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ContraceptionHGOPYNCT03733678

A Randomized-Controlled Trial to Increase the Uptake of LARCs in Cameroon

A study testing Price discounts for SARCs, Price discounts for LARCs and Sequential vs. simultaneous recommendations in people with Contraception and Contraception Behavior, run by World Bank at 1 site in Cameroon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cameroon exhibits a high and non-decreasing level of maternal mortality (roughly 600 per 100,000 live births), partially related to its relatively high total fertility rate (roughly 4.6). Read more about this study

Who is it for?
Ages 10 to 49 years, women onlyHealthy volunteers can take part
What is being tested?
Price discounts for SARCs, Price discounts for LARCs and Sequential vs. simultaneous recommendations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,500 participants
Where
1 siteCameroon
Study dates
23 Mar 2021to 31 Dec 2024
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
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Female
  • Ages 10-49
  • Presenting at HGOPY seeking FP counseling/services
  • HGOPY clients referred to the family planning unit for consultation

Who cannot join

  • No exclusion criteria

Trial locations and contacts

1 site in 1 country.

Cameroon1 site
  • Hôpital gynéco-obstétrique et pédiatrique de Yaoundé (HGOPY)

    Yaoundé

Other trials in Cameroon

About this study

Official title: A Sequential and Adaptive Experiment to Increase the Uptake of Long-acting Reversible Contraceptives in Cameroon

Cameroon exhibits a high and non-decreasing level of maternal mortality (roughly 600 per 100,000 live births), partially related to its relatively high total fertility rate (roughly 4.6). Survey evidence furthermore suggests that a significant fraction of these pregnancies is unwanted or considered mistimed by the mother, especially among females aged 15-19. Despite this, the rate of utilization of family planning (FP) is low: e.g. only 48% of sexually active unmarried women use any form of (modern) contraception, or MC, and even then, it is primarily condoms. The use of LARCs (long-acting reversible contraceptives, i.e. the IUD and implant) is less than 1% according to the most recent Demographic Health Survey.

The study investigators propose to use an integrated behavioral science approach to increase the take-up of both SARCs (short-acting reversible contraceptives, i.e. the pill and injectable) and especially LARCs among reproductive-age females in Cameroon, including adolescents who may be unmarried and/or nulliparous. In addition to decreasing maternal mortality and undesired pregnancies, indirect effects for the community will include: increased welfare from reduced side effects that arise due to current one-size-fits-all FP counseling; healthier children due to improved birth spacing; and increased human capital formation both for children and for young (often school-aged) potential mothers.

The study investigators propose to conduct the study at HGOPY for a duration of 12 months. The study investigators will provide tablets to each of five nurses that conduct FP counseling to participants at the hospital. The tablets contain a counseling "app" (or decision-support tool or a job-aid) that was jointly developed by professionals from HGOPY, the World Bank, and the Ministry of Health. The study investigators propose an individually-randomized experiment, where the participants will be offered randomly varying discounts for the modern contraceptive methods they wish to adopt. The study investigators also propose to experiment with certain aspects of the "app" to improve its effectiveness - both for the participant and for the nurse. More details on the experimental design are provided below.

Being tested
Price discounts for SARCs, Price discounts for LARCs, Sequential vs. simultaneous recommendations
Keywords
adolescent sexual and reproductive health, maternal mortality, teen pregnancy, LARCs, family planning counseling
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.

