NCT06261970

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,134

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

February 22, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
12 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 5, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

February 8, 2024

Last Update Submit

February 3, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Adoption of 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)). We will use the following indicators to measure adoption and continuation of PPFP:

    12 months

  • Currently Using PPFP

    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)).

    At time of 12 month survey

Secondary Outcomes (7)

  • Adopted or Intention to adopt PPFP

    12 months

  • Average Satisfaction with PPFP methods

    12 months

  • Contraceptive Preferences

    12 Months

  • Quality of Family Planning Counseling

    12 months

  • Communication and Agency

    12 months

  • +2 more secondary outcomes

Study Arms (2)

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

Behavioral: Connect

Control

NO INTERVENTION

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

Interventions

ConnectBEHAVIORAL

Community level enhancements

Connect Community Level Enhancements

Eligibility Criteria

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

You may qualify if:

  • Pregnant or has child under 9 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 (2)

EDI

Bahi, Dodoma, Tanzania

Location

EDI

Kongwa, Dodoma, Tanzania

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Sarah Baird, PhD

    George Washington University

    PRINCIPAL INVESTIGATOR

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

February 8, 2024

First Posted

February 15, 2024

Study Start

February 22, 2023

Primary Completion

February 2, 2025

Study Completion

February 2, 2025

Last Updated

February 5, 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