Use of community-based interventions to promote family planning use among pastoralist women in Ethiopia: cluster randomized controlled trial

Background: Afar region is one of the pastoralist dominated regions in Ethiopia. The region is characterized by a low contraceptive prevalence rate (CPR) of 5.4%. Lack of awareness of contraceptive use, husband objection and religious barriers are attributed to low CPR in the region. This study assessed the effect of community-based interventions for promoting family planning (FP) use among pastoralist communities in Ethiopia. Methods: The study design was a three-arm, parallel, clustered randomized controlled trial (CRT). The three study arms were: (1) male involvement in family planning (FP) education; (2) women’s education on FP; and (3) control. A total of 33 clusters were randomized and allocated with a one-to-one ratio. Intervention components included (1) health education on FP to married women and men by faema leaders (a traditional community-based structure that serves as a social support group); (2) video-assisted message on FP; and (3) assisting the faema leader using health workers and health extension workers (HEWs). The intervention was given for a total of nine months. FP use and intentions were measured as outcome variables. In addition, a cluster-level summary considering a cluster effect analysis was performed. The result was presented with t.test, adjusted risks and its 95% confidence interval (CI). Results: The proportion of FP use among the arms was 34% in the male involvement in FP education, 17.5% in women’s education on FP and 4.3% in the control. There was a positive change in the proportion of FP use in the male involvement in FP education and women’s education on FP arms with absolute risk (AR) of 0.29 (95% CI, 0.23,0.34) and 0.13 (95% CI,0.08,0.17), respectively, as compared to the control arm. Similarly, married women in the male involvement in FP education and women’s education on FP arms had 3.4 (2.48, 4.91) and 2.1 (1.50, 2.95) higher intention to use FP, respectively, as compared with the control arm. Conclusion: The present study suggests that in such male-dominated pastoralist communities with more considerable religious barriers, the community-based health education mainly targeting males appears to be a promising strategy for improving FP use and intention to use FP. Trial registration: ClinicalTrials.gov, NCT03450564, March, 2018. A three-arm, parallel, clustered randomized controlled trial (CRT) (male involvement in FP education, women’s education on FP 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 FP use and intention to use among the pastoralist married women. A repeated cross-sectional (cross-sectional at baseline and end-line) type of data was used to collect the intended information from the married women. It contains baseline and end-line data collection with a nine-month duration to assess change over time in the study outcomes. The cluster was created based on geographic boundaries. The clusters included in the study had at least 30 households with married women. They were chosen with natural borders and has enough distance (20–40 km) from adjacent clusters to reduce the risk of contamination information. Inclusion criteria for women participants included being married and residing in a given cluster in the Afar region. In addition, women were excluded from the study if they reported infertility or a severe illness. The study was conducted in the Afar region which is one of the ten regional states of Ethiopia. It is characterized by presence pastoralist and Muslim dominated communities and is composed of five zones, 32 woredas (districts), five town administrations and 404 kebeles (lowest administrative unit). It is home to an estimated population of 1,816,304 (with 799,174 (44%) females)) [26]. Majority of the population reside in rural areas and are pastoralists or agro-pastoralist whose religion is dominantly Muslim [13]. The region is characterized by high rates of early marriage, which is mainly influenced by parental decisions and a high prevalence of early pregnancy and delivery. It is also known for a significantly high illiteracy rate (75.6%), low CPR (5.4%) [11] and high unmet need for FP (17.2%) [10]. Furthermore, a clan-based system favoring large family sizes [16], wide spread practice of being in a polygamous union of marriage and a high burden of work among women are a peculiar characteristics of the people [27]. Poor access to health care facilities forces women in the region to travel long distances [16] and often demand accompany of family members [28]. For this study, three districts (Mille, Afambo and Kori) were included in the intervention. These three districts are found with a radius of 150 km away from the capital city of the region, Semara. These districts have relatively better infrastructures (road accessibility and transportation services) than the other parts of the region. In 2018, majority of the population (76–86%) in these districts were unable to read and write where as in the Afar region it ranges from 75.6 to 89.7% [10, 13]. More than nine-in-ten of the inhabitants were Muslim followers in religion, where as it was 98.8% in Afar region [13]. Nearly nine-in-ten of the inhabitants in the selected three districts and Afar region were pastoralist/agro-pastoralist in occupation [11]. The FP use was 3.4% in Kori, 3.7% in Afambo and 5.7% in Mille, where as it ranges from 5.4 to 12.7% in Afar region [10, 11]. According to the Afar Health Bureau report, the region has one regional hospital, six zonal hospitals, one non-govermental hospital (NGO), 78 health centers and 379 health posts [29]. Moreover, the selected districts have the following health service. In Mille there are (one NGO hospital, three health centers and seven health posts), Afambo (two health centers and five health posts) and Kori (two health centers and five health posts). The health centers and health posts provide maternal and child health service including FP to the pastoralist communities. Likewise, the majority part of the region’s districts has a similar number of health centers and health posts [30]. The intervention was carried out for nine months, January to September 2018. The