in the month of May 2023. The training method was both didactic and participatory. The training targeted the community members specifically, with HCW trained to aid sustainability of trainings at health facilities and within the community during facility outreach campaigns. A brief assessment before and after each training of the participants was performed to assess change in their knowledge. Furthermore, use of visuals on the blister packs and displayed posters was done. This helped in assessing the knowledge level of the participants and immediate contribution of the training to the participants.
There was a mid-term assessment after six months (December 2023) of patients’ adherence to ACT before the final evaluation in February and March 2024. This aimed at keeping a watch on the community but also ensure that information diffusion is taking place as planned.
Stage III: Post-test phase
At the post-test phase (February and March, 2024) following the educational intervention, an evaluation of the intervention was done to measure the change in the knowledge and adherence behavior of the patients to ACT in the management of malaria. The participants were not matched to those in the baseline phase thus unpaired. The resultant change in knowledge and practice was attributed impact of the education intervention in the study.
Ethical considerations
The study was approved by the Maseno University Scientific and Ethics Review Committee (MUSERC/01122/22), the Mengo Hospital Research Ethics Committee (MH/REC/144/10-2022) and the Uganda National Council for Science and Technology (HS2576ES). The study objectives, benefits, potential risks, and procedures were explained to the participants and parents/guardians of the potential study children at each time. Children were only included in the study if their parents or guardians provided written informed consent. If the participant, parent, or guardian could not read or write, a witness chosen by the participant/parent/ guardian co-signed the consent/ assent form.
Data management and analysis
Data capture screens were designed in Epi-data version 3.1 with inbuilt checks and double entry command to minimize data entry errors. Data were entered and secured on a protected computer. Data were transferred from Epi-data to IBM SPSS version 20 software for statistical analyses. Exploratory analyses were done to check for cleanliness and any outliers or erroneous looking data were cross-checked and cleaned where errors were identified. Further analysis was done on tablet count response as a measure of patients’ adherence to ACT prescriptions. Mann-Whitney test was run to compare pre- and post- intervention adherence levels to measure the impact of the education intervention, and effect size of the intervention computed. Statistical significance was established at p < 0.05.