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Introduction Iron and Folic Acid Supplementation (IFAS) is an essential and affordable intervention strategy for prevention of anaemia during pregnancy. The supplements are currently provided for free to pregnant women in Kenya during antenatal care (ANC), but compliance remains low over the years. There is need for diversification of IFAS programme implementation by exploring other distribution channels to complement existing antenatal distribution and ensure consistent access to IFAS supplements. Objectives To determine the effect of a community-based approach of IFAS distribution on compliance and assess side-effects experienced and their mitigation by pregnant women in Kiambu County. Methodology A pretest-posttest quasi-experimental study design was used, consisting of an intervention and a control group, among 340 pregnant women 15-49 years, in five health facilities in Lari Sub-County in Kiambu County, between June 2016 and March 2017. Community health volunteers provided IFAS supplements, counselling and weekly follow-up to pregnant women in the intervention group while the control group followed standard practice from health facilities. Baseline and endline data were collected during antenatal care and compared. Quantitative data was analyzed using STATA version 14. Analysis of effect of intervention was done using Difference-In-Difference regression approach. Results Levels of compliance increased by 8% in intervention group and 6% in control group. There was increased awareness of IFAS side-effects across groups. The intervention group reported experiencing less side-effects and were better able to manage them compared to the control group. Conclusion Implementation a community-based approach improved maternal compliance with IFAS, awareness of IFAS side effects and their management, with better improvement being recorded in the intervention group. Hence, there is need to integrate community-based approach with antenatal distribution of IFAS to improve supplementation.
This study was conducted between June 2016 and March 2017, in Kenya, Kiambu County, Lari Sub-County, in five of its major public health facilities (Lari, Githirioini, Kagwe, Kagaa and Kinale). This was a pretest-posttest quasi-experimental study design with a control group. The study involved three phases as shown in Fig 1, namely inception, implementation and follow-up phases. Inception was the first phase and involved identification and recruitment of study respondents as well as baseline data collection including: socio-demographic characteristics, compliance with IFAS, side-effects experienced with IFAS and their mitigation measures by pregnant women. Implementation was the second phase and involved training of Health Care Providers (HCPs), mostly nurses and Community Health Volunteers (CHVs) on IFAS programme then distribution of IFAS supplements with counselling information. The control group followed standard routine practice of receiving IFAS tablets from HCPs during antenatal care clinics. The intervention group received IFAS tablets from CHVs who distributed the IFAS tablets to pregnant women in their homes. Follow-up was the third phase and involved following the pregnant women up to delivery of their babies as well as collection of endline data. The control group were followed up by HCPs (specifically nurses) during routine antenatal care in health facilities. The intervention group were followed up by CHVs on a weekly basis in their homes. During the weekly home visits, CHVs provided each pregnant woman with the entire week’s supply of IFAS tablets, evaluated previous week’s intake and counselled her on various IFAS topics including common side effects such as black stools, stomach upset, constipation and diarrhea, and their mitigation measures. In addition, the CHVs encouraged pregnant women to attend antenatal care clinics to receive the other antenatal care services. Using a similar questionnaire like that used to collect baseline data, endline data was then collected before delivery, from 36th week of gestation, in both control and intervention groups. This figure shows the three stages that were followed in the implementation of this study. Some of the details of methods adopted for recruitment of the pregnant women involved in this study as well as the ethical considerations have been published elsewhere in other articles [34, 35]. From Kiambu County, two stage sampling method was used to select one Sub-County (Lari) and five of its major public health facilities (Lari, Githirioini, Kagwe, Kagaa and Kinale). The sampling frame consisted of all Sub-Counties in Kiambu County. Lari Sub-County was selected on the basis of having existing functional (active) community units, meaning its community health volunteers were actively involved in provision of community health services to community members. The five health facilities were selected on the basis of existing functional (active) community units attached to them and high client population turnover, due to the low turnover of ANC clients. The study sample size was calculated using the following formula for a binary outcome [36]: D is the expected effect in IFAS compliance of 20% (control 25% to 45% intervention) A consideration of 30% loss to follow-up was added to this sample, making a total sample size of 170. The final sample size per study group was 170 and in both groups was therefore 340. The study population consisted of all pregnant women who attended antenatal care clinic in the five health facilities. The inclusion criteria was: age 18–49 years, below 33 weeks in their pregnancy gestation, not suffering from any chronic illness and who provided informed consent to participate in the study. Consecutive sampling method, which is considered the best type of non-probability sampling with best representation of entire population, was used to include all accessible pregnant women as part of the sample. All pregnant women who met the inclusion criteria were informed about the study and those who provided both verbal and written informed consent to participate in the study were recruited. Those residing in a community that had a functional community unit with active community health volunteers who consented to have IFAS distributed to them in their homes formed the intervention group. Those who consented to participate and were residing in a community that did not have a functional community unit, formed the control group, who received