Effect of Male Involvement in Family Planning Education on Contraceptive Use

Contraceptive Usage Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06450756
• Other study ID #: SAB2019
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: July 3, 2022

Study information

• Verified date: June 2024
• Source: Jimma University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1496
• Est. completion date: July 3, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraceptive Usage
• Family Planning

Intervention

Behavioral:
• Couples arm
The Couples Arm aims to improve family planning (FP) utilization in pastoralist communities, addressing significant disparities in contraceptive use and unmet FP needs between pastoralist and agrarian communities in Ethiopia. Pastoralist areas face challenges such as low contraceptive usage, high unmet FP needs, and elevated rates of maternal and child morbidity and mortality. In 2016, only 9.1% of women in pastoralist areas used contraceptives, compared to a 41% prevalence rate in 2019 for the general population in Ethiopia. Reasons for non-use of contraceptives include lack of knowledge, unwillingness, negative perceptions, desire for many children due to child mortality concerns, and male dominance in FP decision-making. The study hypothesizes that engaging men and educating women about FP could enhance FP utilization, increase male involvement in family planning, and empower women.
• Male arm
This arm focused on promoting male involvement in family planning (FP) through comprehensive health education and video messages. Husbands were encouraged to become supportive partners and share FP information with their wives. Separate education sessions were held for men, recognizing their greater exposure to social activities and information in pastoralist contexts. Pastoralist wives typically rely on their husbands for information due to limited social access. Women in pastoral communities have significant informal power in family decisions, influenced by factors such as age, husband's status, sons' ages, eloquence, and wisdom. Reproductive health discussions are primarily between husband and wife. Education aimed to improve modern contraceptive use, overcoming common barriers like husband objection and religious influence on decision-making.

Locations

Country	Name	City	State
Ethiopia	Jimma University	Jimma	Oromia

Sponsors (1)

Lead Sponsor	Collaborator
Jimma University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contraceptive Utilization Rate	The contraceptive utilization rate was assessed among the study participants. The proportion of married couples who used the contraceptive was compared using the baseline and end-line data from the intervention.	Up to six months
Secondary	Men Involvement in Family planning	The evaluation of male involvement over the 6-month intervention from January 1 to July 3, 2022, was part of the secondary outcome measures. This assessment, conducted at 6 months, utilized a set of 10 items: 3 focused on couples' discussions about family planning (FP) and 7 on husbands' support for their wives. Topics included discussing FP, birth spacing, and limiting births. Spousal support actions assessed included accompanying to health facilities, participating in FP choices, allowing FP use, reminding of schedules, assisting in domestic activities, providing financial support, and being aware of FP side effects. Perspectives on current and future FP support were gathered from both husbands and wives, including both current and non-users of contraception. This allowed for a comprehensive understanding of male involvement in FP decision-making.	Up to six months