Contraception Clinical Trial
Official title:
Evaluation of a Mass Media Family Planning Campaign on the Uptake of Contraceptive Methods in Burkina Faso
In this experiment, the investigators will study the effect of a mass media family planning
campaign on contraception related behavior. The study takes place in Burkina Faso, a country
with an average of six children born to each woman, and a modern contraceptive prevalence
rate (mCPR) estimated at 15% in 2010 at the national level, as per the Demographic Health
Survey (DHS) 2010 report on Burkina Faso.
The aim of this study is to provide robust evidence on the efficiency and cost-effectiveness
of an intense three-year mass media campaign focused on family planning. The campaign will
diffuse messages about the financial and health benefits of family planning, and information
on the different types, sources, advantages, and disadvantages of different contraceptive
methods. The study will target women at the age of reproduction in rural areas of Burkina
Faso to measure the effect of the intervention on total and modern contraceptive prevalence
rates, perceptions of family planning, contraception-related behavior, and general gender
norms.
Burkina Faso is an ideal place to evaluate the impact of a radio campaign because a high
percentage of the rural population listens to local radio which is in the local language.
Radio station areas are distinct because they target very local languages and their reach is
limited by government decree, which allows for the implementation of a randomized control
trial.
Development Media International (DMI), a non-governmental organization (NGO) that runs media
campaigns to induce behavioral change in developing countries, will implement the mass media
campaign in conjunction with community radio stations in rural areas of Burkina Faso. The
study takes place in the coverage areas of 16 radio stations, all selected in a way to
prevent overlap between coverage areas, and to have different local languages through which
the campaign will be diffused. This strategy limits possible "leakages" between the
treatment and the control groups. Out of the 16 clusters of radio stations, 8 will be
randomly assigned to receive the media campaign, and the other 8 will be left as control.
Within each radio station cluster, only small and rural villages with no access to
electricity will be sampled in order to limit access to television. The radio stations being
in urban to semi-urban areas, villages that are more than 5 km away from a radio station
will be excluded. Villages within radio station clusters will be randomly selected to
participate in the study. A household listing survey will be conducted in all selected
villages to get an exhaustive list of households and the basic information on women within
each household. In addition, a village survey will be conducted with village chiefs to get a
better sense of the demographics and the key figures in each village.
Based on the information provided by the listing on women at the age of reproduction,
eligible women will be randomly selected to participate in the study. These women will be
invited to take the baseline survey, and 3 years later, the endline survey, therefore
forming a panel structure.
In addition to the listing, village, and women surveys, a clinics survey will take place to
monitor the demand and supply of contraceptive methods in different areas. The clinics
questionnaire will ask about contraception related behavior, including perception of family
planning, usage of contraception, number of pregnancies and abortions, among other things.
The investigators are also seeking administrative data from clinics within radio stations
areas to examine whether distribution of contraceptive products is higher in treatment
areas.
The effect of the media campaign will be analyzed based on information provided by women on
how they and their partners perceive and use traditional and modern contraceptive methods,
and cross-verified with information provided on demand for contraception and family planning
by the clinics survey.
Qualitative research will take place prior to the launch of the campaign in order to better
formulate messages that could reach the target audience.
-Data collection, reporting, and analysis:
The data collection will be conducted by Innovations for Poverty Action (IPA), and NGO
specialized in conducting randomized control trials (RCTs) with presence and experience in
Burkina Faso.
Data will be collected through questionnaires using Personal Digital Assistance (PDA). For
the qualitative research questionnaires, answers might be recorded using paper. The
surveyors might audio-record some parts of some interviews with women and health facilities
using the PDAs to monitor surveying quality and performance of enumerators. The resulting
datasets will be coded and clearly labeled in accordance with the information provided on
the questionnaires.
Data will be collected by enumerators trained by IPA on the importance of confidentiality of
the data, transparency, and accuracy of reported information. Backchecks will also be
conducted to make sure that the data provided is consistent and correct. Protocols have been
developed to address adverse events during data collection where enumerators go back to
their supervisors and to the IPA office to address any complications. In addition, high
frequency checks will be conducted whenever new data comes in to monitor the quality of data
collection, and how values of different variables and missing values vary by enumerators and
locations. Logic checks will be conducted to make sure that the value of variables fall
within logical ranges. This allows for quick detection and correction of major outliers and
high rates of attrition. Finally, all adverse events will be reported to the Massachusetts
Institute of Technology's internal review board (the Committee on the Use of Humans as
Experimental Subjects) as quickly as possible in accordance with the human subjects
requirements.
-Sample size and minimum detectable effect:
The total sample size is approximately 8,000 women across more than 250 villages in 16 radio
clusters.
To calculate this sample size, power calculations were conducted using simulations in Stata.
Having two levels of clustering (region and village levels), two intracluster correlation
(ICC) levels were used for power calculations, both based on the 2010 DHS data for women in
Burkina Faso. The DHS data revealed a modern contraceptive prevalence rate (mCPR) of 9%
among women of reproductive age (both in union and single) in rural areas and regions where
the study takes place.
For these calculations, a baseline level of mCPR of 12% was assumed, therefore allowing for
some increase in usage over time. Based on these numbers and calculations, the study is
powered to detect a minimum of 6 percentage points increase in the mCPR.
If the assumed baseline level of mCPR is close to the actual one, power is expected to
increase further as the investigators will (1) use a matched stratification on baseline
levels of contraception prevalence rate at the radio station level (the level of treatment
assignment), in addition to stratifying village selection on distance to health clinics, and
individual selection of women on several characteristics such as education and access to a
radio (2) control for baseline levels of explanatory variables and the baseline level of the
outcome, and (3) use a panel structure.
It is possible, however, that the total and modern contraceptive prevalence rates are higher
in the actual sample than the value assumed based on the 2010 DHS data, which could reduce
power.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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