  • Price discounts for SARCsBehavioural

    SARCs are offered free to the client

  • Price discounts for LARCsBehavioural

    LARCs are offered at lower prices to the client

  • Sequential vs. simultaneous recommendationsBehavioural

    Top ranked methods are presented to the client sequentially or simultaneously

Study groups in NCT03733678
Study groupRoleWhat they receive
Free SARC, Free LARC, RecommendationExperimentalFree SARC, Free LARC, Sequential recommendation
Receives: Behavioral: Price discounts for SARCs; Behavioral: Price discounts for LARCs
Free SARC, LARC=500, RecommendationExperimentalFree SARC, LARC=500 CFA, Sequential recommendation
Receives: Behavioral: Price discounts for SARCs; Behavioral: Price discounts for LARCs
Free SARC, LARC=1000, RecommendationExperimentalFree SARC, LARC=1000 CFA, Sequential recommendation
Receives: Behavioral: Price discounts for SARCs; Behavioral: Price discounts for LARCs
Free SARC, LARC=2140, RecommendationExperimentalFree SARC, LARC=2140 CFA, Sequential recommendation
Receives: Behavioral: Price discounts for SARCs; Behavioral: Price discounts for LARCs
Free SARC, LARC=5000, RecommendationExperimentalFree SARC, LARC=5000 CFA, Sequential recommendation
Receives: Behavioral: Price discounts for SARCs
Regular SARC, Free LARC, RecommendationExperimentalRegular price SARC, Free LARC, Sequential recommendation
Receives: Behavioral: Price discounts for LARCs
Regular SARC, LARC=500, RecommendationExperimentalRegular price SARC, LARC=500 CFA, Sequential recommendation
Receives: Behavioral: Price discounts for LARCs
Regular SARC, LARC=1000, RecommendationExperimentalRegular price SARC, LARC=1000 CFA, Sequential recommendation
Receives: Behavioral: Price discounts for LARCs
Regular SARC, LARC=2140, RecommendationExperimentalRegular price SARC, LARC=2140 CFA, Sequential recommendation
Receives: Behavioral: Price discounts for LARCs
Regular SARC, LARC=5000, RecommendationNo interventionRegular price SARC, LARC=5000 CFA, Sequential recommendation
Free SARC, Free LARC, No RecommendationExperimentalFree SARC, Free LARC, Simultaneous recommendation
Receives: Behavioral: Price discounts for SARCs; Behavioral: Price discounts for LARCs; Behavioral: Sequential vs. simultaneous recommendations
Free SARC, LARC=500, No RecommendationExperimentalFree SARC, LARC=500 CFA, Simultaneous recommendation
Receives: Behavioral: Price discounts for SARCs; Behavioral: Price discounts for LARCs; Behavioral: Sequential vs. simultaneous recommendations
Free SARC, LARC=1000, No RecommendationExperimentalFree SARC, LARC=1000 CFA, Simultaneous recommendation
Receives: Behavioral: Price discounts for SARCs; Behavioral: Price discounts for LARCs; Behavioral: Sequential vs. simultaneous recommendations
Free SARC, LARC=2140, No RecommendationExperimentalFree SARC, LARC=2140 CFA, Simultaneous recommendation
Receives: Behavioral: Price discounts for SARCs; Behavioral: Price discounts for LARCs; Behavioral: Sequential vs. simultaneous recommendations
Free SARC, LARC=5000, No RecommendationExperimentalFree SARC, LARC=5000 CFA, Simultaneous recommendation
Receives: Behavioral: Price discounts for SARCs; Behavioral: Sequential vs. simultaneous recommendations
Regular SARC, Free LARC, No RecommendationExperimentalRegular Price SARC, Free LARC, Simultaneous recommendation
Receives: Behavioral: Price discounts for LARCs; Behavioral: Sequential vs. simultaneous recommendations
Regular SARC, LARC=500, No RecommendationExperimentalRegular Price SARC, LARC=500 CFA, Simultaneous recommendation
Receives: Behavioral: Price discounts for LARCs; Behavioral: Sequential vs. simultaneous recommendations
Regular SARC, LARC=1000, No RecommendationExperimentalRegular Price SARC, LARC=1000 CFA, Simultaneous recommendation
Receives: Behavioral: Price discounts for LARCs; Behavioral: Sequential vs. simultaneous recommendations
Regular SARC, LARC=2140, No RecommendationExperimentalRegular Price SARC, LARC=2140 CFA, Simultaneous recommendation
Receives: Behavioral: Price discounts for LARCs; Behavioral: Sequential vs. simultaneous recommendations
Regular SARC, LARC=5000, No RecommendationExperimentalRegular Price SARC, LARC=5000 CFA, Simultaneous recommendation
Receives: Behavioral: Sequential vs. simultaneous recommendations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The client adopted a LARC

    using data from the counseling sessions

    Measured: 1-day

  2. The client adopted a modern contraceptive method (LARC or SARC)

    using data from the counseling sessions

    Measured: 1-day

Secondary outcomes (6)
  1. Was the client treated with respect by the provider during the counseling session?

    Self-reported indicator variable using follow-up surveys two weeks after counseling session

    Measured: 2-weeks

  2. Did the client trust the provider during the counseling session?

    Self-reported indicator variable using follow-up surveys two weeks after counseling session

    Measured: 2-weeks

  3. Did the health provider give information about contraceptive methods that was easy to understand during the counseling session?

    Self-reported indicator variable using follow-up surveys two weeks after counseling session

    Measured: 2-weeks

  4. Client satisfaction with adopted contraceptive method

    using 2-week and 16-week follow-up surveys

    Measured: 2-week and 16-week measurements

  5. Discontinuation of adopted contraceptive method

    using 2-week, 16-week, and 52-week follow-up surveys

    Measured: 2-week, 16-week, and 52-week measurements

  6. Percentage of participants with unintended pregnancy within the time frame

    using 16-week and 52-week follow-up surveys

    Measured: 16-week and 52-week measurements

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start23 Mar 2021
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2024

Resources

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
Sequential
Model description
The study independently experiments with two aspects of the health provider-client relationship: 1. First, a tablet-based counseling app that is used by the provider gives random discounts to clients - separately for LARCs and SARCs. 2. Second, the tablet-based app presents recommendations to the client sequentially (i.e. the top-ranked method, followed by the next one if that recommendation is declined by the client, etc.) vs. simultaneously (i.e. presenting the top recommendations to the client all at once and asking her to choose which one to discuss further).
Masking
Single blind
Who is masked
Participant
Enrolment
2,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03733678
Sponsor's protocol ID
LARCs-2018
Acronym
HGOPY
Status last verified
May 2025
First submitted
31 Oct 2018
Last updated
14 May 2025
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.

Questions about this trial

What is this clinical trial studying?

A study testing Price discounts for SARCs, Price discounts for LARCs and Sequential vs. simultaneous recommendations in people with Contraception and Contraception Behavior, run by World Bank at 1 site in Cameroon.

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 4 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: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 client adopted a LARC (time frame: 1-day). 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 14 May 2025.

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