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

NCT06258200 | Active Not Recruiting

• 1 other identifier: IRB00027395
• Study Type: interventional
• Target: 448
• Locations: 2 countries
• Sites: 19

Brief 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. 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.

Conditions

Gender Equality and Its Impact on Immunization Uptake

Outcome Measures

Primary Outcomes (1)

• 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.

  7 months

Secondary Outcomes (7)

• Couples' communication

  7 months

• Decision-making about child health practices, including vaccination

  7 months

• Vaccination uptake

  7 months

• Acceptability of 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

  Pulse surveys: monthly; Lessons learned workshop: Month 4

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Comparison

EXPERIMENTAL

Participants in this arm will not receive any interventions.

Other: No intervention

Interventions

Gender and immunization activities BEHAVIORAL

Household visits from community mobilizers, participation in couples communication groups, and messaging from community leaders.

Intervention group

No intervention OTHER

Participants in the comparison group will not receive any intervention

Comparison

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Jhpiego: lead
• Gavi, The Vaccine Alliance: collaborator

Study Sites (19)

Community Setting

Uc-10 Pehalwan Goth - Gulshan Town, Karachi East, Pakistan

Location

Community Setting

Uc-11 Garden East - Jamshed Town, Karachi East, Pakistan

Location

Community Setting

UC 10/B, Quetta, Pakistan

Location

Community Setting

UC 13/A, Quetta, Pakistan

Location

Community Setting

Adakpamé, Golfe, Togo

Location

Community Setting

Adamavo, Golfe, Togo

Location

Community Setting

Kanyikope, Golfe, Togo

Location

Community Setting

Ségbé, Golfe, Togo

Location

Community Setting

Gbodjome / Kpogan Agbetiko, Lacs, Togo

Location

Community Setting

Gbodjome /agbataloglo, Lacs, Togo

Location

Community Setting

Moretan /assati, Mono-Est, Togo

Location

Community Setting

Kpekpleme/ Kativou, Moyen-mono, Togo

Location

Community Setting

TADO /tado DOME, Moyen-mono, Togo

Location

Community Setting

Dagbati, Vo, Togo

Location

Community Setting

Dzrekpo /klologo, Vo, Togo

Location

Community Setting

Ahépé, Yoto, Togo

Location

Community Setting

Kouvé, Yoto, Togo

Location

Community Setting

Abobo / LEBE, Zio, Togo

Location

Community Setting

Mission TOVE / Apessito, Zio, Togo

Location

MeSH Terms

Interventions

Sex

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Elaine Charurat

  Jhpiego

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: September 9, 2024
• Primary Completion: August 8, 2025
• Study Completion: December 31, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (4); TO (15)