Clinical trial NCT06258200: The Role of Gender Transformative Interventions to Strengthen Gender Equity and Improve Immunization Outcomes
Official title: Examining the Role of Gender Transformative Community Interventions to Strengthen Gender Equity and Improve Immunization Outcomes in Togo and Pakistan
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gender Equality and Its Impact on Immunization Uptake
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: Gavi, The Vaccine Alliance
First posted: 2024-02-14
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sharing of childcare and household tasks
timeFrame: 7 months
Secondary outcomes:
measure: Couples' communication
timeFrame: 7 months
measure: Decision-making about child health practices, including vaccination
timeFrame: 7 months
measure: Vaccination uptake
timeFrame: 7 months
measure: Acceptability of intervention
timeFrame: Pre/post test: prior to intervention, as part of implementer training (month zero); pulse surveys: monthly; Lessons learned workshop: Month 4
measure: Appropriateness of the intervention
timeFrame: Pulse surveys: monthly; Lessons learned workshop: Month 4
measure: Feasibility of the intervention
timeFrame: Pre/post test: prior to intervention, as part of implementer training (month zero); pulse surveys and supervision data: monthly; Lessons learned workshop: Month 4
measure: Cost of intervention
timeFrame: Months 1-4
Other outcomes:
Locations:
city: Uc-10 Pehalwan Goth - Gulshan Town
country: Pakistan
facility: Community Setting
state: Karachi East
city: Uc-11 Garden East - Jamshed Town
country: Pakistan
facility: Community Setting
state: Karachi East
city: UC 10/b
country: Pakistan
facility: Community Setting
state: Quetta
city: UC 13/a
country: Pakistan
facility: Community Setting
state: Quetta
city: Adakpame
country: Togo
facility: Community Setting
state: Golfe
city: Adamavo
country: Togo
facility: Community Setting
state: Golfe
city: Kanyikope
country: Togo
facility: Community Setting
state: Golfe
city: Segbe
country: Togo
facility: Community Setting
state: Golfe
city: Gbodjome / Kpogan Agbetiko
country: Togo
facility: Community Setting
state: Lacs
city: Gbodjome /agbataloglo
country: Togo
facility: Community Setting
state: Lacs
city: Moretan /assati
country: Togo
facility: Community Setting
state: Mono-Est
city: Kpekpleme/ Kativou
country: Togo
facility: Community Setting
state: Moyen-mono
city: TADO /tado DOME
country: Togo
facility: Community Setting
state: Moyen-mono
city: Dagbati
country: Togo
facility: Community Setting
state: Vo
city: Dzrekpo /klologo
country: Togo
facility: Community Setting
state: Vo
city: Ahepe
country: Togo
facility: Community Setting
state: Yoto
city: Kouve
country: Togo
facility: Community Setting
state: Yoto
city: Abobo / LEBE
country: Togo
facility: Community Setting
state: Zio
city: Mission TOVE / Apessito
country: Togo
facility: Community Setting
state: Zio
Study officials:
affiliation: Jhpiego
name: Elaine Charurat
role: STUDY_DIRECTOR
References: