Clinical trial NCT03450564: Effect of Community-Based Interventions on Increasing Family Planning Utilization in Pastoralist Community
Official title: The Effect of Community-Based Interventions on Increasing Family Planning Utilization in Pastoralist Community of Afar Region Ethiopia: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Size
Lead sponsor: Mekelle University
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 891
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The cluster randomized controlled trail will be designed to enhance family planning (FP) utilization in pastoralist community. An integrated behavioral model was used to guide the intervention. It has three arm and these are two community-based intervention and one control group and it was carried out for 9 months. Baseline and end line data was collected. The package of health education message was given to the married women of both arm (women and male involvement) arm and men in the male arm. Different modality was used in the men and women arm. These are involving faema leader, use of audiovisual materials of role model person in the community and providing training for health extension workers (HEW) and health care provider to assist for the faema leader.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The cluster randomized controlled trial was done in Pastoralist community of Afar region, Ethiopia for a total of nine months. There was three arms in the study. The type of randomization will be a cluster randomized controlled trial where kebele are randomized to two different interventions and control groups. These interventions are women education to use family planning and male education/involvement to enhance family planning use in the community.

Detailed description: The study hypothesized that doing on women education and men education/involvement in family planning utilization would be a practical way to achieve for an increment of family planning utilization in Pastoralist community of Afar region. The study was carried out in Afar region, North Eastern Ethiopia from Jan1, 2018, to September 5, 2018. A three-arm, parallel randomized controlled trial was used to answer the objective of the study. The type of randomization will be a cluster randomized controlled trial where kebele are randomized to two different interventions and one control groups together. These interventions are women education to use family planning and male education/involvement to enhance family planning use in the community.

The unit of randomization was clustered which are kebeles in a different districts. From a given district 11 Kebele were selected randomly gives a total of 33 kebele. The 33 cluster were allocated to the 2 interventions and one control arms. The detail description of the two interventions and one control arm is described below.

* Arm 1): existing standard family planning service provision by the government health sectors.
* Arm 2): It focuses on the involvement of men to enhance the utilization of family planning by their wives and educating the women in the male intervention area.
* Arm 3): It deals with educating married women to use family planning.

Data collection tool, procedures, and follow-up We develop the quantitative tool based on the previous finding in the region. It contains baseline and end line data collection with a nine-month duration. The tool was piloted on 10% (118) of the sample and it was tested for reliability and validity test for items of of knowledge, attitude, subjective norm, perceived behavioral control over FP use, intention to use for FP and male involvement. Accordingly, modification was made based on the finding of reliability and validity test. A tool which has a All items were subjected to exploratory factor analysis to identify the relevant constructs. Items with low load factor (less than 0.3) to the identified constructs were deleted. Then the reliability test was done to assess the consistency of items in each construct (Cronbach's Alpha \> 0.7). At the end, a final tool was prepared based on the finding of the reliability and validity test. Then, it was pretested in 5% (45) of the sample. 6 clinical nurse data collectors and 2 supervisors were used to collect the data after they got training on the items and how to use mobile based application. They were assigned to a different cluster of a given district. The data was collected using mobile based application called open data kit (ODK) for a one month. A similar procedure was used in the end line data collection. Immediately after the data checked for its completeness, it was sent to the Mekelle University (MU) Server. Hence, at the middle of the intervention, qualitative data was collected to identify the participants acceptability and documenting best experience of the intervention.

Intervention description:

The community-based intervention in this study includes two components. These are educating women to use family planning and male involvement for use of family planning.

Analysis plan and statistics methods The type of data used in the intervention study was a repeated cross-sectional. 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 95% confidence interval and p-value \<0.05 to declared statistically significant. Since the number of clusters per arm was 11, a cluster level summary was used to compare the control group with the intervention (women education and male involvement). A separate cluster level summaries analysis was done for control Vs the women arm and control with the male arm by considering the effect of cluster. Finally, the result was described with t-test, df, P-value, mean value of both group and 95% CI of the adjusted risk. Moreover, prevalence ratio of the end line FP user over the baseline FP was done.