interventions were targeted at the cluster level. The following community-based interventions were applied; (1) male involvement in FP education, and (2) women’s education on FP. Each intervention was compared with the control arm in terms of FP use and intention to use. While the targets for male involvement in FP education arm were both married women and men, the targets for women education on FP arm were only married women. The health education in the male involvement in FP education arm was given separately for married women and men. It was designed with the principle of approaching the community with their own community members (faema leaders). The faema structure was assessed to be preferable to provide the intervention in areas like Afar region where the health extension programs (HEP) were not strengthened compared with the agrarian regions of Ethiopia [16]. HEWs are frontline health workers adopted by the government of Ethiopia (GOE) to achieve universal coverage of primary health care among its rural population by 2009. They served as a significant source of health information, including FP [14]. Never the less, HEWs structure has not been strengthened in Afar region. Furthermore, the women development army (WDA) is a structure at the community level, which was evident in the agrarian regions to strengthen the HEP in improving maternal and child health, including FP utilization. However, it has not been yet established in the region [15]. Hence, to enhance FP use among the pastoralist married women, the following approaches were applied to reach the target groups; (1) provision of health (FP) education to married women and men by faema leaders; (2) video-assisted messages on FP from role model people (married women who started to use FP, district’s FP experts, male who actively involved in FP service and religious leader), and (3) assisting the faema leaders using HEWs and health workers in their own communities. Before the FP message was provided 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 maintaining spacing between children than limiting the number of children. In Afar, it was challenging to discuss and raise an issue about FP despite having the highest maternal, neonatal and child mortality rates in the region. After an extensive search to identify the barriers of reproductive, maternal, neonatal and child health (RMNCH) in the region, it was found that FP coverage was the lowest indicator with 5.4% [11]. Along with this fact, the lack of awareness, husband objection and religious influence were potent barriers for not using/ exercising FP [13]. Accordingly, FP messages were developed, qualitative data collected from the key informant on the applicability of the messages and a draft FP messages was prepared by experts (reproductive health specialists and health education and promotion experts). The developed messages were tested with the community representatives (married women, men, FP experts and religious leaders) and collected constructive comments to improve the draft FP message. Finally, a consensus was reached on FP education to the community to emphasize the purpose of FP for spacing between children’s than limiting the number of children to better convey the message through community members (faema leaders in educating the married women and men). The intervention was guided using an integrated behavioral model (IBM) [31]. A detailed description of these community-based interventions based on the type of arm is described below (Fig. 1). Type of family planning education per arms among pastoralist community Afar region, Ethiopia, 2018 (1) Male involvement in FP education arm: In this arm, the following interventions were provided; (1) provision of health (FP) education to both married women and men by female and male faema leaders, respectively; (2) video-assisted message on FP (from married women who started to use FP, district’s FP experts, male who actively involved in FP service and religious leader); and (3) assisting the faema leaders using HEW and health workers. A detailed description of each intervention are described below. (A) Health (FP) Education by Faema leaders: This targeted both married women and men in the cluster. Male faema leaders were used to approach men while the female faema leaders approached married women. Two female and two male faema leaders from each cluster were trained for three days. In the beginning, intensive training was given for the faema leaders on a different aspect of FP. The training for female faema leaders included a detailed description of FP experience of Muslim dominated countries and its relation with reducing total fertility rate (TFR) and maternal mortality [32], and on how to start to positively influence the neighbors in their catchment to use FP and on details of FP. The contents covered under details of FP included definition of FP, types of FP, purpose of FP, effectiveness and duration of prevention from unwanted pregnancy. It also included sessions that covered myths and misconception on FP and its side effects, how to overcome the pressure/ resistance that comes from influential groups (husband, neighbors, clan and religious leaders) and being a role model by starting to use FP. After the training, with the mobilization of the faema leaders, a regular meeting on FP was being organized at center of the cluster. The meeting was held twice a month in the afternoons with a one-hour duration. A regular schedule was prepared to ensure that health education messages were uniform across clusters in each session. Notably, a logbook or registration book was prepared to follow the progress of the intervention. It contained personal details (such as names, sex and age) of the participants and type of FP topic discussed in each health education session. The logbook was checked by the research team once a month. Similar training and meeting modalities (schedule, duration, filing/documentation, etc.) were used for dealing with both male and female faema leaders in the male involvement arm except that in the males group the content gave more focus was given on encouraging men/husbands to actively engage on FP. The males group further emphasized promoting spousal communication, allowing one’s wife to use