Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) to Pregnant Women and Women Within Twelve Months Postpartum in Ethiopia
Phase: NA
Conditions: Contraceptive Usage, Postpartum Family Planning, Contraception, Prenatal Care, Pregnancy
Sponsor: Jhpiego

Page 1 of 23 
 
Pfitzer_ IRB00007143_EthiopiaPPFP_protocol_V2_Oct 24, 2016 
Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) to Pregnant Women and 
Women within Twelve Months Postpartum in Ethiopia  
Study Protocol 
Jhpiego  
Unique Protocol ID: IRB00007143 
February 2, 2018 

Page 2 of 23 
 
Pfitzer_ IRB00007143_EthiopiaPPFP_protocol_V2_Oct 24, 2016 
 
JHSPH IRB Research Plan for New Data Collection  
PI Name:   
 
Anne Pfitzer 
Study Title:  
Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) to Pregnant 
Women and Women within Twelve Months Postpartum in Ethiopia 
IRB No:  
 
IRB00007143 
PI Version No./Date:  V3_February 2, 2018 
I. 
Aims of the Study: Describe the aims/objectives of the research and/or the project’s research questions or 
hypotheses.  
The objectives and sub-objectives of this study are to: 
1) Assess the effect of contacts that women/couples have with the health system (from the kebele [sub-district] level 
to the health facility level and back), into which postpartum family planning (PPFP) messages are systematically 
integrated, on uptake of PPFP through 12 months postpartum in Ethiopia. These health contacts span several levels: 
at health facilities from trained health professionals, and at community settings from Health Extension Workers 
(HEWs) and Health Development Army (HDA), a cadre of community volunteers.  
a. Assess the extent and type of existing contacts that women/couples have with the health system during 
pregnancy, birth, and in the postpartum period and the degree to which they receive PPFP messages during 
these health contacts. 
b. Assess the relationship between frequency and type of contact to uptake of PPFP and recommended child 
feeding and immunization practices (estimate the dose-response effect of each additional health contact). 
2) Estimate the added effect of a community-based intervention (i.e. beyond the health center) to promote PPFP 
messaging at antenatal and postpartum contact points by community health workers (HEWs, HDA)  on uptake of 
postpartum family planning through twelve months postpartum in  two clusters of health center and health posts, , 
as compared to health center-only PPFP counseling and services in two comparison clusters. 
a. Measure “baseline” PPFP uptake through recall of women with prior birth history and their PPFP use after 
those recall births (sub-sample of women with prior birth history) 
b. Prospectively assess uptake of PPFP among postpartum women by type of health contact, timing 
postpartum, and contraceptive method   
3) Explore acceptability and feasibility among HC providers and health extension workers of using record keeping and 
review processes to track women’s decision-making and contraceptive use from pregnancy through to 12 months 
postpartum, 
a. Test provider/health extension worker (HEW)/health development army (HDA) use of health record keeping 
systems as a tool for identifying women who need additional PPFP counseling (prenatal). 
b. Test use of a monthly data review process to combine HEW and HDA health records of pregnant and 
recently delivered women and their babies to ensure maximum coverage of critical health practices 
including antenatal care (ANC), postnatal care (PNC) home visits, PPFP uptake, immunization, infant 
feeding, etc.  
4) Explore factors influencing women’s/couples’ adoption of PPFP during the first twelve months postpartum.   
In both intervention and comparison sites, the study will implement the current Government of Ethiopia policy and 
standard of care concerning systematic integration of PPFP messages and services within antenatal care, labor and 

Page 3 of 23 
 
Pfitzer_ IRB00007143_EthiopiaPPFP_protocol_V2_Oct 24, 2016 
delivery, postnatal care as well as a new proposed targeting of women bringing infants for immunization services with 
PPFP messages and referrals.  
II. Background and Rationale: Explain why this study is being done.  Summarize briefly what is already known about 
the issue and reference previously published research, if relevant. 
Inter-pregnancy intervals of less than 24 months are associated with higher rates of newborn and child mortality, as well 
as higher probability of pre-term and low birth weight newborns, and malnutrition and stunting among children under 
five (Kozuki et al, 2013; Cleland 2012). An MCHIP secondary analysis of the 2011 Ethiopia DHS (MCHIP 2013) revealed 
that among all non-first births, 47% of pregnancies occur at less than the 24 month inter-pregnancy interval (13% of 
women are pregnant before the end of the first year postpartum). Looking at prospective unmet need (defined as 
whether women would like another child within the next two years), among Ethiopian women 0-2 years postpartum (n = 
4,453), 94% of women did not wish another pregnancy at the time of the survey yet only 19% used a modern method of 
contraception, resulting in a prospective unmet need among postpartum women of 74%. This compares to an unmet 
need of 34% among postpartum women using the standard DHS method of calculating unmet need which uses a 
question about the desire for the recently born child for the subset of postpartum women in the total sample (Moore et 
al, 2015).  
Exclusive or predominant breastfeeding offers protection against rapid fertility return during the first 6 months after 
childbirth; however, rates of exclusive and predominant breastfeeding drop off rapidly in Ethiopia starting in the second 
month of life. While 70% of newborns (0-1 month) are exclusively breastfed, only 32% of infants 4-5 months old are 
exclusively breastfed. Only 4% of children 6-23 months are fed appropriately based on infant and young child nutrition 
(IYCN) recommendations and 44% of children less than 5 years of age are stunted (DHS 2011). 
Women in Ethiopia do not access formal health services as frequently as they should. Only 43% access any antenatal 
care services and 19% are seen for at least 4 ANC visits during pregnancy, with wide differences between urban and 
rural women. The majority of births (89.5%) still occur at home, are not attended (3.8%) or attended by a traditional 
birth attendant (TBA) (28.4%) or relative (56.6%). Only 6.7% of mothers and babies had a postnatal check within two 
days of birth. Vaccination coverage is higher with BCG at 79.6%, DPT‐HepB‐Hib1 at 80.0%, DPT-HepB‐Hib3 at 65.7%, 
OPV1 at 90.1%, OPV3 at 70.5%, and measles at 68.2% (Ethiopia NICS 2012), though it falls short of international 
recommendations of country coverage of over 90%.  
Globally, prior efforts to integrate family planning and MNCH including immunization either failed to record the impact 
of integration on MNCH or immunization coverage indicators or did not find any benefit of integration on improving 
immunization coverage. Ethiopia offers an opportunity to improve both MNCH/immunization rates and postpartum 
family planning use since these indicators, while trending upwards, still have room to improve. According to key 
informant interviews conducted in Ethiopia, challenges for PPFP include tracking use of contraception postpartum, 
limited availability of high-quality PPFP materials for clients, and difficulty in reaching the 90% of women who do not 
deliver at a health facility, highlighting the importance of health extension workers in visiting postpartum women in their 
homes (Sonalkar, Mody, Phillips, & Gaffield, 2013). These findings support a focus on improving tracking for uptake of 
PPFP, development of SBCC materials and messages, and implication of community-based resources like the HEWs. 
MCHIP’s work in Ethiopia expanded choices of contraceptive methods in the postpartum by supporting the Government 
of Ethiopia to introduce postpartum IUDs during facility births in selected facilities. Currently, Jhpiego MCSP is planning 
to support the Government in strengthening and potentially expanding this intervention with USAID field support funds. 
Yet facility-based PPFP counseling and services will only reach a small proportion of pregnant and postpartum women 
who need advice and services. To reach women and their families in their communities, the Ethiopian Government has 

Page 4 of 23 
 
Pfitzer_ IRB00007143_EthiopiaPPFP_protocol_V2_Oct 24, 2016 
established the highly functional health extension program, involving formally recognized and government-paid Health 
Extension Workers (HEWs) at the kebele level, supported by community volunteers called the Health Development 
Army. The HEWs deliver a package of mostly preventive health interventions, including vaccines and a range of 
contraceptives that includes implants, along with selective curative interventions targeting newborns and young 
children (see http://www.moh.gov.et/hsep). Prior work on exploring acceptability of integrating family planning and 
immunization in multiple countries found that providers and clients did not have any concerns about linking these 
services (Ryman et al, 2012). 
The Ethiopian health system envisages that a number of health contacts should occur for women and babies from 
pregnancy through to the extended postpartum. Figure 1 below illustrates these contacts. 
 
About 84% infants receive at least one dose and more than 60% receive two doses of basic vaccines.  A substantial 
number of mothers also seek care for their child’s fever, diarrhea and other illness from health providers. This study will 
take these contact occasions as opportunities for promoting PPFP, but also to reinforce the need to fully vaccinate 
children.  
 
III. Study Design 
A. Provide an overview of your study design and methods.  The study design must relate to your stated 
aims/objectives.  Details will be requested later.  If your study also involves analysis of existing data, please 
complete Section XI, “Secondary Data Analysis of Existing Data” in the last part of this research plan.  If your 
study ONLY involves analysis of existing data, please use the research plan template for secondary data analysis 
(JHSPH IRB Research Plan for Secondary Data Analysis of Existing Data/Specimens). 
This implementation research will use a quasi-experimental mixed method design with two arms. The intervention arm 
will have integrated PPFP messages at each level of health system contacts.  The control arm will continue to deliver the 
existing FP services at primary health care centers only.  
The primary study population is a cohort of pregnant women, enrolled between the 2nd and 3rd trimester of pregnancy in 
both arms, who will be followed to twelve months post-partum.  We will interview the women at study enrollment and 
at the end of the study.  We will track women’s contacts with the health system, particularly regarding PPFP counseling, 
decision making and contraceptive adoption, through chart reviews of routinely collected facility and community based 
health records and registers (e.g. family folders that may be modified for study).   
Figure 1: Possible Contacts with the Health System for Pregnant Women in Ethiopia 
Month 
4 
5 
6 
7 
8 
9 
 
1 
2 
3 
4 
5 
6 
Client 
 
 
 
 
 
 
 
 
 
 
 
 
 
HDA 
x 
x 
x 
x 
x 
X 
Home 
X 
x 
x 
x 
x 
x 
HEW 
Quarterly visits: 2-3 times during  
last two trimesters of pregnancy 
 
Quarterly visits: 2-3 times during  
first 12 months postpartum 
HC 
ANC1 
Before 
end of 
4th 
month 
 
ANC2 
24-28 weeks 
ANC3 
32 
weeks 
ANC4 
36 
weeks 
Facility 
PNC 
w/in 48 hours;  
w/in 6 weeks 
 
 
 
DPT1 
6 weeks 
DPT2 
10-14 weeks 
DPT3 
14-22 weeks 
Postpartum Period 
Pregnancy 
Birth 

Page 5 of 23 
 
Pfitzer_ IRB00007143_EthiopiaPPFP_protocol_V2_Oct 24, 2016 
Prior to study implementation, we will conduct a readiness assessment of selected health facilities in both study arms to 
ensure that the supplies, equipment and commodities are available for PPFP counseling and service delivery capacity in 
all health centers.  Gaps in PPFP service delivery will be addressed in both intervention and control study sites.  Health 
center maternity staff will be trained in PPFP (PPFP counseling, postpartum IUD and implant provision, etc.) in 
accordance with current Government of Ethiopia PPFP expansion strategies. The rapid assessment will provide an 
understanding of service delivery capacity and needs and allow MCSP to ensure the same services and equipment are 
available in all sites.  
In intervention sites, both facility-based providers at primary health center and health post levels, including HEW and 
HDAs, will receive training on PPFP counseling and use of adapted health records. Should HEW require refresher training 
in implant provision or other methods, the study will also provide this. 
In addition, we will conduct a rapid formative assessment to understand the health system and cultural contexts of PPFP 
needs during the preparatory phase of intervention implementation. This formative study will include household 
members of pregnant women, community health workers (HDAs), and facility-based providers, including HEWs, and 
managers.  This rapid assessment will support the design of the intervention at the community level which will include 
designing and training HEWs to communicate PPFP messages as part of a bundle of messages that promotes high impact 
maternal, newborn, and child health (MNCH) practices and care-seeking behavior. HEWs at health posts in the 
intervention site only will receive additional training on tracking clients and providing PPFP messaging (as well as other 
FP/implant refresher as needed) at routine antenatal and postpartum contacts. HEWs in the intervention site will train 
HDAs on these messages and will receive job aids and tracking tools for PPFP messaging. Data from chart reviews and 
review of health records in the intervention and control arms will be analyzed to determine differences in PPFP 
counselling, decision-making on method choice, and uptake of PPFP by study arm. 
More robust qualitative evaluation will take place at endline, where secondary participants will include community 
health workers (HDAs), and facility based providers, including HEWs, and managers.  We will collect additional data from 
these informants through interviews, questionnaires and focus group discussions.   
The following conceptual model illustrates the inputs and influencers that affect postpartum family planning uptake and 
how tracking pregnant women will improve the uptake. 
 

Page 6 of 23 
 
Pfitzer_ IRB00007143_EthiopiaPPFP_protocol_V2_Oct 24, 2016 
Figure 2: Conceptual Model 
 
 
 
 
 
 
 
 
  
 
 
PREGNANCY 
BIRTH 
POSTPARTUM 
Influencers/ 
inputs to 
uptake of 
PPFP 
 
 
 
 
 
 
 
Additional 
follow-up as a 
result of 
tracking 
 
 
 
Counseling & 
Services: 
Availability of 
method of 
choice at birth 
Receipt of 
method of 
choice at 
desired contact 
Non-receipt of 
method of 
choice at desired 
contact 
Counseling & Services: 
Availability of method of 
choice at PNC / 
Immunization visits 
Opt out 
of PPFP 
Method 
choice 
DECISION 
DELAY in decision 
Tracking of pregnant 
women in community 
to document: 
• Decision to opt out, 
• Choice of method, or 
• Delay in decision 
Tickler system for 
women close to due 
date without a decision 
recorded  
Additional contact to 
promote decision 
Tracking of postpartum 
women in community 
(excl. opt-outs) to 
document: 
• Choice of method 
• Whether obtained 
method of choice 
Additional contact to 
support women to obtain 
method of choice 
Reporting of ‘missed 
opportunities’ to Woreda 
Health Office 
Services: HTSP/FP 
messages at ANC 
contacts 
• Home visits 
• Facility 
• Community 
engagement 
Individual:  
• Attitudes & 
awareness 
of FP 
(DECISION) & METHOD PROVISION 
Social:  
• Attitudes of 
influencers 
about FP 
• Couple/family 
discussion of 
PPFP 

Page 7 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
The study will collect data from key actors in the implementation of the intervention. The Table 1 describes the actors, 
the type of data and instruments to be collected. 
Table 1: Data Collection Tools and Type of Information Collected 
Study 
Population 
Data Collection Method 
Type of Information/Data Collected 
Health 
Extension 
Workers 
Mixed methods 
questionnaire (going through 
each point of service – ANC, 
delivery, PNC and 
immunization) 
• 
Integration of PPFP messages in ANC, PNC, and immunization 
contacts 
• 
Perceived barriers to uptake of PPFP in community 
• 
Experience with training, mentoring and supervision of HDA in 
promoting PPFP 
• 
Confidence (self-perceived skills and ability) and experience in 
counseling and delivering postpartum implants, LAM counseling 
& EBF support, and other methods 
• 
Ability and willingness to use record keeping and tracking tools 
to assess population level PPFP decision-making and uptake in 
the catchment of the health post 
Health 
Development 
Army 
(HDA)/HDA 
team leaders 
Focus Group Discussions 
• 
Understanding of PPFP benefits, methods, etc. 
• 
Experience promoting MNCH including PPFP 
• 
Description of what they do and how (home visits, community 
meetings, etc.) 
• 
Decision making as to who they target besides pregnant 
women, barriers perceived, coverage of assigned households 
• 
Experience with support from HEWs, team leaders, village 
leaders, use of data at monthly meetings 
Health 
providers (at 
Health Center) 
Mixed methods 
questionnaire (going through 
each point of service – ANC, 
delivery, PNC and 
immunization) 
• 
Integration of PPFP messages in ANC 
• 
Delivery of contraceptive methods at birth, including PPIUD, or 
in postnatal contacts 
• 
Experience with scheduling mobile services or referrals for 
permanent methods 
• 
Barriers to PPFP counseling and service delivery, including stock 
outs, organization of services, manpower, confidence to 
deliver, etc. 
• 
Experience with record keeping and analysis of PPFP data 
District 
(woreda) 
health 
managers 
Key Informant Interviews  
• 
Attitudes towards PPFP integration; 
• 
Barriers/Facilitators 
• 
Experience with data reviews, analysis of data to address gaps 
• 
Experience addressing management or systems issues with FP 
service delivery 
Pregnant and 
postpartum 
Women  
Census of all pregnant 
women in the catchment 
area 
Questionnaire for all women 
6-9 months pregnant 
F/U and re-interview all 
women 1 year later 
Review Integrated 
MCH/Family Health Card 
• 
Attitudes and use of FP – past use, current use (once delivered) 
• 
Family support for FP, spouse, MIL, FIL (ask who are most 
influential) 
• 
Attitudes on immunization, facility delivery, plans for delivery, 
infant feeding, care seeking for self or sick baby 
• 
# of health contacts, # of ANC visits, place of delivery, PNC visits 
at facility or home, immunization visits, BF practices, return to 
fertility, timing of adoption of FP if adopted, rationale for not, 
what was most influential for those who did adopt (and didn’t) 

Page 8 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
Table 1: Data Collection Tools and Type of Information Collected 
Study 
Population 
Data Collection Method 
Type of Information/Data Collected 
• 
Perception of risk of pregnancy and motivation to avoid 
another pregnancy 
• 
Experience with woman held card, if brought with them to all 
contacts with the system; was it helpful? Ability to 
communicate method choice without card  
Registers, 
Referrals at 
Health Center, 
Health post 
level 
(Revised longitudinal 
register)  
Ability to track pregnant women’s PPFP counselling, decision 
making on method choice and uptake of PPFP 
# of women in register, completeness of register 
Follow up mechanism 
 
 
The Table 2 provides details on the general study timeline, program activities and study related activities. 
Table 2: Study Timeline and Activities 
Timeline 
Program Activities 
Research-related Tasks 
Preparatory phase (1st 
4-6 months) 
Woreda level engagement of stakeholders 
Assessment of sampled health facilities 
readiness  
Identification of data collectors 
Development and pretesting of SBCC and 
training materials for HEWs including how 
HEWs will train HDA (in adjoining woreda to 
avoid contamination) 
Pre-testing of translated questionnaires 
for pregnant women and household 
members 
Development and pre-testing of HEW and HC 
M&E Tools 
Abstraction tools for health records, 
development of monthly site monitoring 
visit documentation tool 
PPFP Counseling Training (2 day course, with 
more people) 
Training of data collectors 
PPIUD/Implant Training ( 5 day course for 
subset) 
 
Training of HEWs in PPFP counseling and 
promotion of PPFP messages at community 
level, assessment and refresher in implant 
skills 
 
Baseline  
 
• 
Census of pregnant women, 
enrollment of study participants 
(research team member paired with 
HDA team leader),  
• 
Interviews of study participants and 
household members 

Page 9 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
Table 2: Study Timeline and Activities 
Timeline 
Program Activities 
Research-related Tasks 
Intervention 
implementation run 
time (15 months) 
• 
HEWs train HDA team leaders and team 
leaders train HDA 
• 
Ongoing household visits by HDA and 
HEW and promotion of PPFP at 
community level 
• 
Ongoing monthly meetings between 
HEWs and HDA team leaders – review of 
data on pregnant and recently delivered 
women 
• 
Post training follow up of PPFP/trained 
health providers and HEWs 
Study Monitoring: 
• 
Monthly F/U of HC records, tracking of 
births and PPFP uptake among 
postpartum women using selected 
health facilities 
• 
Record review and abstraction of HEW 
data  
• 
Documentation of PPFP, PNC or 
immunization service delivery issues 
Endline (after 15 
months) 
 
• 
Follow up interviews with enrolled 
women  
• 
Interviews of HCW, HEW, 
• 
Focus Groups with HDA  
• 
In depth interviews of Woreda 
stakeholders 
Analysis and report 
writing (4 months) 
 
Data analysis 
Report Writing 
Journal Writing 
Dissemination 
 
Dissemination workshop in Ethiopia 
 
B. Provide a sample size and a justification as to how you arrived at that number.  If you use screening procedures 
to arrive at a final sample a table may be helpful.    
 
This study will be implemented 2 primary health care units (PHCUs), comprised of one health center and all 
kebeles/health posts in their catchment area, in Hitosa Woreda and 2 PHCUs in Lude-Hitosa Woreda.  We randomly 
assigned 1 PHCU in each Woreda to the intervention and control arms. So out of 4 PHCUs in each Woreda, 1 was 
selected for intervention and 1 for control.   
We obtained the total population for each PHCU. To estimate the number of women age 15-49 and expected 
pregnancies at the time of study survey, we used results from the Ethiopia mini DHS 2014: 43.6% of female residents of 
selected households were age 15-49 and 7.3% of women age 15-49 were currently pregnant at the time of the Mini DHS 
2014. 
Table 3: Estimation of eligible population 
Arm 
Total population 
Female population 
(50%) 
Expected females age 
15-49  
(43.6% of female pop) 
Expected current 
pregnancies 
(7.3% of women 15-49) 
Women 6-9 months 
pregnant  
(pregnancies / 3) 
Intervention 
72,138 
36,069 
15,726 
1148 
382 
Comparison 
52,508 
26,254 
11,446 
835 
278 
 
 

Page 10 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
For pregnant women, we calculated the minimum sample size requirements for this quasi-experimental design for the 
main outcome of interests (adoption of LAM and other modern method by 12-month PP) using the formula: 
 
 
 
Where p1 and p2 are the proportions of women adopting LAM or other modern method in the intervention and control 
arms, respectively, and Z’s are the critical value of the normal distribution at α=0.05 and β=0.20; 1+(m-1) ρ captures the 
design-effect due to cluster based sampling of areas, where m= average size of the clusters and ρ=intra-cluster 
correlation.  We consider a design-effect (deff) of 1.5 for adjusting higher intra-cluster correlation in the observations in 
the quasi-experimental design.   
 
We require a minimum of 299 women in postpartum observation period in each arm to detect an increase of at least 
10% contraceptive prevalence rate (CPR) in the intervention arm, compared to the women in the control arm (20% vs 
10% in the intervention and control arm, respectively) with deff=1.5 at 80% statistical power.   Assuming about 20% lost-
to-follow-up and non-response rate, we target to enroll 375 women in each arm.  We consider that it will be sufficient to 
select 1 PHCU and its attached kebeles in each of the two woredas to ensure adequate sample size, with 2 PHCU 
randomly assigned to the intervention area (1 per woreda) and 2 to the control area (1 per woreda).   The eligible 
women in 3rd trimester who consent to participate in the study voluntarily will be recruited and be interviewed at 
enrollment and at 12-month PP.   
 
We used p1=0.2 (20% PP contraceptive uptake by the final round of observation in the intervention arm) and p2=0.1 
(10% in the comparison arm).  We considered deff=(1+[m-1) ρ]= 1.5. Because we are targeting 375 sample size of 
pregnant women in each arm consisting of 2 PHCUs, this implies m=188 AND ρ=0.0027. 
Because the selected PHCUs are adjoining woredas of the same zone, it is expected that they will be quite similar, and in 
addition, the underlying population are all similar in terms of postpartum status; hence ρ very small (the larger the 
heterogeneity, the larger the  ρ value). The Ethiopia DHS 2011 results suggest that the deff of contraceptive use in all 11 
regions  are much smaller than the national level  deff of CPR (Appendix B – Estimates of Sampling Errors); woreda level 
deff is expected to be much smaller due to less heterogeneity at woreda level, compared to the region/state level. In all 
regions, method specific deff was <1.5.  So, we considered that of deff=1.5 is applied in this study is reasonable and 
practical.  A study on postpartum use of contraceptive method at a woreda level in Ethiopia also had deff=1.5 (Abera Y, 
Mengesha ZB, Tessema GA. Postpartum contraceptive use in Gondar town, Northwest Ethiopia: a community based 
cross-sectional study. BMC Women’s Health. 2015;15:19.)  
Sample size requirements are included below based on the average number of providers and HDAs and managers in 
each kebele.  See Table 4: Sample Size Summary 
 
 
 
 
 
{
}
2
/)
(
,
)
(
)1
(
1(
)
1(
)
1(
)
1(
2
2
1
2
2
1
2
2
2
1
1
1
2
/
1
p
p
p
where
p
p
m
p
p
p
p
z
p
p
z
n
+
=
−
−
+
−
+
−
+
−
=
′
−
−
ρ
β
α

Page 11 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
Table 4:  Sample Size Summary 
Study Participant 
Intervention  
(2 PHCU) 
Comparison  
(2 PHCU) 
Total 
Pregnant women  
375 
375 
750 
Facility Providers working in ANC, L&D, 
postnatal care, immunization, family planning  
10 
10 
40 
District managers and stakeholders  
Not applicable 
 Not applicable 
6 
Health Extension Workers (10 HPs in 
intervention clusters and 8 in comparison 
clusters; each HP has 2 HEWs) 
20 
16 
36 
HDA/HDA Team Leaders (2 FGD/PHCU, 10 
people per FGD) 
40 
40 
80 
Total Sample Size 
455 
449 
910 
 
Since the expected number of eligible women in the selected control PHCUs is less than we require to meet this sample 
size, we will enroll women from adjoining kebeles (villages) in non-study PHCUs to reach the required sample size. The 
kebeles will be selected with local leadership and with the aim to minimize contamination by selecting villages further 
from the intervention PHCU. If we do not reach the required sample size in intervention PHCUs, we will also select 
adjoining kebeles to each the sample size minimum; the HEWs and HDA from these will be trained in the intervention 
package. All health centers in the entire woreda are receiving the same strengthening inputs, so no additional inputs will 
be necessary.     
IV. Participants 
Describe the study participants and the population from which they will be drawn.  Specify the inclusion and 
exclusion criteria.  If you plan to include children, note their ages and whether you will include children in foster 
care. Note if the participants are particularly vulnerable in terms of cognitive limitations, education, legal migration 
status, incarceration, poverty, or some combination of factors.  
 
A. Inclusion criteria: 
 
• 
Pregnant women (including emancipated minors) 
• 
Providers (HDA, HEW, HCW, district managers providing PPFP messages or services in study area) 
• 
Willing to give informed consent 
 
C. Exclusion criteria: 
 
• 
Non – pregnant women, women living outside study area,  facility providers not working in ANC, L&D, PNC 
or immunization.  Providers from other points of service study facilities.  
 
NOTE: If you are recruiting participants or receiving, accessing, or using data from a U.S. health care provider, HIPAA 
review is likely to be required.  If you plan to bring identifiable health information from a foreign country to a 
U.S. covered entity (e.g., lab at the Hopkins SOM), HIPAA may be triggered.  Check “yes” to the HIPAA 
question in the PHIRST application. 
V. Study Procedures  
In this section, provide details of your procedures, particularly as they relate to human subjects. If this is a multi-
center study, make the role of JHSPH clear.  If the JHSPH will serve as data coordinating center, indicate in the 
sections below which procedures JHSPH will not be performing.  Additional information regarding data coordinating 
centers is requested in a later section.  If your study will develop in phases, address each item below by phase. 

Page 12 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
A. Recruitment Process: 
1. Describe how you will identify, approach, and inform potential participants about your study.  Include 
details about who will perform these activities and what their qualifications are. 
 
