Effectiveness of Early Child Development Multi-Media Communication on Caregiver and Community Health Worker Behaviors: Evaluation of the Malezi II Program
Phase: NA
Conditions: Child Development, Father-Child Relations, Knowledge, Attitudes, Practice, Safety Issues
Sponsor: Elizabeth Glaser Pediatric AIDS Foundation

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 1 of 42 
                              
 
 
 
Effectiveness of Early Child Development Multi-Media Communication on Caregiver and 
Community Health Worker Behaviors: Evaluation of the Malezi II Program 
Protocol version 4.0 – 3 August 2020 
Co-Principal investigators, EGPAF 
Gretchen Antelman 
gantelman@pedaids.org 
Elizabeth Glaser Pediatric AIDS Foundation 
Dar es Salaam, Tanzania 
Tel: 255 762 475 145 
 
Josephine Ferla 
jferla@pediads.org 
Elizabeth Glaser Pediatric AIDS Foundation 
Dar es Salaam, Tanzania 
 
Michelle Gill 
mgill@pedaids.org  
Elizabeth Glaser Pediatric AIDS Foundation 
Washington DC, USA 
Co-investigator, MOHCDGEC 
Mary Angelo Mang’enya 
Ministry of Health, Community Development, 
Gender, Elderly and Children 
Dodoma, Tanzania 
 
Co-investigator, PORALG 
Martha Mariki 
President’s Office Regional and Local 
Government  
Dodoma, Tanzania 
 
Co-investigator, Aga Khan University 
Amina Abubakar 
Institute for Human Development 
Aga Khan University (South-Central Asia, East 
Africa, UK) 
3rd Floor, Park Place Building 
2nd Parklands Avenue, Off Limuru Road 
P. O. Box 30270, Nairobi, Kenya GPO 00100 
amina.abubakar@aku.edu  
Co-Investigators, EGPAF 
 
Heather Hoffman  
The George Washington University, Milken 
Institute School of Public Health 
Washington DC, USA 
hhoffman@gwu.edu  
 
Roland van de Ven 
Elizabeth Glaser Pediatric AIDS Foundation 
Dar es Salaam, Tanzania 
roland@pedaids.org 
Co-Investigators, Development Media 
International 
 
Pieter Remes 
Development Media International 
Mwanza, Tanzania 
pieter.remes@developmentmedia.net 
 
Joanna Murray 
Development Media International 
London, UK 
joanna.murray@developmentmedia.net 
 
 

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Contents 
Abstract ............................................................................................................................... 3 
List of Acronyms and Abbreviations ................................................................................. 4 
Background ......................................................................................................................... 5 
Study Aims, Objectives and Research Questions .......................................................... 10 
Methodology...................................................................................................................... 11 
Intervention Description ........................................................................................ 16 
Location ................................................................................................................ 18 
Study Population ................................................................................................... 18 
Sample Size Calculations ..................................................................................... 19 
Selection Criteria for Study Communities ............................................................. 21 
Sampling within Study Communities ..................................................................... 22 
Data Collection: Caregiver Cohort ........................................................................ 24 
Outcomes and Measures: Caregiver Cohort ........................................................ 25 
Recruitment into the CHW Cohort (MRV-CCD Group) ......................................... 27 
Sampling for Observed Sessions.......................................................................... 27 
Data Collection: CHW Cohort ............................................................................... 28 
Outcome and Measures: CHW Cohort ................................................................. 29 
Process Evaluation: MRV-CCD Group ................................................................. 30 
Data Analysis ........................................................................................................ 32 
Ethical Considerations ..................................................................................................... 33 
Informed Consent ................................................................................................. 34 
Human Subjects Training and Confidentiality Protections .................................... 36 
Risks, Benefits and Compensation ....................................................................... 37 
Timeframe .......................................................................................................................... 38 
Policy/Program Significance and Dissemination............................................................ 38 
References ........................................................................................................................ 39 
 
 
 

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ABSTRACT 
Background/Rationale: A recent review on early child development (1) outlines evidence that the 
parent-child relationship, in particular responsive, sensitive care in the earliest years of life, is critical 
for all domains of child development, school achievement, and economic productivity in the adult 
years (2,3). Mass media communication campaigns for public health have also been shown to 
positively impact a wide range of child survival orientated parental health behaviors (4). Beyond 
radio campaigns, interventions at a health facility level have demonstrated that video job aids can be 
effective education tools across a wide range of health topics (5). The Government of Tanzania has 
shown a commitment to early child development through its policies which recognize that a child’s 
right to quality health and basic social services is important for their survival, development, and 
protection.  
The Conrad N. Hilton Foundation supports the Elizabeth Glaser Pediatric AIDS Foundation to 
implement a targeted early stimulation program called Malezi (caring for young children in Kiswahili) 
at selected facilities in Tabora region. This program integrates extended early child development 
(ECD) interventions into reproductive and child health (RCH) and HIV services for young children, 
adapting the UNICEF Care for Child Development (CCD) curriculum to Tanzania, in collaboration with 
the Aga Khan Foundation, UNICEF and the Ministry of Health Community Development, Gender, 
Elderly and Children (MOHCDGEC). A follow-on grant will expand Malezi I coverage of the CCD 
program implementation and introduce a mass media campaign and video job aids. The addition of 
radio messaging in Malezi II aims to promote positive perceptions and knowledge of ECD at the 
community level, and video job aids aim to further support and improve community health worker 
(CHW) education and counseling skills. 
This protocol describes a two-year population-based study to take place in Tanzania 
evaluating the two Malezi interventions.  These include a minimal intervention package, composed 
of radio messaging only (MR), reaching all areas in Tabora, including those where the Malezi I 
program has not been established and the Malezi II full intervention package, composed of radio 
messaging, the introduction of short video job aids primarily for CHW use, and the Malezi I CCD 
program (MRV-CCD), implemented in Malezi program districts.  
Objectives: Specific aims of the research project are to evaluate: 1) the effect of the Malezi II MR 
intervention on caregiver awareness of children’s developmental needs; 2) the extent to which the 
Malezi II MRV-CCD intervention (radio messaging, video job aids, continued CCD program support) 
increases caregiver knowledge and practices as compared to a radio campaign alone (MR); and 3) 
the effect of Malezi II training and video job aids on the quality of CHW counseling support, provided 
in clinics and homes. 
Methods: This study is a two-arm quasi-experimental pre-post evaluation design, comparing two 
interventions to establish their relative impact on caregiver knowledge and behaviors/practices 
among a cohort of caregivers of children 0-24 months at enrolment and under three years after a 9-
month intervention exposure period. In addition, the quality of counseling support to caregivers, at 
health facilities and through home visits, will be assessed at baseline and endline in a cohort of 
CHWs recruited from the MRV-CCD full intervention communities. Caregivers of children age 24 
months or less at enrolment (n=1214), and community health workers (n=123) working with 
selected study facilities will be enrolled in the study. The study will be conducted in catchment 
communities of selected health facilities in four districts in Tabora region (Nzega, Igunga, Kaliua, 
Uyui).  
Policy Significance: Outcomes from this evaluation will inform decision makers in Tanzania about 
the feasibility and effectiveness of a health systems-based ECD intervention, augmented by radio 
communications and/or short video use. 
Timeline and approximate budget: Two years (2019-2020); USD 580,000. 
 
 

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LIST OF ACRONYMS AND ABBREVIATIONS  
CCD 
Care for Child Development package 
CHMT 
Council Health Management Team 
CHW 
Community Health Worker 
ECD 
Early Child Development 
EGPAF 
Elizabeth Glaser Pediatric AIDS Foundation 
EA 
Enumeration Area (of the National Bureau of Statistics) 
ES 
Early Stimulation 
HCW 
Health Care Worker 
LMIC 
Low and Middle Income Countries 
MOHCDGEC 
Ministry of Health, Community Development, Gender, Elderly and Children 
MNCH 
Maternal Neonatal and Child Health 
MR 
Malezi II Radio intervention  
MRV-CCD 
Malezi II Radio, Video, CCD program intervention  
NBS 
National Bureau of Statistics 
NCF 
Nurturing Care Framework 
NIMR 
National Institute of Medical Research (Tanzania) 
PMTCT 
Prevention of Mother to Child Transmission (of HIV) 
PTID 
Participant Identification Number 
RCH 
Reproductive and Child Health 
RHMT 
Regional Health Management Team 
SDG 
Sustainable Development Goals 
SSA 
Sub-Saharan Africa 
 
 
 

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BACKGROUND 
Child development is the “ordered progression of perceptual, motor, cognitive, language, socio-
emotional, and self-regulation skills in children” (2). Children should be supported to grow and 
develop into healthy, productive, moral citizens, who contribute meaningfully to better societies for 
all. The inclusion of early child development (ECD) among the Sustainable Development Goals (SDG) 
(6,7) alongside global strategies such as the ‘Survive, Thrive, and Transform’ goals of the Global 
Strategy for Women’s, Children’s and Adolescent Health, provide the impetus for governments in 
Africa to deliver interventions which improve the developmental outcomes of children (1,8). 
Child development in sub-Saharan Africa 
Nowhere is the need to advance child developmental outcomes more acute than in sub-Saharan 
Africa (SSA). The child population is growing fastest in the poorest nations. Poverty, disease burden, 
violence and gender inequality are widespread and access to health, education and social justice are 
limited. SSA bears a disproportionate burden of disease and children face substantial and cumulative 
threats to their human development and life chances (9). 
The scale of the problem is enormous, with 2016 estimates suggesting that among the 249 million 
children at risk of poor development in all low and middle income countries (LMIC) the SSA region is 
reported to have the highest prevalence (>60%) of at-risk children. These high risk rates are 
attributed to a lack of nurturing care, poverty, malnutrition, and socioeconomic disadvantages (10). 
Compounding this, SSA also carries a disproportionate burden of HIV, accounting for more than 70% 
of the global burden of infection and AIDS related deaths (11,12). 
Strategies for supporting early child development 
Child development is known to be influenced by a myriad of biological, environmental and 
psychosocial risk factors in the parent and the child (9,13). Parental factors could be directly linked 
to the parent’s behavior, cognition and emotions, or indirectly through a variety of familial and 
contextual stressors associated with parent psychological difficulties, including parenting 
difficulties, marital conflict, isolation, and poverty. The Lancet series of Perinatal Mental Health in 
2014, and a similar systematic review of literature from LMIC illustrate that the parent-child 
relationship and the quality of the parenting environment are particularly influential pathways by 
which children’s development is disturbed (13,14). The Lancet series on early child development 
outlines overwhelming scientific evidence that the parent-child relationship, in particular responsive, 
sensitive care in the earliest years of life, is critical for all domains of child development and to later 
school achievement and economic productivity in the adult years (1–3). Importantly, the quality of 
caregiving and the parent-child relationship has been shown to be modifiable in LMIC (15), making 
caregiving an important intervention target. There are several examples which have shown 
successful early life caregiving interventions in SSA settings (6,17–19). A systematic review of 
interventions with potential to improve child development in LMIC (20) has shown that standardized 
interventions aimed at supporting child development by providing training to caregivers on early 
stimulation and responsive care, such as the Care for Child Development (CCD) program, developed 
by the World Health Organization (WHO) and UNICEF, are successful in a variety of lower resource 
contexts (6,17) and may be highly suitable, with adaptation for Tanzania.  
 
 

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The Nurturing Care Framework 
In conceptualizing implementation approaches by which interventions like CCD could be feasibly 
delivered, there is a growing understanding, as documented in the 2018 Nurturing Care Framework 
(21) that the integration of health, nutrition, responsive caregiving, safety and security, and early 
learning interventions into existing services, is important to maximize scalability (1,3,6,17,20). The 
use of multiple entry points, beyond the education sector, is critical to broadening the reach and 
impact of child development interventions. In SSA, the health sector specifically has a particularly 
important role to play given its regular interface and reach to children and caregivers during the first 
one thousand days from pregnancy to two years postnatal (6,21,22).  How these integrated services 
will be feasibly implemented and taken to scale within Tanzania needs to be determined.   
Globally, there is consensus that in-home support, task shifted to community health workers (CHW) 
is critical to increasing access (1,23), particularly were resources are low and in the early 
developmentally sensitive window, when children are less likely to access formal out-of-home 
support (such as ECD centers, crèches or preschool) (16,23). However, there remains a dearth of 
successful program examples of public sector led in-home services that integrate ECD with other 
maternal and child health services in East Africa and rigorous evaluations are needed.  
Increasing efficiencies in large-scale delivery of caregiver interventions and mass 
media interventions 
Systematic evidence from LMIC has shown that the more effective child development intervention 
programs are those with similar characteristics to Malezi I. This includes systematic training for 
CHWs using a structured and evidence-based curriculum, opportunities for parental practice with 
children with feedback, and a high frequency of contact (22).  
Most mass media campaigns in LMIC have focused on parent behaviors which support child survival. 
A recent systematic review has shown that these campaigns can positively impact a wide range of 
child survival oriented parental health behaviors (4). In Africa, given the widespread utilization of 
radio, these approaches are seen as effective tools for disseminating health information and 
supporting health-promoting behaviors (24). These range from information on immunizations in 
Nigeria (25) to sexually transmitted diseases for secondary school students in Tanzania (26). In 
Tanzania, radio and television “edutainment” soap operas have also been shown to have strong 
behavioral effects on self‐efficacy regarding family planning and use of contraception (27). Studies in 
Ethiopia found that the availability or possession of a radio was a predictor of insecticide treated 
nets ownership for malaria prevention, maternal and child health service utilization, and mothers’ 
knowledge on infant and young child feeding recommendations (28–30). Studies suggest that for 
media communication interventions to be effective they need to be delivered at sufficient intensity 
and scale (31). 
While caregiver educational interventions using radio, television, video job aids and other digital 
health interventions have shown some potential, the effects for these information-based, parent-
only interventions were relatively small (32).  Nonetheless, it is plausible that child development 
messaging delivered through media outlets, may offer some advantages in increasing caregiver 
knowledge, and given its substantially lower resource intensity, its contribution warrants 
investigation in contexts like Tanzania where resources are particularly scarce.  

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Video job aids to increase quality of care in health workers 
It is clear from the child development evidence base that quality is a key variable in determining the 
success of CHW led interventions (6,16,20). Beyond radio campaigns which aim to increase caregiver 
knowledge directly, interventions at a health facility level have demonstrated that video job aids can 
be effective education tools across a wide range of health topics (5). Several studies also point to the 
acceptability and feasibility of using videos as a communication strategy for health promotion, to 
reduce the intensity of demands placed on the interventionist, particularly in the context of task 
sharing. One pilot study in South Africa found that using tablets with teaching videos about HIV, 
alcohol, nutrition, and breastfeeding helped ease the workload of the health providers and engaged 
the broader community on topics intended for pregnant mothers and mothers of young children 
(33). A community-based intervention in Congo that used videos to educate over 60,000 people on 
Ebola was effective in improving knowledge, attitudes, and behaviors among a population with 
limited literacy (34). Evidence from radio and video use in Tanzania is limited, although videos have 
been used as effective training tools for identifying respiratory movements related to pneumonia 
(35) and educating school children on tapeworm infections (36).  
Barriers and facilitators to child development in Tanzania 
Tanzania has a high prevalence of children at risk of poor development, with 70% of children being 
considered at risk according to population-level estimates (10).  Despite strong economic growth 
over the past decade, one-quarter of Tanzanians live in poverty (37). The literacy rate among those 
aged 15-49 was 63% among women and 66% among men in Tabora, substantially lower than the 
national estimates of 77% and 83% respectively (38). This is concerning because poverty and lower 
parental education are known to be associated with poor child development outcomes, most likely 
through sub-optimal caregiving capacities, limited early stimulation and impoverished educational 
environments (22). Only 47% of 5-year-old children in Tanzania were enrolled in pre-primary 
education in 2015, with children from poor households three times less likely to attend school than 
those in wealthier households (39).   Census results for Tabora show little improvement primary 
school enrolment, only increasing from 52% in 2002 to 56% in 2012 (40).  
The Government of Tanzania has shown a commitment to early child development through its 
policies which recognize that a child’s right to quality health and basic social services is important for 
their survival, development, and protection. There is recognition that meeting such needs at scale is 
critical for the country’s economic and social development.  Currently, early child development (ECD) 
policy language and technical cadres exist in multiple government ministries (education, health, 
social welfare, and local governments). Government guidelines on early child development now 
appear in the educational policy in terms of mandatory public pre-primary education from 3 years of 
age. A draft early child development policy document is also being incorporated into a national child 
development policy (0-18 years) under the Ministry of Health, Community Development, Gender, 
Elderly and Children (MoHCDGEC). Furthermore, the Reproductive and Child Health of the Ministry 
unit issues guidance on early child development with respect to milestones and recommended early 
stimulation practices for infants/children 0-3 years of age.  
 
 

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Integration of Care for Child Development in the health sector in Tanzania: Boresha 
Afya and the Malezi I Program  
In Tanzania, the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) provides support to both local 
government authorities and to health facilities having maternal, newborn and child health (MNCH) 
and/or HIV service delivery platforms. The USAID Boresha Afya program funds EGPAF to provide 
comprehensive service delivery support and technical assistance to HIV programs in relation to 
identification, linkage and retention of patients living with HIV, and improving the quality of services. 
Through this platform in five regions of Tanzania, and through the Malezi II program in Tabora, 
EGPAF engages with health providers at RCH and prevention of mother-to-child HIV transmission 
(PMTCT) clinics, HIV clinics, and community health cadres. 
The Conrad N. Hilton Foundation supports EGPAF to implement a targeted early stimulation 
program at selected facilities in Tabora region to integrate extended ECD interventions into 
reproductive and child health (RCH) and HIV services for young children regardless of their HIV 
status. During the first phase (2016-17) of the Hilton-supported Malezi I Project (caring for young 
children in Kiswahili), EGPAF adapted and supported implementation of an early child development 
package into MNCH, PMTCT, and HIV care and treatment services at 47 EGPAF-supported facilities in 
three districts: Nzega, Igunga, and Tabora Municipal. The Malezi I intervention was adapted from the 
CCD curriculum in Tanzania by EGPAF in collaboration with Aga Khan Foundation, UNICEF and 
MOHCDGEC and translated into Kiswahili before being delivered to health care providers. The 
classroom and field based training was focused on building providers’ counseling skills and 
understanding the concept of responsive caregiving. Specific topics included counseling caregivers 
on how to identify children’s cues and respond to them appropriately; provide a safe and stimulating 
environment in the home; help caregivers understand if their children are developing well, 
recommend age appropriate play and communication activities, identify children with disabilities or 
developmental delays, provide and follow-up on referrals for specialized care as needed, and 
facilitate CCD group counseling. In addition to training, supervision and mentorship, the Malezi I 
program provided paper-based monitoring and evaluation (M&E) tools, and job aids from the CCD 
package to support group and home-based counseling, primarily done by CHWs, although health 
providers may also lead health education groups at the facility. The full Malezi I CCD intervention 
package included: 
▪ 
ECD (CCD-based) knowledge and education/counseling skills training to facility-based and 
community health providers, including translated CCD-based manual with job aid 
▪ 
Continuing supportive supervision to Malezi-supported facilities and CHWs 
▪ 
M&E tools 
▪ 
Toys (mostly home-made or safe household objects) and play mat for use in facility group 
sessions and during home visits 
▪ 
Creative toy building training to support sustainable replenishment of toys for ECD sessions. 
The Malezi I intervention was found to be feasible and acceptable as an integrated intervention 
within routine MNCH/PMTCT services. The internal Malezi I program evaluation, using a pre/post 
design, found substantial increases in caregiver knowledge and practices as reported through exit 
and household-based interviews. Knowledge among facility-based health providers and CHWs also 
increased significantly, and health providers reported increased access to ECD resources.  

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 9 of 42 
Given the existing and emerging evidence on potential strategies to better engage communities in 
supporting health promotion interventions, the Malezi II grant will expand Malezi I coverage of CCD 
program implementation to nearly double the number of facilities supported, and introduce 
additional components, specifically, a mass media campaign and video job aids. The addition of 
video job aids aims to further support and improve CHW education and counseling skills, and the 
addition of radio messaging aims to promote perceptions and knowledge of ECD, and possibly 
responsive caregiving behaviors, more broadly at the community level.  
The Malezi II program, additional multi-media components, and theory of 
change model informing the evaluation 
The Malezi II grant supports a continuation and expansion of the Malezi I CCD program described 
earlier, plus two additional interventions related to multi-media communications aimed at 
improving ECD perceptions, knowledge and responsive caregiver behaviors. These two approaches 
include a mass media communication strategy using radio messaging and the introduction of short 
video job aids, along with capacity building training for community health workers in the use of 
those job aids. This study is designed to evaluate the comparative effectiveness of the two 
interventions with respect to ECD perceptions, knowledge and responsive caregiving outcomes. In 
addition, by analyzing differences between baseline and endline within each study group (pre/post 
design), we will describe the effectiveness of radio messaging alone compared to no radio 
messaging, and the effectiveness of a fully integrated ECD intervention, including radio messaging, 
short video job aids and Malezi CCD program support compared to CCD program support without 
radio and short video support.  
The Malezi II minimal intervention package, composed of radio messaging only (MR), will reach all 
areas in Tabora, including those where the Malezi program has not been established. The Malezi II 
full intervention package, composed of radio messaging, the introduction of short video job aids 
primarily for CHW use, and the Malezi I CCD program (MRV-CCD), will be implemented in Malezi 
program districts, namely, Nzega, Igunga and Tabora Municipal.   
The theory of change underlying the Malezi II full intervention package design draws on current 
evidence for CCD (6,20) and behavior change literature (41). It proposes that a combination of 
caregiver attitudes and norms (informed by access to information) will influence caregiver intentions 
to behavior, and ultimately their behaviors. Beyond providing caregivers with information to 
improve their knowledge, Malezi II supports caregiver capacity to make the desired changes to their 
caregiving behaviors through group learning (supported by video job aids) and practice and feedback 
(supported through home visiting).  
While caregivers may develop an intention to change through program support, actual behavior 
change could be limited by a lack of skills (capacity) or not being in an appropriately enabling 
environment.  We hypothesize that the addition of enhanced support from the CHW (short video job 
aids) and a more enabling environment from their family members and/or community (radio 
messaging) will lead to behavior change. 
The theory of change is summarized in Figure 1.  
 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 10 of 42 
 
Figure 1. Overview of theory of change 
 
This conceptual model of behavior change underpins the hypothesis that the combined intervention 
of facility-based ECD resources and messaging from providers, CHW group and individual counseling 
in the home and facilities, with support from video job aids, and community-targeted mass media 
radio ECD messaging will have a stronger impact on caregiving behaviors, compared to radio 
messaging alone. It targets two potential pathways to caregiving behavior change: direct educational 
messaging to increase knowledge; and opportunities for practice and feedback to increase capacity. 
However, this augmented Malezi II program model is resource intense. Thus, the research design 
examines the relative benefits of additional resources to change caregiver behaviors, compared to 
the benefits of radio messaging alone, which is potentially more efficient and scalable. 
STUDY AIMS, OBJECTIVES AND RESEARCH QUESTIONS 
Based upon the conceptual model described above, we have articulated research aims to derive 
specific and measureable objectives.  These are presented below in terms of overall aims, specific 
objectives, and illustrative research questions, corresponding to each aim and objective. 
 
Aims 
1. Evaluate the effect of Malezi II radio (MR) messaging on caregiver awareness of children’s 
developmental needs 
2. Evaluate the extent to which the Malezi II full intervention (MRV-CCD: radio messaging, 
video job aids, continued CCD program support) increases caregiver knowledge and 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 11 of 42 
practices as compared to a radio campaign alone (MR), using a quasi-experimental research 
design  
3. Evaluate the effect of Malezi II training and video job aids on the quality of community 
health care worker counseling support, provided in clinics and home 
Objectives  
1. To determine caregiver radio listenership patterns at baseline, exposures to the ECD radio 
messaging nine months’ post-intervention, and effect of radio exposure on caregiver ECD 
perceptions, knowledge and reported parenting practices, using pre-post structured 
interviews in a cohort of caregivers of children age 0-24 months at baseline, in study 
communities from each intervention arm. 
2. To determine whether the Malezi II full intervention (MRV-CCD) significantly increases 
caregiver’s knowledge and parenting behaviors/practices when compared to radio 
messaging alone, using a pre-post quasi-experimental evaluation design with structured 
interviews, in a cohort of caregivers of children age 0-24 months at baseline, in MRV-CCD 
and MR communities. 
3. To determine whether the introduction of short video job aids (training, provision, 
supportive supervision) to the Malezi II CCD program improves the quality of counseling 
provided by the CHWs in the clinic and the home, using pre-post observation fidelity 
checklists for all CHWs working in the MRV-CCD communities. 
Secondary Objectives 
4. Describe community health worker perspectives with regard to the salience and relevance of 
the program to their work, barriers and facilitators to implementing the Malezi II program 
and experiences with use of the short videos as a job aid. 
5. Describe caregiver perspectives on the support they receive from community health 
workers, the expected/perceived role of CHWs in their community, on the short videos, and 
on ECD services in the health facility. 
Research Questions 
▪ 
To what extent does the Malezi II radio messaging reach caregivers of young children? 
▪ 
To what extent are caregiver ECD perceptions, knowledge and reported parenting practices 
changed after introduction of Malezi II radio messaging to their communities? 
▪ 
Is there a relationship between reported listenership and/or message recall (dose) and 
caregiver ECD perceptions, knowledge and reported parenting practices? 
▪ 
To what extent does exposure to the Malezi II full intervention (MRV-CCD: radio messaging, 
video job aids, continued CCD program support) improve caregiver knowledge and parenting 
practices? 
▪ 
Does exposure to the Malezi II full intervention (MRV-CCD) improve caregiver knowledge 
and parenting practices significantly more than exposure to radio messaging alone (MR)? 
▪ 
To what extent do the CHWs adhere to the Malezi II training with regard to use of the video 
job aids, delivery of complete and accurate ECD messages, and general quality of counseling 
support? 
▪ 
Do the Malezi II video job aids improve the quality of CHW ECD counseling support given to 
caregivers in clinic and home settings? 
METHODOLOGY 
This study is a two-arm quasi-experimental pre-post evaluation design, comparing two interventions 
to establish their relative impact on caregiver knowledge and behaviors/practices among a cohort of 
caregivers of children 0-24 months at enrolment (baseline) and under three years after a 9-month 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 12 of 42 
intervention exposure period (endline). In addition, the quality of counseling support to caregivers, 
at health facilities and through home visits, will be assessed at baseline and endline in a cohort of 
CHWs recruited from the MRV-CCD full intervention group. Figure 2a provides an overview of the 
research design for objectives 1 and 2.  Figure 2b provides an overview of the research design for 
objective 3. 
 
Figure 2a. Research design overview – community component 
The study includes enumeration of all households in probability selected geographical units (national 
census enumeration areas) in catchment villages of selected health facilities, about 12-16 per 
intervention group. All households with resident caregivers of children 0-24 months of age will be 
eligible for recruitment into the caregiver cohort. Data collection includes two stages of 
recruitment/participation at baseline, whereby an eligible caregiver will complete a radio 
listenership survey during the household enumeration exercise, and will then be recruited into the 
caregiver cohort at a separate visit. Those consenting to the caregiver cohort will complete a 
detailed home-based caregiver survey at baseline and the same people will complete the 
listenership and caregiver surveys at endline. Table 1 provides an overview summary of data 
gathering activities. 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 13 of 42 
 
 
Figure 2b. Research design overview – community health worker component 

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Table 1. Data gathering activities 
Abbreviated 
Objective 
(1) Caregiver radio listenership patterns, 
exposures, and effect on caregiver ECD 
perceptions, knowledge and reported 
parenting practices nine months post-
intervention 
(2) Effect of Malezi II full intervention (MRV-
CCD) on caregiver’s knowledge and parenting 
behaviors/practices compared to MR 
intervention 
(3) Effect of short video job aids on the quality of 
counseling provided by the CHW in the clinic and the home 
(4) CHW perspectives and experiences with use of the 
short videos as a job aid 
(5) Caregiver perspectives and experiences with CHWs, 
short videos, and ECD services in the health facility. 
Design  
Two-arm pre/post intervention cohort(s) design  
About 30 health facility catchment communities 
(1) 12-16 facilities – MR intervention (radio messaging only) 
(2) 12-16 facilities – MRV-CCD augmented intervention (radio, video job aids, CCD 
package)  
Pre/post cohort, intervention MRV-CCD group only 
12-16 health facility catchment communities selected for 
the Malezi II evaluation study in MRV-CCD group 
Qualitative component with CHW FGDs and caregiver IDIs 
Study 
Activities 
▪ 
Baseline enumeration of households to identify eligible caregivers and administer 
listenership survey (1-2 months, baseline) 
▪ 
Recruitment into caregiver cohort, and baseline survey administration in the home (2-3 
months, baseline) 
▪ 
Conduct CHW training to use short videos (1 month) 
▪ 
Intervention exposure: short video use and radio messaging (9 months) 
▪ 
Caregiver cohort endline data collection (2-3 months) 
▪ 
Recruitment into CHW cohort, baseline questionnaire 
▪ 
Observations conducted in clinic and home (2-3 
months, baseline) 
▪ 
Conduct CHW training to use short videos (1 month) 
▪ 
Intervention exposure: short video use (9 months) 
▪ 
FGDs with subset of CHW and IDIs with caregivers 
during period of intervention exposure  
▪ 
CHW endline data collection (2-3 months) 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 15 of 42 
Abbreviated 
Objective 
(1) Caregiver radio listenership patterns, 
exposures, and effect on caregiver ECD 
perceptions, knowledge and reported 
parenting practices nine months post-
intervention 
(2) Effect of Malezi II full intervention (MRV-
CCD) on caregiver’s knowledge and parenting 
behaviors/practices compared to MR 
intervention 
(3) Effect of short video job aids on the quality of 
counseling provided by the CHW in the clinic and the home 
(4) CHW perspectives and experiences with use of the 
short videos as a job aid 
(5) Caregiver perspectives and experiences with CHWs, 
short videos, and ECD services in the health facility. 
Data sources 
/ methods 
Enumeration/enrolment questionnaire: 
▪ Background / SES 
▪ Listenership survey (dose) 
▪ Basic caregiver 
knowledge/attitudes/practices (awareness 
of developmental needs) 
Administered by data collectors at 
enumeration and endline in community 
Caregiver questionnaire: 
▪ In-depth caregiver capacity and 
psychosocial status (stress, anxiety, 
depression, IQ) 
▪ Parenting attitudes (discipline), practices 
(borrow RISE, MICS, other) 
▪ CHW exposure 
▪ Video exposure and listenership at endline 
Administered by research associates in home 
(by appointment after enumeration) 
CHW questionnaire: 
▪ Background/SES 
▪ CHW practices, attitudes and capacity (IQ) 
▪ Psychosocial status (anxiety, depression) 
▪ Listenership survey  
▪ Use of and attitudes toward videos at endline 
CHW observation checklists: 
▪ Checklist for home (2 visits at baseline; 2 visits at 
endline) 
▪ Checklist for clinic (2 assessments at baseline and 2 at 
endline) 
Completed by research associates in home and clinic 
FGDs/IDIs using qualitative guides 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 16 of 42 
Intervention Description  
In all study districts, study participants will receive services according to the national standard of 
primary under-5 health care. This encompasses MNCH/PMTCT clinical care, routine immunizations, 
and identification and referral of health and development problems to the district hospital, and if 
necessary, referral to the regional level (secondary) or a zonal hospital (tertiary). In addition, 
national guidelines authorize community cadres to support primary health care messaging, patient 
and community education and mobilization to seek health services, and individual referrals from 
community to facility, largely issued during home visiting of pregnant women, mothers of young 
children (under 5), and HIV-positive individuals. Community cadre guidelines for MNCH-trained 
community health workers stipulate that pregnant women should receive four visits, mothers of 
children under one year should receive seven visits, and mothers of children 1-4 should receive 
quarterly home visits. A designated MNCH health provider at facility will supervise CHWs assigned to 
that facility, and is expected to provide periodic mentoring support to the CHWs and to hold 
monthly meetings at the health facility where CHWs compile and submit monthly reports, share 
experiences, and challenges. 
In addition to this national standard of care, two interventions will be delivered as part of this 
evaluation (Table 2). The first intervention introduces ECD radio messaging in Tabora, targeting radio 
stations that are most likely to reach communities in all study areas (Nzega, Igunga, Kaliua, Uyui). 
The second intervention introduces short video job aids and training of CHWs in use of those job aids 
during individual counseling of caregivers at home visits and group counseling of caregivers in 
facilities, in addition to the radio messaging component. Furthermore, this second intervention 
package will also be implemented in areas where the Malezi I CCD program was established in 2016, 
and have received continuous support and monitoring since then from the Malezi program team in 
collaboration with local government authorities as part of routine supportive supervision to health 
services.  
The radio messaging in both intervention groups, and the short videos in the second intervention 
group (only) will be introduced after the baseline assessment of the caregiver cohort. The exposure 
period for the two interventions, as described in Table 2, will be for nine months, followed by the 
endline assessment of caregivers. 
Table 2. Description of intervention packages in two study arms 
Intervention group 
Description and expected exposure (dose) 
Malezi II minimum 
package 
Radio (MR) 
Radio messaging spots  
Dose: Up to 35-40 different messages, 3 stations aired on (2 regional, 1 
national), about 10 times per day; 7 days per week airing frequency; 9 months 
duration of exposure 
▪ 
Caregiver exposure to radio messaging during 9-month period: 
currently unknown, but estimated at 50% of caregivers hearing about 7 
messages/week. 
Malezi II full package 
Radio, Video Job Aids, 
CCD program (MRV-CCD) 
Radio messaging spots  
▪ 
Same as MR group 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 17 of 42 
MRV-CCD 
Short video ECD job aids (with training) 
Five short ECD mobile films (videos) of 3-5 minutes each will feature a mixture 
of real-life testimonies and scripted interactions between health workers and 
caregivers, and demonstrations of caregivers stimulating their young child. Each 
video will show a range of age-appropriate ECD practices that encourage child 
development (play; communication; positive caregiver-child interaction; 
safe/stimulating environment; positive discipline), illustrating skills and 
providing knowledge. All videos will have some cross-cutting content, 
emphasizing the general benefits of ECD activities during the early years, and 
one video will be devoted exclusively to cross-cutting parental guidance 
on developmental milestones and benefits of applying ECD practices. Four 
videos will target specific age groups (0-5, 6-11, 12-23, >=24 months). 
 
Caregiver exposure to group counseling at clinic is estimated to be 2-4 sessions 
in a 9-month period 
 
Caregiver exposure to individual counseling at home is estimated to be 3-6 
sessions in a 9-month period 
MRV-CCD 
Malezi I CCD program established (2016-17), with continuing technical and 
M&E supervision 
▪ 
ECD (CCD-based) knowledge and education/counseling skills training (4 
days didactic and practice) to facility-based and community health 
providers, including translated CCD-based manual with job aid 
▪ 
M&E tools and refresher training 
▪ 
Continuing joint quarterly supportive supervision to Malezi-supported 
facilities and CHWs with government health authorities 
▪ 
Creative toy building training to support sustainable replenishment of 
toys for ECD sessions 
▪ 
Toys (mostly home-made or safe household objects) and play mat for 
use in facility group sessions and home visits 
▪ 
Materials for CHW work in facilities and homes:  
o CCD participants’ manual  
o CCD counseling card or new developed Flipbook which is a 
pictorial modified CCD counseling card  
o A bag of age appropriate play materials 
 
The methodologies of each intervention arm have been tested independently (although not in a 
combined package) in high income countries and in some LMIC, showing varying degrees of 
effectiveness in changing caregiving behaviors (16). This research is therefore not an efficacy study, 
but instead tests the real world effectiveness of the additional value added from multi-media 
interventions. The Malezi Radio (MR) intervention group will assess the effectiveness of a mass 
media communications strategy targeting caregivers in communities, without having built the 
capacity of the health care system to reinforce ECD messaging and responsive caregiving skills. The 
Malezi Radio, Video and CCD (MRV-CCD) intervention group will assess the effectiveness of adding 
mass media communication and CHW-capacity to use short ECD video job aids in the context of a 
health care system with an established CCD program. 
 
 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 18 of 42 
Location 
The research study will be implemented in four selected districts of Tabora region. Recruitment of 
MRV-CCD intervention participants will take place in Malezi health facility catchment areas of Nzega 
and Igunga districts, while recruitment of the MR intervention participants will be done in districts 
outside of the Malezi program areas, Kaliua and Uyui districts.  
 
Figure 3. Tabora Region and Districts 
The Tabora region is home to a predominantly rural (87%) population, located centrally among 31 
regions in Tanzania. Most economic activity in Tabora is agricultural (40). In Tanzania, about 8 in 10 
adults are literate (77% of women and 83% of men), with about half having completed primary 
education, and 23% of women and 28% men having secondary or higher education (38). Currently, 
there is no school enrollment disparity between girls and boys. The Malezi project is implemented in 
three of Tabora’s seven districts: Nzega, Igunga and Tabora Municipal.  
Study Population 
There are two populations in this study:  Caregivers and community health workers.  A caregiver is 
defined as someone who lives in the household, is recognized by others in the family/community as 
the child’s parent or guardian, and is responsible for the child’s eating and sleeping on most days of 
the week.  
Eligibility criteria for caregivers are: 
▪ 
Caregiver to a child aged 0-24 months (the index child) at time of recruitment  
▪ 
Resident in enumerated household and intending to remain resident in the same 
village/community for at least one year* 
▪ 
Willingness to be home-visited by a CHW 
▪ 
Age 18 years or older  
▪ 
Able to understand and willing to provide informed consent 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 19 of 42 
* Only one caregiver per household will be eligible to participate.  In case there is more than one 
present at the time of enumeration, the caregiver of the youngest child will be selected.   
Exclusion criteria for caregivers are: 
▪ 
Index child has an anomaly (congenital) or other disability identifiable at recruitment 
▪ 
Caregiver impairment of hearing, sight or speaking 
▪ 
Working as a CHW or medical provider 
In the Tanzanian setting, CHWs are defined as “female and /or male individuals chosen by the 
community and trained to address health issues of individuals and communities in their respective 
localities, working in close relationship with health facilities.” CHWs work on a volunteer basis, 
receiving a small stipend for their efforts, and are supervised by a facility-based health provider. 
Eligibility criteria for CHWs are: 
▪ 
Assigned to a Malezi II study health facility/catchment community  
▪ 
Working as a Malezi II project CHW (i.e. attended Malezi (I or II) training, or capacitated for 
Malezi II project through on-job training and mentoring) 
▪ 
Able to understand and willing to provide consent 
There are no exclusion criteria for CHWs. 
Sample Size Calculations  
The outcome parameters used for sample size calculations for objectives 1 and 2 are estimated from 
the Malezi I program evaluation baseline data (before introduction of CCD program), comparable to 
what we would expect in the MR intervention group, who have not been exposed to any CCD 
intervention.  From 24-29% of caregivers reported having a local or shop toy in the home, 22% 
reported singing to the child in the past month, and 7-13% reported reading or writing with the child 
in the past week.  
Objective 1: To determine caregiver radio listenership patterns at baseline, and exposures to the ECD 
radio messaging nine months’ post-intervention, and effect of radio exposure on caregiver ECD 
perceptions, knowledge and reported parenting practices, using pre-post surveys in a cohort of 
caregivers of children 0-24 months of age at baseline, in study communities from each intervention 
arm. 
A sample size of 593 enrolled in the MR intervention group will provide 80% to detect a 5% or 
greater change from baseline (10%) to endline (15%) in the MR intervention group, taking into 
account 15% LTFU, design effect of 1.2, and estimated correlation of 0.4 between respondents at 
baseline and endline (Table 3).  This sample size will provide even greater power to detect a 10% 
difference if baseline estimates are higher than 10%. 
 
 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 20 of 42 
Table 3. Sample size estimation* parameters, MR group, caregiver cohort, pre-post 
  
Prevalence of key outcome 
Power 
Sample 
size 
Adjusted Sample 
size (15% LTFU, 
DE 1.2) 
Arm 
Baseline 
Endline 
Expected 
Change 
MR (Malezi radio) 
10% 
15% 
5% 
80% 
420 
593 
20% 
30% 
10% 
99% 
419 
592 
25% 
35% 
10% 
98% 
411 
580 
 *STATA 14 paired proportions large-sample McNemar’s test at 5% level significance. 
 
Objective 2:  To determine whether the Malezi II full intervention (MRV-CCD) significantly increases 
caregiver’s knowledge and parenting behaviors/practices when compared to radio messaging alone, 
using a pre-post quasi-experimental evaluation design in a cohort of caregivers of children 0-24 
months of age at baseline, in MRV-CCD and MR communities. 
The change between baseline and endline in the Malezi I evaluation for the above-mentioned 
indicators ranged from 10-30% after introduction of the Malezi I CCD program.  With the introduction 
of radio messaging only, we estimate a 5-10% effect size, and about a 20-30% effect size in the full 
intervention (MRV-CCD) group (Table 4). 
We estimate that a sample size of n=430 caregivers per intervention group will provide 90% power 
to detect a 15% “difference-in-differences” between the MR and MRV-CCD intervention groups at 
endline, and >80% power to detect a 5% change in the MR intervention group, and a 20% change in 
the MRV-CCD intervention group between baseline and endline, at a level of 5% significance.  Taking 
into account a 15% non-retention rate and a design effect of 1.2, we will aim to enroll 1214 into the 
caregiver cohort or n=607 in each intervention group. 
Table 4. Sample size estimation* parameters, MR compared to MRV-CCD groups, caregiver cohort, 
pre-post and differences-in-differences  
  
Prevalence of key outcome 
Power Sample 
size 
Adjusted 
Sample 
size (15% 
LTFU, DE 
1.2) 
Arm 
Baseline 
Endline 
Expected 
Change 
MR (Malezi radio) 
10% 
15% 
5% 
81% 
430 
607 
MRV-CCCD  
(Malezi radio + radio + CCD program) 
25% 
45% 
20% 
>99% 
430 
607 
Difference 
15% 
30% 
15% 
 90% 
860 
1214 
*Sample Size and Power estimated by a simulation of the DID Analysis using R Software Package. 
 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 21 of 42 
Objective 3. To determine whether the introduction of short video job aids (training, provision, 
supportive supervision) to the Malezi II CCD program improves the quality of counseling provided by 
the CHW in the clinic and the home, using pre-post observation fidelity checklists for all CHWs 
working in the MRV-CCD communities. 
The Malezi I evaluation assessed CHW-reported time spent in the home providing ECD messages to 
pregnant women or caregivers of children under 5 at baseline (14-17%) and endline (64-74%).  While 
the change was substantial, we estimate that the actual CHW counseling skills would be lower using 
an observation checklist compared to CHW self-reported behaviors. We conservatively estimate that 
CHWs in the MRV-CCD intervention group, already trained in the Malezi I CCD program, will score at 
50% on the baseline observation checklists in this evaluation, increasing 15-20% after introduction 
and capacity building in using the short videos. 
Table 5 shows that a sample size of 123 CHWs will achieve 80% power to detect a 15% change 
between baseline and endline in CHW quality of counseling checklist score, taking into account a 
correlation of 0.4 between measures, a 5% non-retention rate and a design effect of 1.1. 
Table 5. Sample size estimation* parameters, MRV-CCD CHW cohort, pre-post 
  
Prevalence of key outcome 
Power 
Sample 
size 
Adjusted Sample 
size (5% LTFU, DE 
1.1) 
Arm 
Baseline 
Endline 
Expected 
Change 
MRV-CCD  
(Malezi radio + radio 
+ CCD program) 
30% 
45% 
15% 
80% 
102 
118 
50% 
65% 
106 
123 
70% 
85% 
78 
90 
*STATA 14 paired proportions large-sample McNemar’s test at 5% level significance. 
 
Selection Criteria for Study Communities 
The study will be implemented in probability selected geographic areas of the catchment villages 
surrounding selected health facilities in four districts of Tabora region. The health facilities will be 
purposefully selected, including the district hospital in each of the four districts.  Each primary health 
facility has clearly designated villages assigned to that facility (about 3-7), and each village has 
recognized boundaries, administrative units and census enumeration areas (EA), defined by the 
National Bureau of Statistics (NBS). Further details on sampling EA units are described later in this 
protocol.  District hospitals do not have village catchments because they are secondary level facilities, 
but up to about 7 villages immediately surrounding the district hospital will be included in the 
sampling frame. 
All facilities will meet the following eligibility criteria at baseline: 
1. Accessible by road in all seasons 
2. Has at least 3 CHWs and sufficient health provider staff to maintain MNCH/PMTCT clinic as 
expected (2-5 days per week) 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 22 of 42 
The MRV-CCD and MR communities each have additional recruitment criteria.  
MRV-CCD catchment communities should also:  
▪ 
Be located in Nzega or Igunga districts  
o Exclusion: Malezi CCD-program supported facilities in Tabora Municipal, because 
there are no comparably urban facilities in non-Malezi districts. 
MR facility catchment communities should also: 
▪ 
Be located in Kaliua or Uyui 
▪ 
Have new antenatal care attendees in the past year comparable to facilities in MRV-CCD 
communities (within about 25% variance). 
Given the small cluster size, it was not possible to randomly allocate sites to intervention groups.  
Sampling within Study Communities 
Study communities are defined as the villages within the catchment area of the selected health 
facilities (n~30). The NBS EA census maps, estimating the total number of households in that EA as of 
the last census (2012) will constitute the sampling frame. The sampling unit will be the EA, and the 
sampling approach will use probability proportional to size (PPS).  This will result in the final 
selection of EAs being statistically representative of the total population within selected study 
communities of each study district. 
EAs average about 50 households, and do not overlap with other recognized administrative units 
(ward, village, hamlet, street), but their area and population size could vary from 20-100 households, 
and household size varies as well. The most recent census showed 19% of rural households had 
children under 5 years, and that Tabora averaged six persons per household. Since this evaluation 
targets caregivers of children 0-24 months of age at the time of recruitment, that means that an 
estimated 7.6% of households would be considered eligible ([19/5]*2). Thus a sample of about 250-
300 EAs will be selected, using the estimate of 8% of households being eligible. Then, recruitment 
rates will be monitored to know whether additional EAs will be needed or not.  In case they are 
needed, a second sampling also using PPS will be done, and all households in the second-sample EAs 
will be visited. In case too many EAs are sampled, and our expected sample size would be far 
exceeded by including all sample EAs, targets by ward will be calculated (proportional to expected 
sample size), and once the target has been reached within a ward, no additional EAs will be included 
for that ward.  However, once an EA is “opened,” all households in that EA should be enumerated, 
even if the target is then exceeded for that ward.   
Recruitment into the Caregiver Cohort 
Recruitment into the caregiver cohort will take place in two stages, whereby potentially eligible 
caregivers are identified through household enumeration, screened for study eligibility, and invited 
to verbally consent to participate in the listenership survey (stage I). On another day during the 
baseline data collection period, all eligible and participating caregivers will be revisited for re-
screening, informed consent, enrolment into the caregiver cohort, and full baseline survey 
administration (stage II). We expect less than 5% loss between recruitment into in stage I 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 23 of 42 
(listenership) and stage II (caregiver cohort).  However, based on study methodology for complete 
enumeration of every “opened” enumeration area, it is possible that we will complete more than 
the expected number of listenership surveys in some wards.  Where the number of listenership 
surveys completed is more than 10% greater than the ward’s target for cohort enrollment, selection 
of listenership participants for caregiver recruitment in that ward will be made using systematic 
random sampling. Those who participate in stage I only at baseline but are not selected for 
recruitment into the caregiver cohort, will not be continued in the study, and will therefore not be 
revisited for the endline listenership survey. 
Data collectors with at least secondary or higher education, and trained in enumeration, eligibility 
determination, verbal consent and listenership survey administration will conduct stage I study 
procedures.  Research Associates (RAs) with at least post-secondary or higher education, and trained 
in eligibility determination, written consent procedures, and the full caregiver survey will conduct 
stage II study procedures.  
Stage I: Enumeration of households and caregiver listenership survey 
Data collectors (enumerators) will be escorted by local leaders to facilitate community entry, 
complete listing within the EA boundary, and household introductions. All households within the 
selected EAs will be enumerated and classified as an eligible household for study recruitment if at 
least one caregiver of a child 0-24 months of age at the time of the enumeration visit resides in that 
household with the child.  
Enumeration is defined as the process of identifying structures that are households (as opposed to 
vacant or commercial buildings), assigning a unique number to each household, and determining the 
study eligibility status of each household. After appropriate introductions, enumerators will ask to 
speak to an adult (>18 years) in the household, and ask how many people live in the household and 
whether the household includes any children “age 2 or younger” and will record the answer. If there 
are no young children reported, the household will be documented as ineligible and no further 
information collected. If there are young children in the household, a complete listing of any child 0-
24 months of age, by first name and date of birth (or approximate age), will be collected. A complete 
listing of children “age 2 or younger” is done to ensure that no child 0-24 months is missed, as it will 
allow for further screening of potentially eligible caregivers by verifying exact age using dates of 
birth as reported by caregivers. 
Household classification outcomes of enumeration are:  
1. Eligible and willing to participate 
o Caregiver-verified child 0-24 months of age lives in household 
2. Potentially eligible 
o Neighbor or other household resident reports child(ren) under 2 live in household, 
but listing not completed and/or caregiver verification not done 
3. Potentially eligible, refused 
o Household informant refused participation at household level 
4. Eligible, refused 
o Caregiver-verified child 0-24 months lives in household, but caregiver refused 
participation 
5. Not eligible 
o No child 0-24 months lives in household 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 24 of 42 
6. Unknown  
o No knowledge of household residents after >=2 attempted visits (vacant, absent) 
 
Caregiver participation outcomes from households classified as eligible and willing to participate (1) 
are: 
▪ 
Verbally consented, completed listenership, accepted referral for recruitment into caregiver 
cohort 
▪ 
Verbally consented, completed listenership, refused referral for recruitment into caregiver 
cohort 
▪ 
Refused listenership (and therefore not referred for recruitment into caregiver cohort) 
 
A household is defined as any structure where one or more people eat and sleep.  Vacant 
households will be enumerated based on information provided by a neighbor or other community 
member (local leader).  There could be several “households” in a family compound, if they are 
separated by their physical structure.   
Selection of caregivers for the listenership survey will be done using the listing of children, age 0-24 
months, in the household. The enumerator will ask to speak with caregivers of all listed children in 
order to identify only those children who are verified as 0-24 months years, by birth date, or 
caregiver reported age. If the household has more than one caregiver of children with verified ages 
0-24 months years, the caregiver of the youngest child will be selected for participation. In case the 
caregiver with the youngest child is not present at the time of enumeration, another eligible 
caregiver will be selected. If no caregiver of listed children is available at the time of enumeration, 
the enumerator may return at a later time or another day to complete the enumeration visit.  
Verbal consent will be obtained before administering the listenership survey and collection of 
contact details for stage II recruitment into the study. During the verbal consent process, the study 
will be described, and respondents will be asked permission to be re-contacted by a RA for further 
discussion about study participation (i.e. written consent and baseline survey). Household address, 
name and phone contacts (if available) will be documented by the enumerator and shared with the 
research associate for stage II recruitment. 
Stage II: Caregiver cohort enrolment and follow-up  
Consenting caregivers at stage I may be revisited by a RA, by appointment or directly through a 
home visit (if no appointment could be made by phone). After a brief study re-introduction, the RA 
will request to come inside the house without the escort and will complete the recruitment 
procedures in a private setting. Recruitment procedures entail eligibility re-screening, written 
informed consent, and documentation of enrolment. After enrolment, the baseline caregiver survey 
will be administered that day or another date/time, as agreed. 
Data Collection: Caregiver Cohort 
Both survey instruments described below will be programmed onto tablets for offline electronic data 
collection, with pre-programmed skip patterns and synchronization to a server as soon as the 
tablet’s data access is enabled.  This will allow for close monitoring of data collected in real time, and 
identification of any systematic errors or weaknesses in specific questions or sections that may 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 25 of 42 
require clarification or re-training of research associates. All interviews should be done in a private 
room or location; the caregiver’s young child(ren) may be present.  
The enumeration listing will require about 5-10 minutes to complete, and will include 
documentation of children in the household 0-24 months, by date of birth, age, and first name.  
Household ID number and location coordinates, and other details describing location will also be 
documented. 
The screening form will require about 5-10 minutes to complete, and will include documentation of 
all inclusion and exclusion criteria, household identification details, and confirmation by the data 
collector that the respondent provided informed verbal consent for participation.  
The locator form will require about 5-10 minute to complete, and will include documentation of the 
household’s location and description, and the caregiver’s contact details (phone numbers), and 
preferred times/days to be re-contacted for stage II participation.  
The listenership survey will require 15-30 minutes to complete, and will include questions about the 
household’s socio-economic status (assets, wall/roof materials) and the informant’s demographics 
(age, sex, position in household in relation to the child, employment, followed by questions about 
their exposure to radio communication, and recall of health education messages (including ECD-
related) with respect to content, and source. Most study questions on this survey instrument have 
been used previously in Tanzania by this team or other researchers.  
The caregiver survey will require about 60 minutes, and include questions as follows: 
▪ 
Child characteristics (registration status, feeding) 
▪ 
Baseline exposure to CHW home visits, child health, health care seeking 
▪ 
ECD and early stimulation knowledge and practices (including discipline) – excerpted from 
UNICEF’s MICS6* tool (42,43) and Stellenbosch University’s RISE tool designed for 
standardized ECD/CCD program monitoring and evaluation 
▪ 
Depression, anxiety, parenting stress, and cognitive ability (non-verbal IQ) 
▪ 
Household environment (safety, play, shared caretaking) 
▪ 
Exposure to Malezi program videos and radio messaging (at endline only) 
Outcomes and Measures: Caregiver Cohort 
Primary outcomes of caregiving behaviors/practices are: 
▪ 
Caregiver knowledge: Reported knowledge about ECD and perceived importance of early 
stimulation 
▪ 
Caregiver behaviors/practices: Reported responsiveness and discipline practices 
▪ 
Child stimulation practices: Reported early stimulation practices, such as play, 
communication, teaching, access to education materials 
Secondary outcomes are: 
▪ 
Child environment: Reported risk and safety measures/practices, observed risks in the 
household environment 
▪ 
Acceptability of videos: Caregiver perceptions of ECD videos (e.g., culturally acceptable, 
useful) 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 26 of 42 
Other measures included as potential confounders or covariates are: 
▪ 
Caregiver cognition: Evidence suggests that maternal intelligence may moderate the 
intervention effects (44). 
▪ 
Parenting stress: Parenting stress, parent-child interactions, perception of child behaviors. 
There is literature to suggest that parenting stress is prevalent in Africa (45) and is strongly 
associated with child neglect and lower quality parenting environments (46). 
▪ 
Caregiver depression: Evidence suggests that depression may reduce the quality of 
caregiving (14). 
The following standardized assessments are included:  
IQ - Ravens Standard Progressive Matrix (Ravens): Maternal cognition will be measured using the 
Raven's Standard Progressive Matrices (often referred to simply as Raven's Matrices) (47). It is the 
most common test administered to groups ranging from 5-year-olds to the elderly and has been 
used widely in Sub-Saharan Africa (48). It is a non-verbal assessment, making it culturally sensitive, 
and takes between 12-15 minutes to administer, dependent on caregiver capacity. It is used to 
measure abstract reasoning, with the score being regarded as a non-verbal estimate of intelligence.  
The measure includes 60 questions, and is presented as a series of 2-dimensional pattern-matching 
matrices in which 1 small section is missing. Participants are asked to choose from 6 options the one 
that best fits the missing section. The items become progressively more difficult, and the assessment 
is stopped when the participant gives 3 consecutive incorrect answers. 
The raw scores from the Ravens assessment will be calculated by totaling the number of correct 
answers given. These continuous raw scores will be used as an indication of general cognition given 
that tables establishing norms for the Tanzanian adult population are not available. Raw scores will 
be tested for normal distribution, and a midpoint continuous score can be used as a cut-off for low 
and high cognition within the group. 
Caregiver stress and the quality of the parent-child relationship - Parenting Stress Index (PSI-36): The 
PSI is a widely used robust measure of three parenting related domains: Parental distress, parent-
child relationship dysfunction (e.g. quality of relationship), and the extent to which the caregiver 
perceives the child is difficult (49). The scale is composed of 36 statements (12 per sub-scale domain) 
which are scored 1 (strongly disagree) to 5 (strongly agree), and can be summed to reflect the total 
score for each domain. A defensive responding score can also be calculated to determine social 
desirability biases.  
To determine parenting stress, items are scored into each of the 3 subscales, with each subscale 
score ranging from 12-60. The PSI-36 Total Stress Score is a composite score of the three subscales 
(scores range 36-180) with higher scores indicating higher parental stress (50).  
Caregiver mental health, depression - 9-item depression/anxiety scales, PHQ-9 and GAD-7:  The 9-
item Patient Health Questionnaire tool has been widely used in resource limited settings, and 
recently validated in a Tanzanian primary care population, showing 78% sensitivity and 87% 
specificity in detecting depression when compared to a gold-standard psychiatric assessment (51). 
The items are scored on a 4-point scale, from 0-3, and a cut-off score of 9 was determined to be 
optimal in classifying depressive symptoms, though a continuous score could also be used.  

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 27 of 42 
The General Anxiety Scale of the Patient Health Questionnaire, measures the seven criteria of 
anxiety in the Diagnostic and Statistical Manual of Mental Disorders (52). These 7 items can establish 
provisional anxiety diagnosis and assess symptom severity. A systematic review and meta-analysis of 
both the PHQ9 and GAD7 (53) found that the GAD-7 has good operating characteristics for detecting 
generalized anxiety, panic, social anxiety and post-traumatic stress disorder. The GAD-7 has been 
used in LMIC settings (54,55), with HIV infected populations (56,57) and in South Africa (58). 
Caregiver behaviors/practices will be measured using the UNICEF Multiple Indicator Cluster Survey 
(MICS): MICS is a widely validated survey used in over 100 countries over the past two decades and 
had been used in large-scale surveys in 27 African countries. The data collection will be limited to 
relevant sub-sections of the MICS -- Early Child Development, Child Discipline, and selected items 
related to birth registration, child feeding, and health seeking/utilization (42,43). 
Recruitment into the CHW Cohort (MRV-CCD Group) 
CHWs will be recruited through the facility they are attached to in the 12-16 MRV-CCD intervention 
group facilities only in Nzega or Igunga districts.  Research associates will liaise with the nurse in-
charge of the reproductive health clinics to know the day/time that CHWs come to the clinic for 
work or reporting responsibilities. The research associate will describe the study to the CHWs in a 
group or individually, and then obtain informed consent in a private meeting.  
Inclusion criteria are: 
▪ 
Assigned to one of the selected MRC-CCD intervention group facilities and catchment 
communities  
▪ 
Working as a Malezi II project CHW* 
▪ 
Able and willing to provide informed consent 
* Attended Malezi I or II training, or capacitated for Malezi II project through on-job training and 
mentoring 
▪ 
There are no exclusion criteria. 
Sampling for Observed Sessions 
Facility group education sessions will be selected by convenience, and will be completed largely 
consecutively, as research associates are able to organize travel to all selected facilities, with 
approvals from and in coordination with District authorities and nurse in-charge of each facility. The 
study coordinator will monitor all completed facility observations and as data collection progresses 
and fewer CHWs at selected sites have not yet completed their observations, the supervisor will 
actively schedule site visits in collaboration with the nurse-supervisor so that duty rosters are 
shared, or even modified as needed to accommodate the data collection schedule.   
Households for observation of CHW counseling to caregivers will be consecutively recruited from the 
enrolled caregiver cohort in the MRV-CCD intervention group.  As caregivers are enrolled, their 
household location will coincide with a particular CHWs’ catchment area and they will be matched to 
their respective CHW.  With an expected 607 caregivers enrolled in the MRV-CCD group and even 
distribution by age group, we would expect about 150 to have children less than 6 months, 150 with 
children 6-11 months, and 300 with children 12-23 months.  Also assuming even distribution of 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 28 of 42 
enrolled caregivers by CHW catchment areas and by child age group, we would expect each CHW 
(about 120) to have about 5 caregiver-cohort enrolled households.  The study coordinator will select 
caregivers for CHW observations largely consecutively, but will also purposely select caregivers of 
children if different age groups.   
Data Collection: CHW Cohort 
CHW’s will be asked to complete baseline and endline structured interviews, and agree to being 
observed, at baseline and endline, during two group education sessions at the facility and two home 
visit counseling sessions with caregivers.  
Pre-post questionnaire: At baseline the enrolment form will be used to collect information, using a 
structured tablet-based interview, on CHW characteristics (demographics, history of CHW work), 
training, ECD knowledge and attitudes. This form will be re-administered at endline, including a 
module on CHW use of, and attitudes toward the ECD videos.  
Observation checklists: Two separate observation checklists will be completed by the RA, one for 
clinic health education session and another for the home session. These checklists will document (a) 
background information on the environment and participants (home/clinic, caregiver relation to the 
child, child age [home], or number of clients in the education session and topics discussed [clinic]); 
and (b) score a series of items describing what the CHW did on a two or three-point scale (done/not 
done or done, partly done, not done). These scored items are either the “soft skills” of mentoring, 
such as “actively listens to the caregiver with minimal interruption” or practical behaviors that help 
to build caregiver skills in early stimulation such as “asks how the caregiver gets the child to smile.”  
The checklists at endline will assess specific aspects of video use, which will not be applicable at 
baseline. 
Clinic observations: As described above, the RA will liaise with the nurse in-charge to know the CHW 
duty roster in order to schedule clinic observation visits. CHWs should not know in advance which 
day they will be observed, though it will be impossible for the CHW not to be aware of the observer 
once the session begins. Prior to the session starting, the RA will introduce him/herself to the 
caregivers attending the CHW’s counseling session and explain his/her purpose for being there. We 
are requesting a waiver of informed consent for the observations as described below. Any caregiver 
who prefers not to be part of the session for any reason will be excused. The clinic sessions will last 
from 10-60 minutes. 
Home observations: Each enrolled CHW will be observed at two home visits with two different 
caregivers. The RA will focus on observing the CHW’s behaviors in mentoring and providing feedback 
to caregivers on ECD and early stimulation (CCD). The observing RA will explain to the CHW that s/he 
should do what they normally do to assess, support, educate and mentor caregivers during a home 
visit. While the CHW may discuss health issues beyond CCD (immunization, postnatal care, medical 
referrals for illness, etc.), the data collection tool completed by the RA will be focused on observing 
and rating of behaviors/practices and interactions related to CCD only. 
Home visit sessions will also be audio/video recorded using lapel cameras worn by the CHW and the 
caregiver. Collecting video observations is a standard observational tool that allows for rigorous 
coding of counselor behaviors.  Lapel video cameras are unobtrusive and can be worn by the CHW 
and caregiver in a manner that captures both perspectives.  Thus, two separate videos of each 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 29 of 42 
session will be viewed by independent RAs who will complete the checklist, in addition to the RA 
who will be present at the session and scoring the observation checklist in real time. 
Only caregivers who have consented to participate in the study cohort will be visited for CHW 
observations.  On arrival at the caregiver’s home, the RA will first remind the participant about the 
study and reconfirm caregiver consent to being observed by the RA and video-recorded during the 
session before the CHW proceeds with the home visit observation. Caregivers will be free to decide 
not to be observed, or to allow observation without video recording, without penalty; the CHW 
counseling session will proceed with or without these evaluation components. The home sessions 
will last about 10-60 minutes. 
Outcome and Measures: CHW Cohort 
Outcomes characterizing CHW capacity and the quality of CHW-caregiver interactions, and how CHW 
capacity and mentoring skills may change between baseline and endline after introduction of ECD 
videos, are grouped into four main categories: 
1. CHW knowledge: of ECD and early stimulation 
2. Compliance with message delivery:  How well does the CHW demonstrate clear 
communication of ECD messages? 
3. Responsiveness and listening skills: Does the CHW demonstrate good listening and 
communication skills, establishing good rapport and showing empathy? 
4. Acceptability of videos: Whether CHW report video job aid to be useful, user friendly and 
acceptable and whether any challenges with use were observed or reported.  
Given their potential to modify CHW capacity to deliver the intervention, the following 
characteristics and standard assessments will also be completed with CHW.  
IQ - Ravens Standard Progressive Matrix (Ravens): Refer to above description. 
Mental health, depression/anxiety (PHQ-9, GAD-7): Refer to above description. 
CHW reported activities: The intensity and frequency of CHW responsibilities (e.g. number of 
households visited, frequency of visits) will be assessed in the pre/post structured interviews, as well 
as CHW training and duration of working as a CHW. 
Media listenership: Questions from the caregiver listenership will be included in the CHW 
baseline/endline questionnaires, assessing exposure to radio communication, and recall of health 
education messages (including ECD-related) with respect to content, and source. 
Scoring observations of CHW sessions  
Video observations will be coded and scored by trained staff using a standardized checklist, and a 
sample of 20% of all videos will be double coded by another trained member of the study team to 
ensure reliability of coding.  
Observation checklists for each CHW, by type of observation (clinic, home) and timing of observation 
(baseline, endline), will be averaged across all measures.  Thus, a CHW’s baseline or endline home 
score will be the average score of the in-person observation checklist scores (2 data points) and the 
video scores from two home visits (2 data points).  A CHW’s clinic score at baseline or endline will be 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 30 of 42 
the average of two data points, based upon the in-person observation checklist scores at two clinic 
sessions.  Each checklist score will impute missing values as the mean score for other values in that 
section, and an observation with more than 20% missing values will be considered invalid (and 
should be re-done). 
Process Evaluation: MRV-CCD Group 
The primary purpose of the process evaluation is to establish the fidelity of CHWs to the full Malezi II 
intervention package, specifically monitoring CHW practices and use of the short videos throughout 
the intervention period.  The process evaluation component will also systematically collect routine 
program monitoring data from the MRV-CCD index facilities and CHWs with respect to 
developmental referrals made, number of group session held, and number of CHW home visits 
reported. 
During the 9-month exposure period, research associates will aim to conduct CHW observation 
checklists (as designed for the baseline/endline data collection) on each MRV-CCD group CHW at 
least once/quarter for clinic sessions and twice/quarter for home sessions. This translates to about 
246 home and 123 clinic checklists completed per quarter (total 369), or about 185/RA/quarter, or 
roughly 3 per day.  
Focus group discussions 
As part of the process evaluation, about four focus group discussions (FGD) will be held with 
approximately 6-10 CHW each in the MRV-CCD intervention group for a total estimated number of 
24-40 purposively selected FGD participants. These will include CHWs from different districts to 
account for any potential geographic differences and CHWs will be further recruited to have a 
gender balance, and to represent those who have checklist scores at the higher and lower end of the 
distribution to ensure that all perspectives including challenges can be elicited. In addition to limited 
demographic data, topics in the FGD guide will address three main areas: CHW salience and 
relevance of the program to the CHW’s work, barriers and facilitators to implementing the Malezi II 
program and experiences with use of the short videos as a job aid.  
The FGDs will be conducted by qualitatively trained researchers and will include a facilitator and 
note-taker for each session. The FGDs will be conducted in Kiswahili and are expected to last 
between one and a half to two hours. All sessions will be audio recorded with the consent of the 
participants to allow for complete data capture and subsequent review for accuracy and quality 
assurance. For each FGD, about 6-10 CHW who work or reside in relative close proximity will be 
informed of the FGD meeting location and date following their agreement to join the study. 
Participants will be reimbursed for their transport to the FGD location and half per diem to cover 
other expenses related to being away from their home and communities for the day.  
In-depth interviews 
A sample of approximately 20-25 caregivers enrolled in the study cohort will be recruited to 
participate in in-depth interviews around the time that the FGDs are conducted. Caregivers who 
were recently visited by a CHW and observed by a research associate will be listed for selection in 
each district. About 20-25 CHWs assigned to those caregivers will be randomly selected, and then up 
to 2 caregivers assigned to those selected CHWs will be purposely selected based on the relative 
proximity to one-another geographically.  If needed, this could allow for a “replacement” caregiver 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 31 of 42 
who lives in the same geographic areas to be recruited if the first caregiver visited is unable to 
participate that day.   
Given the established relationship with the caregiver, the CHW will be asked to call or visit the 
caregiver in advance to provide initial information about the interview and ask permission to visit for 
a possible interview and to schedule an optimal visit time. The research associate will accompany 
the research interviewer in order to facilitate appropriate household introductions because the 
research officer is known to caregivers and the communities through their observation visits with 
CHWs.  CHWs should not be present during the IDI visit to facilitate an honest and open discussion 
about the support received from the CHW. 
The IDIs will be conducted by a qualitatively trained researcher. The interviews will be conducted in 
Kiswahili, follow an IDI guide and are expected to last about 30-60 minutes. All IDIs will be audio 
recorded with the consent of the caregiver to allow for complete data capture and subsequent 
review for accuracy and quality assurance.  
Data management  
The day-to-day management of field operations and study data collection will be the responsibility 
of the study coordinator. The coordinator will oversee the development of a study database, and will 
design and implement data management SOPs and a tracking system for documentation of all 
entries to, and back-ups of the study database. The study coordinator will also work closely with the 
research associates based in Tabora who will play the front-line role in data collection, review and 
verification.  
Data will be captured on some paper (e.g. enumeration activity) but mostly on electronic forms.  
Paper-based recruitment/screening documentation from the enumeration study that contains 
personal identifiers linked to a unique study patient identifier (PTID) will be accessible to study team 
members only, and stored separately from other forms in locked cabinets when not in use. These 
logs will be used to create an electronic master recruitment and enrolment log containing study 
PTID, basic characteristics (age, sex, date of baseline/ endline, household number, etc.), and 
recruitment outcomes (active, withdrawn, refused, ineligible). All paper-based data will be routinely 
collected from sites and brought to the EGPAF office in Tabora for temporary storage. Research 
associates or temporary data clerks will be responsible for close-to-real-time data entry (typically 
within 1-2 days of completion) of screening/recruitment data for internal study monitoring. These 
data will be entered into a cloud-based system (google form or custom database) that synchronizes 
the data to a server accessible by authorized study staff only.   
Caregiver surveys, CHW interviews, video and in-person observation checklists will be completed 
electronically using tablets (Open Data Kit software-based or other similar platform). Any 
questionnaires will include skip patterns, and alerts for missed items will be programmed to avoid 
user error. The quality of data and data entry also will be enhanced by automatic consistency checks 
and feasible range values, programmed into the study database. When there is no data access for 
immediate uploading of completed surveys, data will be stored temporarily on the device, and 
subsequently synchronized to a secure server as soon as the device is within data range (usually 
daily). Those data will be accessible from the server through a password-protected web-based 
dashboard for routine data download, quality reviews and back-ups.  Only authorized study team 
members will be able to access these data.  

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 32 of 42 
Any paper-based data collected will be reviewed for quality control purposes by a study team 
member as soon after completion as possible, and by the coordinator on a routine basis during 
supervision. These data will be double-entered and discrepancies reconciled. Personal identifiers 
such as caregiver and child names will be included in the paper-based data forms for the purposes of 
data cleaning and verification, but no names will be entered into the study database. Video and 
audio files from the FGD will be stored similarly to electronic data back-ups, on secured hard drives 
or cloud storage with only authorized and password-protected access. Video and audio files will be 
archived with cleaned data files for three years after study closure, and then destroyed (i.e., deleted 
from laptops, devices, etc.), with their destruction documented.  
The audio-recorded FGDs and IDIs will be transcribed and translated from Kiswahili to English. 
Transcripts will be reviewed by a member of the study team fluent in English and Kiswahili. 
Transcripts will be imported into a qualitative software program for analysis (MAXQDA or similar 
program).  A codebook will be developed with deductive codes based on the IDI and FGD guides with 
inductive codes added during the coding process as needed. Trained qualitative coders will code the 
transcripts, and a study investigator will review a subset of transcripts to ensure consistency across 
different coders.  
All paper-based study records (excluding regulatory records) will be destroyed three years after the 
analytic database is declared clean and frozen.  
Data Analysis 
Objectives 1 and 2: Caregiver Cohort 
Descriptive statistics (range, median, mean, percent) will be used to review the data overall and 
describe participant background characteristics, radio listenership patterns and parenting 
perceptions, knowledge and practices, identifying any baseline differences in population by study 
group. Confidence intervals (CI) will be calculated around summary measures and statistical tests of 
significance (non-parametric) will be applied where appropriate to compare the distribution of 
characteristics or outcomes across study groups. The effects of radio exposure only (objective 1) will 
be described by comparing study outcomes at baseline and endline within the MR study group only. 
Within study group differences in study outcomes will be described comparing distributions of 
responses to key outcome variables at baseline and endline using statistical testing appropriate for 
paired groups such as the paired t-test, Wilcoxon or McNemar’s tests. Regression modelling may be 
used to estimate the intervention effect while controlling for covariates. 
The additional effects of the combined exposure to radio, short videos and Malezi CCD (MRV-CCD; 
objective 2), as compared to the radio only effect, will be described using a differences in differences 
(DID) analysis.  The treatment effect can be found by obtaining the proportion of caregivers with the 
outcome in the MRV-CCD and MR groups at both time periods. The difference in outcomes between 
study groups at both time periods may be charted to visualize the DID as shown in Figure 4, whereby 
the DID is what remains after subtracting the baseline differences between the two groups from the 
endline differences (30-5%=25%). This will give an estimate of the extent of the improvement by the 
Malezi II full intervention. We will use regression modelling to estimate the intervention effect while 
controlling for covariates. We will use the following general form model:  
𝑌= 𝛽0 + 𝛽1[𝐼𝑛𝑡𝑒𝑟𝑣𝑒𝑛𝑡𝑖𝑜𝑛] + 𝛽2[𝑇𝑖𝑚𝑒] + 𝛽3[𝐼𝑛𝑡𝑒𝑟𝑣𝑒𝑛𝑡𝑖𝑜𝑛· 𝑇𝑖𝑚𝑒] + 𝛽4[𝐶𝑜𝑣𝑎𝑟𝑖𝑎𝑡𝑒𝑠]
+ Ɛ 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 33 of 42 
The interaction term coefficient 𝛽3 will also estimate the extent of the DiD.  
 
 
 
Figure 4.  Differences in differences analysis graphic 
Objective 3: Community Health Worker Cohort 
Quantitative evaluation of the effect of the short videos on quality of CHW counseling will follow 
similar analyses as described above, including characteristics of the population, and statistical 
comparison of outcomes at baseline and endline (post-video introduction) within the CHW cohort.  
Some qualitative analyses will also be done to describe and summarize CHW opinions and 
suggestions regarding video content, design and use. 
The audio-recorded FGDs with CHW will be transcribed and translated from Kiswahili to English by 
qualitative researchers. Transcripts will be reviewed by a member of the study team is in fluent in 
English and Kiswahili. Transcripts will be imported into a qualitative software program for analysis 
(MAXQDA or similar program).  A codebook will be developed with deductive codes based questions 
in the FGD guide with inductive codes added during the coding process as needed. Study team 
members trained in coding skills will be responsible for coding the transcripts. A study investigator 
will review a subset of transcripts to ensure consistency across different coders. 
Objectives 4-5: FGDs with CHWs and IDIs with caregivers 
Qualitative data will be summarized through descriptive, text-based summaries by code. Textual 
data will be carefully read by investigators to identify recurrent patterns and themes, and to draw 
conclusions from issues connected to the study questions. Themes may include acceptability of CHW 
home visitation or use of the videos, perceptions of CHW authority on ECD/parenting, experiences 
with health provider counseling on ECD at health facilities, and recommendations for improving ECD 
education and interventions. 
ETHICAL CONSIDERATIONS 
No data collection will be done prior to approval of this protocol by the National Research Ethics 
Committee of the National Institute of Medical Research and the Advarra Institutional Review Board 
0%
10%
20%
30%
40%
50%
MR
MRV-CCD
baseline
endline
30%
5%

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 34 of 42 
in the USA.  Research participants will only join the study after their informed consent has been 
obtained.  This study will be registered with a clinical trials network. 
Informed Consent 
Study staff will read aloud all consent documents in the local language, Kiswahili. Each consent 
document will include information on who is carrying out the evaluation, the purpose of the 
evaluation, how the findings will be used, what is being asked of participants, risks and benefits of 
participation, the possibility to opt-out at any time, and who to contact for questions or concerns. 
Caregiver and CHW participants will freely choose whether or not to participate in the study. They 
will be informed that their refusal to participate at any time will have no bearing on any community 
or health facility services received or their employment, respectively. The form will also include 
contact information for study investigators if there are questions later and the NIMR Secretariat if 
there are any complaints about the study. A copy of the consent form will be offered to all 
consenting participants.  
As part of written informed consent procedures, the potential participant’s ability to read, 
understand and sign the consent form will be assessed prior to consent. In cases where the 
participant is not literate, a witness will be invited to listen to the consent process from the start, 
and sign the consent document attesting to the fact that the research associate (RA) read the 
consent, answered all questions, and the respondent voluntarily chose to participate. The 
respondent will then place a mark on the form, leaving the space for name and date blank on the 
participant’s line.  The witness and RA will both sign and date the form, documenting the 
participant’s name above the witness’ signature. 
Caregiver participants 
Verbal consent will be obtained from eligible caregivers for enumeration and the listenership survey 
administration after reading the consent document to potential participants.  A waiver of written 
informed consent is requested because participation in the enumeration and listenership survey 
presents no more than minimal risk of harm and involves no procedures for which written consent is 
normally required outside of the research context.  
Written (signed) informed consent will be obtained from caregivers recruited into the caregiver 
cohorts. Caregivers who have verbally consented to participate in the listenership survey may be 
invited to participate further in the caregiver cohort study, after providing informed consent to the 
study procedures pertaining to the caregiver cohort: baseline and endline caregiver survey, endline 
listenership survey, and possible observed CHW visit in the home. 
As described above, RAs will ask caregivers in households selected to participate in this activity to 
reconfirm their consent to be observed and video-recorded in the home. A study SOP will provide 
discussion points for the RA to ensure the observation activity is properly introduced to the 
caregiver. These include: 
▪ 
The purpose of the observation is to learn more about how the CHW supports caregivers 
during home visits. 
▪ 
The caregiver (along with the CHW) will be asked to wear cameras to video-record the 
session for independent scoring of the session.   

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 35 of 42 
▪ 
The RA will be completing a form related to how s/he observes the CHW. The RA will not ask 
any questions to the caregivers and no information provided by the caregiver will be written 
on the form. Only researchers will view the videos and they will only be used to observe how 
the CHW conducted the visit.  The videos will be destroyed after the study is completed.   
▪ 
The caregiver may choose not to allow the observation of the CHW that day, and this will 
not affect how the CHW supports the caregiver that day (RA to wait outside in such cases). 
CHW participants 
Written (signed) informed consent will be obtained from CHWs recruited into the CHW cohort, 
describing the baseline and endline interview, and observations of CHWs doing their work in homes 
and the clinic at baseline and endline. Permission to contact CHWs who are selected for FGDs will be 
included in the CHW consent for the CHW cohort.   
FGD and IDI participants 
An additional signed informed consent will be obtained separately from CHW cohort participants 
and IDI caregiver participants. The rationale for separate and additional consent documentation is 
that only a subset of CHWs (n~24-40) will be invited and the FGDs involve study procedures and 
compensation not described in the cohort written CHW consent. Similarly, only a subset of 
caregivers (n~20-25) will be invited to participate in an IDI and this is not currently described in the 
caregiver cohort consent.  
For FGD participants, the consent process may be conducted in person or over the phone prior to 
the discussion. A member of the study team will meet in person or call selected participants by 
phone to read the consent document, which includes reimbursement of travel expenses and any 
requirements of reimbursement (e.g., official receipt), if applicable, so they are aware of these 
details prior to traveling to the FGD venue. At this time, they will also be provided with the FGD 
meeting location and time. If they agree to participate in the FGD, they must also agree to be audio-
recorded. If they are consented in person, participants will be asked to sign and date the form and 
will be offered a copy of the consent to keep. If they are consented over the phone, participants will 
be provided with a copy of the form to read once they arrive at the FGD venue, will be asked to sign 
and date the form if they still agree, and will be offered a copy of the consent form to keep.  
For IDI participants, the consent process will be conducted in person at the caregiver’s home. If they 
agree to participate in the FGD, they must also agree to be audio-recorded. Participants will be 
asked to sign and date the form and will be offered a copy of the consent to keep. In cases where 
the participant is not literate, the same processes will be followed as described above.  
Caregivers present at clinic-based CHW observed sessions 
Verbal permission will be sought from caregivers who are present during the CHW observations of 
clinic group counseling sessions.  For those caregivers who will be part of an observed group 
counseling session at the health facility, a study SOP will provide discussion points for the RA to 
ensure the observation activity is properly explained to caregivers prior to the start of the session. 
These include:  
▪ 
The purpose of the observation is to learn more about how the CHW supports caregivers 
during group counseling at health facilities. 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 36 of 42 
▪ 
The RA will be completing a form related to how s/he observes the CHW. The RA will not ask 
any questions to the caregivers and no information provided by the caregivers will be 
written on the form.  
▪ 
No names or other information that could identify the caregiver will be documented.  
▪ 
The caregiver may choose not to be a part of the observed counseling session, and this will 
not affect any medical services provided to the caregiver. 
Because these sessions often take place in public settings, such as the clinic waiting area inside or on 
a verandah, or a gathering place outside (under a tree), and caregivers move in and out of the 
session as they arrive or are called by the providers for services, it is not feasible to limit attendance 
to only those who were present at the start of the session.  Therefore, at the close of the session, 
the RA will thank the caregivers for allowing the observation and offer to meet with any caregiver 
who joined during the group (and missed the introduction) for explanation of what was happening 
and why. 
A waiver of informed consent of caregivers attending these observed group sessions is requested 
based on the following criteria:  
CFR 45.116.(3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent 
as described in this subsection, the IRB must find and document that: 
 
