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

Contraception Clinical Trial

— HGOPY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03733678
• Other study ID #: LARCs-2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: World Bank
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Contraception Behavior
• Contraceptive Method Switching
• Contraceptive Usage

Intervention

Behavioral:
• Price discounts for SARCs
SARCs are offered free to the client
• Price discounts for LARCs
LARCs are offered at lower prices to the client
• Sequential vs. simultaneous recommendations
Top ranked methods are presented to the client sequentially or simultaneously

Locations

Country	Name	City	State
Cameroon	Hôpital gynéco-obstétrique et pédiatrique de Yaoundé (HGOPY)	Yaoundé

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

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The client adopted a LARC	using data from the counseling sessions	1-day
Primary	The client adopted a modern contraceptive method (LARC or SARC)	using data from the counseling sessions	1-day
Secondary	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
Secondary	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
Secondary	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
Secondary	Client satisfaction with adopted contraceptive method	using 2-week and 16-week follow-up surveys	2-week and 16-week measurements
Secondary	Discontinuation of adopted contraceptive method	using 2-week, 16-week, and 52-week follow-up surveys	2-week, 16-week, and 52-week measurements
Secondary	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