- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03725358
A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon.
A Cluster-randomized Controlled Trial to Increase the Uptake of Long-acting Reversible Contraceptives Among Adolescent Females and Young Women in Cameroon
Study Overview
Status
Intervention / Treatment
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control: no training, low subsidies
No provider training and low (status quo) subsidies received: business as usual
|
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.
|
Experimental: No training, medium-level subsidies
No provider training, but receiving medium-level PBF payments for contraceptive methods provided
|
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.
|
Experimental: No training, high-level subsidies
No provider training, but receiving high-level PBF payments for contraceptive methods provided
|
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.
|
Experimental: Training, low-level subsidies
Providers being trained on modern contraception, but receiving low-level (status quo) PBF payments for contraceptive methods provided
|
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.
|
Experimental: Training, medium-level subsidies
Providers being trained on modern contraception, but receiving medium-level (status quo) PBF payments for contraceptive methods provided
|
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.
|
Experimental: Training, high-level subsidies
Providers being trained on modern contraception, but receiving high-level (status quo) PBF payments for contraceptive methods provided
|
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.
|
Experimental: 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
|
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.). |
Experimental: 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
|
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.). |
Experimental: 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
|
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.). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The total number of modern contraceptives (SARCs + LARCs) administered per facility per quarter
Time Frame: 12 months
|
12 months
|
The total number of LARCs administered per facility per quarter
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The total number of counseling sessions conducted per facility per quarter
Time Frame: 12 months
|
12 months
|
Prices charged for LARCs and SARCs per quarter
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LARCs-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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