Clinical trial NCT06261970: Increase First-time Mothers' Use of Postpartum Family Planning in Tanzania: The Connect Project
Official title: Leveraging and Strengthening Local Systems to Increase First-time Mothers' Use of Postpartum Family Planning in Tanzania: A Cluster Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Contraceptive Usage
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Save the Children
name: Save the Children International Tanzania
name: Bill and Melinda Gates Foundation
First posted: 2024-02-15
Enrollment: 1134
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 use of contraception among first time mothers (FTMs), difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. 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 postpartum Family Planning (PPFP) adoption among FTMs. The investigators will evaluate Connect's approach through a cluster randomized control trial.

Detailed description: While a growing body of programs have shown promise to increase use of contraception among first time mothers (FTMs), difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. 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 postpartum Family Planning (PPFP) adoption among FTMs. The investigators will evaluate Connect'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 uptake 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 interventions-or "enhancements"-on adoption and continued use of modern PPFP methods among adolescent (ages 15-19 years) and young (ages 20-24 years) FTMs. These interventions are community support groups (CSGs) with PPFP-specific content and enhanced training for community health workers (CHWs) around PPFP for delivery during home visits.

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

There are four specific aims for understanding the efficacy for Connects 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 among FTMs ages 15-24 in two districts in Tanzania.
2. To examine the causal impact of Connect's community-level interventions (compared to a control) on secondary outcomes (specified below) among FTMs ages15-24 in two districts in Tanzania.
3. To compare the impacts of Connect's community-level interventions on adolescent FTMs (ages 15-19) versus young FTMs (ages 20-24).
4. To use mixed-methods research to unpack the mechanisms by which the various interventions work, as well as understand for whom they work and why (exploratory analysis).

Eligibility criteria: Inclusion Criteria:

* Pregnant or has child under 9 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 of Postpartum Family Planning (PPFP):
timeFrame: 12 months
measure: Currently Using PPFP
timeFrame: At time of 12 month survey
Secondary outcomes:
measure: Adopted or Intention to adopt PPFP
timeFrame: 12 months
measure: Average Satisfaction with PPFP methods
timeFrame: 12 months
measure: Contraceptive Preferences
timeFrame: 12 Months
measure: Quality of Family Planning Counseling
timeFrame: 12 months
measure: Communication and Agency
timeFrame: 12 months
measure: PPFP Attitudes
timeFrame: 12 months
measure: PPFP Knowledge
timeFrame: 12 months
Other outcomes:
Locations:
city: Bahi
country: Tanzania
facility: EDI
state: Dodoma
city: Kongwa
country: Tanzania
facility: EDI
state: Dodoma
Study officials:
affiliation: George Washington University
name: Sarah Baird, PhD
role: PRINCIPAL_INVESTIGATOR
References: