A cluster-randomized trial of parallel design with three arms (women’s education on FP, male involvement in FP education, and control) was used. One to one ratio allocation of the intervention with a control arm was employed to assess the effect of community-based interventions to promote family planning (FP) use and intention among the pastoralist community. A repeated cross-sectional (cross-sections at baseline and end line) type of data was used to collect the intended information from married women. It contains baseline and end-line data collection with a nine-month duration.
Cluster was created based on geographic boundaries. The clusters included in the study had at least 30 households with married women. Cluster are with natural borders and have enough distance (20-40km) from adjacent clusters to reduce risk for contamination. Inclusion criteria for woman’s were: being married, and resides in a given cluster as usual place whereas those who declared infertile and seriously ill during data collection were excluded.
Study setting and period
The cluster randomized controlled trial was conducted in the Afar region. Afar Region is one of nine regional states of Ethiopia. The region is composed of five 5 zones, 32 districts, five town administrations and 404 kebeles (lowest administrative unit), and having an estimated population of 1,816,304 out of those 799,174(44%) are females. The majority of the population reside in rural, and are pastoralists or agro-pastoralist in occupation and are Muslim religious followers (4). Three districts namely Mille, Afambo, and Kori were included in the intervention. The region is characterized by high early marriage which is mainly influenced by parental decision, and with a high prevalence of early pregnancy and delivery. It also expressed with high illiterate rateand high unmet need for FP (6, 22, 25). A clan-based system favoring large family size, being in a polygamous union of marriage, and a high burden of work among the women is a peculiar characteristic of the Afar women (21, 26, 27). Poor access to health care forces women to travel long distances and often demand the accompany of family members to seek health care including FP. The intervention was carried out for 9 months; from January to September 2018.
Study design, sample size determination, and sampling procedure
The sample size was calculated using the literature of Richard and Lawrence-(28)- to determine the number of clusters required to detect a difference among different arms. Given a current FP utilization in Afar region of 11.6% -(6)-expected changes to be acquired following the intervention of 20%, 90% power, 95% confidence interval, considering the intracluster correlation of ρ=0.05, adjusting for non-response of the individual in a household of 20% and a design effect of 2.2. Taking an assumption of an equal number of clusters and the cluster sample size, the final sample size was 33 clusters and 891 married women. One cluster had 27 married women. Per arm, we include 11 clusters and 297 married women. A systematic sampling technique was used to select 27 married women from one cluster. A sampling fraction was calculated based on the total number of married women in the cluster. A random start number was selected to identify the first married woman in the clockwise direction. Hence, 9 clusters (5 male involvement and 4 women education) of Afambo, 7 clusters (5 male involvement and 2 women education) of Mille and 6 clusters (2 male involvement and 4 women education) of Kori were included in the intervention. We used the same sampling procedure to collect the follow-up data for the baseline and end line data.
We used a cluster randomized controlled trial parallel-group design with three arms. Using a computer-generated random number, the number of clusters was allocated into three arms (women’s FP education, male involvement in FP education, and control) in simple randomization. To avoid bias during the process, the allocation of the clusters was done by another researcher and the result was communicated with the principal investigator. Clusters were randomized into two intervention arms and control conditions before the initiation of enrollment..Moreover, the study participants were not specifically informed in which intervention arm.
The interventions targeted at the cluster level with community-based interventions. It includes 1) male involvement in FP education and 2) Educating women in FP. Each intervention (educating women in FP and male involvement in FP education) was compared with the control arm in terms of FP use and intention. The intervention targeted married women in educating women in FP arm and married women and men in the male involvement in FP education arm. The health education in male involvement in the FP education arm was given separately for married women and men. It was designed with the principle of approaching the community with their community member (faema leaders). Faema is a traditional community-based structure that serves as a social support group. It has a leader, good community acceptance with a separate structure for males and females. It has a long history and feasible to provide the intervention in an area where the health extension programs (HEP) did not strengthen as compare with the agrarian region of Ethiopia (12). HEWs are frontline health worker adopted by the government of Ethiopia (GOE) with a view to achieving universal coverage of primary health care among its rural population by 2009. They served as a major source of health information including FP message(23).
Moreover, the women development army (WDA) is a structure at the community level which was evident in the agrarian region to strengthen the HEP in creating awareness, increase health-seeking behavior, and building a community sense of ownership hasn’t been yet established(22). Hence, to enhance FP use and intention among pastoralist community the following community-based interventions 1) health education on FP to married women and men by faema leader, 2) Video-assisted message on FP and 3) Assisting the faema leader using HEW and health workers. It should be noted that, before we provide the FP message to the community a tailored message which is highly acceptable in the community was discussed. Accordingly, the emphasis of the message was given on the purpose of FP for spacing than limiting the number of children. The intervention was guided using an integrated behavioral model (IBM)(29). A detailed description of these community-based interventions described based on the type of arm as illustrated below.
1) Male involvement in FP education arm: In this arm we provide the following community-based interventions 1) health education on FP to married women and men by female and male faema leader, respectively 2) Video-assisted message on FP and 3) Assisting the faema leader using HEW and health workers.
