Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06261970
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-08
Brief Title:
Increase First-time Mothers Use of Postpartum Family Planning in Tanzania The Connect Project
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
Leveraging and Strengthening Local Systems to Increase First-time Mothers Use of Postpartum Family Planning in Tanzania A Cluster Randomized Control Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Connect TZ
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 Connects 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 Connects 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 Connects 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 Connects 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 Connects 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 Connects 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 Connects 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 Connects 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
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 Connects 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 Connects 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 Connects 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 Connects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None