Gender Equality and Its Impact on Immunization UptakeNCT06258200
The Role of Gender Transformative Interventions to Strengthen Gender Equity and Improve Immunization Outcomes
A study testing Gender and immunization activities in people with Gender Equality and Its Impact on Immunization Uptake, run by Jhpiego at 19 sites in 2 countries.
Trial summary
The goal of this clinical trial is to test the role of community-based men's engagement interventions in improving immunization uptake and strengthening gender equity at the household level. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender Equality and Its Impact on Immunization Uptake
- What is being tested?
- Gender and immunization activities
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 9 Sep 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caregivers Pakistan:
- Adult women and men aged 18-49 who are in a monogamous relationship, or polygamous relationship in which the male partner agrees to participate with one female partner, and are together caregivers of at least one child 12 months of age or younger
- Have lived in the study site for at least one year
- Plan to continue to live in the study site for at least one year from time of recruitment
- If the caregiver is drawn from one of the intervention Union Councils, must be willing to fully participated in the intervention for the full implementation period
- Caregivers Togo:
Show all 48Show fewer
- Adult women and men aged 18-49 who are in a monogamous relationship, or are in a polygamous relationship in which the man resides only with the woman who is also involved in the study, and who and are together caregivers of at least one child 12 months of age or younger
- Have lived in the study site for at least one year
- Plan to continue to live in the study site for at least one year from time of recruitment
- If the caregiver is drawn from one of the intervention communities, must be willing to fully participate in the intervention for the full implementation period
- Community mobilizers Pakistan:
- A woman or man currently living in the intervention Union Councils
- Has at least one child who has received the complete vaccine series
- Fluently speak the language that is most commonly spoken in the Union Council in which they live
- Be able to read and write
- Have previous experience of working on advocacy and community mobilization
- Have previously worked on childhood immunization mobilization
- Are familiar with the community influencers
- Are willing to complete training for the intervention
- Must be willing to actively implement intervention for the full implementation period
- Papas Champions Togo:
- Be a married man with children, who has demonstrated his involvement in his children's health
- Has at least one child who has received the complete vaccine series
- Currently live in the intervention community
- Fluently speak the language that is most commonly spoken in the community in which they live
- Be able to read and write
- Be willing to promote the benefits of vaccination to other fathers in the community
- Be willing to work on a voluntary basis*
- Be accepted by the local community and recognized as a responsible and respectable person.
- Be willing to complete training for the intervention
- Be willing to actively implement the intervention for the full implementation period
- CSO Leaders Pakistan:
- Be based in one of the intervention Union Councils
- Actively support implementation intervention
- CSO Leaders Togo:
- Be based in one of the intervention districts
- Actively support implementation intervention
- Community Leaders Pakistan:
- Be based in one of the intervention Union Councils
- Have known influence on gender dynamics, caregiving, and child health behaviors including immunization
- Be willing to participate in the values clarification and attitudinal transformation activities conducted as part of the intervention
- Community Leaders Togo:
- Be based in one of the intervention communities
- Have known influence on gender dynamics, caregiving, and child health behaviors including immunization
- Be willing to participate in the community sensitization activities conducted as part of the intervention
- EPI Stakeholders Pakistan/Togo:
- Be based in one of the study districts since the beginning of the study
- Be familiar with the operations research intervention conducted as part of the study
Who cannot join
- Any individuals that do not meet all of the above inclusion criteria or do not agree to participate in the study will be excluded from data collection. In addition, individuals who are unable to make decisions/respond to questions on their own without assistance by someone else will also be excluded from enrolment.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Togo15 sites
Community Setting
Abobo / LEBE, Zio
Community Setting
Adakpamé, Golfe
Community Setting
Adamavo, Golfe
Community Setting
Ahépé, Yoto
Community Setting
Dagbati, Vo
Community Setting
Dzrekpo /klologo, Vo
Community Setting
Gbodjome / Kpogan Agbetiko, Lacs
Community Setting
Gbodjome /agbataloglo, Lacs
Community Setting
Kanyikope, Golfe
Community Setting
Kouvé, Yoto
Community Setting
Kpekpleme/ Kativou, Moyen-mono
Community Setting
Mission TOVE / Apessito, Zio
Community Setting
Moretan /assati, Mono-Est
Community Setting
Ségbé, Golfe
Community Setting
TADO /tado DOME, Moyen-mono
Pakistan4 sites
Community Setting
UC 10/B, Quetta
Community Setting
UC 13/A, Quetta
Community Setting
Uc-10 Pehalwan Goth - Gulshan Town, Karachi East
Community Setting
Uc-11 Garden East - Jamshed Town, Karachi East
About this study
Official title: Examining the Role of Gender Transformative Community Interventions to Strengthen Gender Equity and Improve Immunization Outcomes in Togo and Pakistan
The goal of this clinical trial is to test the role of community-based men's engagement interventions in improving immunization uptake and strengthening gender equity at the household level. The main questions it aims to answer are: (1) Does household and community engagement of male caregivers and couples improve equitable gender relations, including increased male involvement in household tasks and childcare, in Togo and Pakistan, compared with communities that did not receive an intervention? (2) Can household and community engagement of male caregivers and couples increase support for and rates of age-appropriate timely immunization among children under 12 months of age, in Togo and Pakistan, compared with communities that did not receive an intervention? (3) How feasible, acceptable, and appropriate is it for CSO staff/volunteers to engage female and male caregivers and community leaders using gender transformative approaches (including household visits and group discussions) as assessed over a seven-month period? (4) What is the cost of gender transformative engagement of male and female caregivers and community leaders by CSO staff/volunteers compared to standard childhood immunization outreach services over a seven-month period?
