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Effect of Community-Based Interventions on Increasing Family Planning Utilization in Pastoralist Community

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ClinicalTrials.gov Identifier: NCT03450564
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Mussie Alemayehu, Mekelle University

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.

Condition or disease Intervention/treatment Phase
Family Size Behavioral: Women Education Behavioral: Male Involvement Other: Control group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 891 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
Masking Description: The study was masked to the participants in which they don't disclose the type of intervention.
Primary Purpose: Health Services Research
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
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : September 5, 2018
Actual Study Completion Date : September 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Women Education
In the married women arm there was an intervention with health education provision based on the baseline finding so as to fill the gap.Faema leader and video from (role model women who start to use FP, FP experts was used.Health extension workers were responsible in assisting the faema leader. Twice a month there was a provision of health education message about family planning for a total of 9 months.
Behavioral: Women Education
This intervention intends to provide health education message for women enhance FP utilization in pastoralist community. It was cognizant that, Ethiopia is the second most populous country in Africa. And there is a great discrepancy between contraceptive use, unmet need for FP and maternal and child morbidity and mortality between the pastoralist and agrarian community. Pastoralist community in the country expressed as low contraceptive users, a high unmet need for FP and highest maternal and child morbidity and mortality. The previous study indicates that only 5.4% of the women use contraceptive. The most common reason mentioned for not using of contraceptive are lack of awareness, demand for a large number of children and male dominance in all decision making power in general and FP in particular. In light of this, the study hypothesized that working with men and educating women towards the use of FP could enhance the use of family planning utilization.
Other Name: Women empowerment

Experimental: Male Involvement
In the married women arm there was an intervention with health education provision based on the baseline finding so as to fill the gap.Faema leader and video from (role model women who start to use FP, model who allows his wife to use FP, religious leader, FP experts was used.Health extension workers were responsible in assisting the faema leader. Twice a month there was a provision of health education message about family planning for a total of 9 months.
Behavioral: Male Involvement
Male involvement was a feature of intervention in this arm. Comprehensive health education about FP was given in addition to the video message about FP. In pastoralist community the most reason mentioned for not using of FP are husband objection and religion influence. And most of the decisions are in the palm of husband to seek care for reproductive, maternal and neonatal health in general and FP in particular. Besides, the pastoralist community manifested by high total fertility rate and maternal and child morbidity and mortality.
Other Name: women empowerment through men involvement

Control group
The third arm in this community-based intervention was following the community without provision of male and married women education. In this arm, there was no intervention by the researchers. However, the activities performed by the government about family planning provision was maintained.
Other: Control group
The third group in this community based intervention was following the community without provision of male iand married women education. In this group there was no intervention by the researchers. However, the activities performed by the government about family planning provision was maintained.
Other Name: Active comparator




Primary Outcome Measures :
  1. Family planning utilization [ Time Frame: 9 months ]
    the family planning utilization will be assessed by asking the participant either use or not use of contraceptive during data collection.Both the ever use or current use of the family planning will be collected from the married women.


Secondary Outcome Measures :
  1. Intention to use family planning [ Time Frame: 9 months ]
    A total of 9 items which has a natural ascending order was used. The items includes the following points. I am not clear with the benefits of using family planning , at this moment, I can list some of the benefits of family planning use I would gain if I use it, I am happy if I could use family planning to space the number of children I would have in the future, I am willing to use family planning to space/limit number of children, I have already decided that I should use family planning in the near future, I have ever used family planning in the previous 6 months and I found it relevant me, I have ever used FP in the past 6 months and I am quite sure I will continue using it in the future and It is expected that women in our community should use family planning and so do I.



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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450564


Locations
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Ethiopia
Afar Region
Semera, Zone 1, Ethiopia, 231
Sponsors and Collaborators
Mekelle University
Investigators
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Study Director: Belete Assefa Mekelle University College of Health Science, Academic and research Director
Study Chair: Mohamed Ahmed Semera University, Director of Research and community Service
Study Chair: Yasin Habib Deputy Head of Afar regional Health Bureau
Principal Investigator: Mussie Alemayehu Mekelle University, College of Health Sciences, School of Public Health

Publications:
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

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Responsible Party: Mussie Alemayehu, Principal Investigator, Mekelle University
ClinicalTrials.gov Identifier: NCT03450564     History of Changes
Other Study ID Numbers: Mekelle University RIF Project
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual data will not be shred to other individual to keep the confidentiality of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No