NCT06266780

Brief Summary

The goal of this study is to explore approaches to improve postpartum contraceptive counseling, information, and uptake through a collaboration between the Harvard Chan School, Rutgers School of Public Health, Jacaranda Health, Jhpiego, and IPSOS, leveraging an existing mobile health platform for intervention delivery and Jacaranda's established partnership with the Kenyan Ministry of Health, county health offices and public maternity hospitals. Jacaranda's PROMPTS mHealth platform has reached over two million pregnant women and new mothers, providing them with needed, tailored information about prenatal and postpartum health along with access to a mobile helpdesk to triage users' questions. Using a targeted human-centered-design process with early postpartum mothers, we developed targeted messaging around family planning and contraceptive method options, with the goal of integrating this new content into Jacaranda's PROMPTS platform. We will conduct a randomized controlled trial with pregnant women engaged with the PROMPTS platform to determine the impact of the intervention package on information and utilization of postpartum contraception. If proven effective, the results of this intervention will be integrated into Jacaranda's PROMPTS system at full scale.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 2, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

February 11, 2024

Last Update Submit

February 11, 2024

Conditions

Keywords

Maternal HealthPostpartum HealthContraceptionFamily PlanningBirth Spacing

Outcome Measures

Primary Outcomes (2)

  • Use of postpartum family planning at 3 months

    The outcome is a binary variable, set to 1 if a participant reports using any modern family planning method (including Lactational Amenorrhea Method (LAM)) at the time of the survey. The modern methods considered will include sterilization (both male and female), implants, Intrauterine Device (IUD), injectables, oral contraceptives (pill), condoms (both male and female), diaphragm, foam/jelly, and LAM.

    3 months

  • Use of postpartum family planning at 6 months

    The outcome is a binary variable, assigned a value of 1 if a participant reports using any modern family planning method, excluding LAM, at the time of the survey. The modern methods considered include sterilization (both male and female), implant, IUD, injectables, oral contraceptives (pill), condoms (both male and female), diaphragm, foam, and jelly.

    6.5 months

Secondary Outcomes (13)

  • Knowledge of return to fertility

    3 months postpartum

  • Knowledge of safe birth spacing

    3 months postpartum

  • Knowledge of lactational amenorrhea (LAM) method

    3 months postpartum

  • Intention to continue family planning method

    3 and 6.5 months postpartum

  • Intended duration of continued family planning method use

    3 and 6.5 months postpartum

  • +8 more secondary outcomes

Other Outcomes (2)

  • Quality of helpdesk team in counselling on family planning

    6.5 months postpartum

  • Quality of message flow on method selection

    6.5 months postpartum

Study Arms (2)

Intervention Group

EXPERIMENTAL

Group receiving enhanced package of postpartum family planning support

Behavioral: PROMPTS Enhanced Family Planning Counselling

Control Group

NO INTERVENTION

Group receiving basic postpartum family planning information

Interventions

Based on a targeted human-centered-design process with pregnant and early postpartum mothers, the intervention consists of informative messages, counselling and reminders regarding postpartum family planning and birth spacing, leveraging an existing mobile health platform (PROMPTS) for intervention delivery and Jacaranda's established partnership with the Kenyan Ministry of Health, county health offices and public maternity hospitals method options. The intervention includes several features: activation of family planning discussions between pregnant and postpartum women and their health care providers, information provision, method selection support to help women choose their preferred method, and reminders to follow-up. The key feature is to help women make an informed plan about family planning in the prenatal or early postpartum period and follow through with this plan.

Intervention Group

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 15 and over,
  • Pregnant at 7-8 months gestation,
  • Consented to be enrolled in the PROMPTS text-messaging platform and who have provided informed consent to be part of this research study
  • Have access to a mobile phone

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacaranda Health

Nairobi, 00000, Kenya

RECRUITING

Study Officials

  • Anneka Wickramanayake, MPH

    Jacaranda Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anneka Wickramanayake, MPH

CONTACT

Jessica Cohen, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2024

First Posted

February 20, 2024

Study Start

February 2, 2024

Primary Completion

August 30, 2024

Study Completion

December 31, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations