Contraception BehaviorNCT03725358
A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon.
A study testing Training and App in people with Contraception Behavior and Contraceptive Usage, run by World Bank.
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. Read more about this study
- Who is it for?
- Ages 10 to 49 years, women only
- Conditions the study is for
- Contraception Behavior, Contraceptive Usage, Contraceptive Method Switching
- What is being tested?
- Training and App
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Facilities in the East Region of Cameroon providing family planning services under the performance-based financing (PBF) system.
Who cannot join
- Facilities that have not administered any modern contraceptive methods in the past quarter
About this study
Official title: A Cluster-randomized Controlled Trial to Increase the Uptake of Long-acting Reversible Contraceptives Among Adolescent Females and Young Women in Cameroon
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.
- Conditions
- Contraception Behavior, Contraceptive Usage, Contraceptive Method Switching, Contraception
- Being tested
- Training, App, Control
- Keywords
- adolescent sexual and reproductive health, maternal mortality, teen pregnancy, LARCs
- Medical subject headings
- Contraception Behavior, Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
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.
AppBehavioural
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.).
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control: no training, low subsidies | Experimental | No provider training and low (status quo) subsidies received: business as usual Receives: Behavioral: Control |
| No training, medium-level subsidies | Experimental | No provider training, but receiving medium-level PBF payments for contraceptive methods provided Receives: Behavioral: Control |
| No training, high-level subsidies | Experimental | No provider training, but receiving high-level PBF payments for contraceptive methods provided Receives: Behavioral: Control |
| Training, low-level subsidies | Experimental | Providers being trained on modern contraception, but receiving low-level (status quo) PBF payments for contraceptive methods provided Receives: Behavioral: Training |
| Training, medium-level subsidies | Experimental | Providers being trained on modern contraception, but receiving medium-level (status quo) PBF payments for contraceptive methods provided Receives: Behavioral: Training |
| Training, high-level subsidies | Experimental | Providers being trained on modern contraception, but receiving high-level (status quo) PBF payments for contraceptive methods provided Receives: Behavioral: Training |
| Training+App, low-level subsidies | Experimental | 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 Receives: Behavioral: App |
| Training+App, medium-level subsidies | Experimental | 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 Receives: Behavioral: App |
| Training+App, high-level subsidies | Experimental | 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 Receives: Behavioral: App |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total number of modern contraceptives (SARCs + LARCs) administered per facility per quarter
Measured: 12 months
The total number of LARCs administered per facility per quarter
Measured: 12 months
Secondary outcomes (2)
The total number of counseling sessions conducted per facility per quarter
Measured: 12 months
Prices charged for LARCs and SARCs per quarter
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: Problems with the Performance-Based Financing System in Cameroon, combined with the restrictions on movement brought on by the Covid-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraception BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- three supply-side interventions (including control condition) are being crossed with three levels of subsidies for LARCs
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- World Bank
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, George Washington University, University of Exeter, University of California, San Diego, Yaounde Gynecology, Obstetrics and Pediatrics Hospital
- Responsible party
- Principal investigator, Berk Ozler, World Bank
- Investigators
- Berk Ozler, PhD, Principal investigator, World Bank
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725358
- Sponsor's protocol ID
- LARCs-2019
- Status last verified
- Oct 2020
- First submitted
- 29 Oct 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will likely share de-identified anonymous participant data publicly after the trial ends and our analyses are completed.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-randomized Controlled Trial to Increase the Uptake of Long-acting Reversible Contraceptives Among Adolescent Females and Young Women in Cameroon
- ClinicalTrials.gov ID
- NCT03725358
- Acronym / sponsor ID
- LARCs-2019
- Conditions
- Contraception Behavior, Contraceptive Usage, Contraceptive Method Switching, Contraception
- Keywords
- adolescent sexual and reproductive health, maternal mortality, teen pregnancy, LARCs
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Problems with the Performance-Based Financing System in Cameroon, combined with the restrictions on movement brought on by the Covid-19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- World BankUniversity, hospital or other
- Collaborators
- Stanford University, George Washington University, University of Exeter, University of California, San Diego, Yaounde Gynecology, Obstetrics and Pediatrics Hospital
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- three supply-side interventions (including control condition) are being crossed with three levels of subsidies for LARCs
| Arm | Type | Receives |
|---|---|---|
| Control: no training, low subsidies | Experimental | Behavioral: ControlNo provider training and low (status quo) subsidies received: business as usual |
| No training, medium-level subsidies | Experimental | Behavioral: ControlNo provider training, but receiving medium-level PBF payments for contraceptive methods provided |
| No training, high-level subsidies | Experimental | Behavioral: ControlNo provider training, but receiving high-level PBF payments for contraceptive methods provided |
| Training, low-level subsidies | Experimental | Behavioral: TrainingProviders being trained on modern contraception, but receiving low-level (status quo) PBF payments for contraceptive methods provided |
| Training, medium-level subsidies | Experimental | Behavioral: TrainingProviders being trained on modern contraception, but receiving medium-level (status quo) PBF payments for contraceptive methods provided |
| Training, high-level subsidies | Experimental | Behavioral: TrainingProviders being trained on modern contraception, but receiving high-level (status quo) PBF payments for contraceptive methods provided |
| Training+App, low-level subsidies | Experimental | Behavioral: AppProviders 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 |
| Training+App, medium-level subsidies | Experimental | Behavioral: AppProviders 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 |
| Training+App, high-level subsidies | Experimental | Behavioral: AppProviders 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 |
Who may qualify
- Ages
- 10 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Facilities in the East Region of Cameroon providing family planning services under the performance-based financing (PBF) system.
Key exclusion criteria (1 listed)
- Facilities that have not administered any modern contraceptive methods in the past quarter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingHealth 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. | Behavioural | Training, high-level subsidies, Training, low-level subsidies, Training, medium-level subsidies |
| AppHealth 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.). | Behavioural | Training+App, high-level subsidies, Training+App, low-level subsidies, Training+App, medium-level subsidies |
| ControlThe 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. | Behavioural | Control: no training, low subsidies, No training, high-level subsidies, No training, medium-level subsidies |
Primary outcome
The total number of modern contraceptives (SARCs + LARCs) administered per facility per quarter
Time frame: 12 months
The total number of LARCs administered per facility per quarter
Time frame: 12 months
2 secondary outcomes
The total number of counseling sessions conducted per facility per quarter
Time frame: 12 months
Prices charged for LARCs and SARCs per quarter
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Undecided. We will likely share de-identified anonymous participant data publicly after the trial ends and our analyses are completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berk Ozler, PhD principal investigator
World Bank
Questions about this trial
What is this clinical trial studying?
A study testing Training and App in people with Contraception Behavior and Contraceptive Usage, run by World Bank.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total number of modern contraceptives (SARCs + LARCs) administered per facility per quarter (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.