Family Size Clinical Trial
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
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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