Randomized Controlled Trial to Address Unintended Pregnancy Rates in Low Resource Settings
Phase: NA
Conditions: Contraceptive Usage, Unintended Pregnancy
Sponsor: University of North Carolina, Chapel Hill

 
Randomized Controlled Trial to Address Unintended Pregnancy Rates 
in Low Resource Settings 
 
 
 
NCT number NCT05328648 
Document Date 11/07/2024 
 

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PROTOCOL  
 
Complete Title: Randomized Controlled Trial to Address Unintended Pregnancy Rates in Low Resource 
Settings 
 
 
 
Initial Protocol Date: November 15, 2021 
Updated Protocol Date: November 7, 2024 
 
 
 
 
 
 
 
 
 
 
 
 
Study Principal Investigator: Katherine Tumlinson, PhD 
University of North Carolina at Chapel Hill 
Phone:  
919-824-4722  
email: ktumlin@email.unc.edu 
 
Protocol Version: 02 
Version Date: November 7, 2024 
 
 
 
 
 
 
 
 
 

Intervention protocol template_Draft_29AUG2016 
 
 
 
TABLE OF CONTENTS 
 
Table of Contents ........................................................................................................... 2 
Abbreviations and Definitions of Terms .......................................................................... 3 
Protocol Synopsis ........................................................................................................... 4 
1 
BACKGROUND  AND RATIONALE.................................................................................................................... 7 
2 
STUDY OBJECTIVES ......................................................................................................................................... 9 
3 
INVESTIGATIONAL PLAN ............................................................................................................................... 10 
4 
STUDY PROCEDURES .................................................................................................................................... 12 
5 
STUDY EVALUATIONS AND MEASUREMENTS .............................................................................................. 12 
6 
STATISTICAL CONSIDERATIONS .................................................................................................................... 12 
7 
STUDY INTERVENTION (DEVICE OR OTHER INTERVENTION) ....................................................................... 15 
8 
SAFETY MANAGEMENT ................................................................................................................................ 18 
9  DATA COLLECTION AND MANAGEMENT ........................................................................................................ 19 
10 RECRUITMENT STRATEGY ............................................................................................................................ 20 
11 CONSENT PROCESS ...................................................................................................................................... 21 
12 PUBLICATION................................................................................................................................................ 21 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
Abbreviation 
Definition 
AE  
Adverse events 
DiD 
Difference-in-difference model 
FGD 
Focus group discussion 
IDI 
In-depth interview 
IRB 
Institutional Review Board 
ISM 
Independent safety monitor 
KDHS 
Kenya Demographic and Health Survey 
LIC 
Low-income countries 
NIH 
National Institutes of Health  
UHC 
Universal Health Coverage  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Intervention protocol template_Draft_29AUG2016 
 
PROTOCOL SYNOPSIS 
 
Study Title 
Randomized Controlled Trial to Address Unintended Pregnancy 
Rates in Low Resource Settings 
Funder 
Eunice Kennedy Shriver National Institute of Child Health and 
Human Development 
Study Rationale 
Unintended pregnancy is a major contributor to maternal and 
infant mortality in low-income countries (LICs). More than 300,000 
women and 2.7 million newborns die every year in LICs due to 
complications from childbirth and pregnancy. Nearly half of the 200 
million pregnancies occurring annually in LICs are unintended. High 
numbers of unintended pregnancy are primarily the result of non-
use of contraception. Non-use of contraception is more likely to 
occur among potential users who experience poor provider care. 
Providers who are frequently absent, solicit informal payments 
from clients, and deny methods to unmarried or nulliparous 
women are a major barrier to women seeking family planning. Yet, 
removing these barriers is difficult due to low supervision and 
accountability in under-resourced public facilities. Such findings 
highlight the need for interventions that increase quality of care via 
alternative mechanisms for monitoring providers. The social 
accountability approach solicits citizen feedback with the goal of 
improving provider performance and service delivery. To date, 
there is limited rigorous evidence on the effectiveness of social 
accountability interventions to increase contraceptive use and on 
the conditions necessary for successful and sustainable scale-up of 
these interventions. Further, no prior study has rigorously assessed 
social accountability in a setting where Universal Health Coverage 
(UHC) is already operating. Based on these knowledge gaps, we 
propose to evaluate the impact of two social accountability 
interventions using rigorous methods. We propose this study in 
Kenya, which rolled out UHC in late 2018 and where one out of 
every 42 women will die from complications related to pregnancy 
and childbirth.  
Study Objective(s) 
Our overall objectives in this proposal are to (i) assess the impact of 
two social accountability approaches on contraceptive use, (ii) 
assess the impact of these approaches on community 
empowerment and quality of care, and (iii) assess the scalability of 
these approaches to additional settings. 
Test Article(s) 
Community Scorecard 

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(If Applicable) 
In the Community Score Card approach, community members 
come together to document challenges they encounter when 
seeking services and develop a corresponding set of indicators that 
can be used to produce a validated facility score. The score is 
shared with the community and a collaborative process between 
key community members and facility staff takes place to develop 
feasible solutions and a strategic joint action plan, to be carried out 
by both providers and community members over the coming 
months.  
Citizen Report Card 
In the Citizen Report Card approach, individual-level feedback is 
collected from actual clients of target facilities, via a structured 
questionnaire, to assess facility performance and generate a public 
record of service quality. In addition to sharing the final report card 
with communities, engaged policymakers are invited to use the 
citizen feedback to improve service delivery. 
Study Design 
 
Our study design is a three-arm cluster-randomized controlled 
experiment in which all 147 public healthcare facilities in the 
county will be randomized to one of three study arms: 1. 
Community Score Card treatment, 2. Citizen Report Card treatment 
or 3. control. 
Subject Population 
key criteria for Inclusion 
and Exclusion: 
For this study, all women are included if they reside in randomly 
selected households and are between the ages of 18-49 years. 
Women who are less than 18 years old or older than 49 years will 
be excluded from the individual-level women's questionnaire.  
Providers will be eligible for inclusion in the survey if they provide 
family planning or reproductive health services within a public-
sector healthcare facility located in Kisumu County. 
Qualitative In-Depth Interviews (IDIs) and Focus Group Discussions 
(FGDs): Key intervention facilitators will be eligible to participate in 
the post-intervention focus group discussions. In-depth interviews 
will be conducted with providers and community members who 
participated in the interventions. All qualitative data collection will 
be among individuals 18 years and above. 
Number Of Subjects  
 
5500 individuals 
Study Duration 
Each subject’s participation will last twenty minutes to three hours. 
The entire study is expected to last approximately two years. 

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Study Phases 
Screening 
Study Treatment 
Follow-Up   
This is a three-arm cluster randomized experiment in which all 147 
public healthcare facilities located in Kisumu county will be 
randomly assigned to one of three study arms: 1. The Community 
Score Card treatment arm, 2. The Citizen Report Card treatment 
arm, and 3. The control arm. Each study arm will contain 
approximately 48 facilities, which, on average, serve approximately 
2,500 households each. Prior to randomization, we will ensure the 
three arms each contain similar numbers of each type of facility by 
first stratifying by facility type, a designation that includes three 
categories: 1. clinics and dispensaries (the smallest public facility 
type); 2. health centers; and 3. hospitals (sub-county or county 
hospitals). Individual-level data will be collected form women of 
reproductive age (18-29) in the catchment area of each facility. 
Pre-intervention/baseline data collection will be conducted in 
2021, with a repeated cross-sectional endline survey conducted in 
2022/23. 
Efficacy Evaluations 
Individual level questionnaires with women of reproductive age 
Facility level data on family planning quality of care 
Safety Evaluations 
Given our focus on improving quality of care among health care 
providers and the fact that we are not administering drugs or 
invasive measures, we anticipate a limited number of adverse 
events. Nevertheless, community monitoring of provider 
performance may increase stress for either community members 
or providers; therefore, facility staff and community 
members participating in any study component will be instructed 
to report any perceived adverse events related to any portion of 
this study to local project personnel, who will in turn 
inform Dr. Tumlinson throughout the trial.  
Statistical And Analytic 
Plan 
Our approach to testing the working hypothesis will be to use a 
difference-in-difference (DiD) model to estimate differential 
change in contraceptive use over time in each of the two treatment 
areas versus the control area. Contraceptive use will be a binary 
variable (0=non-use; 1=use), attained by asking participants, “Are 
you (or your partner) currently doing something or using any 
method to delay or avoid getting pregnant?” We will define 
modern contraceptive methods to include female or male 
sterilization, intrauterine device, implant, injectable contraception, 
oral contraceptive pill, or male or female condom. 

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DATA AND SAFETY 
MONITORING PLAN 
The intervention and measurement protocols pose minimal risk to 
participants. Because of this low-risk status, the data and safety 
monitoring plan for this trial focuses on close monitoring by the 
principal investigator (Dr. Tumlinson) and a local co-investigator in 
conjunction with an Independent Safety Monitor (ISM), along with 
prompt reporting of any serious adverse events to the NIH and to 
the University of North Carolina IRB and the Kenyan IRB committee 
reviewing the research protocol. 
 
1 
BACKGROUND AND RATIONALE 
Social accountability interventions are designed to improve the performance of service providers via public 
monitoring and the use of feedback mechanisms to address deficiencies in service delivery, but little is known 
about their true impact on contraceptive use, especially in the context of Universal Health Coverage. This 
study aims to implement and evaluate two social accountability interventions: the community score card and 
the citizen report card. 
1.1 
Introduction 
Family planning saves lives but is underutilized in low-income countries (LICs) where healthcare providers 
often discourage family planning use by engaging in negative behaviors. These negative behaviors include 
absenteeism, solicitation of informal fees, and withholding methods from young or unmarried clients. Recent 
data collected by the PI in Western Kenya revealed more than 50% of public-sector providers are absent at any 
one time, contributing to long wait times and abbreviated family planning counseling. Additionally, 23% of 
public-sector family planning clients are asked to pay for free commodities and 14% are unable to obtain any 
method due to provider bias towards women who are unmarried or nulliparous. These negative behaviors are 
reinforced by a disempowered clientele who lack knowledge of their patient rights and are further enabled by 
weak supervision of providers. Yet, increased supervision often is not feasible in resource-constrained settings.  
An alternative and promising approach, known as social accountability, is to engage local citizens in 
monitoring publicly funded healthcare facilities. What remains lacking, however, is a strong evidence-base for 
the impact of social accountability approaches on contraceptive use, particularly in settings that have 
implemented Universal Health Coverage (UHC). Therefore, there is a critical need to estimate the impact of 
social accountability interventions on provider performance and client contraceptive use in the UHC context 
and to ascertain the scalability of this approach. Without sufficiently addressing negative behaviors among 
providers, progress towards reducing unmet need for family planning will likely be limited.  
Our study design is a three-arm cluster-randomized controlled experiment in which all 147 public healthcare 
facilities in the county will be randomized to one of three study arms: 1. Community Score Card treatment, 2. 
Citizen Report Card treatment or 3. control. Our central hypothesis is that social accountability efforts will 
result in increased community empowerment, provider performance, and service utilization which, in turn, 
will increase contraceptive use. The rationale for this project is that a determination of highly impactful 
strategies for reducing unmet need is vital for countries burdened with high rates of maternal and infant 
mortality. 

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1.2 
Name and Description of Investigational Product or Intervention  
The following social accountability tools will be developed, applied, and evaluated in a three-armed cluster 
randomized controlled trial.   
- 
Community Score Card  
- 
Citizen Report Card 
In the Community Score Card approach, community members come together to document challenges they 
encounter when seeking services and develop a corresponding set of indicators that can be used to produce a 
validated facility score. The score is shared with the community and a collaborative process between key 
community members and facility staff takes place to develop feasible solutions and a strategic action plan.  
In the Citizen Report Card approach, individual-level feedback is collected from actual clients of target 
facilities, via a structured questionnaire, to assess facility performance and generate a public record of service 
quality. In addition to sharing the final report card with communities, engaged policymakers are invited to use 
the citizen feedback to improve service delivery.    
1.3 
Non-Clinical and Clinical Study Findings 
Intended participants of this study are: 
- 
Women of reproductive age (18-49 years),  
- 
Family planning providers at public facilities 
- 
Community members involved in intervention activities 
 
There are no anticipated or know potential risks for the participants in this study, besides potential breach of 
confidentiality. Participants in all surveys will be informed during the consent process that they may refuse to 
participate or may refuse to answer any question they do not want to answer, and no harm will come to them 
regardless of their participation decisions. All enumerators employed in any aspect of this research will receive 
extensive training on research ethics and confidentiality and will pledge to adhere to a strict confidentiality 
policy. (For more details on data management and collection see section 10.) 
 
There are no or minimal prospects of benefits to subjects participating in this study. Respondents will gain 
from contributing to research that will inform improvements in maternal and child health. The new knowledge 
generated through this study can benefit the local society and its members through improved accountability 
and delivery of health care services. The study has budgeted for dissemination plans.  This will include 
communicating our findings to local and national representatives of the Ministry of Health and other 
interested parties.  The research team will also present to any other Kenyan counties who would be interested 
in scaling up the social accountability interventions. Additionally, the research team will publish the results in 
peer-reviewed journals and present at international conferences. 
 
There are also substantial benefits to the scientific research, policy, and health communities: extensive 
research using these data will be published in health policy and public/reproductive/sexual health journals. 
We hope that this study will ultimately lead to improvement in understanding of the key community-level 
factors related to improved service delivery within public-sector healthcare facilities and improved health 
outcomes for women and children in Kenya. 
 

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Because the risks to subjects are very minimal, they are reasonable in relation to the anticipated benefits of 
improved understanding of factors contributing to increased contraceptive use.    
 
1.4 
Relevant Literature and Data 
- 
Bjorkman, M.  and J.  Svensson, Power to the people:  evidence from a randomized field 
experiment of a community-based monitoring project.  Quarterly Journal of Economics, 2009.  
124(2):  p.  735-69. Gullo, S., et al., Effects of a social accountability approach, CARE’s Community 
Score Card, on reproductive health-related outcomes in Malawi:  A cluster-randomized controlled 
evaluation.  PLoS One, 2017. 12(2).  PMCID:  PMC5302808  
- 
Gullo, S., C. Galavotti, and L.  Altman, A review of CARE’s Community Score Card experience and 
evidence.  Health Policy Plan, 2016.  31(10):  p.  1467-78.  PMCID:  PMC5091339  
- 
Björkman, M.  and J.  Svensson, when is community-based monitoring effective? Evidence from a 
randomized experiment in primary health in Uganda.  Journal of the European Economic 
Association, 2010.  8(2‐3):  p.  571-581.  
- 
Hoffman, K.D., The Role of Social Accountability in Improving Health Outcomes:  Overview and 
Analysis of Selected International NGO Experiences to Advance the Field.  2014, CORE Group: 
Washington, DC.  
- 
CARE Malawi, The Community Score Card (CSC):  A generic guide for implementing CARE’s CSC 
process to improve quality of services.  2013, Cooperative for Assistance and Relief Everywhere, 
Inc.  
- 
Waglé, S., J.  Singh, and P.  Shah, Citizen Report Card Surveys - A Note on the Concept and 
Methodology, in Social Development Notes:  Participation and Civic Engagement.  2004, The World 
Bank:  Washington, DC.  
- 
Asian Development Bank (ADB) and Asian Development Bank Institute (ADBI), Improving Local 
Governance and Service Delivery:  Citizen Report Card Learning Tool Kit.  2007. 
 
2 
STUDY OBJECTIVE  
Our long-term goal is to develop, evaluate, and implement evidence-based strategies that reduce unmet need 
for family planning in LICs. 
2.1 
Primary Objective 
Our overall objectives in this proposal are to (i) assess the impact of two social accountability approaches on 
contraceptive use, (ii) assess the impact of these approaches on community empowerment and quality of 
care, and (iii) assess the scalability of these approaches to additional settings. The proposed aims will be 
carried out in Kisumu County (Kenya) in close collaboration with the county health department. 
 
Aim 1: Estimate the impact of two social accountability interventions on modern contraceptive use. We 
will collect pre- and post-intervention measures of current modern contraceptive use in a representative 
sample of 2,268 women of reproductive age residing in Kisumu, using two independent cross-sectional 
surveys. We will use a difference-in-difference (DiD) model to estimate differential change in contraceptive use 
over time in each of the two treatment areas versus the control area. 
 
Aim 2: Estimate the impact of two social accountability interventions on community empowerment and 
quality of care. In addition to measuring contraceptive prevalence, our pre- and post-intervention surveys will 

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measure changes in community empowerment and the quality of family planning service delivery as important 
outcomes along the causal pathway from treatment to increased contraceptive use. Understanding the impact 
of the interventions on these intermediate outcomes will increase knowledge of the mechanisms by which the 
social accountability approach impacts health outcomes. As in Aim 1, we will use DiD models to estimate 
differential change for these intermediate outcomes over time. 
 
Aim 3: Using implementation science methods, assess the quality, scalability, and replicability of two 
social accountability interventions for uptake by the public-sector healthcare system. Little is known 
about how citizens and providers experience monitoring of providers. Negative perceptions from citizens or 
providers could ultimately reduce engagement in these approaches and hinder positive and sustainable 
outcomes. We will use validated measures of provider job satisfaction in the facility survey, as well as in-depth 
interviews with providers and community members, to assess local perspectives on citizen monitoring. 
Additionally, we will conduct focus groups with key facilitators in the two interventions to better understand 
implementation challenges and potential barriers to scale-up. 
 
3 
INVESTIGATIONAL PLAN (brief overview) 
3.1 
Study Design 
- 
 
This is a three-arm cluster randomized experiment in which all 147 public healthcare facilities located 
in Kisumu county will be randomly assigned to one of three study arms: 1. The Community Score Card 
treatment arm, 2. The Citizen Report Card treatment arm, and 3. The control arm. Each study arm will contain 
approximately 43 facilities, which, on average, serve approximately 2,500 households each. Prior to  
randomization, we will ensure the three arms each contain similar numbers of each type of facility by first 
stratifying by facility type, a designation that includes three categories: 1. clinics and dispensaries (the smallest 
public facility type); 2. health centers; and 3. hospitals (sub-county or county hospitals). 
 
Before and after implementing the two treatments, individual- and facility-level pre- and postintervention 
surveys will be conducted. The individual-level surveys will be conducted within a representative sample of 
women of reproductive age, stratified by study arm and cluster, and will be used to establish the primary 
outcome, modern contraceptive use, in all three study arms, pre- and post-treatment. The individual-level 
surveys will also measure multiple linking constructs such as community empowerment and quality of care. 
The facility-level surveys will be conducted in a census of all public-sector facilities located in Kisumu county 
and will be used to measure quality of family planning service delivery and negative provider behaviors. 
 
3.2 
Allocation to Treatment Groups  
This is a three-arm cluster randomized experiment in which all 147 public healthcare facilities located in 
Kisumu county will be randomly assigned to one of three study arms: 1. The Community Score Card treatment 
arm, 2. The Citizen Report Card treatment arm, and 3. The control arm. Each study arm will contain 
approximately 43 facilities, which, on average, serve approximately 2,500 households each. Prior to 
randomization, we will ensure the three arms each contain similar numbers of each type of facility by first 
stratifying by facility type, a designation that includes three categories: 1. clinics and dispensaries (the smallest 
public facility type); 2. health centers; and 3. hospitals (sub-county or county hospitals). 
 
3.3 
Study Duration, Enrollment and Number of Subjects 

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Mystery clients and unannounced visitors: All 147 public-sector healthcare facilities in Kisumu County will be 
included in this study. Each facility will receive two unannounced visitors and three mystery client visits at 
baseline and then again at endline.  
Provider interviews: Provider interviews will be conducted in all 147 public facilities in Kisumu 
County at baseline and endline. The total number of provider interviews conducted per facility will depend on 
the facility size but will average three per facility and will range from one to ten. The unannounced visitor will 
take a roster of providers who offer family planning services that are scheduled to work that day. If the facility 
has more than ten providers who provide family planning services scheduled to work that day, then ten 
providers will be randomly selected to participated. If the facility has less than ten providers scheduled to 
work that day, then all providers who offer family planning services will be interviewed. 
Individual-Level Interviews: 18 women will be sampled from each of the 42 clusters in each of the three arms. 
Households will be selected at random and approached by trained enumerators who will discuss the study and 
survey with the household head and then approach eligible women to review the consent process.  This cross-
sectional survey will be conducted at both baseline and endline.  
In-depth interviews: Thirty qualitative in-depth interviews will be conducted at endline with providers and 
community members to explore nuanced perspectives on formal feedback mechanisms and impact on 
provider job fulfillment. The UNC-based and local research teams will use convenience sampling to ensure that 
community members and providers who participated in the interventions are included. Once potential 
respondents have been identified, the local partner will invite potential respondents to participate in the 
interviews. 
Focus Group Discussions: Four focus group discussions will be conducted at endline with two groups per 
intervention arm. These discussions will bring together key facilitators who were instrumental in 
the implementation of the two interventions. The UNC-based team will work with our local partner 
to identify key figures in the implementation process and invite them to join these discussions. Approximately 
55 individuals will be recruited to participate in these focus group discussions. 
Focus Group Discussions for Citizen Report Card Approach: Formative qualitative data collection will happen 
before the baseline survey to inform the contents of the Citizen Report Card.  Three focus group discussions 
will be conducted with family planning clients (2 FGDs) and providers (1 FGD) to identify the most important 
indicators to include in the Citizen Report Card. The UNC-based and local partner teams will work with local 
community health workers to identify participants to include in these discussions.  Approximately 40 
individuals will participate in these focus group discussions.  
 
3.4 
Study Population 
For this study, all women are included if they reside in randomly selected households and are 
between the ages of 18-49 years. Women who are less than 18 years old or older than 49 years will 
be excluded from the individual-level women's questionnaire. 
  
Providers will be eligible for inclusion in the survey if they provide family planning or reproductive 
health services within a public-sector healthcare facility located in Kisumu County. 
 
Qualitative In-Depth Interviews and Focus Group Discussions: Key intervention facilitators will be 
eligible to participate in the post-intervention focus group discussions. In-depth interviews will be 
conducted with providers and community members who participated in the interventions. All 
qualitative data collection will be among individuals 18 years and above. 
 

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4 
STUDY PROCEDURES (what will be done) 
Please see Section 7 for a description of the research methods (procedures, observations, and 
measures). Please see Section 8 for a description of the treatment and related protocols. 
1.1 Not applicable. 
 
4.1 
Subject Completion/ Withdrawal procedures 
Respondents will be reminded during the consent process that they are free to withdrawal from the survey or 
interview whenever they desire.  Following the survey, respondents will have completed their involvement 
with the study.   
 
5 
STUDY EVALUATIONS AND MEASUREMENTS (how measurements will be made)   
- 
The baseline evaluation and planned measures are described in subsequent Sections. 
 
6 
STATISTICAL CONSIDERATION    
1.1 Primary Endpoint 
Aim 1 Methods: Estimate the Impact of Two Social Accountability Interventions on Modern 
Contraceptive Use. 
Overview. Weak accountability mechanisms in public-sector facilities result in poor provider performance, 
creating barriers to family planning use among women with a desire to space or limit future pregnancy. The 
objective of this aim is to estimate the impact of the Community Score Card and the Citizen Report Card, 
relative to the control arm, on current use of a modern contraceptive method. To attain this objective, we will 
test the working hypothesis that social accountability efforts result in increased community empowerment, 
provider performance, and service utilization which, in turn, increases contraceptive use. Our approach to 
testing the working hypothesis will be to use a difference-in-difference (DiD) model to estimate differential 
change over time in each of the two treatment areas versus the control area. The rationale for this aim is that 
the results will contribute to a nascent body of literature on the impact of social accountability interventions 
on family planning use. We expect to identify the potential contribution of social accountability efforts to 
increased contraceptive use. Such findings are important because they inform much needed 
knowledge of effective strategies for reducing unmet need for women living in LICs. 
 
Research Design. To assess the causal effect of the interventions, we will use a difference-indifference 
(DiD) model to estimate differential change over time in each of the two treatment areas versus the 
control area. The DiD model is commonly used in the social sciences [45, 46] and is described as follows: 
 
Y=β0 + β1POST + β2T1 + β3(POST*T1) + β4T2 + β5(POST*T2) + β4X + ui (1) 
 
In this equation, Y is a binary variable for current modern contraceptive use (0=non-use; 1=use), attained by 
asking participants, “Are you (or your partner) currently doing something or using any method to delay or 
avoid getting pregnant?” We will define modern contraceptive methods to include female or male 
sterilization, intrauterine device, implant, injectable contraception, oral contraceptive pill, or male or female 
condom. 
Stacking pre- and post-data, POST is an indicator variable (0=baseline;1=endline) and T1 and T2 are indicator 
variables for assignment to the Community Score Card or Citizen Report Card, respectively (1), or control (0). 

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The interaction between POST and T1 or T2 gives the difference between the change in the value of Y in 
either treatment group versus the same change in the control group. Equation (1) also includes a vector, X, of 
demographic characteristics. For any covariates that are not balanced across the study arms we will control for 
them in the regression, using their baseline values [47]. These covariates could include age, religion, ethnicity 
(tribal group), marital status, literacy/education, parity, distance to public facility, and household wealth. This 
model can also be used to test whether there is a large difference between the treatments by testing the 
equality of β3 and β5. 
Expected Outcomes. This aim is expected to provide critical knowledge of whether social 
accountability efforts can increase family planning use in LICs. Additionally, this aim will determine whether 
the two primary approaches to community engagement are largely different in their impact on women’s 
contraceptive behavior. This work is crucial to global efforts to address facility-level barriers to contraceptive 
use. 
 
Potential Problems and Alternative Strategies (for Aims 1 & 2). Our working hypothesis for this aim is that 
community engagement activities impact the contraceptive use of community members. Although our 
preliminary data strongly support this hypothesis – as does prior work by Bjorkman (2010) and Gullo (2017) – 
there is the remote possibility that contamination between arms of the trial could invalidate our hypothesis. 
Contamination is unlikely given community units are well-defined and mutually exclusive, but it is possible 
that those on the border of the community units, or those that move to a different community during the one 
year of treatment, could introduce contamination. If this happens, we would conduct a contamination 
adjusted intention to treat analysis. Towards this end, we will collect data in the individual-level survey that 
will allow us to ascertain movement between clusters during treatment as well as the actual facility used. 
Notably, it is unlikely that providers working at different facilities to supplement their income will contaminate 
across study arms because these supplemental positions occur within the private sector and not in other 
public facilities. Finally, we are unable to test for heterogeneity of treatment effect (i.e. variation in how 
specific sub-groups respond to the two treatments) due to necessary sample size restrictions. However, as 
described below, we will measure the intermediate outcomes that occur along the causal pathway between 
treatment exposure and the outcome of increased contraceptive use, helping to better understand how social 
accountability interventions work and which populations are likely to benefit most or least. 
 
Empowerment and Quality of Care. 
Overview. The changes that take place between intervention activities and the primary health outcome 
are referred to as linking constructs and are important in the evaluation of social accountability interventions. 
The objective of this aim is to estimate the impact of the two treatments, relative to the control arm, on 
several outcomes that potentially occur along the causal pathway from the treatments to the primary 
outcome of increased contraceptive use. To attain this objective, we will test the working hypothesis that 
social accountability efforts result in increased community empowerment and quality of care. Our approach to 
testing this working hypothesis will be to, once again, use a DiD model to estimate differential change over 
time in each of the two treatment areas versus the control area. Our rationale for this aim is that, currently, 
little is known about the causal mechanisms through which community monitoring activities impact health 
behaviors. We expect to identify the primary intermediate outcomes between the intervention and outcome. 
Such findings are important because they provide valuable information on which specific components of the 
interventions produce the change in contraceptive behavior. 
 
Research Design. As in Aim #1, we will use DiD models to estimate differential change in each of the 

Intervention protocol template_Draft_29AUG2016 
 
two treatment versus the control areas over time for each of the outcomes described below. In constructing 
the indicators that will fulfill this aim, we will refer to Kuhlmann et al.’s 2017 Malawi study; as in the Malawi 
study, we will invite Kisumu county health officials to provide select additional indicators of high relevance. 
Following Kuhlmann’s approach, community empowerment will be measured via questions related to 
individual knowledge and awareness of patient rights such as the right to receive family planning regardless of 
age, the right to free family planning services (without making informal payments), and the right to complain 
when encountering a provider who is disrespectful. As a subset of community empowerment, we will also 
include indicators of community engagement designed to gauge collective efficacy (i.e. How sure are you that 
the people in your community could work together to improve how women are treated at the health facility?) 
and social participation (i.e. In the past six months have you joined together with other people in your 
community to improve health services for women?). These measures will be included in the individual 
pre/post surveys. 
 
The individual-level pre- and post-intervention surveys will also include measures of perceived quality of care 
(choice of methods, information, and appropriate follow-up as well as informal fee solicitation and respectful 
care for all ages, regardless of marital status or parity). Actual quality of care will also be measured during pre 
and post-intervention facility-level surveys including mystery client surveys (standardized across enumerators) 
and unannounced enumerator visits (to ascertain absenteeism). Facility-level data collection will also include a 
provider survey that will ascertain changes in provider self-efficacy (as a subset of service quality), via 
questions related to provider confidence in their ability to speak up in community meetings as well as their 
ability to improve their own performance. 
 
Expected Outcomes. This aim is expected to identify the intermediate outcomes that occur along the 
causal pathway between treatment exposure and the outcome of increased contraceptive use. This work is 
critical for understanding the mechanisms of effect for improvement and replication of social accountability 
interventions in additional settings. 
 
Aim 3 Methods: Using Implementation Science Methods, Assess the Quality, Scalability, and 
Replicability of Two Social Accountability Interventions for Uptake by The Public-Sector Healthcare 
System. 
Overview. Despite steadily growing popularity of the social accountability approach, little is known 
about how communities and providers experience giving and receiving formal feedback. 
 
Research Design. To assess provider burnout and professional fulfillment, we will include a short 
module in the facility-level provider survey, using the validated Professional Fulfillment Index. We will also 
conduct in-depth interviews (n=30) with providers and community members to explore nuanced perspectives 
on formal feedback mechanisms and impact on provider job fulfillment. Additionally, we will conduct four 
focus groups (two/arm) with key facilitators in the two intervention approaches to better understand 
implementation challenges and potential barriers to scaling up these interventions to other regions or 
countries. Finally, we will obtain estimates of the parameters needed to estimate the costs to scale up each 
intervention. 
 
Expected Outcomes. This aim is expected to increase knowledge of how community members and 
providers experience the community monitoring process and will also identify challenges to intervention 
replication and scale up. This knowledge will be important for further uptake of social accountability efforts. 
 
1.1 Statistical Methods 

Intervention protocol template_Draft_29AUG2016 
 
Our approach to testing the working hypothesis will be to use a difference-in-difference (DiD) model to 
estimate differential change over time in each of the two treatment areas versus the control area. The 
rationale for this aim is that the results will contribute to a nascent body of literature on the impact of social 
accountability interventions on family planning use. We expect to identify the potential contribution of social 
accountability efforts to increased contraceptive use. Such findings are important because they inform much 
needed knowledge of effective strategies for reducing unmet need for women living in LICs. 
 
6.1 
Sample Size and Power 
For the individual-level surveys, we estimate a design effect of 1.56 for modern contraceptive prevalence due 
to our cluster-based sampling procedure, based on information provided in the 2014 Kenya Demographic and 
Health Survey (KDHS) Final Report, Appendix B, Table B2. We calculate our necessary sample size assuming 1.) 
50% current modern contraceptive prevalence in Kisumu; 2.) 42 clusters in each study arm [clusters=facility 
catchment areas (All public facilities have a catchment area which is clearly defined, mutually exclusive, and 
exhaustive); we are allowing for potential closure of one facility per arm)]; 3.) an effect size of two standard 
deviations (which correlates to a change in the prevalence of modern contraceptive use of approximately 10 
percentage points). With these parameters, we will need to survey 18 women in each of the 42 clusters in 
each of the three study arms, resulting in a total sample size of 2,268 women of reproductive age in the 
individual-level surveys. The 18 women sampled from each cluster will be selected at random. We will follow 
KDHS procedures in cases where there is more than one eligible woman in the household.  
 
For the facility-level surveys we will measure family planning service quality and negative provider behaviors 
via interviews with one to ten providers, depending on total staff at each of the 147 facilities. This will result in 
approximately 385 provider interviews, with approximately 128 in each study arm. Unannounced visitors and 
mystery clients will also be deployed to secure less biased estimates of provider absenteeism, informal fee 
solicitation, and disrespectful/biased treatment of clients; mystery clients will also collect data on traditional 
measures of family planning service quality such as choice of methods and information on side effects. All 147 
facilities in Kisumu will receive two unannounced visits and three mystery client visits.   
 
Post-treatment, we will repeat the individual-level survey, within a newly sampled cross-section of the 
population. We will also repeat all facility-level data collection in all 147 public facilities in the county. The 
changes in contraceptive use, quality of care, and community engagement resulting from the Community 
Score Card and the Citizen Report Card interventions will be evaluated via data collected in these pre- and 
post-intervention surveys. The sampling frame for both individual-level surveys will come from the Kenyan 
National Bureau of Statistics, which completed a new household-level census in all counties in Kenya in August 
2019. 
 
7 
STUDY INTERVENTION (drug, device or other intervention details) 
- 
Description 
The Community Score Card Approach 
 
In the Community Score Card approach, community members come together to document challenges 
they encounter when seeking services and develop a corresponding set of indicators that can be used 
to produce a validated facility score. The score is shared with the community and a collaborative 
process between key community members and facility staff takes place to develop feasible solutions 

Intervention protocol template_Draft_29AUG2016 
 
and a strategic action plan. 
 
Step 1: Preparation (3 months). During this phase, the PI will consult with the Kisumu County Health Director 
to confirm the geographic coverage of the community score card intervention (the catchment area 
of the 43 public healthcare facilities in this arm). Training manuals and facilitation guides will be developed. 
Experienced facilitators will be identified and trained in the community score-card approach. The communities 
and facility staff will be engaged and sensitized to the community score card via a meeting that discusses the 
community score card purpose and approach; a date, location, and general process for conducting the 
community score cards will be selected/designed.  
 
Step 2: Conducting the community score card with target communities (1 month). During this phase, all 
communities associated with the targeted facilities will assess the primary barriers to quality family planning 
service delivery and develop corresponding indicators, assisted by an experienced facilitator. The communities 
will then each complete the score card and generate ideas for quality improvement. 
 
The first activity in this phase will be to divide the community into groups based on shared characteristics. 
Groups will be determined using a social mapping exercise with a diverse group of community members who 
know the community well and are able to identify vulnerable households. The social mapping exercise is 
designed to ensure marginalized populations are included in the score card activities. Possible groups 
determined by the social mapping exercise may include women, young women, men, young men, female 
headed-households, households with orphans, and people living with HIV/AIDS. 
 
Once the groups have been determined, a facilitator with a relationship of trust within each group will be 
identified and assigned to facilitate each group in a participatory manner. Of note, groups will meet in 
separate areas when developing their scorecard. Each group will be invited to generate a list of issues related 
to the delivery of healthcare services, with an emphasis on family planning services. The facilitator will elicit 
issues by asking questions like, “How are things going with health services at your public facility? What is going 
well? What is not going well?” For all issues generated, the facilitator will ask for suggestions of how to 
improve service delivery. Additionally, because a large number of issues may be identified, group members 
will also be asked to prioritize issues by agreeing on the most important and urgent issues to resolve first. This 
information will be fed into an issue matrix. Each group will decide for themselves the issues, solutions, and 
priorities in their matrix. 
 
Information from the issue matrix will be used by study team members to develop the scorecard indicators for 
the larger community. Each of the groups will be given a scoring matrix of final indicators and will score these 
indicators (a suitable scoring system will be developed with community input). Study team members, 
collaborating with community members, will meet to consolidate scores across groups. 
 
Step 3: Conducting the community score card with family planning providers (1 month – simultaneous with 
Step 2). Family planning providers in the target facilities will meet and determine the barriers to high quality 
family planning service delivery.  Providers will decide on priority areas and make suggestions for improving 
service delivery. This step will be similar to step 2, using the same participatory facilitation methods, but the 
pace may be quicker as providers generally form only one group and have a higher literacy level. Providers 
may derive a similar list of issues/indicators as the community. When scoring the indicators, the facilitator will 
be sure to include the views of quieter providers. 
 

Intervention protocol template_Draft_29AUG2016 
 
Step 4: Connecting the patients and providers and determining an action plan (1 month). This is where 
community members and service providers share their respective scorecards and jointly develop an action 
plan. A skilled facilitator with strong negotiation skills will ensure the meeting is positive and productive. 
Family planning patients and providers - as well as community leaders and process facilitators - will come 
together to present their findings and to jointly determine the priority areas and develop an action plan. 
Within the action plan, agreed upon responsibilities will be assigned and a timeline will be communicated. For 
example, one priority issue may be punctuality of staff and the determined action may be for staff to observe 
official hours. This action would be led by the providers, in collaboration with the facility manager, and the 
expected timeline/date of completion may be the following month. 
 
 
The Citizen Report Card Approach (CRC) 
In this approach, individual-level feedback is collected from actual clients of target facilities, via a structured 
questionnaire, to assess facility performance and generate a public record of service quality. In addition to 
sharing the final report card with communities, engaged policymakers are invited to use the citizen 
feedback to improve service delivery. 
 
Step 1: Preparing for data collection and dissemination (1 month). The PI will consult with the Kisumu County 
Health Director to confirm the geographic coverage of the citizen report card. The PI will also collaborate with 
staff in the county health office to develop a post-survey publicity strategy. The strategy could include 
community dialogues, radio call-in shows, television, and newspaper coverage.  
 
Step 2: Designing the CRC survey (3 months). We will conduct three focus groups (two with family planning 
clients stratified into younger versus older women and one with service providers). This will help to identify 
key service challenges and inform the content of the CRC questionnaire by allowing citizens to articulate and 
prioritize relevant indicators for monitoring and reporting on service provider performance. Focus groups with 
service providers may elicit suggestions for the type of feedback they would find most useful for improving 
their service delivery. In general, both providers and clients will be asked about the problem areas related to 
family planning service delivery. Once focus group discussions are completed and the data are analyzed, 
investigators will identify the prominent themes related to family planning service delivery that emerge from 
the focus group data. In turn, these themes will inform the main content of the CRC questionnaire. 
 
All survey questions wll be grouped into modules including demographic characteristics (age, marital status, 
education, etc.), contraceptive use, and service quality indicators. Survey questions will be translated into local 
languages and retranslated back to English to confirm accuracy of translations. Once drafted and translated, 
the CRC questionnaire will be field-tested in a neighboring county. Prior to survey implementation, 
communities in the catchment area of the selected facilities will be sensitized to the survey, in collaboration 
with the county health director and the primary elder for each community. 
 
Step 3: Execute the survey (3 months). The survey will be administered within a representative sample 
(N=300, ideal size to capture representative community opinions on facility performance, per 
recommendation of report card developers) of reproductive age women in the catchment areas of facilities 
randomized to the Citizen Report Card study arm. To obtain a representative sample of women from each 
catchment area, we will use a multi-stage sampling design in which government census enumeration areas 
from the 2019 national census will serve as primary sampling units. Within each selected unit, a random 
sample of 25 households will be selected, during which a list of usual household residents will be obtained. To 
obtain the list of household residents, a trained enumerator will approach the household head to explain the 

Intervention protocol template_Draft_29AUG2016 
 
study and obtain permission to list household residents. All eligible women aged 18–49 on the household list 
will be approached by a trained and experienced female enumerator who will explain the study purpose. 
Eligible women will be asked to participate in the survey via an informed consent protocol; those providing 
written consent will be interviewed by a female enumerator who will record responses on a password-
protected and encrypted electronic device. The interview will not exceed 30 minutes. Pre-survey filters will 
exclude those women who do not use family planning obtained from a public facility (this cannot be 
ascertained during the household listing with the household head (often male) as women may use family 
planning covertly). Thorough quality checks (spot monitoring of interviews and data checks for inconsistent 
responses) will be conducted. 
 
Step 4: Analyze the data (2 month). We will analyze data from the CRC questionnaire and translate results into 
a report card. Prior to dissemination, we will conduct cognitive interviews with a convenience sample of 20 
people to inform the design and presentation of ‘user-friendly’ results; this will help to ensure citizens can 
easily and quickly absorb the findings. The report card will also be translated into the local languages (Kiswahili 
and Dholuo) so that it is accessible to a broad range of stakeholders. 
 
Step 5: Disseminate results to the community (1 month). Extensive dissemination activities will ensure the 
Citizen Report Card is widely shared with members of the community. Report card findings will be presented 
at a high-profile press conference and press kit materials with short, readable stories will be distributed to 
members of the print, radio, and television media. The goal is to create a public record of service quality 
 
8 
SAFETY MANAGEMENT 
A Data and Safety Monitoring Plan has been developed for the purpose of this study. Below is an extract from 
this plan:   
  
The intervention and measurement protocols pose minimal risk to participants. Because of this low-risk status, 
the data and safety monitoring plan for this trial focuses on close monitoring by the principal investigator (Dr. 
Tumlinson) and the local co-investigator (Dr. Onyango) in conjunction with an Independent Safety Monitor 
(ISM), along with prompt reporting of any serious adverse events to the NIH and to the University of North 
Carolina IRB and the Kenyan IRB committee reviewing the research protocol. Our proposed plan entails 
regular safety reports which will be prepared by Dr. Tumlinson, with input from Dr. Onyango. Dr. Tumlinson 
will be responsible for assembling the data and producing these reports, as well as assuring that all parties 
obtain copies of these reports. The research team will meet with the ISM twice during each project year to 
review the reports and discuss any concerns that arise. 
 
Qualifications and responsibilities of the Safety Monitor:  The Independent Safety Monitor (ISM) will be a 
researcher, independent of this research team, identified through the Kisumu County Health Department 
and with expertise in the areas of reproductive health and community engagement. The ISM will review safety 
reports and will determine whether there is any corrective action, trigger of an ad hoc review, or stopping rule 
violation that should be communicated to the study investigators, institutional IRBs, and the 
NIH program officer.   
 
Review Process:  Dr. Tumlinson will provide the ISM with administrative reports describing the study progress, 
subject recruitment, subject demographic data, subject status, and inclusion/exclusion criteria. These reports 
will be reviewed by Drs. Tumlinson, Onyango, and additional study team members prior to being presented to 
the ISM. Dr. Tumlinson will notify the ISM if any events pose statistical concern or occur in disproportionate 

Intervention protocol template_Draft_29AUG2016 
 
numbers throughout the intervention and control groups. A summary of the administrative reports produced 
each project year will be included in the annual report to NICHD for R01 HD101453-01A1.  
 
Independent Safety Monitor (ISM) Activities:  The ISM will review the protocol to ensure adequate measures 
are designed to ensure subjects’ safety and identify any needs for modification. The ISM will provide review of 
recruitment data, protocol adherence, as well as identify needs regarding subject safety. Additionally, 
the ISM will make recommendations for appropriate analyses and suggestions for recruitment and safety 
issues.   
 
Measurement and reporting of adverse events:  Given our focus on improving quality of care among health 
care providers and the fact that we are not administering drugs or invasive measures, we anticipate a limited 
number of adverse events. Nevertheless, community monitoring of provider performance may increase stress 
for either community members or providers; therefore, facility staff and community members participating 
in any study component will be instructed to report any perceived adverse events related to any portion of 
this study to Dr. Onyango, who will in turn inform Dr. Tumlinson and the ISM throughout the trial. Dr. 
Tumlinson will immediately report any adverse events to the institutional IRBs, and the NIH program officer.  
 
Stopping rules:  In this minimal risk intervention trial it is unlikely that excess adverse events will occur and 
require stopping the trial. Other issues relating to stopping rules for this trial include significant new 
information. It is exceedingly unlikely that any new information will become available during this trial that 
would necessitate stopping the trial.    
 
Process for Handling and Reporting Adverse Events (AEs): We will institute two primary mechanisms 
for handling AEs.   
1. Facility staff and community members participating in any study component will be instructed 
to report any perceived adverse events related to any portion of this study to Dr. Onyango, who 
will in turn immediately inform Dr. Tumlinson and the ISM.   
2. Additionally, for each data collection activity, all enumerators will participate in 
a weekly briefing with a senior field officer (SFO), during which time any concerns can be 
conveyed. The SFO will immediately relate any concerns to the Assistant Field Manager who 
will immediately communicate with Drs. Onyango and Tumlinson.   
 
Across both mechanisms, Dr. Tumlinson will immediately report any adverse events to the institutional IRBs 
and the NIH program officer and will follow any additional AE reporting requirements according to the 
protocols approved by the IRBs at the University of North Carolina at Chapel Hill and the local Kenyan IRB.  
 
9 
DATA COLLECTION AND MANAGMENT  
No private identifiable information will be collected from either individual or facility-level survey participants 
or from any of the participants in the qualitative study components. No previously collected data or records 
will be used in the proposed activities.  All individual and facility-level (and qualitative) data will be collected 
by a team of Kenyan supervisors and enumerators. The field team will undergo a major training program led 
by PI Tumlinson prior to baseline; before end-line data collection the team will undergo additional and 
extensive training. 
 
The primary risks posed to individuals who have contributed information to this study derive from the threat 
of breach of confidentiality, although this risk is minimized given that we are not collecting any personally 

Intervention protocol template_Draft_29AUG2016 
 
identifying information for any of the three study aims.  Further, PI Tumlinson has received extensive training 
regarding the protection of human subjects and has had prior experience with the conduct of primary data 
collection.  Dr. Tumlinson will draw upon this training and experience and take all necessary precautions to 
ensure that no individual’s confidentiality is breached. The Carolina Population Center houses several projects 
based on confidential data and the systems personnel developed data security protections that meet all 
federal standards. 
 
The quantitative data that is collected electronically (mystery client observation, unannounced visits, provider 
surveys, and individual-levels interviews with women) will be collected on an encrypted, password-protected 
electronic device using Survey CTO, an electronic data collection program. This program offers encryption for 
all data. The data will be transmitted to the UNC research team via a secure cloud-based server.  The data will 
then be downloaded by the UNC PI and the unannounced visitor portion that contains provider names will be 
immediately de-identified. The names of facilities will also be immediately de-identified. The identifiers will be 
stored separately, as described above, and accessible only to the UNC study PI. The thoroughly de-identified 
data will be accessed by members of the UNC team via UNC's OneDrive. Once transcribed and translated, all 
data from the focus group discussions and in-depth interviews will be transmitted to the UNC research team 
via a secure cloud-based server. This data will be entirely anonymous and will be accessed by members of the 
UNC team via UNC's OneDrive. 
 
Data sources: Quantitative data for this project will be collected using electronic questionnaires implemented 
by highly experienced and carefully trained local enumerators. Qualitative data will be sourced from focus 
group discussions and in-depth interviews, guided by semi-structured questionnaires with responses captured 
by audio recording.   
 
Data security: All quantitative data will be collected on encrypted, password protected electronic devices 
and uploaded to a secure cloud-based server where it can be accessed daily by Drs. Tumlinson and Onyango. 
All qualitative data will be audio recorded and the recordings will be stored in a locked cabinet in a locked 
office at the official Kisumu offices of Innovations for Poverty Action. Once transcribed and translated, all data 
from the focus group discussions and in-depth interviews will be transmitted to the UNC research team via a 
secure cloud-based server. Original audio recordings will be destroyed after a period of three years. Across all 
types of data, electronic communication with outside collaborators will involve only unidentifiable 
information.  
 
Quality assurance: For the individual and facility-level baseline and endline questionnaires, mystery client 
observations, and unannounced visits, local senior field officers will regularly conduct random spot checks in 
the field to ensure enumerators are visiting the correct locations at the scheduled 
times. Further, two senior research associates will execute daily data quality assurance checks and provide 
weekly reports on progress to Drs. Tumlinson and Onyango. Drs. Tumlinson or Onyango or senior study 
staff will review all data collection forms on an ongoing basis for data completeness and accuracy as well as 
protocol compliance.  
 
10 
RECRUITMENT STRATEGY 
For the individual-level survey in aims 1 and 2, households are selected at random, and women of 
reproductive age will be invited to participate. For the facility-level survey in aims 1 and 2, providers at all 
public facilities will be invited to participate (up to 10 at each facility).  For all qualitative data collection, we 
will use snowball sampling to recruit study participants. 

Intervention protocol template_Draft_29AUG2016 
 
After households are randomly selected, a female resident of reproductive age will be selected at random (if 
there is more than one in a household) and a female enumerator will read a consent script outlining the 
purpose of the study, potential risks to respondents, the time commitment involved in the study, and the 
potential benefits to respondents of participating in the study.  For research involving children:  The age of 
majority in Kenya is 18 and we will invite women between the ages 18 to 49. There is only minimal risk to 
participants in this age group, who may feel uncomfortable answering questions about contraceptive use. 
However, we will take steps to minimize discomfort, including conducting the interview in private and with a 
female interviewer.  The benefit of including this age group is high as this age group is particularly vulnerable 
to unplanned pregnancy as well as the potentially negative outcomes of an unplanned pregnancy including 
loss of educational attainment, employment, and social stigma in the case of unmarried adolescents.  
Therefore, it is extremely important to include this group and we will follow all local ethical regulations, 
customs, and research norms regarding assent/consent of this age group for studies on contraceptive use.    
11 
CONSENT PROCESS 
 
All providers will be asked to participate through an informed consent process.  A trained data collector will 
explain the purpose and confidentiality of the study to selected service providers; those that provide consent 
will be asked about their demographic characteristics, quality of care delivered, and self-efficacy and 
professional fulfillment.  The information is not sensitive, and the provider’s participation is brief, voluntary, 
and anonymous. There is minimal risk to providers who participate. For visits from mystery clients and 
unannounced visitors (both will be highly experienced and well-trained data collectors), informed consent will 
be obtained from facility supervisors. The research assistant will explain the purpose and confidentiality of the 
study to the facility-in-charge or facility supervisor (but will not tell the manager when the visits will occur in 
order not to disrupt the study design). Those facilities with a supervisor who provides documentation of 
consent will be eligible to participate and will receive mystery client and unannounced visits during baseline 
and endline data collection.  The participation of facilities is brief, voluntary, and anonymous. There is minimal 
risk to facilities who participate in mystery or unannounced visits. Data Page 118 Protection of Human 
Subjects Contact PD/PI: Tumlinson, Kat collectors serving as mystery clients will undergo extensive training to 
ensure they are fully able to avoid any unwanted exams or procedures that may be suggested by the service 
provider. As no identifying information is collected, participants will be asked to provide verbal consent.  All 
those selected for participation will have the opportunity to opt out of the study if they do not wish to 
participate. All recruitment and informed consent protocols will be reviewed and approved by the UNC-CH 
IRB. 
 
12 
PLANS FOR PUBLICATION 
Findings from this study will be disseminated through publications in peer reviewed health policy and 
public/reproductive/sexual health journals, written in conjunction with Innovation for Poverty Action and all 
co-investigators and collaborators.  
Publications based on data from study will comply with applicable NIH data sharing and dissemination policies 
for NIH-funded trials. In addition, every attempt will be made to publish results in peer-reviewed journals.  
Data from this study may be requested from other researchers by contacting the Principal Investigator.