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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03725358
Recruitment Status : Withdrawn (Problems with the Performance-Based Financing System in Cameroon, combined with the restrictions on movement brought on by the Covid-19 pandemic.)
First Posted : October 31, 2018
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
Stanford University
George Washington University
University of Exeter
University of California, San Diego
Yaounde Gynecology, Obstetrics and Pediatrics Hospital
Information provided by (Responsible Party):
Berk Ozler, World Bank

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.

Condition or disease Intervention/treatment Phase
Contraception Behavior Contraceptive Usage Contraceptive Method Switching Contraception Behavioral: Training Behavioral: App Behavioral: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: three supply-side interventions (including control condition) are being crossed with three levels of subsidies for LARCs
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Cluster-randomized Controlled Trial to Increase the Uptake of Long-acting Reversible Contraceptives Among Adolescent Females and Young Women in Cameroon
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Control: no training, low subsidies
No provider training and low (status quo) subsidies received: business as usual
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.

Experimental: No training, medium-level subsidies
No provider training, but receiving medium-level PBF payments for contraceptive methods provided
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.

Experimental: No training, high-level subsidies
No provider training, but receiving high-level PBF payments for contraceptive methods provided
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.

Experimental: Training, low-level subsidies
Providers being trained on modern contraception, but receiving low-level (status quo) PBF payments for contraceptive methods provided
Behavioral: 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.

Experimental: Training, medium-level subsidies
Providers being trained on modern contraception, but receiving medium-level (status quo) PBF payments for contraceptive methods provided
Behavioral: 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.

Experimental: Training, high-level subsidies
Providers being trained on modern contraception, but receiving high-level (status quo) PBF payments for contraceptive methods provided
Behavioral: 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.

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
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.).


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
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.).


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
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.).





Primary Outcome Measures :
  1. The total number of modern contraceptives (SARCs + LARCs) administered per facility per quarter [ Time Frame: 12 months ]
  2. The total number of LARCs administered per facility per quarter [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The total number of counseling sessions conducted per facility per quarter [ Time Frame: 12 months ]
  2. Prices charged for LARCs and SARCs per quarter [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725358


Sponsors and Collaborators
World Bank
Stanford University
George Washington University
University of Exeter
University of California, San Diego
Yaounde Gynecology, Obstetrics and Pediatrics Hospital
Investigators
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Principal Investigator: Berk Ozler, PhD World Bank
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Responsible Party: Berk Ozler, Principal Investigator, World Bank
ClinicalTrials.gov Identifier: NCT03725358    
Other Study ID Numbers: LARCs-2019
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will likely share de-identified anonymous participant data publicly after the trial ends and our analyses are completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Berk Ozler, World Bank:
adolescent sexual and reproductive health, maternal mortality, teen pregnancy, LARCs