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临床试验/NCT06261970
NCT06261970已完成不适用

Leveraging and Strengthening Local Systems to Increase First-time Mothers' Use of Postpartum Family Planning in Tanzania: A Cluster Randomized Control Trial

George Washington University2 个研究点 分布在 1 个国家目标入组 1,134 人开始时间: 2023年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,134
试验地点
2
主要终点
Currently Using PPFP

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
14 Years 至 25 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant or has child under 9 months
  • Aged 14-25

排除标准

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

研究组 & 干预措施

Connect Community Level Enhancements

Experimental

Community Support Groups (CSGs)*: Connect enhances Lishe Endelevu's to require at least four FTMs to be recruited into each CSG established. Connect enhances the CSG toolkit to include FTM focused content, including information on birth spacing and PPFP.

Home visits*: the CHWs who facilitate the community support groups also conduct home visits to FTMs. CHWs are provided a job aid to counsel FTMs and their families on PPFP. Counseling addresses myths about FP, norms around fertility and spacing, and includes prompts to engage family and male partners when present. Counseling also integrates timely nutrition information from the support groups with PPFP information. CHWs can provide non-clinical FP methods (pills, condoms) and provide referrals for services at public health facilities

干预措施: Connect (Behavioral)

Control

No Intervention

No additional Connect intervention. Lishe Endelevu Community Support Groups Operate per usual.

结局指标

主要结局

Currently Using PPFP

时间窗: At time of 12 month survey

Currently using a modern contraceptive method (among women who have given birth). modern methods are defined here as male condoms, oral contraceptive pills, injectables, and long-active reversible contraception (LARC) methods (implants and intrauterine device (IUD)).

Adoption of of Postpartum Family Planning (PPFP):

时间窗: 12 months

1\. Indicator for adopted a modern contraceptive method within 12 months after giving birth (among women who have given birth). Adoption of a modern contraceptive method in the first year after giving birth, among FTMs who have given birth-modern methods are defined here as male condoms, oral contraceptive pills, injectables, and long-active reversible contraception (LARC) methods (implants and intrauterine device (IUD)). We will use the following indicators to measure adoption and continuation of PPFP:

次要结局

  • Quality of Family Planning Counseling(12 months)
  • PPFP Attitudes(12 months)
  • PPFP Knowledge(12 months)
  • Adopted or Intention to adopt PPFP(12 months)
  • Average Satisfaction with PPFP methods(12 months)
  • Contraceptive Preferences(12 Months)
  • Communication and Agency(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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