NCT03725358

Brief Summary

The study investigators propose to test various supply-side approaches to increase the numbers of both SARCs (short-acting reversible contraceptives, i.e. the pill and injectable) and especially LARCs (long-acting reversible contraceptives, i.e. the IUD and implant) administered by health facilities to reproductive-age females in Cameroon, particularly adolescents who may be unmarried and/or nulliparous. The study investigators will do this via interventions at primary health facilities, which include training of providers on family planning; the introduction of a tablet-based decision support tool for counseling women on family planning; and increased subsidies for LARCs within the performance-based financing (PBF) system. This approach is expected to benefit the population directly by decreasing maternal mortality and undesired pregnancies and indirectly by reducing side effects that arise due to current one-size-fits-all FP (family planning) counseling; improving the health of children due to improved birth spacing; and increasing human capital accumulation among children and young (often school-age) potential mothers.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2021

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
2.8 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

October 29, 2018

Last Update Submit

October 5, 2020

Conditions

Keywords

adolescent sexual and reproductive health, maternal mortality, teen pregnancy, LARCs

Outcome Measures

Primary Outcomes (2)

  • The total number of modern contraceptives (SARCs + LARCs) administered per facility per quarter

    12 months

  • The total number of LARCs administered per facility per quarter

    12 months

Secondary Outcomes (2)

  • The total number of counseling sessions conducted per facility per quarter

    12 months

  • Prices charged for LARCs and SARCs per quarter

    12 months

Study Arms (9)

Control: no training, low subsidies

EXPERIMENTAL

No provider training and low (status quo) subsidies received: business as usual

Behavioral: Control

No training, medium-level subsidies

EXPERIMENTAL

No provider training, but receiving medium-level PBF payments for contraceptive methods provided

Behavioral: Control

No training, high-level subsidies

EXPERIMENTAL

No provider training, but receiving high-level PBF payments for contraceptive methods provided

Behavioral: Control

Training, low-level subsidies

EXPERIMENTAL

Providers being trained on modern contraception, but receiving low-level (status quo) PBF payments for contraceptive methods provided

Behavioral: Training

Training, medium-level subsidies

EXPERIMENTAL

Providers being trained on modern contraception, but receiving medium-level (status quo) PBF payments for contraceptive methods provided

Behavioral: Training

Training, high-level subsidies

EXPERIMENTAL

Providers being trained on modern contraception, but receiving high-level (status quo) PBF payments for contraceptive methods provided

Behavioral: Training

Training+App, low-level subsidies

EXPERIMENTAL

Providers being trained on modern contraception and receiving a tablet-based decision-support tool (app), but receiving low-level (status quo) PBF payments for contraceptive methods provided

Behavioral: App

Training+App, medium-level subsidies

EXPERIMENTAL

Providers being trained on modern contraception and receiving a tablet-based decision-support tool (app), but receiving medium-level (status quo) PBF payments for contraceptive methods provided

Behavioral: App

Training+App, high-level subsidies

EXPERIMENTAL

Providers being trained on modern contraception and receiving a tablet-based decision-support tool (app), but receiving high-level (status quo) PBF payments for contraceptive methods provided

Behavioral: App

Interventions

TrainingBEHAVIORAL

Health facilities assigned to this group will receive a two-week training intervention on modern contraceptive methods and counseling techniques - aimed at nurses conducting family planning services. This new curriculum was developed by a large group of experts convened by the Ministry of Health in February 2018. The cascade training that is developed by the national government (cascading down to regions, districts, and finally health facilities) is a 15-day training module that targets family planning nurses, covering theory, practical knowledge (practicing administrations and removals), and counseling of clients.

Training, high-level subsidiesTraining, low-level subsidiesTraining, medium-level subsidies
AppBEHAVIORAL

Health facilities assigned to this group will receive the same programming as the facilities in S1, but they will also be provided with tablets equipped with the "job aid," which subsumes the basic data collection software used by the remaining facilities. They will also receive additional training on the use of the tablet-based "job aid." The "app" is a tablet-based decision-support tool, which is designed for use by the family planning nurse conducting counseling sessions and records the answers to a series of questions that elicit the client's life goals, fertility plans, needs, and preferences regarding contraceptive methods, as well as her medical eligibility (birth history, pregnancy check, breastfeeding status, blood pressure, medications, etc.).

Training+App, high-level subsidiesTraining+App, low-level subsidiesTraining+App, medium-level subsidies
ControlBEHAVIORAL

The comparison group includes facilities that continue business as usual (no FP training or tablet-based job aid). Each facility in this group will receive a tablet equipped with basic data collection software and a one-day training to use the tablets.

Control: no training, low subsidiesNo training, high-level subsidiesNo training, medium-level subsidies

Eligibility Criteria

Age10 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Facilities in the East Region of Cameroon providing family planning services under the performance-based financing (PBF) system.

You may not qualify if:

  • Facilities that have not administered any modern contraceptive methods in the past quarter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Contraception BehaviorMaternal Death

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehaviorParental DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Berk Ozler, PhD

    World Bank

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: three supply-side interventions (including control condition) are being crossed with three levels of subsidies for LARCs
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2018

First Posted

October 31, 2018

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

January 1, 2023

Last Updated

October 8, 2020

Record last verified: 2020-10