A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon.

NCT ID: NCT03725358

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraception Behavior Contraceptive Usage Contraceptive Method Switching Contraception

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

three supply-side interventions (including control condition) are being crossed with three levels of subsidies for LARCs
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control: no training, low subsidies

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

Group Type EXPERIMENTAL

Control

Intervention Type BEHAVIORAL

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.

No training, medium-level subsidies

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

Group Type EXPERIMENTAL

Control

Intervention Type BEHAVIORAL

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.

No training, high-level subsidies

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

Group Type EXPERIMENTAL

Control

Intervention Type BEHAVIORAL

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.

Training, low-level subsidies

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

Group Type EXPERIMENTAL

Training

Intervention Type BEHAVIORAL

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, medium-level subsidies

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

Group Type EXPERIMENTAL

Training

Intervention Type BEHAVIORAL

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 subsidies

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

Group Type EXPERIMENTAL

Training

Intervention Type BEHAVIORAL

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+App, low-level subsidies

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

Group Type EXPERIMENTAL

App

Intervention Type BEHAVIORAL

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, medium-level subsidies

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

Group Type EXPERIMENTAL

App

Intervention Type BEHAVIORAL

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 subsidies

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

Group Type EXPERIMENTAL

App

Intervention Type BEHAVIORAL

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.).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Training

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.

Intervention Type BEHAVIORAL

App

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.).

Intervention Type BEHAVIORAL

Control

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Facilities that have not administered any modern contraceptive methods in the past quarter
Minimum Eligible Age

10 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stanford University

OTHER

Sponsor Role collaborator

George Washington University

OTHER

Sponsor Role collaborator

University of Exeter

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

Yaounde Gynecology, Obstetrics and Pediatrics Hospital

UNKNOWN

Sponsor Role collaborator

World Bank

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Berk Ozler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Berk Ozler, PhD

Role: PRINCIPAL_INVESTIGATOR

World Bank

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LARCs-2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Long-Acting Reversible Contraception
NCT01299116 COMPLETED PHASE4