The Role of Gender Transformative Interventions to Strengthen Gender Equity and Improve Immunization Outcomes

September 11, 2025 updated by: Jhpiego

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:

  • 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
448

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Karachi East
      • Uc-10 Pehalwan Goth - Gulshan Town, Karachi East, Pakistan
        • Community setting
      • Uc-11 Garden East - Jamshed Town, Karachi East, Pakistan
        • Community setting
    • Quetta
      • UC 10/B, Quetta, Pakistan
        • Community setting
      • UC 13/A, Quetta, Pakistan
        • Community setting
  • Togo
    • Golfe
      • Adakpamé, Golfe, Togo
        • Community setting
      • Adamavo, Golfe, Togo
        • Community setting
      • Kanyikope, Golfe, Togo
        • Community setting
      • Ségbé, Golfe, Togo
        • Community setting
    • Lacs
      • Gbodjome / Kpogan Agbetiko, Lacs, Togo
        • Community setting
      • Gbodjome /agbataloglo, Lacs, Togo
        • Community setting
    • Mono-Est
      • Moretan /assati, Mono-Est, Togo
        • Community setting
    • Moyen-mono
      • Kpekpleme/ Kativou, Moyen-mono, Togo
        • Community setting
      • TADO /tado DOME, Moyen-mono, Togo
        • Community setting
    • Vo
      • Dagbati, Vo, Togo
        • Community setting
      • Dzrekpo /klologo, Vo, Togo
        • Community setting
    • Yoto
      • Ahépé, Yoto, Togo
        • Community setting
      • Kouvé, Yoto, Togo
        • Community setting
    • Zio
      • Abobo / LEBE, Zio, Togo
        • Community setting
      • Mission TOVE / Apessito, Zio, Togo
        • Community setting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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:

  • 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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Participants in this arm will receive behavioral interventions, including household visits, participation in couples discussion groups, and messaging from community leaders.
Behavioral: Gender and immunization activities
Household visits from community mobilizers, participation in couples communication groups, and messaging from community leaders.
Experimental: Comparison
Participants in this arm will not receive any interventions.
Other: No intervention
Participants in the comparison group will not receive any intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Couples' communication
Time Frame: 7 months

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)
7 months
Decision-making about child health practices, including vaccination
Time Frame: 7 months

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
7 months
Vaccination uptake
Time Frame: 7 months

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)
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
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.
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
Measured through monthly pulse surveys administered to community mobilizers as well as a lessons learned workshop immediately following the intervention
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
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
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

This will include analysis of:

  • CSO costs
  • Technology support costs
  • Materials and training costs
  • Other costs as appropriate
Months 1-4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jhpiego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gavi, The Vaccine Alliance

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Elaine Charurat, Jhpiego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00027395

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The de-identified data set will be uploaded in an online repository accessible to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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