Participants (male and female caregivers of children under 12 months of age) will be sorted into intervention or comparison groups based on their community of residence. Participants in the intervention group will:
Read more
- Receive household visits to raise awareness of immunization benefits and gender equity
- Participate in couples communication discussion groups
- Receive immunization and gender equity messaging from community leaders and other influencers.
Researchers will compare the intervention group with comparison groups in similar communities to see if the intervention group demonstrates improved equitable gender relations and increased rates of immunization compared to the comparison group which does not receive the intervention.
- Being tested
- Gender and immunization activities, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gender and immunization activitiesBehavioural
Household visits from community mobilizers, participation in couples communication groups, and messaging from community leaders.
No interventionOther
Participants in the comparison group will not receive any intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in this arm will receive behavioral interventions, including household visits, participation in couples discussion groups, and messaging from community leaders. Receives: Behavioral: Gender and immunization activities |
| Comparison | Experimental | Participants in this arm will not receive any interventions. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sharing of childcare and household tasks
Administered to all male caregivers via survey, sample of female caregivers via FGDs:
How do you divide the following childcare and household tasks: (1) washing clothes/laundry; (2) cleaning the house and surroundings; (3) cooking for the household; (4) making the bed; (5) providing daily care of children; (6) bathing children. [Gendered division of household labor]
Responses range from 1 = woman always does the task, 3 = shared equally or done together, 5 = man always does the task.
Measured: 7 months
Secondary outcomes (7)
Couples' communication
Administered to all male caregivers via survey, sample of female caregivers via FGDs:
In the last three months, how many times have you discussed with your partner about immunizing your child, and offered your opinion about immunizing your child as part of the discussion? [MOMENTUM]
Responses range from 0 = never, 1 = rarely (1-2 times), 2 = sometimes (3-5 times), 3 = a lot (6 or more times)
Measured: 7 months
Decision-making about child health practices, including vaccination
Administered to all male caregivers via survey, sample of female caregivers via FGDs:
Did you take part in the decision to immunize your child? [Adapted from Galle et al, 2011]
Responses range from 1 =I was the sole decision-maker; 2 = I made the decision jointly with my partner; 3 = I made the decision jointly with someone else; 4 = My partner was the sole decision-maker
Measured: 7 months
Vaccination uptake
Review of vaccine cards or interviewee responses for date of the following vaccines:
- Penta 1 (six weeks)
- Penta 3 (14 weeks)
- MCV 1 (9 months)
- MCV 2 (15 months)
Measured: 7 months
Acceptability of intervention
Measured through monthly pulse surveys to community mobilizers, through pre/post tests during the training of community mobilizers, and through a lessons learned workshop at the end of the intervention.
Measured: Pre/post test: prior to intervention, as part of implementer training (month zero); pulse surveys: monthly; Lessons learned workshop: Month 4
Appropriateness of the intervention
Measured through monthly pulse surveys administered to community mobilizers as well as a lessons learned workshop immediately following the intervention
Measured: Pulse surveys: monthly; Lessons learned workshop: Month 4
Feasibility of the intervention
Measured through monthly pulse surveys to community mobilizers, through pre/post tests during the training of community mobilizers, monthly supervision data, and through a lessons learned workshop at the end of the intervention
Measured: Pre/post test: prior to intervention, as part of implementer training (month zero); pulse surveys and supervision data: monthly; Lessons learned workshop: Month 4
Cost of intervention
This will include analysis of:
- CSO costs
- Technology support costs
- Materials and training costs
- Other costs as appropriate
Measured: Months 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start9 Sep 2024
- Primary completion8 Aug 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender Equality and Its Impact on Immunization UptakeStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will have two arms, an intervention and comparison arm, and participants will be grouped into arms based on their community of residence. Participants in the intervention arm will receive behavioral interventions, including household visits, participation in couple discussion groups, and messaging from community leaders.