A) The health education on FP by faema leader targets married women and men in the cluster. We use male faema leaders to approach for the married men and female faema leader to the married women. In the beginning intensive training was given for the faema leader on a different aspect of FP by the research team. We trained 2 females and 2 males faema leader from each cluster for 03 days. The training for female faema leaders includes a detailed description of Muslim dominating countries’ FP experience and its relation with reduction of TFR and maternal mortality -(30)- how to starts positively influencing the neighbors in their catchment to use FP and on different content of FP. The content includes information on the definition of FP, type of FP, the purpose of FP, effectiveness, and duration of prevention. It also included sessions that covered myths and misconception on FP and its side effects, how to overcome the pressure/ resistance comes from influential groups (husband, neighbors, clan and religious leaders) on FP and being a role model by starting using of FP (Figure 1). After the training, with the mobilization of the faema leader, a regular meeting on FP was organized at the center of the cluster. The meeting was held twice a month with a 1-hour duration and it was done in the afternoon. Overall, the intervention was given for a total of 9-months. A constant schedule was prepared to keep the provision of health education message uniform across clusters in each session. Importantly, a logbook or registration book was prepared to follow the progress of the intervention. It contains the name of the participants, age, and type of topic discussed FP in each session of health education. The logbook was checked for its delivery by the research team once a month.
Furthermore, the training, organizing meeting, schedule, time allocated for health education and having and filing of a log book for the male faema leader was similar to the female faema leader, except, the content of the health education gives due focus on the active involvement of males in FP service. It includes promoting spousal communication, allowing his wife to use FP, accompanying her to the health facility, reminding her the schedule of taking FP, participating in choosing the type of FP, providing her financial support, and helping her in domestic activity.
B) Video-assisted message on FP: Video of married women who start to use FP, district’s FP experts, male who actively involved in FP service and religious leader was recorded. The video recorded message from married women deals with the life experience related to FP (its process, benefit, possible challenges, and action taken). The video recorded message from the district’s FP experts includes the benefit of FP, type of FP, possible side effect, management of side effect, and availability of FP in health facilities. Along with, the life experience of those men who actively involved in FP services such as; allowing his wife to use FP, accompanying her to the health facility, participating in choosing the type of FP, providing financial support and helping her in domestic activity was recorded and used to teach the male in the male involvement in FP services arm. In addition, a video recorded message from a religious leader were delivered for the male in the cluster. In the beginning, the importance of FP use for spacing the number of children was discussed with the religious leaders and a consensus was reached. After they agreed on the importance of FP, the message on FP vs Islamic religion with the focus of FP use did not contradict with their religion was recorded and disseminated. The recorded video message of (women who start to use FP, district’s FP experts, male who actively involved in FP service and religious leader) on FP was uploaded to tablet smartphone. The tablet with its accessories was given for the faema leaders (male and female) to disseminate the FP message while they teach the community under their cluster. It was given for a total of 6 months. Training on how to operate, deliver, and teach the recorded video message was demonstrated and re-demonstrated by the faema leaders. All the FP message was prepared in the local language “Afarri”.
C) Assisting the faema leader using HEW and health workers. In the beginning, the HEWs and health workers working at FP were trained. Along with the provision of health education at the cluster level by the faema leaders, the health care providers working in FP at the at the male involvement in FP education arm took orientation and training on making the health facility ready for FP service, availing method mix, managing side effect, and counseling married women on FP use based on informed consent. Furthermore, the HEW at this arm were trained on how to assist faema leaders during FP related health education programs and provide house to house counseling to voluntary married women on how to use FP services. They also facilitate opportunities for using health centers when married women prefer to use FP including long-acting FP.
2)Women’s Education on FP use arm: In this arm we provide the following community-based interventions 1) health education on FP to married women by female faema leader 2) Video-assisted message on FP and 3) Assisting the faema leader using HEW and health workers. The type of community-based interventions in this arm was similar with male involvement in FP Education arm except the following point 1) on the health education on FP by faema leader it targets only married women in the cluster 2) The video assisted message on FP recorded from married women and district’s FP to teach the married women in the cluster and 3) On the assisting the faema leader using HEW and health workers, they support for female faema leaders to teach the married women in their clusters.
3) Control arm: In this arm we don’t carried the provision of health education to the married women and men by faema leader, record video from (married women who start FP use, male who actively involved in FP service, religious leader and districts FP expert) and providing training to the HEW and health workers. In this arm the routine provision of FP by the government was maintained. It was cognizant that FP service was given at health facilities by health workers. Along with volunteer married women contacts HEW or health workers to use FP. In this arm we collect the baseline and end line data to compare with the intervention’s arms (women’s education on FP use and Male involvement in FP service).
