NCT06450756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,496

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 5, 2024

Last Update Submit

June 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Men Involvement in Family planning

    Up to six months

Study Arms (3)

Couples arm .

EXPERIMENTAL

The Couples Arm intervention addressed gaps identified from baseline findings. It involved comprehensive family planning education delivered to married women and men by community agents, Health Extension Workers, and FP experts using flyers, booklets, and face-to-face discussions. Health Extension Workers supported community agents in delivering health education messages about family planning twice a month for 6 months, with each session lasting 2 hours. Note: The group size for the Couples Arm was 748 couples (374 women and 374 men).

Behavioral: Couples arm

Male arm

EXPERIMENTAL

The intervention in the married male arm provided health education based on baseline findings to address gaps. Community agents and videos featuring men involved in family planning (FP), a male model supporting his wife's FP use, and a supportive husband sharing information with his wife were used. Clan leaders "Abbaa Gada" (Indigenous Oromo), religious leaders, and district FP experts also played key roles. Monthly 1-hour sessions over 6 months delivered health education messages about FP. The 374 men selected were the husbands in the intervention group, participating in household and individual-level interventions alongside their wives and attending community gatherings twice. Note: The group size for the male arm (Male Involvement group) was 374 men.

Behavioral: Male arm

Control arm

NO INTERVENTION

This arm of the Couples-based intervention involves observing the community without providing male education or couples' education at the household/individual level. There is no active intervention by the researchers, but government family planning activities continue. Couples in the control arm are not exposed to the comprehensive interventions of the intervention arms. They only receive the standard intervention as per national guidelines, involving routine reproductive health care. 748 couples (374 women and 374 men) were assigned to the control group, with routine healthcare access or no specific intervention. Note: The group size for the control arm was 748 couples (374 women and 374 men).

Interventions

Couples armBEHAVIORAL

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.

Also known as: Women Empowerment.
Couples arm .
Male armBEHAVIORAL

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.

Also known as: Male Involvement Arm
Male arm

Eligibility Criteria

Age15 Years - 49 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipants self-identifying as male were included in the evaluation to assess male involvement in family planning decision-making and support.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jimma University

Jimma, Oromiya, 378, Ethiopia

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Tefera Belachew, PhD

    Jimma University

    STUDY CHAIR
  • *, Sileshi Garoma, PhD

    Departments of Public Health, Adama Hospital Medical College, Adama, Ethiopia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Only the study participants were masked.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer of Statistics, Population studies(Reproductive Health), and Public Health Senior Researcher

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 10, 2024

Study Start

January 1, 2022

Primary Completion

June 27, 2022

Study Completion

July 3, 2022

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations