Contraceptive UsageNCT06450756
Effect of Male Involvement in Family Planning Education on Contraceptive Use
A study testing Couples arm and Male arm in people with Contraceptive Usage and Family Planning, run by Jimma University at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years
- Conditions the study is for
- Contraceptive Usage, Family Planning
- What is being tested?
- Couples arm and Male arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,496 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Jan 2022to 3 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Contraceptive Usage, Family Planning
- Being tested
- Couples arm, Male arm
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples armBehavioural
Also called Women Empowerment.
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 armBehavioural
Also called Male Involvement 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to six months
Secondary outcomes (1)
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.
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jan 2022
- Primary completion27 Jun 2022
- Study completion3 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Adugna Beyene, Jimma University
- Investigators
- Tefera Belachew, PhD, Study chair, Jimma University*, Sileshi Garoma, PhD, Study chair, Departments of Public Health, Adama Hospital Medical College, Adama, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450756
- Sponsor's protocol ID
- SAB2019
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06450756
- Acronym / sponsor ID
- SAB2019
- Conditions
- Contraceptive Usage, Family Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,496 participants (actual)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 3 Jul 2022 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Couples arm . | Experimental | Behavioral: Couples armThe 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). |
| Male arm | Experimental | Behavioral: Male armThe 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. |
| 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). |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couples armAlso: Women Empowerment.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. | Behavioural | Couples arm . |
| Male armAlso: Male Involvement ArmThis 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. | Behavioural | Male arm |
Primary outcome
Contraceptive Utilization Rate
Time frame: Up to six months
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.
1 secondary outcome
Men Involvement in Family planning
Time frame: Up to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tefera Belachew, PhD study chair
Jimma University
*, Sileshi Garoma, PhD study chair
Departments of Public Health, Adama Hospital Medical College, Adama, Ethiopia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couples arm and Male arm in people with Contraceptive Usage and Family Planning, run by Jimma University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive Utilization Rate (time frame: Up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.