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

Sponsor
World Bank (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03725358
Collaborator
Stanford University (Other), George Washington University (Other), University of Exeter (Other), University of California, San Diego (Other), Yaounde Gynecology, Obstetrics and Pediatrics Hospital (Other)
0
9
16

Study Details

Study Description

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
  • Behavioral: Training
  • Behavioral: App
  • Behavioral: Control
N/A

Study Design

Study Type:
Interventional
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 LARCsthree 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
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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.).

Outcome Measures

Primary Outcome Measures

  1. The total number of modern contraceptives (SARCs + LARCs) administered per facility per quarter [12 months]

  2. The total number of LARCs administered per facility per quarter [12 months]

Secondary Outcome Measures

  1. The total number of counseling sessions conducted per facility per quarter [12 months]

  2. Prices charged for LARCs and SARCs per quarter [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

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

  • Principal Investigator: Berk Ozler, PhD, World Bank

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Berk Ozler, Principal Investigator, World Bank
ClinicalTrials.gov Identifier:
NCT03725358
Other Study ID Numbers:
  • LARCs-2019
First Posted:
Oct 31, 2018
Last Update Posted:
Oct 8, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Berk Ozler, Principal Investigator, World Bank

Study Results

No Results Posted as of Oct 8, 2020