Ethical consideration Permission to undertake the study was obtained from Mekelle University College of Health Sciences institutional review board with a reference number ERC 1435/2018. And an official letter of cooperation was given to Afar Regional Health Bureau. Permission was obtained from all relevant authorities in the Afar regional health bureau and participating district health offices (Afambo, Kori and Mille). At the beginning community consent was secured from the influential group (religious and clan leader). Verbal consent was secured before conducting interviews and parental/guardian consent was waived to include the minors to the study by the ethical board. The informed consent was secured continuously every three months. A one-page consent letter was attached to the cover page of each questionnaire as an information sheet which includes a detail description about the benefit and risk of participating in the study, participation is on voluntary basis, the right to withdraw from the study, identification of informant was possible only through specific identification numbers and the privacy of collected information. Data collection was conducted through electronically smartphone mobile based application (ODK) and it was confidentially.

Eligibility criteria: Inclusion Criteria:

* A household was considered eligible for the study if the following criteria are met:

  * at least one married women with reproductive age group (15-49) year's child
  * able to provide a consent and voluntary to participate in the study
  * Cluster which has more than 30 married women. A household was excluded if the woman or her husband will not volunteer to participate in the study.

Exclusion Criteria:

* Married women who are not volunteer to provide informed consent
* Married women who are declared infertile

Primary outcomes:
measure: Family planning utilization
timeFrame: 9 months
Secondary outcomes:
measure: Intention to use family planning
timeFrame: 9 months
Other outcomes:
Locations:
city: Semera
country: Ethiopia
facility: Afar Region
state: Zone 1
Study officials:
affiliation: Mekelle University College of Health Science, Academic and research Director
name: Belete Assefa
role: STUDY_DIRECTOR
affiliation: Semera University, Director of Research and community Service
name: Mohamed Ahmed
role: STUDY_CHAIR
affiliation: Deputy Head of Afar regional Health Bureau
name: Yasin Habib
role: STUDY_CHAIR
affiliation: Mekelle University, College of Health Sciences, School of Public Health
name: Mussie Alemayehu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alemayehu et al. Family planning use and associated factors among pastoralist community of afar region, eastern Ethiopia. BMC Women's Health (2016) 16:39 DOI 10.1186/s12905-016-0321-7 Afework B., Alemayehu M., Znabu H., Araya AM., Mohammed A., Afework M. Factors influencing contraceptive use among women of reproductive age from the pastoralist communities of Afar, Ethiopia: a community-based cross-sectional study. Ethiop. J. Health Dev. 2018;32(Special Issue):28-33 Znabu H., Alemayehu M, Araya AM., Afework M. Drivers to have more children in the pastoralist communities of Afar, Ethiopia: an explorative qualitative study. Ethiop. J. Health Dev. 2018;32(Special Issue):21-27 Alemayehu M., Araya AM., Afework M.A review of evidence on barriers to and facilitators of the utilization of reproductive, maternal and neonatal health services among pastoralist communities in Sub-Saharan Africa. Ethiop. J. Health Dev. 2018;32(Special Issue):43-49 Key CW., Araya AM.,Mark S., Mussie A.,Selemawit AB.,Abiy HS.,Ephrem TL., Afework M.Best practices for addressing socio-cultural barriers to reproductive, maternal and neonatal health service utilization among women from pastoralist communities of Afar, Ethiopia: A qualitative study. [Ethiop. J. Health Dev. 2018;32(Special Issue):4-12 Alemayehu M.,Araya AM, Kibrom B, Yemane G., Tesfay H.,Selemawit AB., Mohammed A., Afework M.The Levels of utilization of reproductive, maternal and neonatal health services among women from pastoralist communities in Afar, Ethiopia: across-sectional survey. Ethiop. J. Health Dev.2018;32(Special Issue):34-42
citation: Alemayehu M, Medhanyie AA, Reed E, Bezabih AM. Use of community-based interventions to promote family planning use among pastoralist women in Ethiopia: cluster randomized controlled trial. BMC Womens Health. 2021 Aug 18;21(1):305. doi: 10.1186/s12905-021-01434-x.
citation: Alemayehu M, Medhanyie AA, Reed E, Mulugeta A. Individual-level and community-level factors associated with the family planning use among pastoralist community of Ethiopia: a community-based cross-sectional study. BMJ Open. 2020 Sep 9;10(9):e036519. doi: 10.1136/bmjopen-2019-036519.