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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Contraception; Contraception Behavior; Contraceptive Usage; Contraceptive Method Switching
• Intervention / Treatment: Behavioral: Price discounts for SARCs; Behavioral: Price discounts for LARCs; Behavioral: Sequential vs. simultaneous recommendations

• Study Type: Interventional
• Enrollment (Actual): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Berk Ozler, PhD; Phone Number: 2023684109; Email: bozler@worldbank.org

Study Locations

• Cameroon
  • Yaoundé, Cameroon
    • Hôpital gynéco-obstétrique et pédiatrique de Yaoundé (HGOPY)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

* No exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

20

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Free SARC, Free LARC, Recommendation; Free SARC, Free LARC, Sequential recommendation	Behavioral: Price discounts for SARCs; SARCs are offered free to the client; Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client
Experimental: Free SARC, LARC=500, Recommendation; Free SARC, LARC=500 CFA, Sequential recommendation	Behavioral: Price discounts for SARCs; SARCs are offered free to the client; Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client
Experimental: Free SARC, LARC=1000, Recommendation; Free SARC, LARC=1000 CFA, Sequential recommendation	Behavioral: Price discounts for SARCs; SARCs are offered free to the client; Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client
Experimental: Free SARC, LARC=2140, Recommendation; Free SARC, LARC=2140 CFA, Sequential recommendation	Behavioral: Price discounts for SARCs; SARCs are offered free to the client; Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client
Experimental: Free SARC, LARC=5000, Recommendation; Free SARC, LARC=5000 CFA, Sequential recommendation	Behavioral: Price discounts for SARCs; SARCs are offered free to the client
Experimental: Regular SARC, Free LARC, Recommendation; Regular price SARC, Free LARC, Sequential recommendation	Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client
Experimental: Regular SARC, LARC=500, Recommendation; Regular price SARC, LARC=500 CFA, Sequential recommendation	Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client
Experimental: Regular SARC, LARC=1000, Recommendation; Regular price SARC, LARC=1000 CFA, Sequential recommendation	Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client
Experimental: Regular SARC, LARC=2140, Recommendation; Regular price SARC, LARC=2140 CFA, Sequential recommendation	Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client
No Intervention: Regular SARC, LARC=5000, Recommendation; Regular price SARC, LARC=5000 CFA, Sequential recommendation
Experimental: Free SARC, Free LARC, No Recommendation; Free SARC, Free LARC, Simultaneous recommendation	Behavioral: Price discounts for SARCs; SARCs are offered free to the client; Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client; Behavioral: Sequential vs. simultaneous recommendations; Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Free SARC, LARC=500, No Recommendation; Free SARC, LARC=500 CFA, Simultaneous recommendation	Behavioral: Price discounts for SARCs; SARCs are offered free to the client; Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client; Behavioral: Sequential vs. simultaneous recommendations; Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Free SARC, LARC=1000, No Recommendation; Free SARC, LARC=1000 CFA, Simultaneous recommendation	Behavioral: Price discounts for SARCs; SARCs are offered free to the client; Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client; Behavioral: Sequential vs. simultaneous recommendations; Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Free SARC, LARC=2140, No Recommendation; Free SARC, LARC=2140 CFA, Simultaneous recommendation	Behavioral: Price discounts for SARCs; SARCs are offered free to the client; Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client; Behavioral: Sequential vs. simultaneous recommendations; Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Free SARC, LARC=5000, No Recommendation; Free SARC, LARC=5000 CFA, Simultaneous recommendation	Behavioral: Price discounts for SARCs; SARCs are offered free to the client; Behavioral: Sequential vs. simultaneous recommendations; Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Regular SARC, Free LARC, No Recommendation; Regular Price SARC, Free LARC, Simultaneous recommendation	Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client; Behavioral: Sequential vs. simultaneous recommendations; Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Regular SARC, LARC=500, No Recommendation; Regular Price SARC, LARC=500 CFA, Simultaneous recommendation	Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client; Behavioral: Sequential vs. simultaneous recommendations; Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Regular SARC, LARC=1000, No Recommendation; Regular Price SARC, LARC=1000 CFA, Simultaneous recommendation	Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client; Behavioral: Sequential vs. simultaneous recommendations; Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Regular SARC, LARC=2140, No Recommendation; Regular Price SARC, LARC=2140 CFA, Simultaneous recommendation	Behavioral: Price discounts for LARCs; LARCs are offered at lower prices to the client; Behavioral: Sequential vs. simultaneous recommendations; Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Regular SARC, LARC=5000, No Recommendation; Regular Price SARC, LARC=5000 CFA, Simultaneous recommendation	Behavioral: Sequential vs. simultaneous recommendations; Top ranked methods are presented to the client sequentially or simultaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The client adopted a LARC	using data from the counseling sessions	1-day
The client adopted a modern contraceptive method (LARC or SARC)	using data from the counseling sessions	1-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2-weeks
Did the client trust the provider during the counseling session?	Self-reported indicator variable using follow-up surveys two weeks after counseling session	2-weeks
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	2-weeks
Client satisfaction with adopted contraceptive method	using 2-week and 16-week follow-up surveys	2-week and 16-week measurements
Discontinuation of adopted contraceptive method	using 2-week, 16-week, and 52-week follow-up surveys	2-week, 16-week, and 52-week measurements
Percentage of participants with unintended pregnancy within the time frame	using 16-week and 52-week follow-up surveys	16-week and 52-week measurements

Collaborators and Investigators

• Sponsor: World Bank
• Collaborators: University of California, San Diego; Stanford University; George Washington University; University of Exeter; Yaounde Gynecology, Obstetrics and Pediatrics Hospital
• Investigators: Principal Investigator: Berk Ozler, PhD, World Bank

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 4, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: adolescent sexual and reproductive health, maternal mortality, teen pregnancy, LARCs, family planning counseling
• Other Study ID Numbers: LARCs-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will likely share de-identified anonymous participant data publicly after the trial ends and our analyses are completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No