Prior to the development of this protocol, a concept note was written and the Federal Ministry of Health 
was consulted about the general idea for this study. The Federal Ministry of Health convened a stakeholders 
meeting where input on the priorities for research questions were discussed and incorporated into this 
protocol.  Furthermore, the research team contacted the national and regional/ woreda level authorities in 
person and writing, describing the study to them and received permission to carry out the study. 
 
 
Prior to the study start, the relevant authorities will communicate to the selected Woreda (and health 
facility leaders) about the study through usual channels such as letters introducing the research team to 
them.   Working in conjunction with woreda health managers, the study team will orient the site and 
community health staff to the purposes of the study.  Jhpiego/ MCSP staff will provide training on PPFP 
counseling, promotion of PPFP to HDAs and provide orientation to the modified health record tools.  MCSP-
recruited data collectors will work with HEWs and HDAs to develop lists and approach pregnant women in 
their catchment area and describe the study to them using Study Tool R1: Recruitment Script for Pregnant 
Women.  If they are interested in learning more about the study, a full consent script will be read as 
described below in Section 5B of this protocol.   
  
 
 
For district managers, health providers, health extension workers and health development army data 
collection will take place at the end of the study. The research team will contact regional health bureau and 
woreda authorities in intervention and control sites and work through government administrative structures 
to recruit participants using Study Tools R2: Health Extension Workers, HDA, R3: Health providers (at Health 
Center), and R4: District Managers.  If interested in learning more about the study, consent process will 
begin as described below. 
 
 
2. Address any privacy issues associated with recruitment.  If recruitment itself may put potential participants 
at risk (if study topic is sensitive, or study population may be stigmatized), explain how you will minimize 
these risks. 
 
The recruitment will take place in a private location in the community, either in or outside the home, or in a 
quiet location near the home at the discretion of the participant.  There is limited risk to participants during 
the recruitment. 
 
B. Consent Process:   
 
Members of interview teams including supervisors and data collectors will be trained using the JHSPH 
Human Subjects Research Ethics Field Training Guide. Interview team members will also be oriented on the 
study protocols, data storage procedures, recruitment and consent forms and data collection tools. 
Additional training will be provided on interviewing techniques. Jhpiego/ MCSP Program Technical and M&E 
staff will supervise the interview team during the data collection process. Throughout field-based activities, 
the data collected will be reviewed weekly to identify any potential issues with the interview tools or 
interviewers. Participants will be assigned study IDs.  
 
If the pregnant woman is interested in learning more about the study, the trained data collector will use the 
consent form (C1: Pregnant Women) to obtain oral consent to participate in the study.  Data collectors will 
explain the purpose of the study, how the pregnant woman was selected, interview procedure, risks and 

Page 13 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
benefits.  The participants will be informed they can stop the interview or withdrawal from the study at any 
time. Emancipated minors (according to local legal definition) who are 15-17 years and pregnant, will 
provide their own consent as participants. Respondents will be asked to suggest a private location in the 
homestead or close by where an interview can be conducted in private; all interviews will be conducted at 
locations that assure audio privacy.  Privacy and confidentiality will be maintained during interviews and 
handling of data obtained.  
 
For health providers and managers, health extension workers and health development army, if they are 
interested in learning more about the study, a trained data collector will use the consent form (C2: Health 
Extension Workers, HDA, C3: Health providers (at Health Center) and C4: District Managers to obtain oral 
consent to participate in the study.   Respondents will be asked to suggest a private location in the facility or 
surrounding area where an interview can be conducted in private; all interviews and focus group discussions 
will be conducted at locations that assure audio privacy.  Privacy and confidentiality will be maintained 
during interviews and handling of data obtained. 
 
We are seeking a waiver of written consent for several reasons.  This study is minimal risk and involves only 
interviews with women once during pregnancy and again at about a year postpartum, facility and 
community providers and some senior family members.   . Many of the clients will be low-literate and a 
signature may not be feasible.  
 
For providers, including health center, health post/HEW, a waiver of signed informed consent allows for 
better protection of confidentiality as no identifiers will be collected, including signatures. Provider 
questionnaires will be administered using tablets, with a built in consent script and yes/no pause, with the 
no button ending the interview. By not having the participant sign or mark a consent form, we can avoid 
collecting or keeping any identifiers. 
 
Similarly, for focus group discussions with HDA, a waiver of signed informed consent allows for better 
protection of confidentiality as no identifiers will be collected, including signatures. Many of the HDAs have 
low or no literacy. The FGD will be recorded for ease in transcription and translation of the discussion, but 
any names or nicknames will be removed from the transcripts. FGDs will be audio recorded; recordings will 
be kept in a locked cabinet or room and will be destroyed after the study is complete and the file is closed. 
 
2. Identify the countries where the research will take place, and the languages that will be used for the consent 
process.   
Country 
Consent Document(s) 
(adult consent, parental permission,  
youth assent, etc.) 
Languages 
Ethiopia 
Consent  
Amharic, Afan Oromo 
C. Study Implementation: 
     
 See Table 5 for information on study implementation 
 

Page 14 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
Table 5: Study implementation procedures 
Study 
Population 
Main Data 
Collection 
Method 
Other Study 
Procedures 
Number of 
contacts 
Duration of 
Research 
Interview 
(Only)  
Place of 
Interview 
Health 
Extension 
Workers 
Post 
intervention 
Questionnaire 
(covering each 
point of service 
– ANC, delivery, 
PNC &  
immunization)? 
Orientation to study 
Training on PPFP 
counseling and 
promotion of PPFP 
to HDA 
Training on health 
records tools  
Monthly follow up 
~19: Pre study 
training and start 
up (~3); monthly 
during study (15 
months); Endline 
(1)  
60 minutes 
Health Post 
Health 
providers (at 
Health Center) 
Post 
intervention 
Questionnaire 
(covering each 
point of service 
– ANC, delivery, 
PNC &  
immunization) 
Orientation to study 
 
Training on PPFP 
counseling  
 
Training on PPIUD 
and implants 
(subset of providers) 
 
Training on health 
records tools (and 
analysis?) 
 
Monthly follow up 
~19: Pre study 
training and start 
up (~3); monthly 
during study (15 
months); Endline 
(1)  
60 minutes 
Health 
Center 
Health 
Development 
Army 
(HDA)/HDA 
team leaders 
Post 
intervention 
Focus Group 
Discussions 
Existing HEW/HDA 
contacts utilized for 
study activities.   
 
1: FGDs 
120 
minutes 
Health Post 
District 
(woreda) 
health 
managers 
Post 
intervention 
Key Informant 
Interviews  
Orientation to study 
Ad hoc debrief on 
study monitoring 
~6 
45 minutes 
Woreda 
Health 
Office 
Pregnant and 
Postpartum 
Women  
Pre-intervention 
questionnaire 
for all women 6-
9 months 
pregnant 
 
Post 
intervention 
F/U 
questionnaire 6-
9 months 
postpartum  
 
 
2 
Pre-
Interview: 
60 
 
Post- 
Interview: 
60 
Household 

Page 15 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
Table 5: Study implementation procedures 
Study 
Population 
Main Data 
Collection 
Method 
Other Study 
Procedures 
Number of 
contacts 
Duration of 
Research 
Interview 
(Only)  
Place of 
Interview 
 
Review Client 
held Integrated 
MCH/Family 
Health Card 
(post 
intervention) 
Registers, 
Referrals at 
Health Center, 
Health post 
level 
(Revised 
longitudinal 
register)  
 
For HEW 
monitoring tool: 
Ease of use, 
helpful for  data 
review 
meetings, etc 
 
12: monthly data 
review and 
abstraction 
N/A 
Health Post 
and Health 
Center 
 
 
4.    Provide a brief data analysis plan and a description of variables to be derived.  
 
After data have been thoroughly examined for quality, the study team will perform exploratory data analysis of 
the key variables for checking frequency distributions, measures of variability, central tendency, and data 
outliers.  We will also check for incomplete data and undertake an imputation strategy, if needed. 
 
We will examine the differences in contraceptive use behavior by study arms for the following outcomes:  
• 
Baseline only: % with past use of postpartum family planning among women with non-first pregnancies 
• 
% of postpartum women who choose a method prior to delivery (by # of ANC contacts) 
• 
% uptake of FP by PP timing (Delivery, PNC, immunization) and type of method 
• 
% of ANC and PNC contacts where FP was discussed or provided (by type of contact, i.e., HDA, HEW, 
HCW, other) 
• 
Duration of exclusive breastfeeding/Introduction of complementary foods 
• 
% initiated LAM and the duration of LAM use 
• 
% of women received counseling during immunization 
• 
Immunization coverage of infants of enrolled women by month postpartum (doses of DPT1, 2 and 3 and 
drop out rates)  
 
We will perform both “intent to analysis” to examine the net differences between the two study arms, adjusted 
for confounding covariates, and “per-protocol analysis” to examine “dose-effect” of health system contacts.  We 
will fit multivariable logistic regression models for examining the differences in binary outcome variables (e.g., 
method selection during ANC; FP discussions during contacts, etc). We will use hazards regression model for 
examining the duration (discontinuation) of LAM use in first 6-month PP and for analyzing the uptake of modern 
contraceptive method by timing since delivery. 
 

Page 16 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
1. Describe whether you are collecting or storing personal identifiers, and if yes, why you need them, and 
when and how you plan to dispose of them.  Signatures on consent forms are considered to be identifiers. 
 
For pregnant women enrolled in the study, each woman will be assigned a unique study ID.  The information 
linking the women’s personal information and study ID will be kept in a separate locked, password protected file 
only accessible by study personnel.  For other study participants, we will not collect personal identifiers on any 
of the questionnaires, in-depth interviews, or focus group discussions and transcripts.   
 
A study logbook will also be maintained to track providers participating in the study including the provider 
name, study ID, date of interview and interviewer.  This logbook will be kept by the data coordinator at each 
facility in a locked, secure place during data collection along with logbooks referenced above.  This will only be 
accessible by the counselor and Jhpiego/MCSP study staff.  The names of providers will not be entered into the 
electronic database and the logbook will be destroyed 6 months after completion of the study. 
VI. Data Custody, Security, and Confidentiality Protections 
The sections below describe types of data sources and how they will be protected. For the type(s) of data you will 
have, put an “X” in the appropriate box to the left of the section that best describes how you will minimize the risk 
of a breach of confidentiality for your study.  Note, as appropriate, how you will record/store data.  These 
descriptions represent MINIMAL measures; you may add more stringent protections and other relevant information 
in B.  
Confidentiality: The LOSS OR THEFT of 1) original/duplicate version of physical data collection instruments (forms, 
tapes, etc) or 2) physical devices containing electronic data (i.e. laptop/mobile device, external flash drive(s), is a 
threat to subject confidentiality.  Risk of such a loss/theft is increased during movement/transport of data (in any 
format), such as in a vehicle or other move.  Be sure to train anyone (co-investigators, staff, students, etc.) who might 
be engaged in the oversight of data handling/storage about this problem.  Some typical risk-mitigation strategies 
would include: 
• 
minimizing the physical movement of data and/or devices containing data 
• 
encrypting electronic data (especially when stored on any mobile device, including flash memory tools, 
phones, tablets, etc, or when transferring across networks) 
• 
making use of reliable courier services (FedEx, DHL, etc) when physical transport of bulk data forms is 
necessary 
• 
minimizing the transfer of identifiable data in physical or electronic form (i.e. removing/separating/destroying 
identifiable data, when physical transfer of data is necessary) 
A. Data Storage  
1.  Hard Copies of Data Collection Forms.   
 
This activity will not involve receiving and/or accessing hard copies of data 
 
X 
Health workers and volunteer. Data collection forms RECORD NO PERSONAL IDENTIFIERS connecting 
study participants, and there are no codes providing a link.  Data are anonymous. 
 
Data collection forms INCLUDE IDENTIFIERS.  The forms are locked in a secure cabinet or room with 
limited access by authorized individuals.  Forms will be kept in study team’s possession during 
transport and will not be left unattended in a vehicle.  When possible, de-identified copies will be used 
for coding and analysis. 
X 
Women’s survey. Data collection forms ARE CODED with study participants’ random study ID numbers.  
Codes/links between study IDs and identifiers are stored securely in a separate place (locked storage 
cabinet or secure electronic database.)   
 
Other: 

Page 17 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
2.   Electronic Data 
X 
Audio files of health workers and volunteers. The data do not contain personally identifiable 
information 
 
X 
Women’s survey. These data are stored on a secure server protected by limited access and strong 
password systems.  Data are coded when possible.  Portable electronic devices will not contain 
identifiable information unless encrypted. 
 
Other:   
3.   Other Identifiable Data Storage, Retention, and Destruction (Audiotapes, videotapes, photographs, etc.) 
will be retained and stored securely (locked in cabinet or room) until: 
X 
Transcription is complete, then audio files will be destroyed a maximum of 3 months later. 
 
Analysis is complete, then will be destroyed. 
X 
Study is complete and file is closed. 
 
Indefinitely.  Provide justification for indefinite retention: 
 
4.  Existing Biospecimens to be used in this study: N/A 
 
HAVE NO PERSONAL IDENTIFIERS. 
 
INCLUDE IDENTIFIERS AND ARE CODED; the PI will not have access to the link or code connecting the 
identifiers to the specimens.  
 
INCLUDE IDENTIFIERS, and the PI has access to those identifiers or to the link/code connecting 
specimens to individuals.  The identifiers and/or code will be stored securely until the study is 
complete. 
 
B. Certificate of Confidentiality 
Will the study data stored in the United States be protected by a Certificate of Confidentiality?  If yes, explain 
who will apply for and maintain the Certificate. (http://grants.nih.gov/grants/policy/coc/appl_extramural.htm) 
N/A 
C. Data Security and Sharing 
PIs have the responsibility for responsible stewardship of data and protecting data confidentiality. This 
responsibility includes protecting physical custody of the data, storage and sharing with appropriate data use 
agreements that contain the appropriate security provisions.  Describe any additional plans beyond those 
identified in the table that you have for storing and sharing the study data and/or materials, and how 
responsibility for the data will be managed.  Include the following details: 
 
1.   Where will the study data be stored? 
2. Who controls access to the data? 
3. Will data be shared only if de-identified?  
4. What additional (if any) security controls will be in place? 
 
