A Pilot Study to Estimate the Impact of a Screening and Referral Service on Contraceptive Use
Phase: NA
Conditions: Contraception Behavior
Sponsor: Duke University

A Pilot Study to Estimate the Impact of a Screening and Referral Service on 
Contraceptive Use
Research Design and Analysis Plan
July 13, 2017
Eric Green, Ph.D.
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Changelog:
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1. Specific aims
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2. Intervention: A digital family planning screening and referral service
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3. Research Design
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3.1 Setting and Participants
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3.1.1 Inclusion and Exclusion Criteria
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3.1.2 Recruitment
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3.2 Procedures
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3.3 Analysis Plan
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3.3.1 Sample Size
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3.3.2 Primary Outcome
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3.3.3 Estimate Impact
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3.3.4 Subgroup Analyses
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4. Study Team
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5. Conflicts of Interest
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6. ClinicalTrials.gov Registration
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Changelog:
July 18, 2017: Added table of contents; added Section 6 on ClinicalTrials.gov registration
July 24, 2017: Added ClinicalTrials.gov ID number
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1. Specific aims
Based on global projections, meeting the unmet demand for contraceptives would prevent more 
than  two-thirds  of  unintended  pregnancies  and  more  than  two-thirds  of  maternal  deaths. 
Voluntary family planning has also been shown to improve newborn health outcomes, advance 
women's empowerment, and bring socioeconomic benefits through reductions in fertility and 
population growth. Yet among the populations that would benefit the most from family planning, 
uptake remains too low. 
The specific aim of this pilot study is to estimate the impact of a new digital health service on the 
uptake of family planning among Kenyan women with an unmet need for contraception. This 
service promotes uptake by offering free screening and referral. Women text the service for free, 
complete a short automated screening over the phone, and receive a list of recommended 
methods and a referral to local family planning providers offering those methods. The main 
hypothesis is that the service will increase the uptake of family planning among these users.
2. Intervention: A digital family planning screening and referral service 
Women text the service and receive a free call back to complete an automated family planning 
counseling session that results in a set of recommended methods that fit the client's preferences 
and goals. The client is matched to several local family planning providers that offer these 
methods, and the service sends a referral code via SMS that the client can redeem at the facility. 
Unless the client requests otherwise, the service follows-up on every automated counseling 
session.  When  someone  receives  a  referral  code,  the  service  tracks  them  through  their 
encounter with a local provider (public and private) to learn about their experience with the 
service, the provider, and their choice in contraception (or not). The service also follows-up with 
clients who do not act on referrals to better understand their reasons tries different behavioral 
nudges that encourage the caller to visit a facility (e.g., sending a transportation voucher). The 
service does not pay for any costs the client may incur at the facility.
3. Research Design
The service is available to anyone living in the catchment area, so it is not possible to randomly 
assign access to the service and estimate impact through a traditional randomized controlled trial 
(RCT). Likewise, at this early stage it is not be feasible to randomize access at a higher level, such 
as counties or subcounties. In situations like this, a variation on the traditional randomized 
controlled trial called a randomized encouragement design can be very effective.
In  a  randomized  encouragement  design  (RED),  participants  are  randomized  to  receive  an 
invitation or special encouragement to receive a treatment. Not everyone who is encouraged will 
take up the service, but as long as those randomly selected to receive the encouragement (the 
treatment group) use the service at a higher rate than the control group, the impact of the service 
can be estimated.
3.1 Setting and Participants
The target population for this study is women who have an unmet need for family planning; that 
is, women who are not currently using family planning but wish to delay or prevent pregnancy. 
Participants will be recruited from markets throughout Bungoma County in areas where the 
service is active at the time of recruitment.
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3.1.1 Inclusion and Exclusion Criteria
To be eligible for the study, women must: 
1.
be between the ages of 18 and 35 (inclusive);
2.
have an unmet need for family planning;
3.
live in the service catchment area;
4.
demonstrate phone ownership;
5.
opt-in to receiving calls and/or SMS messages from the study team;
6.
demonstrate basic ability to operate study tablet; and
7.
consent to participate in the study. 
Phone ownership is a requirement because the design will lead to two-sided non-compliance, 
and it will be necessary to track participants use (or not) of the service. Women need to own their 
own phones to decrease the likelihood of calling or texting the service from a number not 
registered with the study. Women do not need special phones or data plans to participate, just a 
phone that can make and receive calls and text messages. 
Women who are pregnant or < 4 months postpartum are ineligible because they will not be ready 
to act on family planning referrals.
3.1.2 Recruitment
We will rent stall space in several Bungoma markets on market days with signage advertising our 
study on women's health. Women between the ages of 18 and 35 (inclusive) and in possession of 
a phone will be invited to complete a brief screening on a tablet computer. Interested women will 
use headphones to listen to recorded questions and tap the screen to record their answers 
(audio computer-assisted self interviewing, ACASI, with female enumerators standing by to assist 
when needed).
If a woman is eligible to participate in the study based on her responses to the screening, the 
tablet will instruct the enumerator to review the informed consent form with her. If the woman 
consents to participate, the enumerator will record her name and contact details in a study 
register. Her study register entry will be associated with a unique ID that the enumerator will 
enter into the tablet before closing out the screening.
We will not collect identifying information from any woman who is not eligible or declines to 
participate in the study.
Every woman who completes the brief screening will receive an honorarium of Ksh 200 to 
appreciate their time answering study questions. This honorarium will be provided regardless of 
whether a woman: (i) is eligible to participate in the study or (ii) consents to participate in the 
study.
If we do not generate sufficient interest in the study via the methods described above, we will 
create a print advertisement with a phone number to call and complete the screening over the 
phone through an automated interactive voice response system. Female enumerators will then 
call back eligible women and invite them to visit the market stand to complete the screening and 
enrollment process.
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3.2 Procedures
After  a  woman  enrolls  in  the  study,  she  will  be  randomized  to  1  of  2  study  arms:  (i) 
encouragement to try the service or (ii) control (no encouragement). See the study workflow in 
Figure 1.
Figure 1. Study workflow.
Women randomized to the encouragement arm will receive an invitation via SMS to call the 
service and complete the free family planning screening (plus ~$2.00 USD phone credit). Women 
randomized to the control arm will receive a different set of messages that do NOT include any 
special encouragement to try the service.
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Screening for eligibility in 
markets
Ineligible
Randomize eligible women in 
blocks
Encouragement arm
Control arm
Send encouragement to try 
service via SMS
Send study thank you messages 
via SMS
Found to have tried service
No evidence tried service
Follow-up survey 1-month post encouragement (outcome assessors blinded)
Review service call logs 1-month post-encouragement messages

This study will likely result in two-sided non-compliance with respect to random assignment:
1.
Every woman randomized to the encouragement arm will receive a special invitation to try 
the service, but only a subset of women in this group will take up this offer.
2.
Women randomized to the control arm will NOT receive a special invitation to try the 
service, but some will learn about the service through other channels and try it out on 
their own.
Encouragement  designs  account  for  this  non-compliance  by  estimating  the  local  average 
treatment effect (LATE). In this study, LATE will be the effect of trying the service on 'compliers'—
those who tried the service because they were randomly encouraged to but would not have 
called otherwise. 
Figure 2. Randomized encouragement as an instrumental variable.
In order to estimate LATE, we will collect data on two key indicators: (i) use of the service and (ii) 
family planning uptake.
(i) Use of the Service. We will use two data sources to determine whether an enrolled participant 
tried the service. 
First,  we  will  examine  the  service  call  logs  to  see  if  the  phone  numbers  linked  to  study 
participants appear. 
●
Tried the service: Study participant phone number is present in service call logs
●
Completed screening: Referral code sent to study participant phone number via SMS 
(indicator of completed screening)
Second, we will conduct a follow-up survey with all study participants 1-month after enrollment 
messages are sent (per block). This data collection will uncover potential use cases in which a 
woman called the service from a phone number not known to the study team. 
(ii) Family planning uptake. During the follow-up survey we will ask ALL women if they started 
using any modern method contraception since the start of the study.
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3.3 Analysis Plan
3.3.1 Sample Size
In a traditional parallel randomized controlled trial, we would need a total sample size of 48 
women to detect a shift of 30 percentage points from 5% uptake of family planning in the control 
group to 35% uptake in the treatment group, assuming alpha of 5% and power of 80%. However, 
power calculations for randomized encouragement designs are complicated by the fact that only 
a  portion  of  the  treatment  group  will  take  up  the  treatment.  Since  we  expect  that  the 
encouragement will increase the probability of using the service from 20% (control) to 80% 
(treatment), we must increase the sample by a factor of 2.8 [1/(0.8-0.2)^2)= 2.8] to 134.
3.3.2 Primary Outcome 
The primary outcome will be whether or not a woman reports adopting a modern method of 
family planning.
3.3.3 Estimate Impact
Randomizing  encouragement  will  only  impact  the  probability  of  using  the  service,  not  the 
probability of family planning uptake. To estimate the impact of the service on family planning 
uptake,  we  will  use  random  assignment  to  encouragement  as  an  instrumental  variable. 
Regressing uptake of family planning on the assignment to encouragement will give us the 
intent-to-treat estimate. We will estimate LATE by dividing the intent-to-treat estimate by the 
differential uptake of the service by treatment assignment. We will use IV regression to obtain 
robust standard errors.
3.3.4 Subgroup Analyses
We hypothesize that the intervention effect will be larger for women with more education and for 
women who have used contraception in the past (discontinued). We will also examine subgroup 
effects by marital status (married/in-union vs not married/in-union).
4. Study Team
Principal Investigator: Eric Green, Ph.D. (eric.green@duke.edu)
Co-Investigator: Violet Naanyu, Ph.D.
Student Researcher: Arun Augustine
5. Conflicts of Interest
Dr. Green is a co-founder of the digital health service. He has equity in the company that 
operates this service, and he has a seat on its Board of Directors. Duke University has a Conflict 
of Interest Management Plan on file to guide his involvement in research involving this service.
6. ClinicalTrials.gov Registration
July 12, 2017: Record created
July 18, 2017: Record release for PRS Review
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July 24, 2017: Public record posted (NCT03224390)
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