FP, accompanying her to health facility for FP use, reminding her of the schedule of taking FP, participating in choosing the type of FP, providing her financial support and helping her in domestic work. (B) Video-assisted message on FP: Recorded videos on FP from married women who started to use FP, district’s FP experts, married men who actively involved in FP service and religious leaders were prepared. The video message from married women dealt with the life experience related to FP (its process of using FP, benefit, challenges faced and actions taken). The video message from the district’s FP experts discussed the benefits of practicing FP, types of FP, possible side effects of FP, management of FP side effects and availability of FP in health facilities. The experience of a husband who was actively involved in FP services such as allowing his wife to use FP, accompanying her to 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 men under the male involvement in FP education arm. Also, a video-recorded message from a religious leader was delivered for the men in the cluster. Earlier, the importance of FP for maintaining spacing between one’s children was discussed with the religious leaders, and a consensus was reached. After they agreed on the importance of FP, ensuring harmony/alignment of the message on FP with Islamic religion, and identifying type of FP which did not contradict their religion, the video-assisted message was recorded and disseminated. The recorded video messages of the different groups (women who started to use FP, district’s FP experts, etc.) were uploaded to tablet smartphones. The tablets, with their accessories, were given to the faema leaders (male and female) to help them disseminate the FP messages while teaching the community under their respective clusters. It was given for a total of six months. Training on operating, delivering, and teaching the recorded video messages was demonstrated and re-demonstrated by the faema leaders. All the FP messages were prepared in the local language “Afarrigna”. (C) Assisting the faema leader using HEWs and health workers. In the beginning, the HEWs and health workers working at FP were trained on FP. The health workers working at FP took special training (making the health facility ready for FP service, availing method mix timely, managing side effect following FP use and counselling married women on FP use based on informed consent). Furthermore, the HEWs were trained to assist faema leaders (male and female) during FP health education programs and provide house-to-house counselling to voluntary married women to use FP services. They also facilitate referral linkage for married women who prefer to use FP, including long-acting FP, to the health centers. (2) Women’s education on FP use arm: Interventions provided under this arm were; (1) health (FP) education to married women (only—excluding their husbands) by female faema leader; (2) video-assisted message on FP and (3) assisting the faema leader using HEW and health workers. This arm type was similar to male involvement in the FP education arm except for the points described below. Firstly, the FP health education by faema leaders targeted only married women in the cluster and did not include male as described in the male involvement in the FP education arm. Secondly, the video-assisted message on FP was recorded only from married women who started to use FP and the district’s FP expert to teach the married women on (benefit of FP, type of FP, possible side effect, management of side effect and availability of FP in health facilities). It should be noted that the content of the video-recorded message from married women who started to use FP and the district’s FP expert was similar to the male involvement in the FP education arm. However, this arm, it did not use a recorded video message from married men who had been actively involved in FP service. Likewise, messages from religious leaders were not included unlike in the male involvement in FP education arm. Thirdly, on the assistance of the faema leader using HEW and health workers, the activities of health workers on (making the health facility ready for FP service, availing method mix timely, how to manage side effect following FP use and counselling married women on FP use based on informed consent) was similar with the male involvement in FP education arm except with the target/support of HEWs. The HEWs’ target in this arm was to support only the female faema leaders as there were no male faema leaders. However, there was no difference in the activities (assisting faema leaders during FP health education programs and providing house-to-house counselling to voluntary married women to use FP services and facilitating referral linkage for married women who prefer to use FP) with the male involvement in FP education. (3) Control arm: In this arm, the control communities did not receive the above mentioned interventions which were applied to the first two arms, but received just the standard intervention according to the national guideline, which includes assigning health professionals at health facilities, availing FP supply and providing standard FP training to HEW and health workers. It should be noted that there was no difference in the FP supply among the control and intervention arms because the government is responsible for availing it (Fig. 1). The purpose of this study was to evaluate the effect of community-based interventions (male involvement in FP education and women’s education on FP) compared to the control arm at the cluster level to increase rate of FP use and intention to use. FP indicators were measured based on the number of married women’s who use and intend to use FP. The primary outcome variable was actual practice or use of modern FP method (s) with the question of “Are you or your partner currently doing something or using any method to delay or prevent getting pregnant?”. Moreover, the type of modern FP alternative (pill, Depo-Provera, condom, Jadelle, Implanon, IUCD, etc.) used by the woman or her husband was collected. Intention to use FP was taken as a secondary outcome variable. A total of eight items that ranged 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) were used to initiate responses. The responses ranged from 1 (uncertain/disagree) to 3 (certain/agree). The responses were summed up to form a continuous variable. It was categorized based on the response of married women mean value into “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. First, the community responsibility was collected to describe spouse’s responsibility either as a clan, religious and faema leader. In line with this, being a faema leader for married women also included as a community responsibility. Second, along with a positive/yes response by married women for FP’s current use, the husband’s knowledge (whether he is aware or not) about the current use of FP and the type of support obtained from him were included in the study. Types of support which were checked whether they were provided by the husband or not included accompanying one’s partner to the health facility, reminding her of the schedule for taking the chosen FP alternative, participating in choosing the appropriate type of FP alternative and helping her in domestic activity. The sample size was calculated using the literature of Richard and Lawrence [33] to determine the number of clusters required to detect a difference among different arms. The sample size calculation considers the current FP use in Afar region of 11.6% [10] 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. Considering an equal number of clusters and cluster sample size, the final sample size was 33 clusters where each cluster had 27 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, nine clusters (five in male involvement in FP education and four in women’s education on FP) of Afambo, seven clusters (five in male involvement in FP education and two in women’s education on FP) of Mille and six clusters (two in male involvement in FP education and four in women’s education on FP) of Kori were included in the intervention. The same sampling procedure was used to collect the follow-up data for the baseline and end-line data. A cluster randomized controlled trial, parallel-group study design with three arms was implemented. Simple randomization was used to allocate the number of clusters into three arms (male involvement in FP education, women’s education on FP and control) using a computer-generated random number. A different person’s allocation was done other than the principal investigator to avoid bias during the process. In addition, clusters were randomized into two intervention arms and control conditions before the initiation of enrollment. A questionnaire was developed for this study and attached as an additional file. The tool was developed by reviewing different literatures on previous findings that explore barriers and facilitators to Reproductive Maternal Neonatal Health (RMNH) services including FP and Ethiopian Demographic Health Survey (EDHS) report [10, 11, 13]. The developed tool was piloted in 10% of the sample and exposed to a reliability and validity 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 [34]. After all necessary corrections made 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 there was a fear of high migration among the pastoralist community. The secondary outcome variable (intention to use of FP) was constructed of eight items that had Cronbach alpha of 0.93, explained 87.7% of the variance with Kaiser–Meyer–Olkin (KMO) of 0.84 and Bartlett’s Test of Sphericity of chi-square (df) value of 9248 [28] and significant at a p-value of < 0.001 [34]. Six clinical nurse data collectors and two supervisors were used to collecting the data after 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. A reliable and valid tool was used to measure the outcome variables. The data collectors and supervisors were trained. The supervisors made regular supervision and follow-up. The data were collected using a friendly to use mobile-based application (ODK.) It ensures skip pattern, immediate scanning of the server’s collected tool, and avoids paper duplication costs. A team from Mekelle and Samara Universities and the Afar regional health bureau was established to monitor data safety. A volunteer married woman went to a health facility and counselled to use contraceptives based on her informed consent by health care providers. Furthermore, the research team effort to minimize the risk and maximize the benefit by following the provision of intervention using the protocol. Moreover, there was no risk of reporting following the provision of the community-based interventions. 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 a 95% confidence interval (CI) and p-value < 0.05 to declared statistically significant. Since the number of clusters per arm was 11, a cluster-level summary was used [28] to compare the male involvement in FP education and women’s education on FP arms with the control arm. A separate cluster-level summary analysis was done to compare the control arm with the male involvement in FP education and women’s education on FP arms 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 education on FP arms. Finally, the result of FP use and the intention was described with t-test, degree of freedom (df), p-value, the 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 into baseline data) was calculated. Finally, the odds ratio was calculated manually for FP use and intention from the absolute risk value to make our interpretation more understandable and informative [35]. Even though efforts were made to strictly adhere to the originally established protocols, the following deviations were actually observed. Firstly, in the beginning, it was intended to provide the intervention for six months, however as the project life extended, the interventions were also extended for another three bringing the overall study period to nine months and, so, some arrangement of time were made in the provision of the interventions. Secondly, initially the data was planned to be analyzed using Generalized Estimating Equation (GEE) which allows for baseline or covariate adjustment in the final model. However, we could not run the model with GEE due to the limited number of clusters per arm (< 15). Hence, cluster-level summarizes was used to analyze the collected data and report the results [35].