Measurement of the outcome variables
The purpose of this study was to evaluate the effect of community-based interventions (women’s education on FP and male involvement in FP education) compared to the control group at the cluster level to increase the women's FP use and intention. It was measured based on the married woman’s FP use and intention. The primary outcome was modern FP use with the question of “Are you or your partner currently doing something or using any method to delay or prevent getting pregnant”. Moreover, a modern type of FP (pill, Depo-Provera, condom, Jadelle, Implanon, IUCD, etc) currently used by the women or her husband was collected. Intention to use of FP was used as a secondary outcome variable. A total of 8 items that range from the lowest level (At this moment, I can list some benefits of FP use and I would gain if I use it) to the highest level of intention to use FP (It is expected that women in our community should use FP and so do I) was used. The response ranges from 1(uncertain /Disagree) to 3(Certain/Agree). The response was summed up to form a continuous variable. It was categorized based on the response of married women mean value in to “low intention to use FP” and “high intention to use FP” for those married women who scored mean and below mean and above mean, respectively. In addition to the primary and secondary outcomes, the following variables were collected. The community responsibility was collected to describe the responsibility of her husband either as a clan, religious, and faema leader. In line with this, being a faema leader for the married women also included as community responsibility. Along with a positive/yes response for the current use of FP, the status of her husband to know for the current use of FP, and the type of support obtained from her husband included in our study. To list the type of support; accompany the health facility, reminding the schedule for taking the FP, participating in choosing the type of FP, and either helping them in domestic activity or not.
Data collection tool and procedure
We developed a questionnaire for the purpose of this study and attached as Additional File 1. The developed tool was piloted in 10% of the sample after it was developed by reviewing different literature on the previous finding that aims to explore barriers and facilitators to Reproductive Maternal Neonatal Health (RMNH) services including FP (6, 9, 10, 25). The collected piloted tool was exposed to a reliability test. It was done to assess the consistency of items in each construct (Cronbach’s Alpha > 0.7). Besides, exploratory and confirmatory factor analysis was done (31). After all necessary modifications followed the piloted test, the tool was pretested in 5% of the sample to assure wording, skip pattern, and determine the time allotted to complete one interview. A repeated cross-sectional type of follow up data (baseline and end-line data) was used to collect the data as we fear high migration among the pastoralist community. For the secondary outcome variable intention to use of FP was constructed of 8 items had Cronbach alpha of 0.935, explained 87.7% of the variance with Kaiser-Meyer-Olkin (KMO) of 0.846 and Bartlett's Test of Sphericity of 0.00(31). Six clinical nurse data collectors and 2 supervisors were used to collecting the data after they got training on the items and how to use mobile-based applications. They were recruited outside the study/intervention areas and assigned to a different cluster of given districts. The baseline and end-line data were collected using an electronically smartphone-based application open data kit (ODK). Immediately after the data checked for its completeness, it was sent to the Mekelle University (MU) server where the data were accessed and utilized by the research team.
Data Quality Control
The data collectors and supervisors were trained. Regular supervision and follow-up were made by supervisors. A reliable and valid tool was used. The data were collected using a mobile-based application (ODK) which ensures skip pattern; immediate scanning of the collected tool in the server, friendly to use, and avoids cost for paper duplication. Intensive training was given for faema leaders, HEW, health care providers, and religious leaders.
Data Monitoring and Safety
A team from Mekelle University, Samara University, and the Afar regional health Bureau was established to monitor data safety. Hence, volunteer married women will go to a health facility and counseled to use contraceptives based on their informed consent at health facilities by the health care providers. The research team takes an effort to minimize the risk and maximize the benefit by following the provision of intervention using the protocol. And, there was no risk reported following the provision of the intervention.
The data collected using ODK was exported to R software version 3.4.2 for analysis. Intention to treat analysis was used as a framework of analysis. All the analysis was used with a 95% confidence interval (CI) and p-value < 0.05 used to declared statistically significant. Since the number of clusters per arm was 11 per arm, a cluster-level summary was used(28) to compare the women’s FP education and male involvement in FP education arm with the control group. A separate cluster-level summary analysis was done the control arm with the women’s FP education arm and the male involvement in FP education arm with the control arm by considering the cluster effect. It should be noted that, the interest of this study was to compare the control arm separately with the intervention arms. Hence, no analysis was made between male involvement in FP education and women’s FP education arms. Finally, the result of FP use and the intention was described with t-test, degree of freedom(df), P-value, mean value of both groups (control and intervention), and adjusted risk with its 95% CI. Moreover, the prevalence ratio (the number of FP users at the end line divided to baseline) was done. Along withan odds ratio were calculated for FP use and intention to use from the absolute risk value manually to make our interpretation more understandable and informative (32).
Any changes to the trial outcomes after trial commenced
Even though, we strictly follow the protocol we have the following deviation from the original: First, in the beginning, we intend to provide the intervention for six months, however as the project life extended we provide the intervention for 9 months ; Second) we plan to analyze that data using Generalized estimating equation (GEE) which allows for baseline or covariate adjustment in the final model. However, we are unable to run the model with GEE due to the limited number of clusters per arm (<15). Hence, we use cluster-level summarizes to analyze the collected data and to report our result (32).