Data will be collected either on paper or on mobile devices.  The women’s surveys will be captured on mobile devices, 
while the health worker and volunteer data will be captured on paper and with audio-recordings. In general, the data 
collectors will keep the completed questionnaires securely in sealed envelopes and bring them back to the 
Jhpiego/MCSP Ethiopia office once the data collection is finished. Study personnel (e.g., supervisors and the study 
manager) will be allowed access to the written data during the field work. Once the Jhpiego/MCSP Ethiopia Study 
Manager obtains the completed data collection forms, the data will be entered into electronic databases on password-
protected computers at the MCSP office.  Hard copies will be stored in locked cabinets in the Jhpiego/MCSP Ethiopia 
office.  Names and participant identifiers will be maintained in a study log book that is kept locked in a separate location 
from the completed data collection forms.  At all times, the data will be treated confidentially and only the study staff 

Page 18 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
will be allowed access to the raw data.  De-identified and/or aggregate data may be analyzed by the study team.  Data 
collected on tablets using a software that allows for data encryption.  
VII.  Risks of the Study 
A. Describe the risks, discomforts, and inconveniences associated with the study and its procedures, including 
physical, psychological, emotional, social, legal, or economic risks, and the risk of a breach of confidentiality.  
These risks should be described in the consent documents. 
 
There are no anticipated physical risks for participation in this study.  The potential non-physical risk for recent 
mothers and health workers include their personal information being shared with the study personnel, Ministry 
of Health personnel or community members.  This can be considered minimal risk, as little or no information of 
a confidential nature will be collected.  All information collected during the assessment will be treated as 
confidential. During focus group discussions, some participants might feel a bit uncomfortable discussing some 
of the topics. This will be mitigated by assuring the participants of confidentiality of information during the 
consent process.  Participants will also be assured that they may choose not to continue with the questionnaire 
or focus group at any time. Furthermore, study identifiers will be used on paper and in electronic database 
further ensuring confidentiality.  
 
B. Describe the anticipated frequency and severity of the harms associated with the risks identified above; for 
example, if you are performing “x” test/assessment, or dispensing “y” drug, how often do you expect an 
“anticipated” adverse reaction to occur in a study participant, and how severe do you expect that reaction to 
be?   
 
Expected harm as a result of participating in this study is minimal for all participant types.   
 
C. Describe steps to be taken to minimize risks.  Include a description of your efforts to arrange for care or referral 
for participants who may need it. 
 
Interviews will be administered in a private area within the homestead or nearby – respondents will not be 
required to travel away from their homes in order to participate. These respondents and health providers will 
assist in identifying a suitable location.  
 
D. Describe the research burden for participants, including time, inconvenience, out-of pocket costs, etc.  
 
The only burden for respondents is time they spend participating in an interview. There will be no payments or 
monetary compensation of study participants since the interviews will be done at their homes.   
 
E. Describe how participant privacy will be protected during data collection if sensitive questions are included in 
interviews. 
 
Private locations will be located for interviews to project participant privacy. No sensitive questions, such as HIV 
status, will be asked. 
 
VIII. Direct Personal and Social Benefits 
A. Describe any potential direct benefits the study offers to participants (“payment” for participation is not a direct 
personal benefit). 
 
There will be no direct benefits to individual study participants; they will not receive any payment or other 
compensation.  

Page 19 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
 
B. Describe potential societal benefits likely to derive from the research, including value of knowledge learned. 
 
It is expected that through the study information; community level coverage of PPFP knowledge and services 
will improve which may lead to improved health situation or outcomes in the community. 
 
IX.  Payment:   
A. Describe the form, amount, and schedule of payment to participants. Reimbursement for travel or other 
expenses is not “payment,” and if the study will reimburse, explain. 
 
No payment will be made to study participants. 
 
X. Study Management 
A. Oversight Plan:  
1. Describe how the study will be managed. 
 
The PI will oversee the study.  She will work with the study team to carefully establish study 
procedures, including human subject protection, training tools for data abstractors and data collection 
steps. She will be in regular contact with the study team and provide oversight for data collection, 
review, analysis and report writing.  In Ethiopia, there will be a co-investigator and study manager to 
recruit data abstractors, oversee and manage the data collection at health facilities.  This person will be 
responsible for local data management, texts and phone calls with providers.  The co-investigators are 
expected to lead the orientation of study managers and support training of data abstractors. The study 
managers will be drawn from M&E staff in the Jhpiego office in Ethiopia.  The PI will establish weekly 
check in calls during the data collection period with the co-PIs responsible for data collection to review 
procedures, challenges and discuss opportunities to explore additional datasets. 
 
 
2. What are the qualifications of study personnel managing the project? 
 
Anne Pfitzer, MHS, is the PI and is the Family Planning Team Leader for the global USAID-funded 
Maternal and Child Survival Program. She is responsible for interactions with the donor funding this 
study in addition to managing oversight of the study. 
 
Deborah Sitrin, MHS, is a co-investigator on this study and is a Sr. Monitoring and Evaluation Advisor 
for Jhpiego and the Maternal and Child Survival Program. She has extensive prior experience working 
in international health including based in Africa as well as in research in Ethiopia. She is a member of 
the Jhpiego/MCSP Family Planning team.  
 
Ephrem Daniel is a co-investigator on this study. He is Jhpiego and MCSP Monitoring and Evaluation 
Advisor based in the Addis Ababa office. He was involved at the beginning of the study in its design and 
brings background experience with other implementation research efforts in Ethiopia.  
 
Firew Ayalew Desta is co-investigator on this study. He is Jhpiego/MCSP Research Team Leader based 
in the Addis Ababa Office. Firew is leading the coordination of the Ethiopia study team and interfacing 
with the Federal Ministry of Health in Ethiopia and the Arsi University co-investigator. 

Page 20 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
 
Gebir Hussein, Epidemiologist at Arsi University, is a co-investigator with the study. The Federal 
Ministry of Health asked that we work in partnership with a local university. Arsi University is near to 
our study area. He will be engaged in data collector training, supervision of baseline and endline, and 
when feasible monthly visits to sites. 
 
Dr. Tsigue Pleah is co-investigator on this study and will act as Study Manager, provide support to the 
implementation of PPFP clinical activities, support development of tools for abstracting records and 
collecting clinical data and support analysis and interpretation of clinical data. 
 
Tigist Worku Belete is co-investigator in this study. She is FP/RH Advisor for MCSP/Ethiopia based in 
the Addis Ababa office. Her role will be to ensure technical support to providers and health workers 
delivering integrated services. She is also the overall program manager for the study. 
 
Dr. Eva Bazant has been added as a co-investigator to the study, with a specific mandate to support 
more rigorous implementation and analysis of the endline qualitative data. She is Jhpiego’s Research 
Team Lead, in the Monitoring, Research and Evaluation Office. She will provide training to qualitative 
interviewers as well as guide the qualitative data coding and analysis. 
 
3. How will personnel involved with the data collection and analysis be trained in human subjects research 
protections?  (Use the JHSPH Ethics Field Training Guide on our website.) 
 
All co-investigators have completed the CITI course and uploaded a copy of their certificates.  All in-
country data collectors will be trained by the PI in human subjects using the JHSPH guide. 
 
4. If the PI will not personally be on-site throughout the data collection process, provide details about PI site 
visits, the supervision over consent and data collection, and the communication plan between the PI and 
study team. 
 
The study manager and co-investigators involved in data management are Jhpiego employees and 
experienced in human subject research. Weekly telephone calls will take place during data 
collection.  
 
B. Recordkeeping:   
Describe how you plan to ensure that the study team follows the protocol and properly records and stores study 
data collection forms, IRB regulatory correspondence, and other study documentation.  For assistance, contact 
housecall@jhsph.edu. 
 
Protocol, IRB regulatory correspondence and other study documentation: We will establish a 
regulatory binder and keep it in the PI’s office. A short binder of key forms will be shared with field co-
investigators.  We will develop and maintain a password protected study database for data 
management.  Only de-identified data will be entered into the database.  For logbooks that include 
identifiable data, these will be kept by the local study manager, under lock and key.   
 
Study Data Collection Forms: Paper forms will remain in-country during data collection. They will be 
stored securely in the study team’s possession or in a locked cabinet in each main Jhpiego country 

Page 21 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
office, under the supervision of a Monitoring and Evaluation Officer. Once entered into a database, and 
the data cleaned, paper forms will be destroyed. 
 
C.  Safety Monitoring 
 
N/A 
 
D.  Reporting unanticipated problems/adverse events (AE’s) to the IRB (all studies must complete this section):   
Describe your plan for reporting to the IRB and (if applicable) to the sponsor.  Include your plan for government-
mandated reporting of abuse or illegal activity.  
NOTE:  The IRB does not require submission for all AEs, only those that are unanticipated, pose risk of harm to 
participants or others, and are related to the study. 
 
Any adverse events will be reported to both the local and JHSPH IRBs in writing as soon as possible 
after the event occurs. Any loss of data will be reported using the IRB-mandated procedures. Any 
misinformation or incident related to the study, the data collection process or involving access to 
patient data will first be reported urgently to the PI who will gather as much information as possible, 
then report to IRB. The IRB support team at Jhpiego will be called upon to assist in such an eventuality. 
 
E.  Other IRBs/Ethics Review Boards:   
If other IRBs will review the research, provide the name and contact information for each IRB/ethics review 
board and its Federal Wide Assurance, if it has one (available on OHRP’s website at 
http://www.hhs.gov/ohrp/assurances).   
 
The Oromia Regional Health Bureau IRB will review this study. 
 
F. Collaborations with non-JHSPH Institutions:  
For studies that involve collaboration with non-JHSPH institutions, complete the chart below by describing the 
collaboration and the roles and responsibilities of each partner, including the JHSPH investigator.  This 
information helps us determine what IRB oversight is required for each party. Complete the chart for all multi-
collaborator studies. 
  
 
Jhpiego 
MOH 
(national and 
regional) 
Arsi University  
Primary Grant Recipient 
X 
 
 
Collaborator 
 
X 
X 
For the following, indicate “P” for “Primary”, “S” for “Secondary” as appropriate to role and level of 
responsibility.) Add additional items if useful.  
1 
Human subjects research ethics training for 
data collectors 
P 
S 
S 
2 
Day to day management and supervision of 
data collection 
P 
HEWs - S 
S 
3 
Reporting unanticipated problems to the 
JHSPH IRB/Sponsor 
P 
 
S 

Page 22 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
4 
Hiring/supervising people obtaining 
informed consent and/or collecting data 
P 
HEWs - S 
S 
5 
Execution of plan for data 
security/protection of participant data 
confidentiality, as described in Sect. 5. 
P 
 
S 
 
COMPLETE THE FOLLOWING SECTIONS WHEN RELEVANT TO YOUR STUDY:  
 
XI.   Secondary Data Analysis of Existing Data: see above 
XIII. Creation of a biospecimen repository: N/A 
 
 
 
 
 
XIV. Data Coordinating Center:  N/A 
 
 
 
 
 
 
 
XV.  Drug Products, Vitamins, Food and Dietary Supplements:  N/A 
XVI.   Investigational Medical Devices:  N/A 
 
 
 

Page 23 of 23 
 
Ethiopia Comprehensive PPFP_ Pfitzer_IRB00007143 _V2_Oct 24, 2016  
 
Appendix 1. FP [and MNCH] Tasks by type of facility and cadre 
Level of facility 
Type of health 
personnel available 
FP Services* 
MNCH Services 
Health Post 
Health Extension 
Workers 
• 
Counsel on FP and other RH issues  
• 
Counsel on natural FP methods  
• 
Provide injectables  
• 
Insert Implanon  
• 
Refer to health center for other 
long-acting and permanent 
methods  
• 
Do planning based on local data 
• 
Limited ANC + 
Referral to Health 
Center 
• 
PNC 
• 
Immunization 
 
Health Center 
Health Officers (HOs), 
Midwives, Clinical 
Nurses, Public Health 
Nurses, Laboratory 
Technicians 
The above activities, plus:  
• 
Conduct general physical and 
pelvic examinations, including 
VIA/VILI  
• 
Insert and remove implants  
• 
Insert and remove IUCD  
• 
(Where a trained GMP/HO is 
available), provide tubal ligation 
and vasectomy  
• 
Manage complications and side 
effects  
• 
Provide syndromic management of 
STIs  
• 
Provide HCT, including care  
• 
Train community-level workers 
and junior health professionals in 
FP  
• 
Conduct monitoring and 
facilitative supervision 
The above activities, 
plus 
• 
Labor and delivery 
(BeMONC) 
Primary Hospital 
Non physician 
clinicians, GMPs, HOs, 
Midwives, Clinical 
Nurses, Public Health 
Nurses, Laboratory 
Technicians 
The above activities, plus:  
• 
Provide permanent methods of 
contraception  
• 
Receive referrals  
• 
Manage complications and side 
effects  
• 
Do work-ups for infertility 
The above activities, 
plus:  
• 
Caesarean section  
• 
Blood transfusion 
• 
Receive Referrals 
• 
Manage 
Complications 
• 
KMC 
General and Referral 
Hospitals 
Obstetrician-
Gynecologists, GMPs, 
HOs, Midwives, Clinical 
Nurses, Public Health 
Nurses, Laboratory 
Technicians 
The above activities, plus:  
• 
Manage infertility  
• 
Manage complicated STIs  
• 
Manage complications and side 
effects of contraceptive methods  
• 
Manage ROCs Perform research 
The above activities, 
plus: 
• 
Emergency 
obstetric and 
newborn referral 
service 
*Content on FP services taken verbatim from “National Guidelines for Family Planning Services in Ethiopia”, Federal 
Ministry of Health, 2011.