NCT06666036

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\'s approach through a cluster randomized control trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,308

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2025

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

October 29, 2024

Last Update Submit

February 10, 2026

Conditions

Keywords

postpartum family planningfirst time mothersmodern contraception

Outcome Measures

Primary Outcomes (4)

  • Adoption of Postpartum Family Planning (PPFP):

    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)).

    12 months

  • Currently using PPFP

    2\. 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)).

    12 months

  • Postnatal Care uptake

    3\. Indicator for received any PNC, among FTMs who have given birth. Uptake of facility-based PNC for mother and baby. Care that is reported to be a PNC visit but occurs outside of a health facility is not considered a PNC visit for these indicators.

    12 months

  • Timing of Postnatal Care (PNC)

    4\. FTM received PNC within 72 hours of delivery, among FTMs who have given birth more than 72 hours ago. Care that is reported to be a PNC visit but occurs outside of a health facility is not considered a PNC visit for these indicators.

    12 months

Secondary Outcomes (9)

  • Adopted or Intention to adopt PPFP

    12 months

  • Quality of additional PNC

    12 months

  • Quality of early PNC

    12 months

  • Contraceptive Preferences

    12 months

  • Quality of Family Planning Counselling

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Connect Community Level Enhancements

EXPERIMENTAL

At the community level, Connect enhancements build on standard community health worker (CHW) home visits implemented by the government and pre-existing courtyard meetings implemented by the Government of Bangladesh. Courtyard meetings are led by CHWs and convened monthly for new mothers and their families. CHWs sensitize participants to postpartum family planning (PPFP) and share the importance of available services from facilities. Connect reinforces the regularity of these meetings. CHWs receive additional training to be sensitized to the needs of first time parents and engage first-time mothers to attend. Home Visits: CHWs conduct home visits to women who are pregnant or recently gave birth in their catchment areas. During these visits CHWs provide basic care, information on ANC, PNC and PPFP, and provide access to FP methods. Connect targets home visits to first time mothers and those who gave birth at home. They provide print materials to support PPFP and PNC care.

Behavioral: Connect

Control

NO INTERVENTION

No additional Connect intervention. Pre-existing institutionalized services for expecting and new mothers.

Interventions

ConnectBEHAVIORAL

Community level enhancements

Connect Community Level Enhancements

Eligibility Criteria

Age14 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identifies as a first time mother
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technical Assistance Inc

Cox’s Bāzār, Bangladesh

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2024

First Posted

October 30, 2024

Study Start

May 15, 2023

Primary Completion

February 2, 2025

Study Completion

February 2, 2025

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Deidentified data will be made publicly available

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
2025

Locations