Incentives for Postnatal Care Demand
Phase: NA
Conditions: Maternal Death, Neonatal Death
Sponsor: Harvard School of Public Health (HSPH)

 
Incentives for Postnatal Care Demand 
NCT02936869 
July 7, 2016 

 
HLMA Research Protocol  
For use by HMS, HSDM and Harvard Chan School Investigators 
 
Research Protocol Template | HRP-503 | Version date: September 17, 2015 | Page 1 of 22 
Longwood Medical Area IRB http://www.hsph.harvard.edu/ohra/ 
Instructions: The purpose of this research protocol is to provide IRB members and reviewers with sufficient 
information to conduct a substantive review.  If a separate sponsor’s protocol exists, submit it in addition to this 
document. 
 
Complete all of the sections below.  For more detailed instructions, consult the Investigator’s Manual or IRB 
website (links provided below).  
 
GENERAL INFORMATION 
Protocol # (if assigned): IRB16 - 0923 
Version Date: 7/7/2016 
Version Number: 1 
Principal Investigator: Margaret McConnell, Ph.D. 
Protocol Title: Partnering with Traditional Birth Attendants (TBAs) to Increase Postnatal Care Demand in 
Nigeria 
 
1. Specific Aims 
a) To determine perceptions of TBA involvement in postnatal care referrals among health care 
providers, TBAs, and mothers 
b) To define barriers and enablers of TBA involvement in postnatal care referrals 
c) To estimate the impact of performance-based monetary incentives to TBAs on postnatal care 
referrals of delivery clients 
d) To estimate heterogeneity in impact of performance-based monetary incentives to TBAs on 
postnatal care referrals of delivery clients 
2. Background 
2.1 
Provide the scientific background and rationale for the study 
The traditional birth attendant or TBA is a traditional, independent (of the health system), non-formally trained, 
and community-based provider of pregnancy-related care (WHO, 2004).  TBAs often do not understand how to 
appropriately manage complications during child birth, so that mothers and neonates they care for are at higher 
risk of death from delivery complications relative to those cared for by skilled health workers (Itina, 1997). The 
World Health Organization recommends that the best role for the TBA is to serve as an advocate for skilled care 
(WHO, 2004). However, there are strong social norms of pregnant women patronizing the TBA for antenatal 
care and delivery services as TBAs are highly respected in their communities. The TBA is also paid for her 
services. Therefore, referring women to skilled health providers for antenatal and delivery care goes against the 
financial and social interests of the TBA. The pronouncement that TBAs are not part of the Nigerian health 
system has not changed patterns TBA patronage for antenatal and delivery care (Owens-Ibie, 2011).  
 
In contrast to antenatal and delivery care, only 4 percent of Nigerian mothers receive postnatal care from a TBA 
indicating that there is potentially less competition between the TBA and skilled health workers after delivery 
for the high-risk mother (NPC and ICF International, 2014). Postnatal care within 48 hours of childbirth (early 
PNC) offers the opportunity for early detection of complications, prevention of mother to child transmission of 
HIV, and provision of other critical support, to reduce mortality risk. There is therefore the potential for 
partnerships with TBAs to be effective in increasing uptake of early PNC among Nigerian mothers, which in 
turn could reduce preventable mortality.   
 
 
2.2 
Describe the significance of the research, and how it will add to existing knowledge 
There are few studies that explore the involvement of TBAs in referrals for postnatal care. There is also no 
experimental evidence on the effectiveness of performance-based incentives for TBA referrals in the postnatal 
period. We propose to conduct a mixed methods study on the engagement of TBAs for postnatal care demand-
generation among their delivery clients (mother who are attended at delivery by the TBA). The qualitative study 
will involve focus group discussions with TBA delivery clients, TBAs, and skilled health workers, to clarify 

 
HLMA Research Protocol  
For use by HMS, HSDM and Harvard Chan School Investigators 
 
Research Protocol Template | HRP-503 | Version date: September 17, 2015 | Page 2 of 22 
Longwood Medical Area IRB http://www.hsph.harvard.edu/ohra/ 
perceptions about, barriers to, and enablers of TBA engagement in postnatal care referrals. Informed by a 
recently completed qualitative pilot study (there was no control group), we will also identify the causal impact 
of performance-based incentives in increasing postnatal care referrals by TBAs, via a randomized controlled 
trial (Oyebola, et al., 2014). The persistent high rates of non-facility births attended by TBAs across Africa 
imply that the findings of this study can broadly inform policy aimed at reducing preventable maternal and 
neonatal death on the continent. 
 
3. Study Setting  
3.1. Identify the sites or locations where the research will be conducted.  
The study will be conducted in approximately 67 purposively selected villages in South-Eastern Nigeria, in 
Ebonyi State.  The intervention focuses on villages rather than health care facilities, as traditional birth 
attendants do not work from facilities and they are the focus of the intervention. We have not selected study 
villages at this point in the study and can add the full list as a modification – we need IRB approval to observe 
postnatal care to decide on villages with adequate facilities. We anticipate that at 1 facility per village, we will 
end up with at least 67 facilities. Some mothers will attend postnatal care in facilities outside their village as 
well though so that the full list of attended facilities cannot be obtained ex ante. It will be ascertained in the 
follow-up survey of delivery clients of traditional birth attendants.  
The villages will be chosen such that: 
1. 
there is a facility offering postnatal care within 1-hour walking distance of most households;  
2. 
postnatal care practice in the facility involves routine visits within 24-72 hours, 7-14 days, and 42 
days of delivery in line with national recommendations; and  
3. 
the relationship between TBAs and health workers is sufficiently cordial to encourage partnership on 
postnatal care referrals.  
 
A list of villages chosen for the study will be added as a modification. 
 
 
3.2. Describe the Principal Investigator’s experience conducting research at study site(s) and 
familiarity with local culture 
The Principal investigator has worked on a number of health studies in similar contexts across Africa. These 
include “Financing the Delivery or Efficient, Effective, and Equitable Primary Health Care Systems in Africa” 
(PI: Peter Berman); “Do Financing and Fathers Lead to Better Birth Preparedness and Safer Motherhood? 
Proposal for a Randomized Controlled Trial in Nairobi, Kenya” (PI: Jessica Cohen); “Negotiating Delivery: Can 
Spousal Involvement Improve Maternal Health?” (PI: Jessica Cohen and Margaret McConnell, Funders: Lab for 
Economic Applications and Policy); “Identifying Barriers to Investments in Health: Making the transition from 
biofuel to gas cooking in Ghana” (PI: Margaret McConnell, Funder: Harvard Sustainability Science Program); 
“Behavioral Economics and Demand for Maternal Health Services: A Series of Experiments in Kenya” (PI: 
Jessica Cohen and Margaret McConnell).  
 
3.3. Is the research conducted outside the United States?  
No 
Yes:  If yes; describe site-specific regulations or customs affecting the research, local 
scientific and ethical review structure 
We are required to obtain ethical approval from the the Research and Ethics Committee, Federal Teaching 
Hospital Abakaliki, prior to commencing data collection. Local ethical approval will be attached to the Harvard 
IRB application when it is obtained, and will cover all local implementing partners and local research staff in 
this study. 
 