- Masking
- None (open label)
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- Gavi, The Vaccine Alliance
- Responsible party
- Sponsor
- Investigators
- Elaine Charurat, Study director, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258200
- Sponsor's protocol ID
- IRB00027395
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The de-identified data set will be uploaded in an online repository accessible to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Role of Gender Transformative Community Interventions to Strengthen Gender Equity and Improve Immunization Outcomes in Togo and Pakistan
- ClinicalTrials.gov ID
- NCT06258200
- Acronym / sponsor ID
- IRB00027395
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- Gavi, The Vaccine Alliance
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Feb 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.
The goal of this clinical trial is to test the role of community-based men's engagement interventions in improving immunization uptake and strengthening gender equity at the household level. The main questions it aims to answer are: (1) Does household and community engagement of male caregivers and couples improve equitable gender relations, including increased male involvement in household tasks and childcare, in Togo and Pakistan, compared with communities that did not receive an intervention? (2) Can household and community engagement of male caregivers and couples increase support for and rates of age-appropriate timely immunization among children under 12 months of age, in Togo and Pakistan, compared with communities that did not receive an intervention? (3) How feasible, acceptable, and appropriate is it for CSO staff/volunteers to engage female and male caregivers and community leaders using gender transformative approaches (including household visits and group discussions) as assessed over a seven-month period? (4) What is the cost of gender transformative engagement of male and female caregivers and community leaders by CSO staff/volunteers compared to standard childhood immunization outreach services over a seven-month period?
Participants (male and female caregivers of children under 12 months of age) will be sorted into intervention or comparison groups based on their community of residence. Participants in the intervention group will:
- Receive household visits to raise awareness of immunization benefits and gender equity
- Participate in couples communication discussion groups
- Receive immunization and gender equity messaging from community leaders and other influencers.
Researchers will compare the intervention group with comparison groups in similar communities to see if the intervention group demonstrates improved equitable gender relations and increased rates of immunization compared to the comparison group which does not receive the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will have two arms, an intervention and comparison arm, and participants will be grouped into arms based on their community of residence. Participants in the intervention arm will receive behavioral interventions, including household visits, participation in couple discussion groups, and messaging from community leaders.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Gender and immunization activitiesParticipants in this arm will receive behavioral interventions, including household visits, participation in couples discussion groups, and messaging from community leaders. |
| Comparison | Experimental | Other: No interventionParticipants in this arm will not receive any interventions. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (48 listed)
- Adult women and men aged 18-49 who are in a monogamous relationship, or polygamous relationship in which the male partner agrees to participate with one female partner, and are together caregivers of at least one child 12 months of age or younger
- Have lived in the study site for at least one year
- Plan to continue to live in the study site for at least one year from time of recruitment
- If the caregiver is drawn from one of the intervention Union Councils, must be willing to fully participated in the intervention for the full implementation period
- Adult women and men aged 18-49 who are in a monogamous relationship, or are in a polygamous relationship in which the man resides only with the woman who is also involved in the study, and who and are together caregivers of at least one child 12 months of age or younger
Key exclusion criteria (1 listed)
- Any individuals that do not meet all of the above inclusion criteria or do not agree to participate in the study will be excluded from data collection. In addition, individuals who are unable to make decisions/respond to questions on their own without assistance by someone else will also be excluded from enrolment.
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 |
|---|---|---|
| Gender and immunization activitiesHousehold visits from community mobilizers, participation in couples communication groups, and messaging from community leaders. | Behavioural | Intervention group |
| No interventionParticipants in the comparison group will not receive any intervention | Other | Comparison |
Primary outcome
Sharing of childcare and household tasks
Time frame: 7 months
Administered to all male caregivers via survey, sample of female caregivers via FGDs: How do you divide the following childcare and household tasks: (1) washing clothes/laundry; (2) cleaning the house and surroundings; (3) cooking for the household; (4) making the bed; (5) providing daily care of children; (6) bathing children. [Gendered division of household labor] Responses range from 1 = woman always does the task, 3 = shared equally or done together, 5 = man always does the task.
7 secondary outcomes
Couples' communication
Time frame: 7 months
Decision-making about child health practices, including vaccination
Time frame: 7 months
Vaccination uptake
Time frame: 7 months
Acceptability of intervention
Time frame: Pre/post test: prior to intervention, as part of implementer training (month zero); pulse surveys: monthly; Lessons learned workshop: Month 4
Appropriateness of the intervention
Time frame: Pulse surveys: monthly; Lessons learned workshop: Month 4
Feasibility of the intervention
Time frame: Pre/post test: prior to intervention, as part of implementer training (month zero); pulse surveys and supervision data: monthly; Lessons learned workshop: Month 4
Cost of intervention
Time frame: Months 1-4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No. The de-identified data set will be uploaded in an online repository accessible to other researchers.
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.
Elaine Charurat study director
Jhpiego
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gender and immunization activities in people with Gender Equality and Its Impact on Immunization Uptake, run by Jhpiego at 19 sites in 2 countries.
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 48 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Togo, Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Sharing of childcare and household tasks (time frame: 7 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 17 Sep 2025.