their IFAS from fixed health facilities during antenatal care clinics, until the required sample size of 170 was reached. A semi-structured interviewer-administered questionnaire consisting of 23 closed ended questions including; 11 on socio-demographic data, and 12 on IFAS utilization at health facility, was developed, pre-tested and used for data collection in this study. To address any potential bias in data collection, four research assistants were trained on research ethics, protocols and quality data collection at Kiambu level 5 hospital where the research questionnaires were pretested. To ensure reliability of the questionnaire, a test re-test method was adopted in pre-testing, whereby a repeat pre-test was conducted after two weeks, and Cohen’s kappa statistic was used to measure the level of agreement of the results from the two pre-tests. The questions which were re-tested included: on socio-demographic data: age, education level, occupation, income, gestation, parity and gravidity; on IFAS utilization: frequency of taking IFAS, duration of taking IFAS, timing when IFAS was taken, number of tablets taken in the past 7 days, IFAS side effects experienced and how the pregnant women mitigated the side effects. All the questions repeated had a kappa value of above 0.7 after comparison thus the questionnaire was considered reliable, hence all the questions were retained. To ensure validity of the questionnaire, it was shared and discussed with experts from the Ministry of Health, division of nutrition, and the study supervisors. The feedback obtained from these experts and pre-testing results was used to refine the tool and improve its quality to ensure the questions were able to test what was intended. The trained research assistants then administered questionnaires to all pregnant women who met the inclusion criteria and consented to participate in the study. The compliance with IFAS was assessed based on the reported number of IFAS tablets taken in the preceding one week (seven days) before the interview. The IFAS compliance status was defined as the number of IFAS tablets taken in the preceding seven (7) days. Pregnant women who took at least 70% of the expected dose of the IFAS tablets in the week preceding the interview, an equivalent of five IFAS tablets per week, were considered compliant with IFAS [37, 38]. Conversely, the respondents who took less than 30% of the expected IFAS dose, an equivalent of less than five IFAS tablets, were considered non-compliant. Women who had attended the first ANC visit in the current pregnancy and reported not to have received IFAS tablets before, were excluded in the assessment of compliance since pregnant women routinely receive IFAS during ANC visits. In order to examine effectiveness of the intervention, baseline and endline surveys were conducted in both study groups, using a similar questionnaire. To ensure adherence to optimal data quality standards, the researcher closely supervised the research assistants. Quantitative data at both baseline and endline was coded after collection then entered into the computer, cleaned and validated using Statistical Package for Social Sciences (SPSS) statistical software version 22. Data entry was done during the study data collection process to minimize errors. The entered data was then exported to STATA version 14 for analysis. To ensure confidentiality, the computer access was restricted by password protection. Each questionnaire had a unique identifier to allow validation. Data cleaning and validation was done prior to analysis. Descriptive statistics, including univariate analysis: simple proportions, n (%), for categorical variables and mean with standard deviation for continuous variables, were reported at baseline and endline. Characteristics of respondents were also described in both intervention and control groups. To ensure the change caused by the intervention was not by chance, similarity of baseline characteristics in both groups was ascertained. Homogeneity of study groups at baseline was determined by comparing socio-demographic characteristics of both groups. Side-effects experiences and the measures applied by pregnant women to mitigate them were recorded. Bivariate analysis, using the chi-square test, was done for comparison between groups and multivariate analysis was used to control for confounders. The analysis of effect of the intervention was done using a Difference-In-Difference (DID) regression model to compare outcomes between intervention and control groups before (baseline) and after (endline) the intervention. The changes in the dependent variables in the intervention group (from baseline to endline) were compared to changes in the control group (from baseline to endline) as shown in Table 1 below [39]. The intervention effect was measured by odds ratio and 95% confidence level of the interaction term between study groups (intervention and control) and period of survey (baseline and endline) in the regression model. A p-value of 0.05 was considered statistically significant. Since the same respondents who participated in the baseline are the same who participated in the end term evaluation, the analysis adopted a paired analysis with repeated measures instead of treating the respondents in baseline and endline as independent groups. Source: Kothari and Garg, 2014 pg 41 Scientific and ethical approval was sought and obtained from Kenyatta National hospital/University of Nairobi Ethics and Research Committee (KNH-ERC/A/90 protocol number–P706/11/2015). Research permit was sought and obtained from the National Commission for Science, Technology and Innovation (NACOSTI/P/18/81499/22319). Authority to conduct the study was obtained from Kiambu County, Lari Sub-county authorities and all health facilities involved. Respondents were fully protected from any form of harm. Participation in the study was purely voluntary. The purpose of study was clearly explained to respondents who were required to provide informed verbal and written consent. Emphasis on confidentiality and privacy were made clear at the time of consenting to participate and upheld throughout the study. No name appeared on the questionnaires so no participant identification with information could occur. Respondents were at liberty to discontinue from the study at any time without facing any adverse consequences. Information was kept confidential by restricted access and coding of questionnaires.
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