3.4 
Are there any permissions that have been or will be obtained from cooperating institutions, 
community leaders, or individuals, including approval of an IRB or research ethics committee? 
No 
Yes:  If yes; provide a list of the permissions (also include copies with the application, if 
available) 

 
HLMA Research Protocol  
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We will obtain permissions from the following prior to implementation, which will be uploaded via a 
modification: 
a) Community heads of participating villages for access to community spaces 
b) State office of National Primary Health Care Development Agency for access to health care 
facilities 
c) Health Research Ethics Committee of the University of Nigeria Teaching Hospital, Enugu State for 
ethical approval of the study 
 
4. Study Design 
4.1. Describe the study design type  
We will conduct a mixed methods study on the engagement of TBAs for postnatal care demand-generation 
among their delivery clients. The qualitative study will involve focus group discussions with TBA delivery 
clients, TBAs, and skilled health workers, to clarify perceptions, barriers, and enablers of TBA engagement 
in postnatal care referrals for non-facility births.  We will also conduct a randomized controlled trial to 
identify the causal impact of performance-based incentives in increasing postnatal care referrals of TBA 
delivery clients.  
 
4.2. Indicate the study’s duration - and the estimated date of study completion 
We anticipate that the study will extend from 14 July 2016 to 31 May 2017, over 10 months and 18 days. 
 
4.3. Indicate the total number of participants (if applicable, distinguish between the number of 
participants who are expected to be screened and enrolled, and the number of enrolled 
participants needed) 
The qualitative study will recruit up to 10 TBA delivery clients, health workers, and traditional birth attendants 
each, aiming for a minimum of 6 participants in each category who consent and join the focus group 
discussions.  
 
The randomized controlled trial will screen 200 traditional birth attendants in all and requires a minimum of 160 
TBAs to consent and enroll into the study as justified in the power calculations below. The total TBA 
enrollment for the study will not exceed 200. We expect that TBAs will deliver an average of 5 clients per 
month. We intend to survey each of these clients. Thus, over the 5-month intervention period, the randomized 
controlled trial team will approach up to 5000 TBA delivery clients (200 *5*5). 
 
4.4. List inclusion criteria  
Focus Group Discussions 
S/No 
Group 
Inclusion Criteria 
1 
TBA delivery 
clients 
Mother beyond 42 days after 
culmination of first pregnancy, 
who have thus had the opportunity 
to choose to attend postnatal care 
given current policy 
recommendations; resident in 
community; was delivered by a 
TBA; willing to participate in 
study; over 18 years of age 
2 
TBAs 
Resident in community; TBA role 
(on-formally trained, independent 
of health system, provider of 
pregnancy-related care) confirmed 
by village head; willing to 
participate in study 

 
HLMA Research Protocol  
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3 
Health Workers 
Involved in postnatal care delivery 
within formal health care system, 
precisely direct patient care; works 
in same community; willing to 
participate in study 
 
Randomized Controlled Trial 
TBAs will be identified as community-based providers of antenatal and/or delivery care, and who are non-
formally trained. TBAs must be resident within the community, must not plan to relocate over the intervention 
duration, must be reachable via mobile phone, and will be identified in partnership with community leadership. 
They will be willing to participate fully in the study, including having their clients contacted to verify delivery 
details and postnatal care use. 
 
All delivery clients of TBAs will be interviewed, that is women who gave birth assisted by TBAs (and reported 
by the TBA to the study team as described below). 
 
We will conduct baseline surveys of facilities in potential villages in which the study will be conducted. These 
surveys will involve anonymized observations of random postnatal care visits to ascertain process quality of 
care received. Villages in which postnatal care is of adequate quality will be selected. 
 
 
 
4.5. List exclusion criteria 
 
Focus Group Discussions 
S/No 
Group 
Exclusion Criteria 
1 
TBA delivery 
clients 
First pregnancy before 42 days of 
culmination; unwilling to 
participate in study; was not 
delivered by TBA; under 18 years 
of age; non-resident in community 
2 
TBAs 
TBA role not confirmed by village 
head; unwilling to participate in 
study; under 18 years of age 
3 
Health Workers 
Not involved in postnatal care 
delivery; unwilling to participate 
in study; under 18 years of age  
 
Randomized Controlled Trial 
We will exclude TBAs that plan to relocate over the intervention duration, who cannot be contacted via mobile 
phone, and who are not confirmed by community leadership. We will also exclude TBAs that do not provide 
informed consent for the entire study protocol including agreeing to have their delivery clients contacted to 
verify deliveries. 
 
 
 
4.6. Describe study procedures 
 
 
 

 
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Focus Group Discussions 
The study will involve approximately 60-minute group discussions with 6-10 TBA delivery clients, TBAs, and 
health care providers separately. The discussions will be scheduled at the participant’s convenience and to hold 
prior to the start of the randomized controlled trial.  These discussions will be moderated by a trained qualitative 
researcher in the local implementing partner organization, Health Policy Research Group, using semi-structured 
discussion guides. An audio recording of the discussions and hand-written notes will also be made by another 
member of the local study team. Following transcription of audio recording to Microsoft Word of the 
discussions, all recordings and participation sheets with identifiers will be destroyed. Data analysis will involve 
de-identified data. Quotes by respondents will be identified by labels as follows: gender, age, occupation, e.g. 
Female, 40 years, Midwife. Focus group discussions will be held in quiet, secluded community spaces pre-
identified with the help of community leaders in the language preferred by the majority of discussants – English 
or Igbo language. The choice of location will depend on the community leadership and participant preferences. 
We will ask for secluded and quiet spaces in selected communities that are options for meeting places. We will 
then sample opinions among discussion participants for the option that is most convenient for majority of 
participants. We will also make photo and video records of brief (~2min) segments of the discussions for 
presentation purposes. 
The focus group discussions will collect the following data: 
i. 
From TBA delivery clients: 
• 
Perceived need for postnatal care 
• 
Understanding of community postnatal care norms – provider, location, timing, content 
• 
Perceived barriers and enablers of postnatal care attendance 
• 
Perception of the TBA role across the continuum of maternal care – from the antenatal 
to postnatal period 
• 
Potential implications of both referrals and incentives for referrals on perception of 
TBA role 
ii. 
From TBAs: 
• 
Services provided in community – content, timing, client base 
• 
Motivation for service provision  
• 
Perception of service quality relative to formal health care providers 
• 
Relationship between TBAs and formal health care providers in community 
• 
Current participation in referrals across the continuum of maternal care 
• 
Perceived barriers and enablers to participation in referrals for postnatal care 
• 
Potential implications of incentives for referrals on program participation  
iii. 
From health care providers: 
• 
Perception of maternal and neonatal need for routine PNC 
• 
Understanding and practice of current PNC recommendations – timing, content, 
provider 
• 
Perception of TBA role across the continuum of maternal care 
• 
Relationship between TBA and health care providers in community 
• 
Perceived health worker factors that enable or act as barriers to TBA participation in 
identified roles 
 
Randomized Controlled Trial 
The primary outcome for this study is the proportion of delivery clients each TBA successfully refers for 
postnatal care within 48 hours of delivery. 
 
The team will conduct postnatal care observation surveys in potential study villages. We will select villages that 
meet the criteria outlined in Section 3.1. 
 

 
HLMA Research Protocol  
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At baseline, trained enumerators will interview TBAs and complete a survey over 60 minutes in a private 
location chosen by the TBA. The information collected will include demographic data, stated motivation for 
services, description of services provided, and social network of the TBAs. We will make photo recordings of 
these interactions (between TBAs and enumerators) for the purpose of presentation as described below.  
 
All TBAs that participate in the study will receive the following: 
• 
Information on the study aims (attached to submission), the need for postnatal care attendance, and 
verbal encouragement to refer delivery clients to postnatal care within 48 hours of childbirth 
• 
Offer of two-weekly cumulative payouts of $0.70 per reported delivery they take that is verified by 
client. 
• 
Each TBA will be assigned an identification number (TBA ID) and randomized with 50-50 
probability to the referral incentive or control arm. 
 
 
TBAs randomized to the referral incentive arm will also receive an offer of two-weekly cumulative payouts of 
$2.00 per successful referral of delivery clients to early postnatal care in a facility if it is verified by the client. 
Delivery clients are women who have given birth assisted by the TBA. Verification is described below. 
 
Thus, the required follow-up surveys will be conducted every two-weeks, consisting of: 
• 
Self-reported deliveries by TBAs obtained via SMS messages sent by TBAs to the study team. TBAs 
will be asked to send a text message after each delivery they oversee. TBAs will text the name and 
contact details (phone number and address) of clients delivered over the past two weeks. Two-weekly 
calls will also be made by the study team to the TBAs to ensure that all deliveries are reported. Data to 
be recorded includes TBA name as well as TBA delivery client name, phone number, and address. 
• 
 Calls to women who TBAs report they delivered (TBA delivery clients) – these calls will ascertain 
delivery by TBA, date of delivery, date and location of attendance of postnatal care (if attended), 
referral to postnatal care by TBA, incidence of delivery and postnatal complications. In these contexts, 
delivery of a child and where delivery occurs is often common knowledge. The TBA is often involved 
in the naming ceremony that holds soon after. The study team will nevertheless recruit TBAs who are 
willing to share this information and allow both TBAs and their clients to opt out of the study.  
• 
For a random subset of mothers, we will back-check the facility attendance registers to confirm 
postnatal care attendance. We will attach approval for access to patient information as a modification.  
 
The anticipated duration of the intervention is September 2016 to January 31, 2017. 
 
As part condition for the receipt of one of the study grants (Women and Public Policy Program’s Cultural 
Bridge Fellowship), the study coordinator will blog on field research activities related to both the focus group 
discussions and randomized controlled trials. These blogs will contain pictures of survey respondents or focus 
group participants, for which informed consent will be sought.  
 
 
4.7. Does the study involve the collection of data/specimens (including the use of existing 
data/specimens)?  
No 
Yes:  If yes; indicate how, when, where and from whom specimens or data will be 
obtained 
 
4.8. Is there a data and safety monitoring plan (required for greater than minimal risk studies)? 
No 
Yes:  If yes; describe the plan 
 

 
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4.9. Are there any anticipated circumstances under which participants will be withdrawn from the 
research without their consent? 
No 
Yes:  If yes; describe the circumstances as well any associated procedures to ensure 
orderly termination 
TBAs, TBA delivery clients, and health workers will not be withdrawn from the study without their consent.  
 
5. Data/Statistical Analyses Plan 
5.1. Briefly describe the plan for data analysis (including the statistical method if applicable) 
Qualitative Data Analysis: 
If carried out in Igbo, interviews will be translated to English language. All interviews will be transcribed 
verbatim in Microsoft Word, following which recordings will be destroyed. Transcription will ensure that 
grammar, sentence structure, pauses, and unfinished sentences are preserved as much as possible. Written notes 
will be expanded immediately after the discussions. For both written and recorded notes, we will label 
discussion inputs using pseudonyms as described above – all personal identifying information will be destroyed 
within one month of discussions. Finally, ahead of analysis, we will read each transcript and set of notes twice to 
ensure immersion within the dataset. Qualitative data will then be analyzed using thematic analysis to unearth 
themes salient in the group interviews. We will structure and depict these themes using thematic networks as 
described by (Attride-Stirling, 2001). The software for this analysis is NVivo. 
 
Randomized Controlled Trial Data Analysis: 
We aim to identify the intention-to-treat effect of incentives on the proportion of early PNC referrals of TBA 
delivery clients.  
 
Where: 
• 
 is the total proportion of referrals for TBA i, and village j of all her delivery clients; 
• 
is a dummy variable indicating if the TBA is in the treatment arm; 
• 
is a set of baseline individual-level covariates; 
• 
 is the coefficient of interest and gives the average mean difference between the treatment and the 
control arms. 
We will also identify interactions between incentives and baseline TBA characteristics (considered proxies for 
social preferences) in order to clarify pathways through which the intervention might have worked. I will 
specify a series of equations:  
 
Where: 
 
• 
 is a binary baseline characteristic for TBA i in village j previously included in 
; 
• 
 is interpreted as the treatment effect when 
; 
• 
 is the additional effect of  
 
 
 
5.2. Is there a sample size/power calculation? 
No 
Yes:  If yes; describe the calculation and the scientific rationale, and, if applicable, by 
site and key characteristics such as participant demographics  
Qualitative Study Sample Size 
The qualitative study does not require power calculations.  However, the recommended size for focus group 
discussions is 6-12 participants (Kielman, Cataldo, & Seeley, 2012). We will thus recruit 10 participants in each 
group and aim to have at least 6 attendees in each group. 
 
 

 
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Randomized Controlled Trial Sample Size 
Power calculations for this study are based on a comparison of proportion of TBA referrals for early PNC 
between 2 equal-sized arms for H0 =0 against alternative that it is not.  Qualitative evidence of a similar 
intervention in Nigeria was associated with an average of 5 facility referrals per recruited TBA per month 
(Akpan & Lah, 2012). The crude birth rate in Ebonyi State is approximately 42 births per 1000 population 
annually (NPC and ICF International, 2014). If 70 percent of mothers deliver at home, then TBAs can 
potentially deliver up to 29 births per 1000 population in a year. Thus, a total of 68092 births in Ebonyi State are 
eligible for referrals in a year, given the state population of 2.4 million (FMOH, 2011). There is an average of 3 
TBAs per village and 30 villages per LGA. Thus approximately 90 TBAs work in each of the 13 LGAs in 
Ebonyi state (1170 TBAs in total). At an average of 60 deliveries per year (68092/1170), there are 
approximately 5 deliveries per month to each TBA. We have powered the study to detect a difference in 
proportion of referrals of 0.20, that is 1 extra referral/TBA/month given 5 deliveries. Assuming standard 
deviation in proportion of referrals equivalent to study by (Rai, 2014) of 0.37 and alpha of 0.05, a minimum 
sample size of 160 TBAs can detect this effect at the 5 percent level with 90 percent power.  With 200 TBAs, 
we can detect this effect size with over 90 percent power at the 5 percent level. Given an average of 5 TBA 
delivery clients per month and 5-month intervention period, we expect to enroll at the minimum 4000 TBA 
clients. With 200 TBAs, we may enroll up to 5000 TBA clients.  
 
The randomized controlled trial study procedures, analysis, and other aspects of the protocol will be registered 
with the American Economic Association’s Registry for randomized controlled trials 
(https://www.socialscienceregistry.org/) prior to baseline data collection.  
 
6. Recruitment Methods 
6.1. Does the study involve the recruitment of participants? 
No: If no, skip to 7.1 
Yes: If yes; indicate how, when, where, and by whom participants will be recruited  
 
Focus Group Discussions 
The study team will approach community leaders that will identify TBAs who are eligible for the study and 
TBA delivery clients to join the study. We will aim to recruit up to 10 TBAs and delivery clients respectively. 
Health workers will be approached in health facilities within the same community. We will aim to recruit up to 
10 health workers. Recruitment will be done by field enumerators in any of the villages in Ebonyi State, and will 
be conducted in July 2016. 
 
Communities are organized differently in this context. There is often a naming ceremony held within the first 
week, to which everyone is invited, the TBA or nurse or midwife is lauded for successful delivery, people rub 
powder on their faces and give the mother gifts. Generally, delivery is celebrated like a wedding. Identifying 
TBAs who are eligible is akin to identifying women leaders - the community leader will help ensure that women 
who are not truly performing this function do not end up in our study. The write-up states we will identify TBA 
clients (without any comment on eligibility, which is something the study team needs to do in line with criteria 
above). 
 
Randomized Controlled Trial 
The study team will purposively select 67 study villages from Ebonyi State, where the randomized controlled 
trial will be carried out. We will identify eligible TBAs via consultation with community leaders.  These 
consultations will be led by field enumerators in July 2016. Health workers will be recruited from primary 
health care facilities in the study villages in South-Eastern Nigeria by the field work team. TBAs will provide 
consent to inform the study team of all delivery clients during the study, and these clients will be approached by 
the study team. Recruitment for the trial will commence in August 2016. 
 

 
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To study the outcome of postnatal care attendance, we need to know if clients delivered by TBAs attend 
postnatal care. We cannot know ahead of time which women will choose to deliver with the TBA versus the 
facility.  Thus unless we could enumerate every single mother who might deliver with a TBA – which is beyond 
the study budget – we have to identify these clients ex post, after they have chosen to delivery with a TBA. As 
only the TBA can provide this information, we ask if she is willing to provide it at recruitment. If she is 
unwilling, she is allowed to drop out of the study. In contexts like this, given the public naming of children and 
celebration of childbirth, the following are often public knowledge - that a woman was pregnant, that she 
delivered, the approximate age of the child (and thus the date of delivery) and the address of the woman (or a 
landmark in lieu of her address). The piece of information that may be concerned private is the clients mobile 
number. TBA clients will be asked at first contact if they are willing to participate in the study and can drop out 
if they so desire.  
 
6.2. Are there any materials that will be used to recruit participants, e.g., emails, posters, and 
scripts? 
No 
Yes:  If yes; provide a list of the materials (also include copies with the application) 
 
Focus Group Discussions 
• 
Recruitment Script (Community Leader Meeting – Focus Group Discussion) 
• 
Recruitment Script (TBA – Focus Group Discussion) 
• 
Recruitment Script (Mother) 
• 
Recruitment Script (Health Worker) 
 
Randomized Controlled Trial 
• 
Recruitment Script (Community Leader Meeting – Randomized Controlled Trial) 
• 
Recruitment Script (TBA – Randomized Controlled Trial) 
 
• 
Recruitment Script (Delivery Client) 
 
7. Available Resources 
7.1. Describe the feasibility of recruiting the required number of participants within the recruitment 
period  
The team will spend June 2016 to August 2016 in Nigeria laying the groundwork for the study, that is obtaining 
the Harvard and local ethical review, obtaining permission from the state health facility board to meet with 
facility heads and use facility data, meeting with community leaders, selecting study sites in partnership with 
local leadership in communities and facilities, and hiring and training the study team. We will collaborate with 
Health Policy Research Group, University of Nigeria, which has extensive research and training experience in 
program evaluation within the study area, and will oversee the field research activities and administration of the 
intervention. Recruitment for the study will begin in July 2016 and we anticipate will continue until September 
2016.  
 
7.2. Describe how the Principal Investigator will ensure that a sufficient amount of time will be 
devoted to conducting and completing the research 
A member of the study team is a doctoral student that has completed all other thesis papers, and will be focused 
on this project for the rest of her doctoral program, spending June 2016 to September 2016 in Nigeria and 
monitoring activities closely after that. 
 
7.3. Are there research staff members, in addition to the Principal Investigator?  
No: If no, skip to 7.5 
Yes: If yes; outline training plans to ensure that research staff members are adequately 
informed about the protocol and study-related duties 
 

 
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Harvard-based Study Partners 
The Harvard research team assisted in the development of the research protocol and assigning study-related 
duties. 
 
Local Study Partners 
Field work training will help to ensure that enumerators are trained to the same standards to minimize variation 
that may occur during the data collection exercise. While training focuses on thoroughly familiarizing 
enumerators with the questionnaire, it also asks that enumerators understand research ethics and how to create 
an atmosphere in the interview process that allows respondents to feel comfortable in answering sensitive 
questions. We will also teach enumerators how to emphasize the confidentiality of the interview and how to 
obtain the respondent’s informed consent to participate in the study in a non-coercive manner. It will be the 
responsibility of the principal investigator and field work manager to train field work enumerators. The 
enumerators practice interviews will serve as pre-tests of both versions of the questionnaire – English and Igbo 
language. Debriefing sessions will capture feedback on translations. Training will occur over two days. 
 
7.4. Describe the minimum qualifications for each research role (e.g., RN, social worker) their 
experience in conducting research, and their knowledge of local study sites and culture  
 
A. Field Work Enumerator 
Tasks 
1. Participate fully in field work training  
2. Assist field work manager and principal investigator in all activities related to the project – including 
data collection, pre-tests, study pilots, and participant enrollment 
3. Travel to study districts and other duties as necessary 
Job Requirements 
1. Secondary school or higher education from a recognized school 
2. Prior experience collecting survey data with study partner, Health Policy Research Group 
3. Fluent in English and Igbo Languages 
4. Comfortable communicating with key study stakeholders – mothers, traditional birth attendants, health 
workers, community leaders, and policy makers 
B. Field Work Manager 
Tasks 
The person will report to and work with the principal investigator to perform a variety of tasks including but not 
limited to:  
1. Supervise the implementation of field operations for the pre-test, pilot, and project, in South-Eastern 
Nigeria 
2. Manage the team of field work enumerators in supporting field operations 
3. Ensure compliance with ethical standards and data management procedures for the study 
4. Manage systems and processes for tracking and monitoring survey activities and report to the principal 
investigator on a frequent basis 
5. Lead focus group discussions 
6. Work with principal investigator to train field work enumerators 
7. Manage and appropriately document field team expenditure, supported by receipts 
8. Store and safely keep all study equipment including android tablets and audio recording devices 
Job Requirements 
1. Master’s degree in public health or related field 
2. Full-time staff of the study partner, Health Policy Research Group 
3. At least 3 years of experience in implementing field operations for multiple projects 

 
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4. Prior experience in the use of android devices for data collection, research compliance, and data security 
protocols 
5. Familiarity with randomized controlled trials and focus group discussion methods 
6. Excellent communication skills/ fluency in English  
7. Fluency in reading, writing and speaking Igbo Language 
8. Excellent management and organizational skills 
 
C. Translator 
Tasks 
1. Attend an initial conceptualization and familiarization meeting, a synchronization meeting, and a pre-
test meeting in connection with the survey and focus group discussion tool translation 
2. Translate surveys and focus group discussion tools into Igbo language as used in day-to-day 
conversations  
Job Requirements 
1. At least 5 years of experience in Igbo translation 
2. Preferably, a journalist working in a local translation 
 
As translator will be hired by the local implementing partner. When the translator is hired, a locally approved 
version of the signed translation attestation form will be attached as a modification with the name of the 
translator. 
 
 
7.5. Briefly describe how the research facilities and equipment at the research site(s) support the 
protocol’s aims, e.g., private rooms available for interviews, etc. 
Focus Group Discussions 
Focus group discussions will hold in secluded, quiet locations identified in the community by the study team and 
community leadership 
 
Randomized Controlled Trial 
In-person surveys will be conducted in a convenient location decided by the respondent at recruitment. 
 
7.6. Are there provisions for medical and/or psychological support resources (e.g., in the event of 
incidental findings, research-related stress)? 
No 
Yes:  If yes; describe the provisions and their availability 
In the event of research-related stress, study participants will be referred to the hospital affiliated with the local 
implementing partner (University of Nigeria Teaching Hospital) for counselling. 
 
 
8. Vulnerable Populations 
8.1. Are there any potentially vulnerable populations (e.g., children, pregnant women, human 
fetuses, neonates, prisoners, elderly, economically disadvantaged, employees or students of the 
investigator or sponsor, undocumented, terminally ill, cognitively impaired or mentally ill, etc.)? 
No: If no, skip to 9.1 
Yes: If yes; identify all vulnerable populations 
 
The study may involve data collection from individuals who are unable to communicate in English language. 
 
8.2. Describe safeguards to protect their rights and welfare  

 
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We will translate all data collection tools and consent forms into the local language (Igbo) so that participants 
understand the terms of participation and can fully engage in the study.  Focus group discussions and 
interviewer-led surveys will be facilitated by study staff who can converse fluently in the local language, have 
collected data in this setting before, and who are trained to elicit consent appropriately irrespective of literacy. A 
signed translation attestation form will be attached to this application as a modification. 
 
9. Consent Process 
9.1. Will consent to participate be obtained? 
No: If no, skip to 9.5 
Yes: If yes; describe the setting, role of individuals involved, timeframe(s), and steps to 
minimize coercion/undue influence during the consent process (at the time of initial consent and 
throughout the study) 
Focus Group Discussions 
Informed consent will be obtained by field enumerators. Given the varying literacy level of the target 
population, the consent form will be delivered orally in the preferred language (English or Igbo language) and a 
signature will be asked for. The consent discussion will last about 20 minutes and be followed by an invitation 
to the venue for the focus group discussion at a later date. The field enumerators will be trained to avoid 
coercion during the consent process. Study staff will continue to ensure participants understand what the 
research is about and what their participation involves. There will be numerous opportunities during recruitment 
and obtaining informed consent for participants to opt out of the study. Any new information which might 
influence a participant’s decision to continue participation will be provided to participants including re-consent. 
 
Attached: 
• 
Focus Group Discussion Consent Form – TBA delivery client  
• 
Focus Group Discussion Consent Form - TBA 
• 
Focus Group Discussion Consent Form – Health Worker 
 
 
Randomized Controlled Trial 
Informed consent will be obtained by field enumerators. In the case of TBA delivery clients, the consent form 
will be delivered orally in the preferred language (English or Igbo language). A signature will be asked for, for 
in-person interviews in the case of TBAs. The consent discussion will last about 20 minutes. Potential 
participants will be given the opportunity to opt out, postpone the decision about joining, consent and postpone 
the survey, or consent and partake in a survey. The field enumerators will be trained to avoid coercion during 
the consent process. Study staff will continue to ensure participants understand what the research is about and 
what their participation involves. There will be numerous opportunities during recruitment and obtaining 
informed consent for participants to opt out of the study. Any new information which might influence a 
participant’s decision to continue participation will be provided to participants including re-consent. 
 
Attached: 
• 
Randomized Controlled Trial Consent Form – TBA 
• 
Randomized Controlled Trial Consent Form – TBA Delivery Client (verbal consent only via phone) 
 
 
We will provide each participant with the contact information of a local research team member to communicate 
their request to have results sent to them when available.  
 
9.2. Are there any special populations?  
No 
Yes:  If yes; describe the process to obtain consent, permission or assent   
 

 
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9.3. Will consent of the participants be documented in writing?  
Yes 
No:  If no; describe the rationale for requesting a waiver or alteration of 
documentation of consent (and/or parental permission) 
 
Consent will be collected verbally for TBA delivery clients in the RCT. In all other cases – TBA in 
FGDs, Health worker in FGDs, TBA delivery clients in FGDs, TBA in RCT – consent will be 
collected in person. 
 
9.4. Will participants be provided with a copy of their signed consent form or information sheet 
(when a consent form is not signed)? 
Yes 
No:  If no; explain any extenuating circumstances that make it impossible or 
inappropriate to meet this requirement, i.e., doing so may place participants at increased risk, if 
inadvertently disclosed 
 
In all cases where consent is collected in writing, participants will be provided with a copy of their signed 
consent form. In one case, for TBA delivery clients in the RCT, consent will be elicited over the phone. In this 
case, participants will not receive a copy of their signed consent form unless they request it. 
 
9.5. Is a waiver or alteration of consent (and/or parental permission) being requested?  
No 
Yes:  If yes; describe the rationale for the request. If the alteration is because of 
deception or incomplete disclosure, explain whether and how participants will be debriefed 
(include any debriefing materials with the application) 
 
Randomized Controlled Trial  
The consent form for the TBAs will not include information on the referral incentive intervention. The 
intervention offers TBAs in the referral incentive arm an incentive for referring mothers to postnatal care in 
facilities. Informing TBAs in the control arm about this incentive during informed consent at baseline will have 
negative consequences, and the research cannot be practicably carried out without this alteration. TBAs in the 
control arm receive information on the need for postnatal care and an incentive for reporting each client they 
deliver (TBAs in the referral incentive arm receive what the control arm receives in addition). We will be unable 
to measure the pure effect of incentives and will instead capture the effect of receipt of incentives by referral 
incentive TBAs and anger or collusion by control TBAs in response to exclusion from receiving the referral 
incentive. We can thus not answer the research question intended. The information that will be elicited during 
the randomized controlled trial do not constitute more than minimal risk to subjects. This information is 
common knowledge in the community including TBA service patterns, demographic information, delivery client 
base etc.   
 
Debriefing 
All TBAs will be provided with additional information on the intervention when all follow-up survey data has 
been collected using the attached debriefing script. Each TBA will be approached in her home (which often 
doubles as the work place) within the community by one of the field enumerators. We will provide information 
on the incentive used in the study, the probability of selection into each study arm, and the opportunity to drop 
out of the study if so desired. 
 
In addition, contact information of TBA delivery clients will be given by TBA to the study team prior to initial 
contact with delivery clients. This information will be collected via follow-up survey tools. This is akin to the 
receipt of contact information for TBA from community leaders prior to initial contact by study team from a 
cultural standpoint – the TBA is not a health worker. She is one community member with no training providing 
a service to another community member. Everyone knows her, and many women deliver with her. I could for 
example, collect this information from the community leader or women leader instead of the TBA – and they 
would probably know who had just delivered and potentially where.  

 
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To try and inform delivery clients ahead of time of the possibility of their contact information being shared and 
being contacted by the research team for recruitment into the study, we can hold a village meeting in every 
village we do the study in and inform everyone about the study. We cannot know every woman who will visit a 
TBA ahead of time, she may come from a village in which we have no selected TBA, but this would ensure 
we’ve tried to inform as many possible participants ahead of time. 
 
We cannot anticipate which women will visit the TBA (rather than the clinic) ex-ante and obtain informed 
consent beforehand. Constraints in study funding also prevent the enrollment of all pregnant women in every 
study village at baseline. Nevertheless, the receipt of services from the TBA by clients is often common 
knowledge in these communities (see below) so that this information is unlikely to constitute more than minimal 
risk to clients. Delivery clients will be given the opportunity to opt out of the study at multiple points – 
enrollment, during elicitation of consent, during the follow-up survey, and after the survey. When informed 
consent is elicited by study enumerators, delivery clients will be intimated on how their contact information was 
obtained – that is they will be informed explicitly that the study team is contacting them based on patronage of a 
TBA who gave the team their contact information. 
 
The ceremony surrounding the birth of a child in these contexts implies the community knows the woman was 
pregnant, has delivered a baby, was delivered by a TBA (who is often involved in the naming ceremony and 
sometimes gives the child one of her/his names), and where she lives (because they all come for the ceremony – 
anyone who hears can stop by and eat food/bring a gift etc.). The phone # is the one piece of information that 
may be private (primarily because that is not typically how people contact each other). We will allow both her 
TBA and herself to opt out if they consider this an invasion of privacy. 
 
10. Risks  
10.1. Are there any reasonably foreseeable risks, discomforts, and inconveniences to participants 
and/or groups/communities? 
No 
Yes:  If yes; indicate probability, magnitude, and duration of each (note that risks may 
be physical, psychological, social, legal, and/or economic) 
 
 
Foreseeable Risks and Mitigation – Focus Group Discussion 
 
 
Foreseeable Risks and Mitigation – Randomized Controlled Trial 

 
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#
Identified risk
Description
Risk mitigation
1.
Loss of time for conduct of antenatal or 
delivery care may be a discomfort for TBAs. 
This is likely to occur for all TBAs for the 
entire duration of the study.
The activities involved in participation will be clearly 
identified and the estimated time commitement 
provided so that potential participants can make an 
informed decision.
2.
TBAs may fear that research projects will 
tend to conclude that their services are 
undesirable as has been the case in the past 
and may not want to participate in research 
that furthers such conclusions.
This is unlikely to occur given the study 
design that focuses on TBA inclusion in 
formal care via the creation of a new role.
This research project has been designed to create an 
alternative long-term role for the TBA that has hitherto 
been excluded from Nigerian health systems; TBAs will 
be honestly informed about the purpose of research to 
increase postnatal care use in facilities.
3.
Some of the survey questions may be 
considered private such as income from 
services, causing discomfort.
Similar survey questions such as the World 
Bank Living Standards Measurement Study 
Survey have not been accompanied by 
discomfort. Thus we do not expect that this 
will occur with high probability. There will be 
a 60 minute baseline survey, and two-weekly 
15-minute surveys throughout the study 
duration.
The information collected using the surveys is justified 
by the study rationale - to define the TBA for whom the 
intervention works so that the study findings are easy 
to translate to policy; The study data management 
plan will minimize the risk of compromise of 
information security; All study participants will be 
informed of their right to withdraw from the study if 
they find any of the procedures uncomfortable.
4.
Participants may be concerned about the use 
of information they provide.
The information elicited is common 
knowledge in the community and should not 
cause concern among TBAs. There is a low 
likelihood of this risk occuring.
Informed consent will include a clear description of the 
intended uses of study information and protections of 
identity of members; Individuals will be offered the 
opportunity to speak with investigators in private 
about data use concerns.
5.
Under-reporting of deliveries and postnatal 
care attendance by TBA clients (mothers 
they deliver) may be a source of 
psychological stress for the TBA, and of 
tensions in the relationship between the TBA 
and client
The TBA depends on delivery clients for 
future streams of income so we do not 
anticipate that the introduction of incentives 
for referrals will interrupt future relations 
between the TBA and her client. There is 
however a low risk of misreporting by clients. 
Given the status of TBAs in communities as 
trusted and respected providers of 
community care, there is very little incentive 
for mothers to fail to report delivery or 
postnatal care referrals.
We will be able to resolve misreporting using facility 
postnatal care registers, so that TBAs can be 
remunerated for their efforts if they notice disparities.  

 
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#
Identified risk
Description
Risk mitigation
1.
Loss of time due to study participation may 
be a discomfort for respondents. 
This is likely to occur for all participants.
The activities involved in participation will be clearly 
identified and the estimated time commitement 
provided so that potential participants can make an 
informed decision.
2.
TBAs may fear that research projects will 
tend to conclude that their services are 
undesirable as has been the case in the past 
and may not want to participate in research 
that furthers such conclusions.
This is unlikely to occur given the study 
design that focuses on TBA inclusion in 
formal care via the creation of a new role.
This research project has been designed to create an 
alternative long-term role for the TBA that has hitherto 
been excluded from Nigerian health systems; TBAs will 
be honestly informed about the purpose of research to 
increase postnatal care use in facilities.
3.
Some of the survey questions may be 
considered private such as income from 
services, causing discomfort.
Similar survey questions such as the World 
Bank Living Standards Measurement Study 
Survey have not been accompanied by 
discomfort. Thus we do not expect that this 
will occur with high probability. 
The information collected using the surveys is justified 
by the study rationale; The study data management 
plan will minimize the risk of compromise of 
information security; All study participants will be 
informed of their right to withdraw from the study if 
they find any of the procedures uncomfortable.
4.
Participants may be concerned about the use 
of information they provide.
The information elicited is largely common 
knowledge in the community and should not 
cause concern. There is a low likelihood of 
this risk occuring.
Informed consent will include a clear description of the 
intended uses of study information and protections of 
identity of members; Individuals will be offered the 
opportunity to speak with investigators in private 
about data use concerns.
5.
Under-reporting of deliveries and postnatal 
care attendance by TBA clients (mothers 
they deliver) may be a source of 
psychological stress for the TBA, and of 
tensions in the relationship between the TBA 
and client
There is a low risk of misreporting by clients. 
Given the status of TBAs in communities as 
trusted and respected providers of 
community care, there is very little incentive 
for mothers to fail to report delivery or 
postnatal care referrals.
We will be able to resolve misreporting using facility 
postnatal care registers, so that TBAs can be 
remunerated for their efforts if they notice disparities 
and we verify their claims.  There is little incentive for 
mothers to under-report care received.
6.
Clients may be concerned that TBAs will 
provide contact information of delivery 
clients to the study team to ascertain the 
study outcome - the incidence of postnatal 
care referrals.
This is the basis for potential inclusion of 
clients. In this context, the following are 
often public knowedge in the community - 
that a client is pregnant, that she has 
delivered a child, that she delivered with a 
TBA, the approximate date of delivery, and 
her address. A contact phone number might 
however not be public knowledge and a 
cause of concern.
We will select TBAs whose relationship with their 
clients allows them to share this information with the 
study team. Both TBAs and delivery clients will be 
allowed to opt out of the study at any point if privacy is 
a concern, and their information will not be used if 
they do, nor will they face any penalty for dropping 
out.
 
 
 
10.2. Identify whether any of the information collected, if it were to be disclosed outside of the 
research, could reasonably place the participant at risk of criminal or civil liability or be 
damaging to the participant’s financial standing, employability or reputation. 
No, we anticipate that information collected is largely common knowledge within these communities related to 
maternal delivery service choices and the livelihoods of traditional birth attendants. 
 
As the TBA does not have an employer per se (she is a woman who in her home or her church delivers women), 
she has no formal training and no supervisor. She is often mentored by another TBA who does not owe her a 
salary and to whom she does not pay a salary. Her services are many times unremunerated. She is given 
payment or gifts depending on the ability of her clients. 
 
10.3. Outline provisions in place to minimize risk 
See within charts above. 
 
 
11. Benefits  
11.1. Describe potential benefits of study participation (indicate if there is no direct benefit) 
There is no direct individual benefit to participation in the focus group discussion. 
 

 
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Randomized Controlled Trial 
Should the intervention prove to encourage TBA’s to refer women they deliver to postnatal care, delivery clients 
of TBAs in the experimental arm may be more likely to seek postnatal care and receive the attendant health 
benefits. 
 
11.2. Describe potential benefits of the research to the local community and/or society 
Mothers who give birth outside facilities and without skilled attendance have a higher risk of death. Increasing 
the use of postnatal care can prevent fatal complications in both mothers and their newborns. The widespread 
involvement of unskilled traditional birth attendants in deliveries across Africa mean the study findings have 
implications for maternal and neonatal mortality reduction on the continent. 
 
 
12. Reportable Events 
12.1. Outline plans for communicating reportable events (e.g., adverse events, unanticipated 
problems involving risks to participants or others, breach of confidentiality) 
All reportable events will be reported to the HLMA IRB within 5 days of the PI becoming aware of the situation 
as per OHRA policy. 
 
13. Research Related Injuries (this section must be completed for any greater than minimal risk 
research) 
13.1  Are there provisions for medical care and compensation for research-related injuries? 
No 
Yes:  If yes; outline these provisions (Please note that although Harvard’s policy is not 
to provide compensation for physical injuries that result from study participation, medical 
treatment should be available including first aid, emergency treatment and follow-up care as 
needed. If the research plan deviates from this policy, provide appropriate justification.) 
 
 
14. Participant Privacy 
14.1. Describe provisions to protect participants’ privacy (their desire to control access of others to 
themselves, e.g., the use of a private interview room) and to minimize any sense of intrusiveness 
that may be caused by study questions or procedures 
 
Group and individual interviews will be conducted in a private place, at the participant’s convenience.  
 
In the randomized controlled trial, we will ask TBAs to give us the names, addresses, and phone numbers of 
clients they deliver on a two-weekly basis. Follow-up calls to these clients will involve eliciting consent for 
inclusion in the study and ascertaining that delivery and referral by the TBA occurred. That is, we obtain 
information on the primary outcome of the study through follow-up surveys with TBA clients. Self-reports by 
TBAs given the incentives offered are likely to be unreliable.  
 
The procedure of informed consent will be non-coercive and conducted in the language of choice for both the 
TBA and her clients. In these settings, it is not generally private information that a woman was pregnant, where 
she lives, and that she has delivered, and where she delivered. However, we will allow both the TBA and her 
clients to opt out of the study at any point that they consider the study procedures intrusive.  The TBA and her 
clients will be informed of this provision. As long as drop-out of the study is non-differential across arms and is 
not in high proportions, this will not affect our ability to estimate effects.  
 
15. Data Confidentiality 
15.1. Will the information that is obtained be recorded in such a manner that participants can be 
identified, directly or through identifiers linked to the participants?  
No: If no, skip to 16.1 

 
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Yes: If yes; either state that participants will be told that their data will be public or describe 
provisions to maintain the confidentiality of identifiable data, e.g., use of password protections  
(please refer to the Harvard Research Data Security Policy (HRDSP), at 
http://vpr.harvard.edu/pages/harvard-research-data-security-policy, for additional information 
about required data security measures) [NOTE: The HRDSP does not always apply if data are 
not being stored at Harvard facilities.  Please consult the HRDSP for additional information.] 
 
Data is classified as Level 3, that individually identifiable information which if disclosed could reasonably be 
expected to be damaging to reputation or to cause legal liability. 
 
Focus Group Discussions 
 
1. 
Responses will not be shared outside of the research team 
2. 
During data analysis, names of participants will be replaced with an ID code, and the key linking 
names and ID codes will be kept in a secure location- stored in encrypted and password-protected 
electronic files in locked cabinets in locked offices. 
3. 
Data will be stored in encrypted and password-protected electronic files; paper data and audio or 
videotapes (indicated in section on study procedures) in locked cabinets in locked offices. 
4. 
We will destroy audio recordings of focus group discussions after transcription and not more than one 
month after recording  
5. 
Names will not be used to identify participants in publications 
 
Randomized Controlled Trial 
 
Confidentiality throughout the trial is maintained according to the Harvard University Information Security 
Policy by: 
1. Password characteristics: 
• 
Strong passwords – Passwords must be of sufficient length and complexity to reasonably 
protect them from being guessed by humans or computers 
• 
No shared passwords – Passwords to devices used for data collection and other access 
credentials will not be shared 
• 
Protect passwords – All passwords must be protected 
• 
Compromised passwords – Passwords must be changed immediately if there is suspicion of 
compromise 
2. Devices 
• 
Configuring devices - All devices used for collection, storage, and transportation of information 
will be configured for secure operation, limiting access to authorized persons 
• 
Loss and disposal of devices – The information on the device must be protected against access 
if the device is lost, disposed of, or stolen. Loss, theft, or improper use of a device storing 
confidential information will be reported promptly. 
3. Information sharing 
• 
Accessing confidential information – Confidential information must only be accessed for 
authorized purposes  
• 
Sharing confidential information – Confidential information must only be shared with those 
authorized to receive it 

 
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15.2. Describe i) whether data will be transmitted, and if so how; ii) how long it will be stored; and iii) 
plans for the data at the end of the storage period (how will it be destroyed, or will it be 
returned to data provider) 
All audio recordings from focus group discussions and participant sheets, following transcription within a month 
of discussion will be destroyed. Respondents will be identified using gender + age + occupation labels. 
 
Data collected by field enumerators offline on the field during surveys will be uploaded in the partner office, 
Health Policy Research Group, to a secure server at the end of each work day. Android devices are stored by the 
field work manager, locked cabinets in locked offices. Following the intervention in January 2017, data will be 
de-identified prior to analysis. During data analysis, names of participants will be replaced with an ID code, and 
the key linking names and ID codes will be kept in a secure location - in encrypted and password-protected 
electronic files - accessible only to the Harvard study team. 
 
 
15.3. Indicate how research team members and/or other collaborators are permitted access to 
information about study participants  
Field enumerators will only have access to data when during collection. Only the Harvard study team will 
have access to the entire study data.  
 
The field work manager requires access to identifiable information about traditional birth attendants to 
implement the intervention – providing rewards for postnatal care referrals. Thus traditional birth attendants 
will inform the study team on a two-weekly basis of deliveries taken. Follow-up of these clients to ascertain 
postnatal care referrals will form the basis for determining rewards.  
 
15.4. If future use of data, data sharing, i.e., required of NIH-funded studies using/generating large-
scale human genomic data, or future open access, i.e., free availability and unrestricted use, of 
data is planned or likely, indicate how data will be shared/released.  
 
No directly identifiable information will be made available to anyone other than the PI and Harvard faculty 
collaborators. Data in which names of participants will be replaced with an ID code may be shared with 
other collaborators as permitted in the consent form. 
 
16. Costs and Payments  
16.1. Identify any costs that participants may incur during the study, including transportation costs, 
childcare, or other out-of-pocket expenses 
 
Randomized Controlled Trial 
The TBA is expected to encourage her delivery clients to take up postnatal care. The means through which she 
does this is at her discretion and will not be manipulated by the study team. However, these means might 
include phone calls, text messages to clients, visiting clients at home to encourage postnatal care attendance, or 
escorting clients to the clinic for postnatal care. The TBA thus incurs opportunity cost (fees for services) of not 
attending to delivery or antenatal clients if she escorts women to the facility for postnatal care or visits them at 
home to encourage them to come. She also spends her own resources on phone calls and text messages. 
 
