Clinical trial NCT06666036: Increase First-time Mothers' Use of Postpartum Family Planning in Bangladesh: The Connect Project
Official title: Leveraging and Strengthening Local Systems to Increase First-time Mothers' Use of Postpartum Family Planning and Improve Postnatal Care in Bangladesh: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Contraceptive Usage
Keywords: postpartum family planning
first time mothers
modern contraception
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Save the Children
name: Save the Children International Bangladesh
name: Bill and Melinda Gates Foundation
First posted: 2024-10-30
Enrollment: 2308
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: While a growing body of programs have shown promise to increase uptake of contraception among FTMs, difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. Despite the importance of PNC it remains a neglected area within the maternal and newborn health continuum of care in many areas around the world. Programs working to improve coverage of PNC and PNHVs have faced difficulties with insufficient human resources and health systems, suggesting a need for prioritization of care in settings with limited human resources. Connect's approach aims to strengthen existing government health systems and community-level health efforts, including those supported through local and international non-governmental organizations, by developing and testing light-touch "enhancements" with the goal of increasing PPFP and PNC uptake among FTMs. The investigators will evaluate Connect\&#39;s approach through a cluster randomized control trial.

Detailed description: While a growing body of programs have shown promise to increase uptake of contraception among FTMs, difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. Despite the importance of PNC it remains a neglected area within the maternal and newborn health continuum of care in many areas around the world. Programs working to improve coverage of PNC and PNHVs have faced difficulties with insufficient human resources and health systems, suggesting a need for prioritization of care in settings with limited human resources. Connect's approach aims to strengthen existing government health systems and community-level health efforts, including those supported through local and international non-governmental organizations, by developing and testing light-touch "enhancements" with the goal of increasing PPFP and PNC uptake among FTMs. The investigators will evaluate Connect\&#39;s approach through a cluster randomized control trial.

The overall goal of this study is to add to the evidence base on scalable and efficacious approaches for increasing PPFP adoption and improving timing and uptake of PNC among adolescent and young FTMs in order to increase spacing before subsequent births and improve maternal and neonatal outcomes.

Specifically, this protocol outlines the parameters for the evaluation of the impact of Connect's package of community-level interventions-or "enhancements"-on adoption and continued use of modern PPFP methods and uptake of PNC among adolescent (ages 15-19 years) and young (ages 20-24 years) FTMs. These interventions are enhanced home visits by family welfare assistants (FWA) and FWA-led enhanced courtyard meetings.

FWA enhanced home visits are targeted based on identification of at-risk mother-baby dyads through a risk-stratification algorithm to ensure home visits to all FTMs who give birth at home and to at-risk mothers, including first time mothers. FWAs performing the enhanced home visits have undergone additional training emphasizing the importance of referring mothers to facility-based providers, encouraging facility delivery, encouraging attendance of courtyard meetings, involving other family members during the visit, and on the specific needs of first-time parents. Invitation cards to go to the nearest facility and mother-baby booklets within formaiton on ANC, PNC, AND PPFP are also provided.

Enhanced courtyard meetings include standard content provided across all locations but Connect reinforces the regularity of these meetings and the FWAs running them will be more sensitized to first-time parents.

Alongside the wider-scale implementation of these enhancements, Connect will support the Ministry of Health as well as local and international NGOs to sustain the enhancements beyond the donor-funded project.

There are four specific aims for understanding the efficacy for Connect's packages:

1. To estimate the causal impact and cost-effectiveness of Connect's community-level interventions (compared to a control) on the primary outcomes of adoption and continuation of modern PPFP methods and timing and uptake of PNC among FTMs ages 15-24 in Noakhali and Madaripur, Bangladesh.
2. To examine the causal impact of Connect's community-level interventions (compared to a control) on secondary outcomes (specified below) among FTMs ages 15-24 in Noakhali and Madaripur, Bangladesh.
3. To compare the impacts of Connect's community-level interventions on adolescent FTMs (ages 15-19) versus young FTMs (ages 20-24).

Eligibility criteria: Inclusion Criteria:

* Pregnant or has child under 5 months
* Aged 14-25

Exclusion Criteria:

* Younger than 14 or over 25
* Has more than one child or is pregnant and has a child

Primary outcomes:
measure: Adoption of Postpartum Family Planning (PPFP):
timeFrame: 12 months
measure: Currently using PPFP
timeFrame: 12 months
measure: Postnatal Care uptake
timeFrame: 12 months
measure: Timing of Postnatal Care (PNC)
timeFrame: 12 months
Secondary outcomes:
measure: Adopted or Intention to adopt PPFP
timeFrame: 12 months
measure: Quality of additional PNC
timeFrame: 12 months
measure: Quality of early PNC
timeFrame: 12 months
measure: Contraceptive Preferences
timeFrame: 12 months
measure: Quality of Family Planning Counselling
timeFrame: 12 months
measure: Communication and agency
timeFrame: 12 months
measure: PPFP knowledge
timeFrame: 12 months
measure: PPFP Attitudes
timeFrame: 12 months
measure: PNC attitudes
timeFrame: 12 months
Other outcomes:
Locations:
city: Cox's Bāzār
country: Bangladesh
facility: Technical Assistance Inc
Study officials:
References: