An Evaluation of the Effectiveness of a Maternal, Neonatal and Child Health Component for the Matasa Matan Arewa and Smart Start Interventions Targeting Married Adolescent Girls in Nigeria and Ethiopia
Phase: NA
Conditions: Pre-conceptual Care, Antenatal Care, Postpartum Family Planning, Adolescent Maternal Health
Sponsor: Population Services International

A360 Amplify MNCH Implementation Science Study Protocol 
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Principal Investigator  
  
Abednego Musau  
Senior Research and Learning Lead: PSI and A360 Amplify 
amusau@psi.org: +254 721 246450  
  
 In-Country Lead Investigator - Nigeria  
 
Roselyn Odeh  
Project Director: A360 Amplify Nigeria- SFH 
rodeh@sfh.org 
 
In-Country Lead Investigator - Ethiopia 
 
Bekele Belayihun  
 Director, Evidence and Learning: PSI Ethiopia   
bbelayihun@psiet.org   
 
Co-Investigators  
  
Erica Felker-Kantor 
Senior Research Advisor: PSI 
efkantor@psi.org  
Meghan Cutherell  
Senior Program Manager: PSI   
mcutherell@psi.org  
Alhaji Bulama 
Regional Learning Advisor: A360 Amplify Nigeria-
SFH 
abulama@sfh.org  
 

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Table of Contents .............................................................................................................................................. 2 
Acronyms ............................................................................................................................................................ 5 
Context ............................................................................................................................................................ 6 
objectives........................................................................................................................................................ 6 
Methods .......................................................................................................................................................... 6 
Time frame ..................................................................................................................................................... 9 
1.0 Background information ........................................................................................................................... 9 
1.1 Introduction ............................................................................................................................................. 9 
1.2 A360 Amplify ........................................................................................................................................ 11 
1.3 Description for the MNCH components ......................................................................................... 12 
1.4 Justification for the Research .......................................................................................................... 14 
1.5 Objectives ............................................................................................................................................. 15 
2.0 Methodology ............................................................................................................................................ 16 
2.1 Study design ......................................................................................................................................... 16 
2.2 Study sites ............................................................................................................................................ 17 
2.3 Study participant groups ................................................................................................................... 17 
2.4 Participant Recruitment ..................................................................................................................... 18 
2.4.1 Recruitment of married AGYW .................................................................................................. 19 
2.4.2 AGYW’s husbands in Nigeria ..................................................................................................... 21 
2.4.3 Health workers and mobilizers .................................................................................................. 21 
2.5 Capturing of Personal-identifying information (PII) for recruitment ......................................... 21 
2.6 Sample size estimation and sampling procedures ...................................................................... 22 
2.7 Data Collection procedures ............................................................................................................... 23 
2.7.1 Quantitative survey ...................................................................................................................... 23 
2.7.2 Qualitative component ................................................................................................................ 26 
2.8 Data Management .............................................................................................................................. 27 
2.8.1 Quantitative data .......................................................................................................................... 27 
2.8.2 Qualitative data ............................................................................................................................ 28 
2.8.3 Quality assurance ........................................................................................................................ 28 
2.9 Data Analysis ....................................................................................................................................... 29 

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2.9.1 Quantitative analysis ................................................................................................................... 29 
2.9.2 Qualitative analysis ...................................................................................................................... 29 
2.10 Data Outputs ...................................................................................................................................... 30 
2.11 Limitations .......................................................................................................................................... 31 
2.12 Dissemination and Data Use .......................................................................................................... 31 
3.0  Ethical Considerations .......................................................................................................................... 32 
3.1 Regulatory Requirements / Human Subjects Protection ............................................................ 32 
3.2 Risks and Mitigating Risks ................................................................................................................ 32 
3.3 Special considerations for gender-based violence (GBV) ........................................................... 33 
3.4 Benefits ................................................................................................................................................. 34 
3.5 Consent Process ................................................................................................................................. 34 
3.5.1 Married AGYW .............................................................................................................................. 35 
3.5.2 Adults ............................................................................................................................................. 35 
3.6 Management of consent documentation ....................................................................................... 35 
3.7 Confidentiality and Privacy ................................................................................................................ 35 
3.8 Subject Compensation ....................................................................................................................... 36 
3.9 Unanticipated Problems .................................................................................................................... 36 
4.0 Activity Plan .............................................................................................................................................. 37 
5.0 References ................................................................................................................................................ 38 
6.0 Appendices ................................................................................................ Error! Bookmark not defined. 
6.1 Recruitment scripts ............................................................................. Error! Bookmark not defined. 
Appendix A: Recruitment Script for Intervention Group -Structured SurveyError! 
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not defined. 
Appendix B: Recruitment Script for Comparison Group - Structured SurveyError! 
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not defined. 
Appendix C: Recruitment Script-Qualitative In-depth Interview (Married AGYW) ................ Error! 
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Appendix D: Recruitment Script-Qualitative FGD for Married AGYWError! 
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not 
defined. 
Appendix E: Recruitment Script for Husbands (Nigeria Only) ........ Error! Bookmark not defined. 
Appendix F: Recruitment Script for Health Workers and MobilizersError! 
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not 
defined. 
6.2: Information Sheets ............................................................................. Error! Bookmark not defined. 

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Appendix G (i): Information Sheet for Married AGYW – Structured SurveyError! Bookmark not 
defined. 
Appendix G (ii): Information Sheet for Married AGYW – FGDs ...... Error! Bookmark not defined. 
Appendix G (iii): Information Sheet for Married AGYW - IDIs ......... Error! Bookmark not defined. 
Appendix H: Information Sheet for Husbands (IDIs)- Nigeria OnlyError! Bookmark not defined. 
Appendix I: Information Sheet for Health Providers and Mobilizers (KIIs)Error! Bookmark not 
defined. 
6.3 Informed Consent Forms ................................................................... Error! Bookmark not defined. 
Appendix J (i): Informed Consent Script for Married AGYW (15-19 years - for Nigeria) and 15-
24 years – for Ethiopia) – Survey  ....................................................... Error! Bookmark not defined. 
Appendix J (ii): Informed Consent Script for Married AGYW (15-19 years - for Nigeria) and 15-
24 years - for Ethiopia) – IDIs ............................................................... Error! Bookmark not defined. 
Appendix K: Informed Consent Script for Married AGYW 15-24 years – FGDsError! Bookmark 
not defined. 
Appendix L: Informed Consent Script for Husbands –IDIs ............ Error! Bookmark not defined. 
Appendix M: Informed Consent Script for Health Workers and Mobilizers - KIIs ................ Error! 
Bookmark not defined. 
6.4: Other Documents ................................................................................ Error! Bookmark not defined. 
Appendix N: Demographic Information Form (for FGDs, IDIs and KIIS)Error! Bookmark not 
defined. 
Appendix O: Study Contact Cards ....................................................... Error! Bookmark not defined. 
Appendix P: Survey Enrolment and Tracking register ..................... Error! Bookmark not defined. 
Appendix Q: Confidential Recruitment List Template ...................... Error! Bookmark not defined. 
Appendix R: Table 1: Sample size estimates using different effect size scenarios. ........... Error! 
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Appendix Q: Participant Follow-up Script – Structured Survey for Married AGYW ............. Error! 
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Appendix T: Back -Check Script for the Structured Survey ............ Error! Bookmark not defined. 
Appendix U: Standard Operating Procedure for making phone calls for ALL study contacts
 .................................................................................................................... Error! Bookmark not defined. 
 
 

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A360 
Adolescents 360 
AGYW  
Adolescent Girls and Young Women   
ANC 
Antenatal Care 
ARI 
Autoregressive Correlation Structure 
CAPI  
Computer Assisted Personal Interview   
CSA 
Central Statistics Agency 
GEE  
Generalized Estimating Equations  
EDHS  
Ethiopia Demographic and Health Survey   
EMwA 
Ethiopia Midwives Association 
FGDs 
Focus Group Discussions 
HCD 
Human Centred Design 
HEWs  
Health Extension Workers   
ICF 
Inner City Fund 
IDIs 
In-depth Interviews 
IRB 
Institutional Review Board 
KII 
Key Informant Interviews 
KPIs  
Key Performance Indicators   
LFH 
Life Family and Health  
MIPCAs 
Male Interpersonal Communication Agents 
MMA 
Matasa Matan Arewa 
MNCH 
Maternal, Newborn, and Child Health 
NPC 
Nigeria Population Commission  
PHC 
Primary Health Centres 
PSI  
Population Services International  
QuIP 
Qualitative Impact Protocol  
REB 
Research Ethics Board 
SNNP  
Southern Nations and Nationalities of Peoples   
SRH  
Sexual Reproductive Health   
SSN 
Smart Start Navigators 
TOC  
Theory of Change   
UNFPA 
United Nations Family Planning Agency 
WDA 
Women Development Army 
WHO 
World Health organization 
PII 
Personal Identifying Information  
 

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Population Services International, Inc. (“PSI”) implements A360 Amplify in Nigeria, Kenya, and 
Ethiopia. A360 Amplify has developed innovative and unique interventions for each geography to 
support adolescent girls to access voluntary modern contraception according to their needs and 
preferences. As part of the current project phase, A360 completed the design of a maternal, 
neonatal and child health (MNCH) component in 2023 that will be layered on Matasa Matan Arewa 
(MMA) in Nigeria and Smart Start interventions in Ethiopia. The intervention components will target 
married adolescent girls 15-19 in both countries with an expansion to include 20-24 years old in 
Ethiopia. There is paucity of evidence on the effectiveness of upstream interventions at creation 
demand and access to antenatal care (ANC) among adolescent girls and young women (AGYW) 
from the regions where A360 operates. Consequently, parallel to the implementation of these two 
components, A360 has designed an evaluation to determine the effectiveness of these 
components in improving the comprehensive knowledge of what is needed to pursue healthy 
pregnancies, increase girls’ self-efficacy to access ANC and increase support from their key 
influencers to pursuing healthy pregnancies.  
The main objective of this evaluation is to determine the effectiveness of MNCH intervention 
components leveraged existing A360 interventions at increasing comprehensive knowledge, self-
efficacy and key influencer support to pursue healthy pregnancies among married AGYW in Nigeria 
and Ethiopia. The secondary objectives of the evaluation are: (a) to evaluate the component’s 
effectiveness at increasing comprehensive knowledge of what care is required to attain healthy 
pregnancies, (b) to evaluate the component’s effectiveness at increasing self-efficacy to attend 
ANC and (c) to determine the component’s effect at eliciting support  from AGYW’s key influencers 
when they are pursuing healthy pregnancies and (d) to surface the system-level barriers, 
facilitators, and opportunities for program improvement during the implementation of the 
intervention components.  
The MNCH component is implemented in the same geographies where MMA and Smart Start are 
implemented in Nigeria and Ethiopia. In Ethiopia, Smart Start is implemented in Oromia, Sidama, 
SNNP, Amhara and South-Western. In Nigeria MMA is implemented in four states (Kaduna, 
Nasarawa, Jigawa and Kano. In Nigeria the MNCH component will be implemented in Jigawa and 
Kaduna, while the South-Western region in Ethiopia will be avoided. Selected woredas and local 
government areas will host the MNCH component, and these locations will host the MNCH 
intervention. The evaluation will use an implementation-effectiveness hybrid design, blending an 
outcome evaluation and an implementation science component. The outcome evaluation will 
constitute of a quantitative survey using a longitudinal approach with two study arms, an 

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intervention, and a comparison arm. It will have three assessment timepoints; a recruitment phase, 
and two follow-ups (3 months after baseline and 8 weeks post-partum (only for pregnant AGYW). 
Follow-ups will be conducted three months after recruitment and eight weeks after the expected 
date of delivery (for pregnant girls only). The sample size will be 545 participants for the 
intervention and 545 for the comparison arm for each country . In Ethiopia, an additional 240 
participants will be recruited (specifically those who are pregnant) to cover for a deficit that 
occurred in the just completed recruitment in four regions – Central Ethiopia, South Ethiopia 
(previously called SNNPR), Sidama and Amhara). From these regions, we recruited 683 
participants - data collection is pending in the Oromia region. For the approved sample of 1,090 
participants in Ethiopia (we intended to have 70% of the sample as pregnant girls i.e., 382/545 in 
each group adding up to 764/1,090 for each country. Out of the 683 participants already recruited, 
238 were pregnant (34.8%) against 478 who were expected - a deficit of 240 participants. The rest 
(445) were non-pregnant. If we maintain the 30% rate to be non-pregnant girls, we should have 
recruited 205 (30%) pregnant girls, so we exceeded the sample for non-pregnant girls by 240 
cases. This is the same as the deficit for pregnant girls. Following the current trend, we will not be 
able attain the projected sample size for pregnant girls. Although we are implementing strategies 
to ensure data collection in Oromia does not violate the projected ratio but that will not even up 
the deficit that has occurred for the completed regions. The failure to attain the projected sample 
for pregnant girls means that we will lose statistical power and therefore be unable to perform a 
robust sub-analysis for the ANC and post-natal outcomes which only pertain to them. To preserve 
the power for this sub-analysis, we propose to recruit 240 additional participants on top of the 
1,090 approved for Ethiopia so that we are able to reach the 763 pregnant participants that had 
been planned.  
These computations are summarized in the schema below 
Attained sample  # Pregnant 
# 
Non-
pregnant 
Expected 
pregnant 
sample (70%) 
Deficit (F-D)) 
Current ratios of 
pregnant 
AGYW
by region 
Amhara  272 
88 
184 
190 
102 
51% 
CE 
139 
34 
105 
97 
63 
48% 
Sidama 
136 
76 
60 
95 
19 
61% 
SE 
136 
40 
96 
95 
55 
50% 
683 
238 
445 
478 
240 
 
The proposed additional participants will be drawn from the same woredas where participants 
were initially recruited, though new but from adjacent kebeles might be required in case adequate 
sample is not generated from the recruitment from the initial kebeles. An exception to the woredas 
is Tehuldere in Amhara where we have selected a complementary intervention woreda (Nineth) 
because after attempting to recruit participants from multiple kebeles, the recruitment yield was 
extremely low. Anecdotal reports suggest that there are existing MNCH programs in the woreda 

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which have been supporting women to adopt contraceptives and MNCH interventions. Since our 
eligibility criteria is AGYW who are not using a contraceptive method and who have not started 
ANC, this implies that it might not be feasible to recruit the desired sample from the same woreda 
even after exhaustively recruiting participants from all kebeles in the woreda. The total sample size 
for the survey therefore increases from 2,180 participants to 2,420 participants – 1,090 in Nigeria 
and 1,330 in Ethiopia. These numerical adjustments only affect the excess sample for non-
pregnant girls since sample for pregnant girls that had been projected is preserved – we are 
topping up to maintain the earlier projection. In both countries, participants in the comparison arm 
will receive services as is expected based on the Ministry of Health guidelines in Ethiopia and 
Nigeria. Therefore, this group will be a partial control group.  
For the implementation science component, we will employ eight (8) focus group discussions 
(FGDs) and 48 semi-structured in-depth interviews (IDIs) with AGYW, 10 IDIs with husbands 
(Nigeria only) and 35 key informant interviews (KIIs) with providers and mobilizers (female 
mentors, ANC providers and male interpersonal communication agents- MPICAs). The 
participants will be shared equally between Ethiopia and Nigeria except MIPCAs who will only be 
from Nigeria. All the FGDs, IDIs and KIIs will be conducted with individuals who have been involved 
in the MNCH components. The qualitative impact protocol (QuIP) approach will guide the 
execution of this component. It will be conducted mid-way through the implementation of the 
intervention. Participant recruitment will be conducted using recruitment scripts after obtaining 
oral consent and the administration of a set of screening questions to assess eligibility. Full 
consenting procedures will be conducted, and written consent obtained prior to involvement in any 
of the evaluation components. A structured questionnaire will be used to gather quantitative data 
from the survey using a Computer Assisted Personal Interview (CAPI) approach. Furthermore, 
FGD, IDI and KII facilitation guides will be used to gather qualitative data and all sessions will be 
audio-recorded. Audio records will be transcribed verbatim and translated. Data will be collected 
by trained enumerators certified to conduct human subjects’ research through Viable Knowledge 
Masters (VKM) in Nigeria and Deep Dive Research and Consulting Inc who have been contracted 
as local research partners (working as consultants) in Nigeria and Ethiopia respectively.  
Analysis of quantitative data will follow a repeated measures approach using Wald Z-test 
employing generalized estimating equations. The repeated measurements of each subject will be 
made at two times and using an autoregressive correlation structure. Between group t-tests and 
chi-square tests of comparison will be conducted to identify secondary outcomes which show 
statistically significant differences between the intervention and comparison groups. The 
qualitative data transcripts will be rigorously analyzed using NVivo or Dedoose. Open-coding and 
closed-coding will be utilized to identify themes in the qualitative data. Claim statements 
attributing change to key intervention drivers will be drawn from narrative stories of program 
beneficiaries guided by the intervention’s theory of change.  
The evaluators will seek ethical approvals from Ethiopian Midwives Association (EMwA) 
Institutional Research Ethics Review Board (IRB) and the PSI Research Ethics Board (REB) prior to 
the enumerators training and field data collection. The IRB approval letters will be submitted to 

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Oromia, Sidama, Amhara and SNNP Regional Health Bureaus and the Kaduna and Jigawa state 
health departments for their reference and support in the management of the field work.  
The evaluation is expected to take twelve months from August 2023 to August 2024.  
Adolescent pregnancy remains a major global health challenge. Annually, 21 million adolescent 
girls conceive, a majority of these in low and lower middle-income countries. Conception during 
adolescence is highly prevalent such that one in every three women will have had their first 
pregnancy by their twentieth birthday. Further, half of these adolescent pregnancies occur before 
the age of seventeen(United Nations Family Planning Agency (UNFPA), 2022).  It is estimated that 
nearly half of girls who conceive before adulthood will have a repeat birth by the time they exit 
adolescence, further doubling the risks associated with pregnancy at this age. Pregnancies 
occurring at this age are associated with multiple health, developmental and socio-economic 
consequences for the adolescent girl, their family and communities (World Health Organization 
(WHO), 2020). The leading causes of adolescent pregnancy include early marriage, gender and 
sexual violence, poverty, limited educational and employment opportunities, and underutilization 
of contraceptives due to various individual, cultural and health system barriers(WHO, 2020). 
The consequences of adolescent pregnancy are diverse. Pregnancy and childbirth are a leading 
cause of morbidity and mortality among adolescent girls. In 2021, maternal conditions were the 
fourth leading cause of disability-adjusted life years and the second leading cause of mortality 
among adolescent girls 15-19(UNFPA, 2023). The negative health consequences of teen 
pregnancies include pregnancy complications (pre-eclampsia, unsafe abortion, anaemia, maternal 
depression), birth complications (pre-term birth, obstructed labour, obstetric fistula), post-partum 
complications (post-partum haemorrhage, puerperal sepsis, neonatal death, low birth weight 
neonates and postpartum depression) and death. Further, pregnancy at adolescence is associated 
with multiple socio-economic outcomes such as discrimination, rejection, social isolation, school 
discontinuation and economic deprivation(Huda et al., 2022). Despite the recognition of these 
consequences and the need to careful monitoring and care needed during pregnancy, most 
pregnant girls receive poor health care. Fewer pregnant girls, compared to their older counterparts, 
initiate ANC, make the recommended number of ANC visits, receive high quality ANC care, are 
supervised during birth by a skilled health worker or receive postpartum care(UNFPA, 2023). There 
is growing global attention for health systems to make strategic investments to avert teen 
pregnancies and to deliver high quality, user-friendly and timely interventions for the adolescent 
girls who conceive.  
Motherhood is a key aspiration for most women including those in adolescence. In patriarchal 
societies, where early marriage is common, girls are expected to begin childbearing immediately 

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after their marriage to prove their fertility. At this age, married adolescent girls lack comprehensive 
knowledge about pregnancy and childbirth, and have limited agency and decision-making power 
to determine what is the best care for them(Ricker & Ashmore, 2020). Delivering high quality and 
timely antenatal care (ANC) is a crucial intervention that could avert most of the risks associated 
with adolescent pregnancy(Hackett et al., 2019). Initiating ANC in early pregnancy provides health 
workers an opportunity to perform health promotion and education, conduct risk assessment and 
action, and monitoring and timely management of pregnancy complications. Yet ANC outcomes 
for pregnant adolescents are wanting. Studies have documented various reasons why ANC 
attendance is poor for adolescent girls(Hackett et al., 2019; Pell et al., 2013; Sewpaul et al., 2022). 
These include health system factors such as the tense relationships with providers, the low level 
of service quality, and long distances to health facilities; social factors such as level of support 
from the male partner and community norms; and individual factors such as age, level of 
education, autonomy, knowledge of the importance of ANC, place of residence, financial factors, 
pregnancy disclosure, parity and marital status(Sewpaul et al., 2022). Holistically addressing the 
factors influencing the timing, consistency and completeness of ANC attendance and improving 
the quality and user-centredness of ANC for adolescent girls using a socio-ecological model could 
improve 
the 
pregnancy 
outcomes 
for 
pregnant 
teens 
and 
reduce 
the 
avoidable 
complications(Mweteni et al., 2021).  
Several interventions have been trialled to increase demand for, utilization and completion of ANC 
among adolescent girls who are pregnant. These include group ANC(Teasdale et al., 2022; 
Vandermorris et al., 2021) and home visits by community health workers(Esopo et al., 2020). 
Findings from these studies has shown a promising outlook on the interventions’ ability to increase 
ANC adherence, reduce the gestational age at first ANC attendance, improve the satisfaction with 
ANC services and skilled attendance at birth(Esopo et al., 2020). Yet not all expected outcomes 
from these interventions were attained and only two of the five studies in a systematic review of 
interventions to increase ANC adherence showed positive results. Group ANC has shown good 
results at increasing the awareness of at least three pregnancy danger signs among pregnant 
adolescent girls(Vandermorris et al., 2021). In a separate study conducted in Kenya, nutritional and 
health knowledge relevant to pregnant women were not substantially different between ANC and 
non-ANC attendees (Nandita. et al., 2013). In a similar study in Tanzania, only 40.2% of women 
were knowledgeable on the danger signs of pregnancy(Massenga et al., 2023). A study in 
Indonesia demonstrated good results of a trial to increasing knowledge across the pregnancy 
continuum (Nuraini & Parker, 2005).  
Although intervening to increase demand and timeliness of initiating ANC, doing so in the pre-
conceptual period, when girls and their partners are considering to conceive offers the most 
opportune window to create awareness of what things they need to do to attain a healthy 
pregnancy. This would include what health issues can affect fertility, the desired nutritional 
behaviours and the signs and symptoms of pregnancy. This would also alert the couple on what 
things are expected in early pregnancy including access to early ANC. Intervening prior to 
conception is important, because it provides health workers an opportunity to screen health risks 

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that could prevent conception, but also those which could negatively affect pregnancy outcomes. 
Despite the recognition of the value of pre-conceptual interventions, there is huge gap of evidence 
on what interventions would work for adolescent girls at risk of pregnancy to increase demand of 
and relevance of ANC. First, interventions in this period are less prioritised by health systems and 
providers. Second, when such interventions exist, they vary widely between geographies with very 
few of these in developing countries and interventions not being tailored to the needs of adolescent 
girls. This was affirmed by a scoping review conducted in 2017 which demonstrated that only 6 of 
the 27 studies on preconceptual interventions were conducted outside of the United States, only 
one in Lebanon (Hemsing et al., 2017). Although, most of the interventions demonstrated 
improvement in preconceptual knowledge, change in dietary habits and use of folic acid, none of 
the studies tracked the impact of the interventions on ANC outcomes, when pregnancy occurred.  
The lack of adolescent-specific evidence and the recognition of the number of teen pregnancies in 
Africa, does present a valid opportunity for programmers to design, implement and evaluate pre-
conceptual and early pregnancy interventions to document their impact on ANC, maternal and 
neonatal and post-partum outcomes. Since late 2012, Population Services International (PSI) and 
its consortium partners, with funding from Bill & Melinda Gates Foundation, employed human 
centred design (HCD) techniques to design a user-centered intervention component targeting 
married adolescent girls in northern Nigeria and Ethiopia under the A360 Amplify project. This 
component would be layered on two signature aspirational sexual and reproductive health 
interventions, Smart Start for Ethiopia and Matasa Matan Arewa (MMA) for northern Nigeria. These 
interventions have shown promising results at increasing demand for and uptake for voluntary 
modern methods of contraception and counselling services in primary care outlets among married 
adolescent girls.  
A360 amplify stands for Adolescents 360 Amplify. Adolescents 360 (A360) was a blueprint project 
led by PSI since 2016 and 2020. It was implemented in Nigeria, Ethiopia, and Tanzania and 
employed HCD and alongside other public health disciplines to develop four interventions, each 
suited for a unique geographic region in these countries: Kuwa Mjanja for Tanzania, Smart Start 
for Ethiopia(Meghan Cutherell; Claire Cole, 2019), 9Ja Girls for southern Nigeria and MMA for 
northern Nigeria. A360 used adaptive implementation to steward implementation targeting 
adolescent girls in the four geographies. By the end of the investment, the interventions had 
reached over 600,000 girls with information on contraceptives and over 420,000 girls had adopted 
a modern method of contraception. Following this success, the A360 donors, Bill & Melinda Gates 
Foundation and Children’s Investment Fund Foundation funded a follow-on investment A360 
Amplify that runs between 2020 and 2025. Kenya was added as a fifth geography. This phase 
seeks to adapt the interventions to provide an expanded package of services that meet the needs 
and aspirations of the girls more wholistically. This expanded package included a component on 
economic strengthening that equips girls with technical and vocational skills to plan, and 
implement income generating activities to increase earnings, savings and increase their 
contribution to household expenses as well as increase their economic autonomy.  

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Additionally, the interventions in Ethiopia and northern Nigeria would be expanded to include a 
maternal and child health component that would target adolescent girls at risk of pregnancy, those 
actively trying to conceive and those in early pregnancy, with a component to stimulate demand 
for preconceptual care and ANC. Between November 2021 and May 2023, design teams in Nigeria 
and Ethiopia engaged married adolescent girls, their spouses, mothers in law, mothers, health 
providers and managers and community mobilisers to co-create these components. The 
component for northern Nigeria is called the Expanded MMA and that in Ethiopia is called Smart 
Pathways.  
Expanded MMA with MNCH 
In northern Nigeria, MMA is supported through the Society for Family Health and is implemented 
through primary care centres (PHCs) in four states: Kaduna, Nasarawa, Jigawa and Kano. MMA 
targets married adolescent girls who are mobilized through trained female mentors who directly 
engage girls in the communities and link them to MMA-supported PHCs. Additionally, trained male 
interpersonal communication agents (MIPCAs) engage men in spots where they congregate to 
illustrate the value of birth spacing to attaining good health of the mother and the child. Men who 
express interest in birth spacing are given referral cards to give to their wives, who walk into PHCs 
to receive counselling and services. At the PHCs girls receive services directly through a trained 
youth-friendly provider and could participate in life, family and health (LFH) classes. LFH consists 
of four guided mentorship sessions conducted over a four-week duration convened by trained 
mentors. During these sessions girls receive information including nutrition, child spacing, 
interpersonal communication, financial management and gains life and vocational skills(Sarah. et 
al., 2021).  
The MNCH component for MMA is built on the LFH classes. Girls who are at risk of pregnancy and 
who don’t want to use a method of contraception or who suspect that they are pregnant are 
mobilized by female mentors or through their husbands to attend LFH sessions at PHCs. Those 
who walk in to receive services are offered the services directly and introduced to the LFH classes. 
The sessions take two hours, are moderated by trained female mentors and attended by ANC 
experts (trained providers) who offer information and counselling on attaining health pregnancies. 
MIPCAs facilitate community sessions with men whose wives (15-19) are pregnant and refer them 
to access ANC services. All mobilized girls who test positive for pregnancy undergo routine ANC, 
enhanced with gestational age-specific messages about the expectations of ANC, birth 
preparedness, nutrition during pregnancy, danger signs and how to avoid them and postpartum 
family planning (PPFP).  
Smart Pathways  
This component is layered on Smart Start. Smart Start targets married adolescent girls 15-19 and 
their spouses in Ethiopia in five regions: Oromia, Amhara, SNNPR, Sidama and South Western. 
Smart Start is implemented as part of the national Health Extension Program (HEP) through health 

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posts. Using a Smart Start discussion guide called a ‘goal card’ health extension workers (HEWs) 
engage married adolescent girls alone or with their husbands to discuss how the use of modern 
contraceptive methods to plan their families can facilitate financial planning and enhance the 
financial security of their families. This seamlessly creates relevance of contraceptives within a 
context where a direct conversation on modern contraceptives would be difficult. Smart Pathways 
(the MNCH component) is an expansion of Smart Start. Unlike Smart Start, it targets AGYW 15-24. 
In the communities, a team of trained FMOH-recognized community mobilizers consisting of 
members of the women development army (WDA) and Smart Start Navigators (SSNs) approach 
married adolescent girls from their communities and introduce them to Smart Start. Married girls 
who express interest to take up birth spacing are linked to HEWs who are working in the 
community or at health posts to receive the Smart Start intervention (pathway 1).  
For girls who are ambivalent to receiving contraceptive counselling and services or those who 
intend to conceive soon, the trained mobilizers link them to an HEW who takes them through the 
Smart Pathways component for non- pregnant girls. When they land at the HEW, the HEW uses 
the Smart Pathways guide to discuss issues related to Preconception Care Counselling and early 
ANC initiation (pathway 2). For girls who have missed their periods or suspect that they are 
pregnant, the trained mobilizers link them to health centres or health posts where HEWs or 
midwives take them through a seven-step process that covers pregnancy testing, building demand 
for ANC, the benefits and components of ANC, danger signs of pregnancy, smart nutrition, 
preparation for delivery and post-partum family planning (pathway 3). Girls in Pathway 2 who 
conceive are referred to navigate through pathway 3 when that time comes. The three pathways 
are illustrated in Figure 1.  
As married pregnant AGYW navigate through ANC, they are offered services based on the Ethiopia 
Federal Ministry of Health antenatal care guidelines (Ministry of Health of Ethiopia, 2022).  

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Figure 1: Smart Steps pathways 
 
Ethiopia and Nigeria have poor MNCH indicators particularly regarding to adolescents, although 
older women are not spared either. According to Ethiopia Mini Demographic Health Survey 
(EMDHS) of 2019, among women 15-49 years old who had a live birth in the five years preceding 
the survey, 74% had at least one ANC visit and only 43% attended four or more ANC visits. The 
rates of ANC attendance were lower among women under 20 years (Ethiopian Public Health 
Institute & ICF, 2019). Earlier in the 2015 EDHS, the median age at first ANC visit was 4.7 months 
and only 20% of women had started ANC by the gestational age of 20 weeks. In that same survey, 
among women 15-49 years who had a live birth in the past five years, 45% were informed of danger 
signs or pregnancy complications during ANC visit, 56% were informed about birth preparedness 
and 11% were informed of the place of birth during ANC. Four in five women 15-49 years who had 
birth in two years before survey did not have a postnatal check-up within 48 hours of delivery(CSA 
and ICF, 2016). 
In Ethiopia, early marriage is common since 17% of adolescent girls aged are married. Teen 
marriage increases to 60% among 20-24-year-old women. Among currently married girls 15-19 
years, 42% have at least 1 living child. Among girls 15-19 who had a live birth or pregnant at time 
of survey, 13% had started childbearing, 10% had birth, and 2% were pregnant. In the 2015 EDHS, 

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among girls under 20 years who had a live birth in past 5 years, 33% had no ANC visit. Further, 
among girls 15-20 years who had ANC for the most recent live birth in the past five years, 60% 
received nutritional counselling, 68% had a blood sample and 66% had urine collected while 68% 
had a blood pressure check. Among the same cohort of girls who had received ANC in the most 
recent live birth in past 5 years, 38% were informed of pregnancy complications and 50.5% were 
informed about birth preparedness. Further, among girls 15-20 years with live birth in past 5 years, 
67% had a home delivery while 87% had no postnatal check within 48 hours of delivery (among 
those with live birth in past 2 years)(CSA and ICF, 2016). According to the survey, the main barriers 
to accessing ANC among girls 15-19 years are lack of financial resources (51%), long distance to 
health facility (47%), not wanting to go home alone (44%), and the need for permission (33%). 
Overall, 68% reported to experience at least one problem in accessing ANC.  
For Nigeria, among women 15-49 who had a live birth in five years preceding the 2021 Malaria 
Indicator Survey (MIS), 76.3% had at least 1 ANC visit and 51.5% had four or more ANC visits. The 
first ANC visit happened between 4-5 months of gestation; the median was 4.7 months (National 
Population Commission- NPC, 2021). In the 2018 Nigeria Demographic Health Survey, among girls 
who had at least 1 ANC visit for most recent birth, 94% had blood pressure checked, 86% provided 
urine sample, and 88% also had a blood sample collected. Among this age group, 39% of women 
delivered their most recent birth at a health facility and only 42% of women who gave birth in past 
two years had postnatal care within 48 hours of delivery (NPC, 2021. Specifically for adolescent 
girls 15-19 years in 2018, 19% of girls had started childbearing; 14% had given birth, and 4% were 
pregnant. In the 2021 MIS, among girls who had a live birth in the five years preceding the survey, 
35.2% of girls had not received ANC, only 44.7% received ANC from a skilled service provider 
(compared to >63% for older women), most girls (63.1%) attended under four ANC visits, and 
median gestational age for first ANC visit was 4.9 months (NPC, 2021). In the 2018 NDHS, 70% of 
births among girls 15-19 years occurred at home. Further, 64% of girls below 20 years had no 
postnatal check-up within 48 hours of delivery. The main barriers reported for girls 15-19 seeking 
ANC were lack of financial resources (44%), long distance to the facility (25%), not wanting to go 
alone (22%) and the need to secure permission (14%)(NPC & ICF, 2019).  
The disproportionately low uptake of ANC by pregnant adolescent girls, delayed initiation of ANC 
and poor adherence to ANC guidelines in Nigeria and Ethiopia warrant that an adolescent-friendly 
intervention that creates a value proposition for adolescents at risk or intending to conceive. 
Further, the paucity of evidence on what interventions or strategies work to increase access to 
preconceptual counselling by adolescents intending to conceive and promote ANC among 
adolescent girls at risk of pregnancy invites for thorough investigation of any interventions 
targeted at this age group. This evaluation is poised to employ mixed methods to document the 
outcomes of the intervention and uncover implementation barriers, facilitators, and opportunities 
for institutionalization within existing health systems.   

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The main objective of this evaluation is to determine the effectiveness of MNCH intervention 
components leveraged on existing A360 interventions at increasing comprehensive knowledge, 
self-efficacy and key influencer support to pursue healthy pregnancies among married AGYW in 
Nigeria and Ethiopia.  
The secondary objectives of the evaluation are:  
(a) To evaluate the component’s effectiveness at increasing comprehensive knowledge of 
what care is required to attain healthy pregnancies. 
(b) To evaluate the component’s effectiveness at increasing self-efficacy to attend ANC.   
(c) To determine the component’s effect at eliciting support from AGYW’s key influencers 
when they are pursuing healthy pregnancies.  
(d) To surface the system-level barriers, facilitators, and opportunities for program 
improvement during the implementation of the intervention components.  
Apart from fulfilling the objectives above, this evaluation will also be used to generate indicator 
values (baseline and follow-up) for the results framework, that are submitted to the donor. Specific 
questions have been uniquely crafted to address these needs. The results framework that has 
been agreed with the donor is included as Appendix V in this protocol.  
This evaluation will use an effectiveness-implementation hybrid study design so that we are able 
to evaluate the impact of the intervention in real-world settings (i.e., effectiveness) and to assess 
best approaches to implement the intervention (implementation research). This approach has 
been established to accelerate the translation of evidence into practice and to increase the 
usefulness and relevance of research findings for policy decisions(Curran et al., 2012). The hybrid 
design will employ mixed methods consisting of a quantitative survey, routinely collected program 
data and qualitative data. A similar approach was used to evaluate group ANC for adolescent girls 
in Senegal(Vandermorris et al., 2021). For the implementation research element, the qualitative 
impact protocol (QuIP) approach will be employed alongside traditional qualitative methodologies. 
To use this approach, independent qualitative researchers who are not familiar with the 
interventions’ theory of change or who have limited knowledge of the expected changes from the 
intervention perform exploratory interviews with the beneficiaries to document change stories 
highlighting what might have contributed to the most significant change in their lives. This reduces 
the bias associated with an inquiry that focuses on the change specifically brought about by the 
intervention where beneficiaries might intentionally or unintentionally attribute change to an 
intervention even when those changes were caused by other factors. This approach involves the 
use of open-ended and exploratory tools starting with the expected changes and rolling back to 
associate these with activities that were happening prior to the evaluation(Copestake et al., 2019). 
The QuIP methodology with be conducted parallel to the quantitative survey and routinely collected 
program data to triangulate the findings.  

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Routinely collected data will constitute aggregated data abstracted from program records 
employed by mobilizers during field activities, the ANC and family planning facility registers 
maintained by the health extension workers and health providers and monthly reporting tools at 
the facilities. The registers used in our study will be those approved by the Ministries of Health in 
the two countries. This element is not detailed in this protocol because it is non-research.  
This study will be conducted in Ethiopia and in Nigeria. It will constitute an intervention and a 
comparison group. In Nigeria the study will be conducted in two states i.e., Kaduna and Jigawa. 
For the intervention group, the study will be conducted in the specific LGAs where the MMA 
program enhanced with the MNCH component is implemented. For the comparison group, the 
study will be conducted in LGAs implementing MMA without the MNCH component. At the LGAs, 
the study will be conducted in specific PHCs which have been purposely selected to host the 
evaluation and the catchment areas that are served by the PHCs.  
In Ethiopia, the study will be implemented in four out of the five regions that implement the Smart 
Start interventions (avoiding the South Western region which started implementing Smart Start in 
2023). Specifically, the intervention group will be based in nine (9) woredas in the four regions 
where Smart Start with Smart pathways is implemented. The comparison group will be based in 8 
woredas geographically distant from those offering Smart pathways but offering Smart Start. In 
Ethiopia, the evaluation will be conducted in health centres and health posts that offer 
comprehensive ANC services.  
For both Nigeria and Ethiopia, comparison areas will be locations implementing the current MMA 
or Smart Start intervention without the MNCH component. These will be carefully selected to 
ensure they match the intervention locations in terms of the demographics of married adolescent 
girls and based on the economic and health indices. Because of comparing the intervention 
outcomes against the current package of interventions, this study will ideally be measuring the 
incremental effectiveness of the expanded interventions and not with a counterfactual (as would 
have been if the comparison was done against routine government-led MNCH components).  
The primary target group for this study will be married AGYW aged 15-19 years from the two states 
in Nigeria and 15-24 years who reside in four regions in Ethiopia. Given that this study explores the 
experiences of AGYW related to planning for pregnancy and experiencing pregnancy, birth and the 
postpartum periods, the study will work to recruit a mix of married AGYW who have both 
experienced a prior pregnancy and those who have not (but at risk of pregnancy).  
The secondary target groups for this study will include: 
i. 
Male partners (husbands) of married AGYW who have received the MNCH intervention in 
Nigeria 
ii. 
Health providers and community health mobilizers from the intervention locations 

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All husbands, health providers and community mobilizers will be over the age of 18 years. The 
inclusion and exclusion criteria for all groups are provided in Table 1.  
Table 1: Inclusion and exclusion criteria 
Group 
Inclusion 
Exclusion 
Married 
AGYW 
(survey) 
• 
Aged 15 to 19 (Nigeria) and 15-24 (Ethiopia)  
• 
Married 
• 
Resident in a study site 
• 
If pregnant should be at most 24 weeks 
gestation 
• 
If not pregnant, at risk of pregnancy (not 
using a contraceptive method at the time of 
the survey with or without intend to 
conceive) 
• 
Consent to participate in the study 
• 
Married AGYW, aged 15-
19 (Nigeria) or 15-24 
(Ethiopia) who decline to 
give consent 
• 
If pregnant, has an 
advanced pregnancy (≥ 
25 weeks gestation) 
• 
If not pregnant, currently 
using a contraceptive 
method  
Married 
AGYW (FGDs 
and IDIs) 
• 
Married and aged 15 to 19 (Nigeria) and 15-
24 (Ethiopia) 
• 
Currently pregnant or in the post-partum 
period (after recent delivery)  
• 
Participated in the full MNCH components 
of MMA or Smart Start  
• 
Consent to participate in the study 
• 
Married AGYW aged 
under 15 or over 19 
(Nigeria) or over 24 
(Ethiopia) 
• 
Not pregnant or not in 
post-partum period 
• 
Did not participate in 
MNCH component 
• 
Decline to consent 
Husbands of 
AGYW 
(Nigeria only) 
• 
Male aged 18 years and over 
• 
Husband of an AGYW aged 15 to 19 
• 
Has participated in husband sessions (at 
the community or facility) of the MNCH 
component 
• 
Consent to participate in the study 
• 
Males under 18 years 
• 
Did not participate in the 
husband sessions for 
the MNCH component 
• 
Husband who decline to 
give consent 
Health 
worker / 
community 
health 
mobilizer 
• 
Employed as a health worker (can be nurse, 
midwife, etc.) or mobilizer (female mentor, 
member of WDA or MIPCA) within the study 
site. 
• 
Served at the facility or community for this 
role for six or more months. 
• 
Provides services along the MNCH 
continuum of care (e.g., ANC, delivery, 
PPFP, etc.) 
• 
Recently employed 
health worker or 
mobiliser (< 6 months)  
• 
Not familiar with MNCH 
or FP services  
• 
Unwilling to consent  
The following section outlines how each group will be recruited to participate. The recruiters’ role 
will be to invite potential participants to the evaluation, briefly assess eligibility and to seek their 

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permission to share their contact details with the research team. They will be guided by a 
recruitment script (see Appendices A-F) so that the procedure is standardized. The recruitment 
procedures for each study group are detailed in the sub-sections below. 
2.4.1 Recruitment of married AGYW 
Different recruitment procedures will be used for the Quantitative survey and the Qualitative 
component.  
(i) For the quantitative survey in both Nigeria and Ethiopia, the research team will leverage 
already existing trained mobilizers (female mentors in Nigeria & members of WDA and female 
SSNs) to perform recruitment procedures. The mobilizers will be trained to identify and recruit 
AGYW from the community guided by a recruitment script. The mobilizers in Nigeria and 
Ethiopia are familiar with their communities and will approach potential participants directly 
by face-to-face contact during their routine household visits, in clinics and/or during 
community gatherings.  
When a mobilizer approaches a married AGYW, she will ask her for verbal consent to speak to 
her in private. She will ask her the four screening questions (in the recruitment script) after 
providing brief details about the nature of the evaluation. If the potential participant is eligible 
and has expressed interest to participate, the mobilizer will obtain the contact details (name, 
phone number and details of residential address) and record these in a recruitment confidential 
contacts’ list (Appendix Q attached to the submission). Details of residential address are 
collected because a substantive number of AGYW in these locations might not own or have 
access to a phone as reported in recent surveys – 40.2% in Ethiopia and 6-21% in northern 
Nigeria (Krug et al., 2021a, 2021b). These lists will be passed to a data collector (research 
assistant) working in the study locality on a daily basis. The AGYW will also be notified that 
they should expect a call or a visit from a female enumerator at a future date. During the period 
when we execute a modification to increase the number of pregnant girls in Amhara, South, 
and Central Ethiopia and Sidama, recruiters will only identify, approach and invite pregnant girls 
only. To do so, they will be trained not to field the screening question on contraceptive use 
(question 3) in the recruitment script - the rest of the procedures and questions will be fielded 
as they are. During this period, they will only capture contact details of eligible pregnant girls in 
the confidential recruitment contact lists. 
Trained enumerators will employ these lists to contact potential participants to provide more 
information about the study guided by the information sheets (attached to the submission) 
and to set an appointment date for the interview (if contact is on phone). If the AGYW listed 
does not have a phone contact, the call is unanswered or the call doesn’t go through, the data 
collector will arrange to pay a physical visit to the AGYW’s residence to make an in-person 
contact. Upon arrival at the residence, the data collector will introduce herself and request to 
speak to the AGYW, without directly disclosing reproductive health. During the visit, the data 
collector will offer brief information about the study. If the AGYW is willing and available for the 
interview at that time, she will continue and perform consenting procedures then conduct the 
interview if consent is granted. This will make it convenient for the participant and the study. 

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However, if the AGYW is unavailable for the interview on during that visit date and time, an 
appointment will be scheduled.  
For the AGYW with an appointment, on the date of the scheduled interview the research team 
will provide detailed information and obtain informed consent form. Thereafter, the data 
collector will perform the interview. For recruitment in the Oromia region only, enumerators will 
be assigned quotas (numbers of pregnant versus non-pregnant girls) to survey from a health 
post. As they continue to consent participants and perform interviews, they will keenly monitor 
these numbers. Once they had reached the allocated sample for a particular group (in most 
cases it will be non-pregnant girls), thereafter they will confirm the pregnancy status of the 
AGYW remaining on the list when contacting them (using the information sheet approved) and 
if an AGYW is not pregnant, they will let them know that the sample has been reached and that 
they will not be included in the study going forward but appreciate them for their interest to 
join the study. They will not invite these AGYW for in-person contact. This will prevent AGYW 
from spending time and effort travelling to the facility when they will not be recruited. If an 
AGYW is confirmed to be pregnant, the study procedures will continue as described earlier.  
The personal identifying information (PII) collected during recruitment will be destroyed under 
the instruction of the PI following the completion of recruitment and will not be recorded 
alongside any data collected in this activity.   
(ii) For the qualitative component, AGYW will be recruited primarily through Smart Start and 
MMA program staff, particularly health extension workers and health providers working at the 
facilities implementing the MNCH component. The recruiters will be provided with guidance on 
who should be recruited for FGDs and IDIs. They will identify AGYW from the service delivery 
records which are used to document the attendance of AGYW to MNCH sessions. They will 
use the instructions provided by the study team to purposely sample enough potential 
participants from the client records. Only AGYW who have phone numbers indicated in the 
client records will be selected. This is because tracing AGYW who do not have documented 
phone contacts will be impossible since detailed physical addresses are not routinely collected 
by providers. Furthermore, the communication of the scheduled date, time and venue for the 
IDIs and FGDs will be impossible without phone contacts.  
Using the recruitment script, recruiters will contact the identified AGYW through the phone 
contacts documented in the program records. During the phone call, once the recruiters have 
introduced themselves and obtained verbal consent, they will ask the potential participants if 
that is a good time to speak. They will also request the AGYW to identify a secluded place that 
offers privacy and then provide a brief description of the evaluation. This will ensure that no 
one could hear what is being communicated during the phone call. Thereafter, they will field 
the screening questions to determine eligibility and then proceed to gather contact details 
which will be documented immediately on the confidential contact lists.   
Once recruitment is completed, the contact information will be compiled together and 
transferred to the lead investigators for each country. The investigator will then coordinate so 
that the qualitative researcher in the team contacts the participant by phone to complete the 
recruitment procedures. The qualitative researcher will then schedule an appointment and 

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venue for the IDI or FGDs. On the scheduled date of the FGD or IDI, full consenting procedures 
will be executed. Similar to the quantitative survey, all PII details will be destroyed by the PI 
once recruitment is completed.  
2.4.2 AGYW’s husbands in Nigeria 
Husbands will be recruited from the same communities as the primary target group. For the 
IDIs with husbands, recruitment will be implemented through male IPCAs who are facilitating 
the MNCH components that involve husbands. They are also familiar with the communities 
they are working in a will be trained to identify potential participants based on the specific 
criteria and specific instructions given on the caliber of husbands to select. Male IPCAs will 
conduct purposive sampling to select husbands from the program activity registers and reach 
each one by one. Only husbands with phone contacts in the activity records could be selected. 
When male IPCAs have reached the required number of husbands, they will start contacting 
them, on phone (only). The male IPCAs, while guided by a recruitment script, will provide brief 
information about the study to the selected husbands (from the attendance records they 
maintain) who have been involved in the intervention and obtain their verbal consent. 
Husbands who express interest to participate will then be invited to respond to a few screening 
questions to determine eligibility. Eligible husbands will be asked to share their contact details 
which male IPCAs will document on the confidential contact lists. The remaining steps of the 
recruitment procedures employed for the AGYW IDIs (step 2 and 3) will be replicated for 
husband IDIs once the confidential contact lists have been developed except than a male 
qualitative researcher will execute these procedures.  
2.4.3 Health workers and mobilizers 
This group will be approached by the research team through contacts shared by the project 
field team. These contacts will be shared with the qualitative researcher who will execute the 
bulk of recruitment procedures. A brief description of the evaluation will be explained to the 
selected potential participants, screening questions fielded and those who express interest 
invited to propose a date and time for the KII.  
As described earlier, PII will be collected as part of the recruitment process. Mobilizers, male IPCAs 
and field program staff will provide the research team with the name, physical address or contact 
details of potential participants. In Nigeria, the recruiters working under SFH will work closely with 
Viable Knowledge Masters’ (VKM) personnel and for Ethiopia recruiters under MOH Ethiopia will 
work with personnel from Deep Dive Research and Consulting PLC. VKM and Deep Dive Research 
and Consulting PLC will be the primary recipients of the PII on behalf of PSI and SFH. The PII will 
be used exclusively for the purpose of inviting participants to participate. The in-country lead 
investigators will be responsible for ensuring that this information is stored securely (in a secure 
location – locked room by VKM and Deep Dive Research and Consulting PLC offices) until 
recruitment has happened. Participant trackers for the survey will be hosted in PSI SharePoint 

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Folder and the access to these files will be restricted to specific VKM and Deep Dive Research and 
Consulting PLC staff. The PI will authorize VKM and Deep Dive Research and Consulting PLC to 
destroy the PII immediately after recruitment has been completed. These data will never be linked 
to data collected as part of the study, nor shared beyond authorized members of the evaluation 
team. In-country Lead investigators will oversee the handling and storage of the PII collected for 
recruitment.  
The sample size for the quantitative survey is estimated using a two-sided Wald Z-test using GEE 
methods, accounting for repeated measures and clustering within groups and assumes no change 
of the estimate for the primary outcome for the study within the comparison group. The primary 
outcome will be a binary measure, which documents whether the AGYW has met criteria for 
‘comprehensive’ knowledge of what is needed at conception to attain a healthy pregnancy. It will 
be estimated from a composite measure made from a combination of questions assessing AGYW 
about their knowledge about behaviors (proper nutrition, screening tests and treatment for HIV 
and sexually transmitted infections, use of prenatal vitamins, and avoidance of harmful 
substances). These questions are curated from a systematic review conducted in Ethiopia on the 
knowledge of preconceptual care and which is also relevant for Nigeria(Ayele et al., 2021). This 
study established a pooled estimate of good knowledge of preconceptual care of 30.9%. In our 
study, an AGYW will be comprehensively knowledgeable if she responds to the affirmative to all 
the questions. The questions will be fielded at the time of recruitment and repeated 3 months later.  
To detect an effect size of 10% (between recruitment and 3 months later assuming no change in 
the comparison group), with a power of 80% at the 95% confidence level (two-sided), we would 
need a sample size of 991 participants in each country equally split between the comparison and 
intervention group. This assumes an adjustment of 10% for non-response and a design effect of 
1.2. Appendix R (page 57) summarizes sample sizes with different scenarios of estimated effect 
sizes. We adjust this sample upwards by 10% to account for attrition that might occur between 
recruitment and the follow-up after 3 months at arrive at a sample size of 1,090 which when split 
between the groups would be 545 AGYW. Cumulatively for Nigeria and Ethiopia, the final sample 
size would entail 2,180 participants. This sample is increased by 240 to 2,420 to account for 
recruitment adjustments for Ethiopia.  
A two-group repeated measures design with a binary response and with 2 measurements for each 
subject will be used to test whether there is a difference in group slopes. The comparison will be 
made using a Wald Z-test using GEE methods. The repeated measurements of each subject will 
be made at 2 times and using an autoregressive correlation structure (AR1). The initial proportions 
P1(0) and P2(0) are estimated at 0.3 based on estimates in the literature (preconception care 
knowledge). P2(1) proportion assumes no change in the primary outcome over the course of the 
intervention. Estimates are adjusted by 10% missing/non-response rate and a design effect of 1.2 
to account for within community or group clustering.   

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Table 2 shows estimated total sample sizes for the primary and secondary target populations 
included in this study.  
Table 2. Sample size estimates for MNCH OE 
 
# of 
participants in 
Ethiopia 
# of 
participants 
in Nigeria 
Cumulative 
Sample size  
Total samples 
Quantitative survey 
Intervention arm 
545+116=661 
545 
1,206 
2,420 
Comparison arm 
545+124=669 
545 
1,214 
Qualitative component 
FGDs with married AGYW 
40* 
40 
80 
173 
IDIs with married AGYW 
24 
24 
48 
IDIs with husbands (Nigeria 
only) 
- 
10 
10 
KIIs with health providers 
and mobilizers 
10 
25 
35 
Cumulative sample for the study 
2,593 
*Each FGD recruits a maximum of 10 participants 
2.7.1 Quantitative survey 
Upon receipt of the confidential recruitment lists from mobilisers, trained enumerators from VKM 
and Deep Dive Research and Consulting PLC will contact the potential participants to arrange for 
the interview date and time (using Information Sheet in Appendix G) as explained in 2.4.1. This will 
be done through a phone contact or a physical visit to the participant’s residential address. In case 
it is a call, enumerators will ensure that only when the AGYW is comfortable to speak and in a 
location that guarantees auditory privacy before that can proceed and make the scheduling call. 
As they schedule the interview, enumerators will guide the AGYW to elect where they would be 
comfortable to take the interview between a selected community safe space, a health facility or at 
their residence. Enumerators will also remind participants that it is voluntary to participate. For 
Oromia region, a slight modification will be made so that enumerators will confirm pregnancy 
status (as they administer the information sheet during the call), as soon as the sample of non-
pregnant girls allocated to them has been reached. This will prevent them from exceeding the 
sample quotas. 
On the date of the baseline interview and upon arrival at the venue for the interview, the enumerator 
participant will confirm that the location offers auditory and visual privacy and ensure everything 
is ready. When the AGYW arrives, the enumerator will introduce herself (all interviewers will be 
conducted by trained young women for gender sensitivity). Before executing the interviews, the 

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enumerator will perform detailed consenting procedures. During the consenting the enumerator 
will explain to the participant why obtaining contact details to facilitate future follow-up is 
necessary. This will also include explaining the reasons for obtaining secondary contact 
information, details about how it will be used and what will be said to camouflage the real details 
of the study. They will also be informed about sharing of the de-identified data in a data repository. 
Informed consent of the participant will then be obtained, and a signature or thumb print 
impression made on a consent form. For both emancipated minors and girls with legal right to 
consent, the same document will be used to obtain consent. After consent is obtained and the 
enumerator verifies that there is auditory and visual privacy, she will conduct the interview. When 
she has completed the interview, the enumerator will provide adequate information about the 
follow-up surveys and obtain contact and physical locator information for the purpose of these 
surveys.  
Before participants leave, they will be issued a unique Study ID and given a study Contact Card 
(Appendix O) on which this number is written (no names will be written on the card). The Card will 
also bear contact details of In-Country Lead Investigator and contact details of the local REB that 
has approved the study just in case girls want to follow-up to receive additional information about 
their rights to participation. The enumerator will the record the participants details (name, contact 
address- primary and alternative or secondary (another phone number through a which a 
participant can be reached if their main contact number is not working), physical address and 
Study ID) in a password protected electronic study tracking register hosted on the data collection 
devices (institutionally-owned) which will be serially completed. This information will enable the 
confirming of the identity of the participant at the follow-ups. Once data is captured on the 
electronic tracking register (Appendix P), the data collector will not be able to edit the entries, nor 
will the entries be downloadable. The tracking register will be hosted in secure cloud in SFH and 
PSI’s SharePoint and only the PI will have authority to decrypt the entries- once the time for the 
follow-ups start. Once all the girls in the confidential contact lists used during recruitment have 
been engaged, these lists will be destroyed immediately. The survey questionnaire will be hosted 
on the Open Data Kit (ODK) platform, specifically SurveyCTO. Survey CTO is a secure android-
based data collection platform that enables remote data collection and permits intermittent 
synchronization with a secured server.  Data will be submitted to the server at least once in a day.  
During follow-up, the enumerators will be provided access to the decrypted registers and only the 
specific record they are responsible for. They will be expected to contact participants two weeks 
before the expected date of the follow-up interview (after 3 completed months after the initial 
interview and 8 complete weeks after the expected data of delivery – pregnant AGYW only). As a 
rule, enumerators will employ the participant’s primary contact details. We will only use secondary 
contact details if the use of the primary contact details is unsuccessful or impossible as can occur 
if the AGYW doesn’t own a phone. Enumerators will attempt at most five times if the mobile 
contact is not going through or is not picked. During these calls, the enumerator will first introduce 

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herself, then confirm that the person speaking on the other side is the AGYW, establish that the 
AGYW is comfortable to speak and has auditory privacy before she can proceed. Enumerators will 
be guided by the follow-up script (Appendix S). During the call, enumerators will also remind 
participants that it is voluntary to participate in the follow-up interviews.  
We will also use locator information (physical address details) collaborating with mobilizers to 
physically locate participants from their residences and schedule dates for interviews. For 
participants who are reached on phone, the exact date and venue of the interview will be decided 
by the participant, ensuring that convenience of the participant is prioritized. In much as possible 
we will suggest that enumerators synchronize the interview date to clinic visits or when the AGYW 
visit places near the study site such as market days.  
During these follow-up calls, if a participant has provided phone details of another person, 
enumerators will ask to speak to the participant without disclosing the exact reasons why we are 
calling her (citing that we are conducting a general health wellbeing follow up from the nearest 
health facility) and without using terms such as sexual and reproductive health or family planning. 
If the participant is not within the proximity of the person who received the call when the phone 
call is made, the enumerator will leave a message that the participant could call or beep back the 
enumerator’s number when she is available so that the enumerator can initiate the call. Only when 
the enumerator is assured that the participant is the one on the other side and has auditory privacy 
will the conversation continue. Otherwise, enumerators will ask the participant to suggest a safer 
time when they could call back. AGYW who are not reached within a one-month period since their 
due data for follow-up will be designated as lost to follow-up and the exact reason for not being 
reached documented in their study record.  
When contacted for follow-ups, participants shall be sensitized on the available options where the 
data collection could take place so that they can voluntarily select their preferred venue and are 
familiar with what to expect. At data collection, the unique Study ID of the participants documented 
in the tracking register will again be entered into the Survey CTO system. Enumerators will confirm 
participant details through the electronic register that was created at recruitment and also using 
the Study Contact Card that was given to the participant at the same time. AGYW will be 
encouraged to carry their Contact Cards when they turn up for follow-ups, although it will not be a 
mandatory requirement for participation since the register will be sufficient. Once data collection 
is completed, participants will be appreciated, and an entry made on the register that a follow-up 
has been completed.  
As explained earlier the second follow-up will target AGYW who are pregnant at baseline and those 
found to be pregnant at the first follow-up (if they were not pregnant at baseline). The participant 
tracking register will be customized to auto-calculate the expected date of delivery (EDD) (using 
Naegele’s rule) using the last menstrual period as a reference(Edwards & Itzhak, 2019). The 
register will then estimate 8 completed weeks from this date. This will be a rough estimate from 

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the date of delivery as the EDD is an approximated value subject to error. This follow-up will be 
done on the first date of week 9 since the EDD. As with the first follow-up, the enumerator will be 
prompted to initiate a scheduling call two weeks before this date. They will use the follow-up script, 
but in this case, they will say the information specific for this follow-up. Enumerators will be 
thoroughly trained to identify and handle scenarios where AGYW are uncomfortable to schedule 
an interview that might be speaking about a pregnancy that had an unfavourable outcome. To 
manage the sensitivities of this follow-up, voluntary participation and withdrawal will be 
emphasized during the calls, visits and when conducting the interview. This will reduce pressure 
on the AGYW who are uncomfortable from participating when they do not.   
The follow-up interviews will follow the same format as the initial interview though the questions 
will be slightly different. Once a follow-up is completed, no entries will be possible on the same 
study record. Some attrition is to be expected, but measures will be taken to reduce this as much 
as possible. This includes multiple call attempts using the primary and secondary contacts, use of 
physical tracing with the help of trained mobilizers and provision of a small stipend (equivalent to 
$2 in local currencies (Naira for Nigeria and Birr for Ethiopia) given in cash for each successful 
baseline and follow-up interview) to reimburse for transport incurred to visit the data collection 
location. Those who participate in phone follow-up interviews will receive $1 airtime on their 
phones. Immediately after all the follow-ups are completed the registers will be destroyed by the 
PI. Participants will not be required to sign any document to confirm the receipt of the 
reimbursements, neither will their personal details be captured in a study document to account for 
the money reimbursed for transport or send as airtime to your phone. Instead, research assistants 
will sign against a document that summarizes the number of participants who have received the 
reimbursement or airtime without capturing any personal information. The field supervisors from 
VKM and Deep Dive Research and Consulting PLC will countersign the summary document for 
each study site to affirm that the cumulative amount of reimbursements given matches the 
number of participants interviewed. This summary will be submitted to the finance departments 
to account for the resources received.  
2.7.2 Qualitative component 
The qualitative component will constitute individual in-depth interviews (IDIs) with married AGYW 
and husbands of AGYW (Nigeria alone), focus group discussions (FGDs) with married AGYW and 
key informant interviews (KIIs) with health providers and mobilizers. Participants for this 
component will have been purposely sampled with the assistance of the program team and then 
approached and the primary contact details for those who express interest to participate gathered 
and shared with the research team. No secondary contact details will be collected. Only AGYW, 
husbands and health workers and mobilizers working in the intervention areas will be eligible for 
this component – comparison areas will be excluded.  

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A few days prior to the date of the IDI, FGD or KII, potential participants will be contacted and asked 
if they are still interested to participate in the study (using Appendix G, H or I). Individuals who are 
still interested will be invited to congregate in a specific venue (a health facility or a community 
social hall) at a specific date and time. This component will be executed at the same time and in 
concurrency (there will be FGDs, KIIs and IDIs scheduled on the same day) and there will be limited 
flexibility on where data collection could occur. This will reduce the costs related to the logistics of 
moving the qualitative team between multiple venues. On the date of the IDI, FGD or KII prior to 
their participation, individual written consent will be obtained. Selected potential participants who 
decline to participate at this point will be replaced. For the FGDs, KIIs and IDIs, the sessions will be 
conducted in quiet secluded venues. The sessions will be recorded (voice only) using digital voice 
recorders and transcribed verbatim subsequently.  Potential participants who decline to have their 
sessions audio recorded at the time of consenting will not be allowed to participate.  
 
2.8.1 Quantitative data 
The quantitative data will be gathered using a Computer Assisted Personal Interview (CAPI) 
approach. SFH and PSI Ethiopia will avail institutional tablets to VKM and Deep Dive Research and 
Consulting PLC for collecting quantitative data at all phases of the evaluation. A data entry 
template shall be developed through Survey CTO software. The survey tool shall be designed in 
English and local languages of the study regions with a drag and drop user interface. Thus, data 
collection as well as data entry shall be accomplished at the same time, accurately and timely. The 
data will be transferred (exported) into STATA software. Before analysis, further data check-up will 
be made. Preliminary analysis such as skewedness and kurtosis tests will be conducted to check 
and confirm that the data set is free from outliers. Appropriate statistical measurements will also 
be made to correct such data.   
Data collection tools will be rigorously pretested before they are used for actual data collection. 
This will involve conducing mock interviews by the core study team (investigators) to detect any 
errors and by the enumerators and the field supervisors during the training prior to data collection. 
Because enumerators and supervisors will be native speakers of the local languages, this pre-
testing will enable the study to identify issues that might have emerged during the translation of 
the tools. By the end of the enumerator training, each enumerator will be expected to have 
conducted a minimum of five mock interviews. All the feedback gathered through the pre-testing 
process will be used to make minor tweaks (such as the framing of questions) to the tools before 
they are ready for fielding to actual participants. Should be any substantive changes such as 
dropping or adding new questions, an amendment submission will be made to the REBs. Pre-
testing will also enable checks to the electronic version of the tool and check for any skip logic 
errors.  

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When building the tool in Survey CTO software automated live data checks, extensive validations 
and cross-checks will be programmed. This will reduce errors and inaccuracies during the personal 
interview. Data shall be uploaded to the cloud daily, to enable the PI and data manager carry-out a 
range of consistency checks daily. Global positioning system (GPS) coordinates will be collected 
for all survey participants (as part of the study record) and will be used to validate the location of 
enumerators and specifically where data has been collected. It will also be used to uncover unusual 
patterns of participant recruitment. Furthermore, the GPS data will also be used to track if there 
are differences in the locations where study participants are interviewed from the initial and follow-
up interviews. GPS data will be stripped out of the dataset during data cleaning and de-
identification. The data will be synchronized with a web-based server intermittently. The mobile 
devices will be password protected and handled only by the enumerators. All phone call logs from 
the phones used to recruit and schedule follow-ups with participants will be deleted immediately 
after each survey phase is completed, under the supervision of field supervisors. Data collection 
will only be performed using institutionally-owned tablets (owned by SFH or PSI-Ethiopia).  
2.8.2 Qualitative data 
The IDIs, FGDs and KIIs will be recorded using digital voice recorders with consent from study 
participants. Audio files will be stored in a password-protected file in the PSI SharePoint until 
transcription is complete. Audio files will be destroyed after transcription is complete. When 
collecting data, we will ensure that the data collected are of high quality so that they can be reliably 
used as the basis to make sound decisions.  
2.8.3 Quality assurance 
The following data quality assurance measures shall be taken throughout the evaluation 
implementation to ensure the collection of high-quality data. The field team members from VKM 
and Deep Dive Research and Consulting PLC will be provided with a three-days’ intensive training 
to undertake the field data collection effectively and efficiently. All data collection tools, recruitment 
scripts and consent forms will be translated to local language (Affan Oromo, Sidamayya and 
Amharic languages in Ethiopia and Hausa for Nigeria) and back translated to English.  
On site supportive supervision, which includes over-the-shoulder observation of enumerators will 
be carried out in every study area by field supervisors from VKM and Deep Dive Research and 
Consulting PLC shadowed by the Co-Investigators from PSI Ethiopia and SFH. The evaluation field 
supervisors shall conduct back-check interviews revisiting about 10% of conducted interviews, to 
observe and make sure whether enumerators were properly administering interviews, as per the 
evaluation protocols. Information about the back-checks has been provided as part of consenting 
procedures but it will be voluntary. It will be guided by a back-check script (Appendix T). Back 
checks will only be conducted among AGYW who have been reached through their primary contact 
details on phone, those reached in-person or through other people’s numbers will be excluded. By 
the end of each field day, a debriefing session will be held. The sessions will be led by the field 
supervisors and will give an opportunity for enumerators to reflect their observations, challenges 

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encountered and other issues. After each debriefing, strategies and mechanisms will be 
disseminated to the entire team to avoid duplication of similar challenges and issues. 
For Ethiopia to address the mishap resulting to over sampling non-pregnant girls, the following 
measures will be executed. We will (1) develop a daily recruitment log, illustrating the proportion 
of participants who are pregnant versus those who are not, at the site level and aggregating these 
upwards to the regional level (2) daily monitoring of the records submitted to Survey CTO using 
the Monitor menu in the software, (3) manual tallying of recruited participants in the Amhara region 
where internet issues were being experienced and therefore the electronic monitoring was 
impossible, (4) allocating the sample quotas to enumerators so that when they reach the allocated 
number of non-pregnant girls, they stop recruiting them and just focus on recruiting pregnant girls 
alone and (5) moving recruitment to an adjacent kebele if the sample numbers for were not 
reached in one kebele but paying closer attention to the study group most affected by the low 
recruitment numbers, (6) more intimate engagement with Deep Dive through a progress review 
meeting twice weekly so that any challenges are discovered and action implemented immediately.  
2.9.1 Quantitative analysis 
Quantitative data will be analyzed using univariate, bivariate and multivariate analysis to address 
the objectives of the study under the stewardship of PSI. Between group t-tests and chi-square 
tests of comparison will be conducted at recruitment phase to identify any areas in which there 
are statistically significant differences between the intervention and comparison groups and also 
compare within individual differences between the initial phase and follow-up phases. The analysis 
for the outcomes of interest will follow a difference-in-difference design (DiD). For the primary 
outcome, a two-group repeated measures design with a binary response and with two 
measurements for each subject will be used to test whether there is a difference in group slopes. 
The comparison will be made using a Wald Z-test using GEE methods. The repeated 
measurements of each subject will be made at 2 times and using an autoregressive correlation 
structure (AR1). At the follow-ups and within reason, any statistically significant differences 
between the intervention and comparison groups will be attributed to the intervention. Generalized 
linear mixed affects models will be employed to control for confounding correcting for individual 
and cluster-level standard errors. 
2.9.2 Qualitative analysis 
The qualitative researchers from VKM and Deep Dive Research and Consulting PLC who conduct 
the FGDs, IDIs and KIIs will transcribe and translate the audio records into written verbatim. A 
second person will check the transcript for quality. The transcripts will be de-identified before they 
could be granted to the analysis team. De-dentification will involve stripping out names of 
participants which might be mentioned (any names in the verbatim will coded) or other people or 
other relevant information in the transcripts that could enable someone to tell who provided the 

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information. All transcripts will be assigned a unique numerical code, the type of qualitative data 
and participant group e.g., 01_FGD_Married AGYW. This de-identified data will also be published 
publicly upon conclusion of the assignment as a requirement by the open access and transparency 
policies by the A360 donors (Bill & Melinda Gates Foundation, 2021; Children's Investment Fund 
Foundation, 2019). The qualitative data will be rigorously analyzed using NVivo or Dedoose as tools 
for data management. Open-coding and closed-coding will be utilized to identify emergent themes. 
Furthermore, a coding book will be established to systematically guide the analysis. Two coders 
will be trained on the codebook. Intercoder reliability will be calculated using Scott’s Pi to determine 
whether or not the coders are consistently coding the data. 
 
 
Table 3: List of Data Collection Tools 
Tool  
Timepoint and number of 
sessions 
1. Quantitative Tool for adolescent girls 
Recruitment phase, and 
follow-ups 
2. Qualitative In-depth Interview Guide for married AGYW 
Midline - once 
3. Qualitative Focus Group Discussion Guide for married AGYW 
Midline - once 
4. Qualitative In-depth Interview Guide for husbands of AGYW  
Midline - once 
5. Qualitative Key Informant Interview Guide for health providers and 
community mobilizers  
Midline - once 
 
A report of the findings of the study shall be prepared and disseminated in the countries and to the 
A360 donors. Initially the draft report will be written by VKM and Deep Dive Research and 
Consulting PLC, then reviewed by SFH and PSI. VKM and Deep Dive Research and Consulting PLC 
will revise the report incorporating the feedback provided to arrive at a final report. The final report 
will be made available through the A360’s website- a360learninghub.org.  The report will describe 
the intervention components and provide the rationale for the study. It will also describe the 
findings and make recommendations on how the findings can be replicated by other programs to 
contribute to improved MNCH outcomes. Further, we shall convene a dissemination webinar 
which will be widely advertised by the participant organizations. The target for the dissemination 
event will include representatives from the A360 donors, SFH, PSI, Federal and State Ministries of 
Health and MNCH implementing partners. Evidence from the study will also be presented at 
different national, regional and global conferences to share learnings about the intervention. 

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Several manuscripts shall be prepared for submission to peer-reviewed journals to document and 
share the findings of the study globally.   
This evaluation will have its own limitations. First, the intervention outcomes will be measured 
between participants who receive the revamped MMA and Smart Start interventions against the 
current package of SRH interventions. So far, it is possible that the current package could be 
delivering some elements of maternal and child health (especially in Nigeria). An ideal comparator 
would have been participants receiving services through routine government facilities that are not 
supported at all by the A360 project. Unfortunately, the recruitment to the evaluation might not be 
feasible. Second, this study will only recruit AGYW from catchments of health facilities (as 
clusters). The clustering of effects within AGYW from specific facility catchments cannot be 
controlled. Third, this evaluation will rely on self-reports to collect data on the primary and 
secondary outcomes. Using self-reports is amenable to social desirability biases. Although we plan 
to meticulously order the survey questions so that sensitive items are only fielded when the rapport 
between the enumerator and the participant has been formed. Furthermore, we will triangulate the 
two main sources of data for this study when processing the findings and complement these with 
comparison of routinely collected program data before we can interpret the data and draw 
conclusions. Fourth, the qualitative component will only involve AGYW, husbands and health 
workers and mobilisers who own a functional primary mobile number. This excludes individuals 
without access to a mobile number and could create a participation inequity. This is unavoidable 
given that the study heavily relies on a phone contact during the recruitment procedures.  
The primary purpose of this study is for internal program improvement purposes, however learning 
from this study will also function as a global good for the A360 project. All possibly identifying 
information will be removed from all datasets from the quantitative and qualitative components 
by the data analyst under the supervision of the PI, whether for internal or external sharing. Well 
labelled files of de-identified data and accompanying metadata will be deposited in accredited 
virtual databases that are recommended by the A360 donors once the publications have been 
developed so that they are accessible for researchers for secondary analysis across the globe.  
Program improvement: Findings will be distilled into digestible formats for A360 implementation 
teams to be able to use in their implementation of the program. Findings will also be shared with 
key stakeholders, particularly government stakeholders to further their understanding of the 
program. 
Global program deliverables: As a global project, A360 has deliverables required by its two 
foundation donors which are tied to the activities within this study. The insights synthesis and 
different concepts / prototypes tested may be distilled into a design report which will be submitted 
to and discussed with the project’s donors.  

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Global learning documents: As a project, A360 is committed to radical transparency about what is 
learned through its continuous improvement processes. As such, the findings from the data 
collected will be used in global thought leadership pieces and disseminated through conference 
abstracts, presentations, webinars, technical publications and peer review journal articles.  
This study has been determined to be human subjects research and as such will be reviewed by 
the PSI REB and concurrently reviewed by the Ethiopia Midwives Association (EMwA) Institutional 
Research Ethics Board in Ethiopia and National Health Research and Ethics Committee (NHREC) 
in Nigeria prior to being fielded. 
The possible risks from participating in this study are risk of breach of confidentiality, particularly 
since this study involves adolescents, and risk of psychological discomfort. Regarding risk of 
breach of confidentiality, field research teams will not keep records with any identifying 
information from adolescents in any way that it can be traced to the survey records.  
Research respondents may experience some psychological discomfort in being asked to discuss 
culturally sensitive topics, such as sexual activity, early and unspaced pregnancy, or the use of 
contraception. Potential participants will be informed of this risk prior to being asked for their 
consent to participate, and informed that they can refuse to answer any questions or stop the data 
collection process at any time, or even just pause for a few minutes before continuing. Participants 
will be informed of their right not to answer any questions and ability to withdraw from the study 
at any time they wished without any consequences. 
Finally, there is a potential risk that the study could divulge information (directly or indirectly) that 
the girls are recruited in the process of accessing pregnancy -related and contraception services. 
To mitigate this risk, the study team will maintain utmost privacy during data collection and 
confidentiality of collected information. The key risks and mitigation measures are summarized in 
Table 4.  
Table 4: Key risks and their mitigation 
 
Key risk 
Mitigation measures 
a.  Breach of 
privacy and 
confidentiality 
All members of the study team will undertake a mandatory protection 
of Human Subjects in Research (HSR) training. Only individuals with a 
valid HSR certificate will be involved as study personnel. This risk and 
its mitigation will also be included as part of enumerators’ training. A 

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strict data management protocol will be adhered to throughout the 
study.  
b.  Social risks 
related to post 
partum 
contraception 
Conduct the study in locations that guarantee visual and auditory 
privacy. Allow participants to use real or proxy names when signing 
consent forms. Tactfully engaging individuals who accompany the 
AGYW to the facilities to seek their permission without disclosure of the 
full details of the study especially on contraception use and child 
spacing. The requirement for parental consent is avoided, to reduce the 
risk that AGYW were engaging with a reproductive health program 
associated with use of contraceptives.  
c.  Psychological 
discomfort  
Participants are informed of the voluntary nature of participation and 
given room to withdraw throughout the recruitment and data collection 
processes. Participants will be encouraged to share their discomfort or 
unfavourable emotions with the enumerators. Questions on the 
pregnancy, perinatal and neonatal outcomes (for follow-up 3) will be 
optional to cushion AGYW from the pressure of responding about their 
unfavourable outcomes and negative experiences. Use of female 
enumerators and qualitative researchers to increase gender sensitivity. 
 
Interviewers for the project shall be selected from a pool of existing female enumerators that have 
worked with VKM and Deep Dive Research and Consulting PLC on previous research projects. If 
there are none in the location of the study, care will be taken to ensure identified enumerators have 
experience conducting such kind of assignments. They will be trained on ethics of collecting data 
from minors and sensitivity to cultural issues. They will also sign a code of conduct which 
stipulates stringent criteria on how to collect data from minors. Only female enumerators will be 
engaged on this project since the participants involved in the study are female for gender-
sensitivity. 
While this research study does not have a direct intent of identifying individual experiences of GBV 
or community norms related to GBV, it is possible that experiences of violence and abuse may 
arise during the data collection process, including witnessing of or actual experiences with 
violence, abuse or coercion. Although participants will not be asked questions about their own 
experiences of violence, these discussions could produce some psychological distress if a 
participant has experienced or witnessed violence in the past. 
We plan to take the following measures to address the possibility of participants reporting on GBV: 

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• 
PSI, SFH, VKM and Deep Dive Research and Consulting PLC field teams will be trained on 
safe research practices, particularly as it relates to GBV, as part of the inception of this 
research. Field research teams will be trained to record any disclosure of violence, abuse 
or coercion (witnessing or direct experience) in a non-judgmental fashion. If a participant 
expresses discomfort or stress during the interview, the interviewer will remind the 
participant that they are free not to answer any questions which make them uncomfortable 
and will give the participant time to recover before proceeding with the interview. Field 
research teams will be instructed not to probe on any instance of violence, abuse or 
coercion, because the topic is not directly related to the study’s objectives, and to transition 
the conversation to another topic when the participant is ready to do so. If there is any 
possibility that confidentiality cannot be maintained while the participant is disclosing 
experiences with violence, members of the field research team will be instructed to stop 
the conversation, move to a more private location, if possible, and ask the participant if they 
wish to continue. In the likely event that there are disclosures relate to perpetration of 
violence, the field research team will uphold confidentiality but could propose that the 
participant seeks mental health assessment and counselling. The field team will maintain 
a directory of facilities where such services are provided and share these with the 
participant. 
• 
Field research teams will be instructed to provide that person with the physical address, 
contact and phone numbers of available support services.  
• 
Counseling services from MOH psychological services providers will also be made 
available to field research teams as required. The availability of this service will be included 
in training materials, and field research coordinators will be instructed to check on their 
teams through daily de-briefs to assess whether team members need this support.  
• 
If there is any indication that a research participant is becoming belligerent or abusive to a 
member of the field research team, team members will be instructed to end the interaction 
and leave the area.  
• 
Our study team will continuously familiarize themselves with all the reporting requirements 
on IPV/GBV based on existing laws and guidelines including handling perpetrators who 
self-disclose engaging in violent acts.  
All research participants will be informed that they will not receive any direct benefit from 
participating in this research. However, they will be informed that their participation will support 
the improvement of services for adolescents in their communities, in Nigeria, and possibly in other 
African countries. A small stipend worth $2 will be offered for the follow-up surveys and for the 
FGD and IDI participants.  

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3.5.1 Married AGYW 
All AGYW who express interest to participate in this research will be screened using the eligibility 
criteria prior to obtaining informed consent. An informed consent from eligible AGYW will be 
documented after the informed consent script has been read by the enumerators/researchers. The 
personnel administering the consent script will be the same sex to study participants. For group 
discussions, consenting procedures will be administered individually before the start of the 
interview. Each participant will be asked to give his/her written consent to participate in the study, 
afterwards the person obtaining consent will sign the informed consent form (see Appendices J-
M for Informed Consents for all participants). No parental consent will be required for married girls 
15-17 since they are precluded from this requirement based on the Policy Statement Regarding 
Enrollment of Children in Research in Nigeria (Policy Regarding Enrollment of Children in Research 
in Nigeria, 2016). According to the Ethiopian National Ethics Guidelines, 2014 section 6.19.3 (Page 
51) which recognizes married AGYW under 18 years as emancipated minors grants a provision for 
them to give informed consent on their own. It also provides for REBs to grant a waiver of parental 
consent for emancipated minors and children when dealing with sensitive subjects(Ethiopia 
Federal Ministry of Science and Technology, 2014). A waiver of parental permission will thus be 
requested from the PSI and local REBs.  
3.5.2 Adults 
Husbands, health providers and mobilizers will be formally consented before they participate. The 
inclusion criteria for these two groups is age 18 years and over and so individuals will be mandated 
to consent on their own. Prior to their involvement in KIIs or IDIs, the member of the qualitative 
researchers will read the informed consent form to each study participant and provide him/her 
with an opportunity to ask questions. Similar to the AGYW, written consent will be employed. The 
researcher obtaining consent will be required to sign the form to affirm that consenting procedures 
have been conducted as mandated.  
Signed consent documentation will be collected by the field research team from VKM and Deep 
Dive Research and Consulting PLC and stored in a locked box. They will be collected, packaged 
and deposited under the oversight of the in-country investigator. At the close of data collection in 
the field, field coordinators will be expected to transport signed forms in a locked box for storage 
at the SFH and PSI Ethiopia offices. Consent forms will not be retained for longer than one year 
from the completion of data collection. Consent forms will include the unique ID code for the 
participant, to permit consent and other study documentation to be linked anonymously. 
Protecting research participants’ privacy is a major goal for this study. Field research teams will 
be trained on study procedures and research ethics to ensure they are sensitized to risks and 
respect of privacy. As previously described, all identifying information needed for the recruitment 

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of study participants, whether adults or AGYW, will be destroyed at the completion of data 
collection. No identifying information will be collected during individual or group discussions.  
All the data from the field will be thoroughly reviewed for identifying information and all these 
stripped off – personal names, phone numbers or addresses. The Investigators will instead devise 
a coding scheme to indicate their sex, age group for AGYW (18-19 or 20-24), and standing in the 
community (health provider, mobilizer, husband), and geographic region. This coding scheme will 
be applied to data outputs before data analysis. Any quotes used in study outputs or shared 
publicly will use this coding scheme (sex, age/community standing, geography) exclusively.  
Research participants will not be financially compensated for participation in this research. 
Participants will receive a small stipend (equivalent to $ 2) to cover the costs of transportation or 
as airtime (for those who are involved in phone follow-up interviews) from VKM and Deep Dive 
Research and Consulting PLC. The $ 2 may cover a private ride home or a quality meal at a modest 
café. Survey participants interviewed on phone will receive airtime worth $1 directly to their 
phones. This is based on past experiences and inflation rates in the countries.  
As part of the research inception, field research teams under the stewardship of the In-country 
Lead Investigators will be instructed on how to identify any ethical and safety concerns, and they 
will be asked to report concerns to the Investigators. 
Serious ethical and safety concerns may include, but are not limited to: 
• 
Incidents when a research participant’s safety is at risk because of participation in the 
study 
• 
Any threats of violence to the research team while conducting the study 
• 
Any incident where the confidentiality of research participants is jeopardized 
• 
Any event related to the research process that results in serious injury, death or arrest (e.g. 
motor vehicle accidents) 
The in-county lead investigator (with guidance from the PI) will be responsible for advising field 
researchers on incidents that have ethical or safety concern, or any event that may constitute a 
violation of this protocol. The following actions may be taken when an incidence occurs. (a) Field 
researchers will immediately report the event to the In-country Lead Investigator who will 
immediately escalate the incidence to the PI. (b) The PI will coordinate a rapid documentation of 
the incident and escalate it to the local IRB and PSI REB using an adverse event report. (c) The PI 
will issue strict instructions to pause any field activities pending feedback from the REBs. (d) Once 
feedback is received from the REBs, the PI will oversee the implementation of the course of action.  
 
 

A360 Amplify MNCH Implementation Science Study Protocol 
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The activities for the study will be conducted during the following quarters in 2023 to 2025. Many 
activities will overlap, so that the study is efficient.  
 
Q3 2023 
Q4 2023 
Q1 2024 
Q2 2024 
Q3 2024 
Q4 2024 
Q1 2025 
Activities  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. Finalize study 
protocol and the 
tools 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2. Submit protocol 
to PSI and Nigeria 
% Ethiopia IRBs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. Recruitment of 
enumerators  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4. Training 
enumerators and 
piloting the tool 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5. Data collection  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6. Data cleaning and 
coding  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.  Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. Report writing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9. Dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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