Clinical trial NCT03733678: A Randomized-Controlled Trial to Increase the Uptake of LARCs in Cameroon
Official title: A Sequential and Adaptive Experiment to Increase the Uptake of Long-acting Reversible Contraceptives in Cameroon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Contraception Behavior
Contraceptive Usage
Contraceptive Method Switching
Keywords: adolescent sexual and reproductive health, maternal mortality, teen pregnancy, LARCs, family planning counseling
Lead sponsor: World Bank
Sponsor class: OTHER
Collaborators: name: Stanford University
name: George Washington University
name: University of Exeter
name: University of California, San Diego
name: Yaounde Gynecology, Obstetrics and Pediatrics Hospital
First posted: 2018-11-07
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The client adopted a LARC
timeFrame: 1-day
measure: The client adopted a modern contraceptive method (LARC or SARC)
timeFrame: 1-day
Secondary outcomes:
measure: Was the client treated with respect by the provider during the counseling session?
timeFrame: 2-weeks
measure: Did the client trust the provider during the counseling session?
timeFrame: 2-weeks
measure: Did the health provider give information about contraceptive methods that was easy to understand during the counseling session?
timeFrame: 2-weeks
measure: Client satisfaction with adopted contraceptive method
timeFrame: 2-week and 16-week measurements
measure: Discontinuation of adopted contraceptive method
timeFrame: 2-week, 16-week, and 52-week measurements
measure: Percentage of participants with unintended pregnancy within the time frame
timeFrame: 16-week and 52-week measurements
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Hôpital gynéco-obstétrique et pédiatrique de Yaoundé (HGOPY)
Study officials:
affiliation: World Bank
name: Berk Ozler, PhD
role: PRINCIPAL_INVESTIGATOR
References: