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Increase First-time Mothers' Use of Postpartum Family Planning in Tanzania: The Connect Project (Connect TZ)

George Washington University (GW) logo

George Washington University (GW)

Status

Completed

Conditions

Contraceptive Usage

Treatments

Behavioral: Connect

Study type

Interventional

Funder types

Other

Identifiers

NCT06261970
999002684

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,134 patients

Sex

Female

Ages

14 to 25 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,134 participants in 2 patient groups

Connect Community Level Enhancements
Experimental group
Description:
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
Treatment:
Behavioral: Connect
Control
No Intervention group
Description:
No additional Connect intervention. Lishe Endelevu Community Support Groups Operate per usual.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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