 
16.2. Is there any payment or reimbursement that participants may receive during the study?  
No 
Yes:  If yes; specify the amount, method and timing of disbursement. (Please refer to 
Harvard University Financial Policy on Human Subject Payments at 
http://policies.fad.harvard.edu/pages/human-subject-payments) 
 

 
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Focus Group Discussions 
Participants in the focus group discussions will receive a stipend of 2000 Naira ($7) for participation in the 
discussion.  
 
Randomized Controlled Trial 
Traditional birth attendants recruited into the randomized controlled trial will receive a two-weekly phone credit 
transfer for notification of delivery clients, at a rate of 200 Naira ($0.70) per verified delivery client. Traditional 
birth attendants in the referral incentive arm will in addition receive 600 Naira ($2) for verified postnatal care 
referrals.  
 
The compensation that TBAs receive for their services is highly variable, often depends on the ability of the 
client to pay, and may be given in-kind (rather than as cash) (Itina, 1997). The amount of compensation used in 
this study is informed by Nigerian pilots that did not include control groups but were well-received by TBAs 
(Akpan & Lah, 2012) (Oyebola, Muhammad, Otunomeruke, & Galadima, 2014). Delivery by the TBA is 
associated with a higher risk of death for both mother and newborn. The expectation is that the incentive is well-
received and leads to a higher number of referrals to postnatal care for mothers and newborns, who would 
otherwise not receive skilled care around childbirth. As compensation is restricted to referrals of clients, we aim 
to reduce risk of death among mothers who choose to receive attendance from the TBA at birth, despite the 
associated dangers. 
 
 
17. Multi-site Study Management  
17.1. Is this a multi-site study? 
No 
Yes:  If yes; describe plans for communication among sites regarding adverse events, 
interim results, protocol modifications, monitoring of data, etc. 
 
 
18. Investigational Drug/Biologic/Device 
18.1. Does this study involve an Investigational Drug/Biologic/Device? 
No: If no; skip to 19.1 
Yes: If yes; identify and describe the drug/biologic/device (e.g., marketing status: Is there an 
IND/IDE, classification of a device as significant vs. non-significant risk) 
 
18.2. Describe its administration or use 
 
18.3. Compare the research drug/biologic/device to the local standard of care 
 
18.4. Describe plans for receiving, storage, dispensing and return (to ensure that they will be used 
only for participants and only by authorized investigators) 
 
18.5. If proven beneficial, describe anticipated availability and cost to participants post-study; plans 
(if applicable) to make available 
 
 
19. HIPAA Privacy Protections 
19.1. Are HIPAA privacy protections required? Please note that only Harvard University Health 
Services and Harvard School of Dental Medicine are covered entities at Harvard.  Harvard is 
otherwise not a HIPAA covered entity.  If, however, data is derived from a Covered Entity (e.g. 
a hospital or community health center), mark ‘yes’ and address the items below. 
No: If no; skip to 20.1 
Yes: If yes; include at least one of the following: 

 
HLMA Research Protocol  
For use by HMS, HSDM and Harvard Chan School Investigators 
 
Research Protocol Template | HRP-503 | Version date: September 17, 2015 | Page 21 of 22 
Longwood Medical Area IRB http://www.hsph.harvard.edu/ohra/ 
Describe plans for obtaining authorization to access protected health information 
 
Provide the rationale for a waiver of authorization or limited waiver of authorization 
request  
 
 
20. Data and Specimen Banking 
20.1. Does the study include Data and Specimen Banking?  
No: If no; skip to 21.1 
Yes: If yes; identify what will be collected and stored, and what information will be 
associated with the specimens 
 
20.2. Describe where and how long the data/specimens will be stored and whether participants’ 
permission will be obtained to use the data/specimens in other future research projects 
 
20.3. Identify who may access data/specimens and how 
20.4. Will specimens and/or data be sent to research collaborators outside of Harvard? 
No 
Yes:  If yes; describe the plan 
 
20.5 Will specimens and/or data be received from collaborators outside of Harvard? 
No 
Yes:  If yes; describe the plan 
 
 
21. Sharing Study Results 
21.1. Is there a plan to share study results with individual participants? 
No 
Yes:  If yes; describe the plan 
 
We will provide each participant with the contact information of a local research team member to communicate 
their request to have results sent to them when available.  
 
21.2. Is there a plan to disseminate aggregate results to the community where the research is 
conducted? 
No 
Yes:  If yes; describe the plan 
 
In August 2016, we will present preliminary results from the qualitative study to the research and policy 
community in South-Eastern Nigeria, in collaboration with Health Policy Research Group. At the study 
conclusion, in April 2017, we will again present results to the research and policy community in South-Eastern 
Nigeria. We will also prepare a manuscript for a peer-reviewed publication in May 2017. 
 
In the event that the study team shares educational resources with the TBA delivery clients (or extra information 
on postnatal care with the TBAs), we will submit these materials as a modification prior to implementation.  
 
22. Regulatory Compliance 
22.1. Describe plan for monitoring regulatory compliance, in order to ensure proper record keeping 
and retention of required regulatory documents 
To ensure compliance with regulations, the principal investigator will: 
1. Conduct one-monthly and ad-hoc reviews of study documents and participant files as needed to monitor 
compliance with IRB policies and procedures 
2. Respond to complaints and non-compliance to identify areas for improvement 
3. Provide training for field work staff to ensure familiarity with study protocol and regulatory 
requirements 

 
HLMA Research Protocol  
For use by HMS, HSDM and Harvard Chan School Investigators 
 
Research Protocol Template | HRP-503 | Version date: September 17, 2015 | Page 22 of 22 
Longwood Medical Area IRB http://www.hsph.harvard.edu/ohra/ 
4. Examine executed informed consent forms and on select days, observe the informed consent process 
5. Report to IRB serious or continuing non-compliance  
6. Ensure that changes to protocol are approved by IRB 
7. Ensure accurate compliance records are kept and stored for up to 7 years following the completion of 
the study. 
 
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Akpan, T., & Lah, J. (2012). Working with Community Health Volunteers to Implement Home Based MNC 
Interventions: A Case Study of TBAs and FOMWAN Volunteers . Abuja: Society for Family Health. 
Attride-Stirling, J. (2001). Thematic Networks: An Analytic Tool for Qualitative Research. Qualitative 
Research, 1(3), 385-405. 
Bergstrom, S., & Goodburn, E. (2001). The Role of Traditional Birth Attendants in the Reduction of Maternal 
Mortality. Studies in Health Services Organisation and Policy, 17, 77-96. 
Chamberlain, A., Higgins-Steele, A., Cummings, E., Davis, R., Cahill, K., Rosenthal, M., . . . Dyson, M. (2013). 
Examining the Role of Traditional Birth Attendants in the Continuum of Care in Sierra Leone. Concern 
Worldwide. 
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Owens-Ibie, N. (2011). Traditional Birth Attendants and the Pursuit of Maternal and Child Health in Nigeria. 
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Western Kenya. PhD Thesis. Washington, D.C.: Georgetown University. 
Sibley, L. M., Sipe, T. A., & Barry, D. (2012). Traditional Birth Attendant Training for Improving Health 
Behaviours and Pregnancy Outcomes. Cochrane Database of Systematic Reviews(8). 
WHO. (2004). Making Pregnancy Safer: The Critical Role of the Skilled Attendant - A Joint Statement by WHO, 
ICM, and FIGO. Geneva: World Health Organization.