Clinical trial NCT06450756: Effect of Male Involvement in Family Planning Education on Contraceptive Use
Official title: Effect of Male Involvement in Family Planning Education on Contraceptive Use Among Married Couples in the Pastoralist Community of Fentale District, Eastern Ethiopia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Usage
Family Planning
Lead sponsor: Jimma University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 1496
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aimed to examine the effect of Male Involvement in Family Planning Education on Contraceptive Use Among Married Couples in the Pastoralist Community of Fentale District, Eastern Ethiopia.

Detailed description: The rationale for conducting this study stemmed from the persistent challenges in family planning (FP) utilization observed within pastoralist communities, particularly in the Fentale District of Eastern Ethiopia. Despite progress in modern contraceptive use and male involvement in FP at the national level, these communities continue to face limited male involvement in Family planning and contraceptive coverage. Therefore, the study aimed to address this issue by implementing an integrated behavioral model through a quasi-experimental design. The objective was to assess the effectiveness of various intervention approaches, including strategies to increase male involvement and household-based education, in improving FP utilization among couples in the Fentale District. This evaluation was deemed crucial to address the ongoing challenges and increase contraceptive uptake in pastoralist regions. Fentale District was selected exclusively for this study due to several criteria, including accessibility, social structure, economic strength, and its pastoralist nature. These factors made it an ideal location to examine the impact of interventions on FP utilization within pastoralist communities. In a quasi-experimental study conducted in Fentale District, Eastern Ethiopia, 1496 married couples (748 controls, 748 interventions) were selected through systematic random sampling. Among them, 748 couples (comprising 374 women and 374 men) were assigned to the intervention group. Simultaneously, the remaining 748 couples (also comprising 374 women and 374 men) were assigned to the control group and received routine healthcare access or no specific intervention. It's noteworthy that the 374 men selected for the study were the same individuals as the husbands in the intervention group, participating in household-level or individual-level interventions alongside their wives. Additionally, these men were also part of the Male Involvement Arm, attending community gatherings for a second time, thereby ensuring their participation in both arms of the study.

Eligibility criteria: Inclusion Criteria:

* Married women aged between 15 and 49 years, along with their husbands.
* Non-pregnant women at the time of the study period were included, along with their husbands.
* Only legally married couples were considered.
* Couples who have resided in the village or an area with consistent mobility for the past year.
* Couples cohabiting in the same house within the study area or in areas with mobility were included.
* Couples intending to stay in the district or areas with mobility for at least one year and six months from the data collection period.
* Inclusion of couples where the husband expressed willingness for his wife to participate in the study.
* Only mentally capable couples, ensuring individuals without cognitive impairments, were part of the research.
* Husbands within monogamous marriages (having only one wife) were eligible for analysis.
* Written informed consent was obtained from husbands on behalf of wives under 18, respecting the cultural context and norms of the study area.

Exclusion Criteria:

* Married women not within the reproductive age range (15-49 years old) were excluded from the study, along with their husbands.
* Not Legally married Couples excluded.
* Couples where the husband was unwilling to include his wife in the study were excluded. - Mentally incapable couples, indicating those with cognitive impairments, were not considered in the study.
* Husbands within polygamous marriages (having more than one wife) were also excluded from the analysis, aiming to streamline the focus on monogamous marital dynamics.
* Pregnant women at the time of the survey, along with their husbands were excluded.
* Couples who had not resided in the village or areas with mobility. For the past year were excluded.
* Couples not cohabiting in the same house in the study area or areas with mobility. Were excluded.
* Those who did not plan to stay in the district area or areas with mobility for at least one year and six months from the time of data collection were excluded.
* These exclusions were implemented to enhance the clarity of the study's focus and minimize redundancy of information

Primary outcomes:
measure: Contraceptive Utilization Rate
timeFrame: Up to six months
Secondary outcomes:
measure: Men Involvement in Family planning
timeFrame: Up to six months
Other outcomes:
Locations:
city: Jimma
country: Ethiopia
facility: Jimma University
state: Oromia
Study officials:
affiliation: Jimma University
name: Tefera Belachew, PhD
role: STUDY_CHAIR
affiliation: Departments of Public Health, Adama Hospital Medical College, Adama, Ethiopia
name: *, Sileshi Garoma, PhD
role: STUDY_CHAIR
References: