A cluster-randomized controlled trial to increase the uptake of long-acting reversible contraceptives among adolescent females and young women in Cameroon
Last registered on October 29, 2018

Pre-Trial

Trial Information
General Information
Title
A cluster-randomized controlled trial to increase the uptake of long-acting reversible contraceptives among adolescent females and young women in Cameroon
RCT ID
AEARCTR-0003505
Initial registration date
October 29, 2018
Last updated
October 29, 2018 5:07 PM EDT
Location(s)

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Primary Investigator
Affiliation
The World Bank
Other Primary Investigator(s)
PI Affiliation
Stanford University
PI Affiliation
George Washington University
PI Affiliation
University of Exeter
PI Affiliation
UC San Diego
PI Affiliation
HGOPY, Yaounde, Cameroon
Additional Trial Information
Status
In development
Start date
2019-01-15
End date
2020-12-31
Secondary IDs
Abstract
We 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. We 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.
External Link(s)
Registration Citation
Citation
Athey, Susan et al. 2018. "A cluster-randomized controlled trial to increase the uptake of long-acting reversible contraceptives among adolescent females and young women in Cameroon." AEA RCT Registry. October 29. https://doi.org/10.1257/rct.3505-1.0.
Former Citation
Athey, Susan et al. 2018. "A cluster-randomized controlled trial to increase the uptake of long-acting reversible contraceptives among adolescent females and young women in Cameroon." AEA RCT Registry. October 29. http://www.socialscienceregistry.org/trials/3505/history/36401.
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Experimental Details
Interventions
Intervention(s)
Training of providers and the introduction of a decision-support tool

Formative qualitative work that the study team has conducted over the past two years, combined with the efforts of a multi-disciplinary working group (comprised of Cameroonian nurses, doctors, researchers, and adolescent health experts; regional and national health officials; as well as economists and public health specialists from the World Bank) revealed a number of barriers to the uptake of modern contraceptives - both on the supply and the demand sides. On the supply side, lack of formal training of health providers on family planning, inexperience in the administration and removal of LARCs, and provider bias against recommending LARCs (especially to adolescents, unmarried women, and nulliparous women) have been identified as the main barriers. Given that follow-up services (such as management of side effects and removal of implants and IUDs) are also of inadequate quality, the government has decided to tackle these supply-side issues first – before trying to increase demand for contraceptives among adolescent females. This was a deliberate decision as the formative qualitative work also indicated a non-negligible risk of young women having negative experiences with the health system, which could influence the willingness of other young women to adopt modern contraceptives.

Therefore, on the supply-side, the study team is proposing to evaluate the effectiveness of two (cumulative) interventions, which were recently developed by the government of Cameroon, over and above business as usual, with respect to family planning services provided at health facilities: (a) training of nurses using a newly-developed curriculum on MC methods (theory, practice, and counseling), and (b) the introduction of a tablet-based job aid (or a decision-support tool) for nurses to counsel female clients. This design implies a cluster-RCT with three arms implementing the following interventions:

C: No formal training on MCs (business as usual): 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. The study will also serve the purpose of piloting a transition of health facilities from paper-based records and PBF declarations to digital ones.

S1: Training of nurses using a new curriculum on MCs: 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. The training of regional and district trainers in the East is currently underway and the training sessions for health facilities, which will take place after random assignment of each facility to an intervention arm, are tentatively scheduled for January 2019. Each facility, like the control group (C), will also receive a tablet equipped with basic data collection software and a one-day training to use the tablet.

S2: S1 + the introduction of a tablet-based decision-support tool for nurses to counsel female clients: 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 “job aid” (or the “decision-support tool” or simply the “app”) was developed by a multi-disciplinary working group formed in Cameroon and comprised of nurses, doctors, and researchers from HGOPY, public health and adolescent health specialists from the Department of Family Health in the Ministry of Health, public health and economics researchers focusing on adolescent health from the World Bank, members of local NGOs focused on the sexual and reproductive health of adolescent females and young women (such as ACMS), as well as a digital health consultant who programmed the “app”.

The “app,” which takes a patient-centered approach to counseling, is designed to explicitly and fully incorporate the life goals, fertility plans, needs, and preferences of the client regarding contraceptive methods into the counseling session, which is not only recognized as having utmost importance for her to be able to make an informed decision, but is also empowering – endowing her with agency and making her feel respected. At the same time, the working group also acknowledged that clients, especially adolescent ones, may need some guidance from the health provider in terms of the contraceptive methods that are most suitable to their needs and preferences, but that the providers also have their own biases. Hence, 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.). Based on the client’s answers to these questions, the “app” then ranks contraceptive methods (that are not contra-indicated) from most suitable to least suitable for the client. The nurse then uses these rankings to discuss these methods in order until the client decides to adopt a method (or refuse all of them). The questions included in the “app” and the language used by the nurse to discuss options with the client can be found in Section 21.

