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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03725358
Other study ID # LARCs-2019
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2021
Est. completion date January 2023

Study information

Verified date October 2020
Source World Bank
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2023
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender Female
Age group 10 Years to 49 Years
Eligibility 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 Design


Intervention

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.
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.).
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.

Locations

Country Name City State
n/a

Sponsors (6)

Lead Sponsor Collaborator
World Bank George Washington University, Stanford University, University of California, San Diego, University of Exeter, Yaounde Gynecology, Obstetrics and Pediatrics Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The total number of modern contraceptives (SARCs + LARCs) administered per facility per quarter 12 months
Primary The total number of LARCs administered per facility per quarter 12 months
Secondary The total number of counseling sessions conducted per facility per quarter 12 months
Secondary Prices charged for LARCs and SARCs per quarter 12 months
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