Optimizing PBF payments to facilities for family planning services

Under the PBF system that Cameroon has in place, each facility enrolled in PBF signs a quarterly contract with the government and is paid a price (an incentive) for each unit of eligible services it provides that are covered under that contract, subject to the verification of its declaration of quantity of services provided and an independent audit of the quality of those services. Each PBF contract has two line items specifying payment amounts per LARC and SARC administered by the facility.

The study team hypothesizes that the social cost of unwanted and mistimed pregnancies to young women in Cameroon is such that the current level of PBF payments for SARCs and LARCs (at 1,500 and 2,250 CFA Francs, respectively) are sub-optimal. Specifically, we believe that the level of payments for LARCs is too low – both in absolute value and relative to the level of payments for SARCs.

The study aims to test this hypothesis by randomly varying these two PBF payments across facilities. Block stratified by the main interventions (C, S1, and S2) described above – i.e. within each of study arm of C, S1, and S2 – facilities will be randomly assigned to receive one of three types of PBF contracts at the start of 2019 that fixes the PBF payments for SARCs fixed at their current (status quo) level, but adjusts the PBF payments for LARCs as follows:

• low (the status quo payment of 2,250 CFA francs per LARC administered),
• medium (4,000 CFA francs per LARC administered), and
• high (6,000 CFA francs per LARC administered).

Optimizing PBF payments to facilities for family planning services

Finally, the government would also like to answer the question of whether providing family planning services to adolescents (females aged 24 or younger) would be more cost-effective than allowing health facilities to set their own prices for these services. Currently, under the PBF model, facilities are allowed to set their own prices for each method of contraceptive, although many facilities charge prices recommended by the Ministry of Health or non-governmental organizations they work with. As adolescent females are less likely to have their own money to seek family planning services and purchase contraceptives, free services for them may improve outcomes.

To test this hypothesis, the PBF contracts for half of the facilities in the study sample will require the facility to provide family planning services to adolescents for free in order to receive the stipulated PBF payments (Low, Medium, or High – depending on their treatment status described above). The other half will be free to set their own prices as usual. The comparison of these two groups (approximately 90-95 facilities each) will reveal which approach is more successful (and cost-effective) in increasing the number of adolescent clients adopting reliable modern contraceptive methods.
Intervention Start Date
2019-01-16
Intervention End Date
2019-12-31
Primary Outcomes
Primary Outcomes (end points)
The primary outcomes in this study are:
1. The total number of modern contraceptives (SARCs + LARCs) administered per facility per quarter, and
2. The total number of LARCs administered per facility per quarter.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
The secondary outcomes in this study are:

3. The total number of counseling sessions conducted per facility per quarter, and
4. Prices charged for LARCs and SARCs per quarter.
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The block-stratified, factorial study design can be summarized as follows: 180 facilities will be assigned equally (60 facilities each) into three supply-side interventions (C, S1, and S2) and into three PBF payment levels for LARCs (low, medium, and high). The factorial design implies that each study arm (a cell in the table above) will contain 20 unique facilities that is receiving a unique combination of the supply-side and the PBF payment interventions.
Experimental Design Details
Not available
Randomization Method
Randomization done in office by a computer (using block stratification)
Randomization Unit
Health Facilities in the East Region of Cameroon
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
180 health facilities
Sample size: planned number of observations
Approximately 21,600 clients over the course of 12 months.
Sample size (or number of clusters) by treatment arms
60 facilities control, 60 facilities training, 60 facilities training + app

in a factorial design with

60 facilities status quo (low-level) subsidies, 60 facilities medium-level subsidies, and 60 facilities high-level subsidies.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
As described above, the sample size in the proposed study is approximately 180 facilities (and no more than 190 facilities). The most recent data from the PBF portal suggests that, the average number of verified modern contraceptive methods (i.e. LARCs plus SARCs) per facility between October 2017 and June 2018 is 33.8 per quarter, with a standard deviation of 41.4. The same figures for the total number of LARCs are 8.5 and 15.2, respectively. Power calculations (using power=80%, alpha=0.05, with repeated quarterly measurements and using the lagged value of the outcome indicator as a covariate in the analysis) suggest that the minimum detectable effect for S1 or S2 (in comparison with the control group C) is 7.5 (or 0.18 standard deviations) for the total number of modern contraceptives dispensed and 4.0 (or 0.26 standard deviations) for LARCs only. Hence, we would be able to detect small to moderate increases in the number of LARCs and SARCs dispensed by the facilities in the study sample. The power calculations are symmetric for the PBF payments, i.e. for comparing medium or high PBF payments to low (status quo) payments. Statistical power is lower when comparing individual cells: for example, the estimated minimum detectable effect for the total number of modern contraceptives dispensed is 13.5 (or 0.33 standard deviations) when comparing S1 or S2 to C within the group receiving the low level of PBF payments.
Supporting Documents and Materials

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IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
IRB Approval Date
IRB Approval Number