i. 
The research involves no more than minimal risk to the subjects: A member of the study 
team will observe a routine clinic activity that is focused on general child development, not 
on discussions of sensitive health information.  
ii. 
The research could not practicably be carried out without the requested waiver or alteration: 
This is due to the fluidity of the sessions as described above.  
iii. 
If the research involves using identifiable private information, the research could not 
practicably be carried out without using such information in an identifiable format: This 
activity does not involve the collection of identifiable private information.  
iv. 
The waiver or alteration will not adversely affect the rights and welfare of the subjects: It will 
not adversely affect participants’ rights and welfare given the very minimal risk involved, 
including for any privacy or confidentiality breaches.  
v. 
Whenever appropriate, the subjects or legally authorized representatives will be provided 
with additional pertinent information after participation: Not applicable  
 
Human Subjects Training and Confidentiality Protections 
All EGPAF staff, including temporary or contracted data collectors will complete an appropriate 
training in human subjects’ protections. This training will emphasize the ethical conduct of research 
such as the basic principles of research, responsibilities of researchers, examples of unethical 
research, informed consent, personal information, confidentiality, and documentation standards. In 
addition, all research staff will be required to sign a confidentiality agreement prior to interacting 
with participants. 
All tablets used for electronic data capture will be kept in a secure location with password 
protection. Electronically collected data will be encrypted at the time of submission and stored to a 
secure server. The electronic database will also be password protected with use restricted to 
members of the study team only. Analytic databases will not record participant names or any other 
identifying contact details, but will be identified by unique PTID only. Names and contact details for 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 37 of 42 
listenership respondents, caregivers and CHWs who are recruited into the study will be documented 
only on screening/recruitment documentation, whereby these identifiers are needed to ensure 
review of eligibility, verification of data integrity, verification of consent, and identification/tracing of 
cohort respondents for endline assessments. Those names and contact details will remain on 
separate screening, consent and master recruitment lists, and will only ever be linked to any 
participant’s characteristics collected through the study using the study PTID. All documents linking 
identifiers and PTID (recruitment, consents) will be stored securely in locked drawers or cabinets 
when not in use. All electronic data will be housed in password-protected personal computers.  
For the FGD, transcripts will not contain any participant names. We will request all participants to 
refer to themselves and others by their assigned number and not their names. Any names or other 
personally identifying information inadvertently spoken during the FGD and captured on the audio 
recording, will be removed during the transcription process. Names and contact details for CHW 
invited to FGDs will be documented only insofar as they are required to arrange logistics for their 
attendance at the groups. Names will also be viewed by non-study finance staff at EGPAF as required 
to account for their transport and per diem payments.  Those names and contact details will not be 
linked to any particular group’s transcript, audio-recording or demographic data.  
Risks, Benefits and Compensation 
This study does not pose more than minimal risk to participants. The majority of the content of 
questionnaires and observation assessment tools is not considered sensitive or personal 
information, with the exception of some questions on socioeconomic status, discipline practices, 
psychosocial status, and household risks. Thus, there is some risk of disclosure of information that 
some people might consider private and confidential to unauthorized persons. We will seek to 
mitigate this risk by (1) holding the interviews/observations in a private place; (2) ensuring that all 
study related personnel are trained in basic research ethics, which emphasizes the importance of 
confidentiality and data security; and (3) implementing strict protocols on data security and handling 
to minimize loss or unauthorized sharing of personally identifiable or sensitive (confidential) 
information. 
Respondents in the caregiver cohort will be offered an age-appropriate toy as an expression of 
thanks for their time, equivalent to less than USD 5 (~11,000 Tanzanian Shillings [Tsh]), at both 
baseline and endline assessments. The toy will be a locally made of soft material, such as doll, animal 
or book.  There will be no compensation provided to caregivers at the stage I listenership survey 
participation. CHWs will receive transport reimbursement of <USD 5 (Tsh 10,000) for meeting the 
interviewer at the clinic for baseline and endline interviews and for four home visits total (Tsh 5,000 
for each).  CHW cohort participants joining the FGDs will receive half per diem (about Tsh 30,000 or 
about 13 USD equivalent) to cover costs related to travel and being away from their homes and 
communities for a working day, and reimbursement of their transport, if applicable, as per official 
receipt.  This compensation is determined according to EGPAF policies and is therefore subject to 
minor changes. 
Caregivers participating in IDIs will not receive any compensation as these interviews are taking 
place at their homes, and the visit will be no longer than about one hour. 

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Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 38 of 42 
TIMEFRAME  
The overall evaluation is expected to take about 2 years.   
POLICY/PROGRAM SIGNIFICANCE AND DISSEMINATION 
Outcomes from this evaluation will inform decision makers in Tanzania about the feasibility and 
effectiveness of a health systems-based ECD intervention, augmented by radio communications 
and/or short video use. The feasibility and potential contributions of ECD short videos to CHW skills 
and caregiver behaviors will inform the potential scale-up of digital job aids, and is an area the 
Government of Tanzania has already invested in through various other digital health initiatives. 
While this evaluation is not designed to be generalizable to other countries or globally, we believe 
that the findings from this evaluation can still make substantive contributions to literature on how 
nurturing care (ECD) interventions can be integrated into routine MNCH and HIV care in resource-
constrained settings.  
Results from this evaluation will be disseminated locally through meetings with R/CHMTs, nationally 
with Government policy-makers and program implementers, and internationally through 
presentations at scientific conferences and peer-reviewed journal publication. 
 

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REFERENCES 
1.  
Britto PR, Lye SJ, Proulx K, Yousafzai AK, Matthews SG, Vaivada T, et al. Nurturing care: 
promoting early childhood development. Lancet. 2017;389(10064):91–102.  
2.  
Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, et al. Early childhood 
development coming of age: science through the life course. Lancet. 2017;389(10064):77–90.  
3.  
Shonkoff JP, Radner JM, Foote N. Expanding the evidence base to drive more productive early 
childhood investment. Lancet. 2017 Jan;389(10064):14–6.  
4.  
Naugle DA, Hornik RC. Systematic review of the effectiveness of mass media interventions for 
child survival in low-and middle-income countries. J Health Commun. 2014;19:190–215.  
5.  
Tuong W, Larsen ER, Armstrong AW. Videos to influence: a systematic review of effectiveness 
of video-based education in modifying health behaviors. J Behav Med. 2014 Apr;37(2):218–
33.  
6.  
Richter LM, Daelmans B, Lombardi J, Heymann J, Boo FL, Behrman JR, et al. Investing in the 
foundation of sustainable development: pathways to scale up for early childhood 
development. Lancet. 2017;389(10064):103–18.  
7.  
Sachs J. From millennium development goals to sustainable development goals. Lancet. 2012 
Jun;379(9832):2206–11.  
8.  
Dua T, Tomlinson M, Tablante E, Britto PR, Yousafzai AK, Daelmans B, et al. Global research 
priorities to accelerate early child development in the sustainable development era. Lancet. 
2016;4:e887–9.  
9.  
Walker SP, Wachs TD, Grantham-McGregor S, Black MM, Nelson CA, Huffman SL, et al. 
Inequality in early childhood: risk and protective factors for early child development. Lancet. 
2011 Oct;378(9799):1325–38.  
10.  
Lu C, Black M, Richter L. Risk of poor development in young children in low-income and 
middle-income countries: an estimation and analysis at the global, regional and country level. 
Lancet. 2016;4(12):e916–22.  
11.  
UNAIDS. UNAIDS Data 2018 Factsheet [Internet]. 2018. Available from: 
http://www.unaids.org/sites/default/files/media_asset/unaids-data-
2018_en.pdf%0Ahttp://www.unaids.org/sites/default/files/media_asset/20170720_Data_bo
ok_2017_en.pdf 
12.  
Short SE, Goldberg RE. Children living with HIV-infected adults: Estimates for 23 countries in 
sub-Saharan Africa. PLoS One. 2015;10(11):1–17.  
13.  
Herba CM, Glover V, Ramchandani PG, Rondon MB. Maternal depression and mental health 
in early childhood: an examination of underlying mechanisms in low-income and middle-
income countries. Lancet Psychiatry. 2016 Oct;3(10):983–92.  
14.  
Stein A, Pearson RM, Goodman SH, Rapa E, Rahman A, McCallum M, et al. Effects of perinatal 
mental disorders on the fetus and child. Lancet. England; 2014 Nov;384(9956):1800–19.  
15.  
Yousafzai AK, Rasheed MA, Rizvi A, Armstrong R, Bhutta ZA. Parenting Skills and Emotional 
Availability: An RCT. Pediatrics. 2015 May;135(5):e1247-57.  

________________________________________________________________________________________________ 
Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 40 of 42 
16.  
Aboud FE, Yousafzai AK. Global health and development in early childhood. Annu Rev 
Psychol. 2015 Jan;66:433–57.  
17.  
Singla DR, Kumbakumba E, Aboud FE. Effects of a parenting intervention to address maternal 
psychological wellbeing and child development and growth in rural Uganda: A community-
based, cluster-randomised trial. Lancet [Internet]. 2015;3(8):e458–69. Available from: 
http://dx.doi.org/10.1016/S2214-109X(15)00099-6 
18.  
le Roux IM, Tomlinson M, Harwood JM, O’Connor MJ, Worthman CM, Mbewu N, et al. 
Outcomes of home visits for pregnant mothers and their infants: a cluster randomized 
controlled trial. AIDS. 2013 Jun;27(9):1461–71.  
19.  
Richter L, Rotheram-Borus MJ, Van Heerden A, Stein A, Tomlinson M, Harwood JM, et al. 
Pregnant women living with HIV (WLH) supported at clinics by peer WLH: A cluster 
randomized controlled trial. AIDS Behav. 2014;18(4):706–15.  
20.  
Lucas JE, Richter LM, Daelmans B. Care for Child Development: an intervention in support of 
responsive caregiving and early child development. Child Care Health Dev. 2018;44(1):41–9.  
21.  
World Health Organization, UNICEF, World Bank. Nurturing care for early child development: 
A framework for helping children survive and thrive to transform health and human 
potential. Geneva, Switzerland; 2018.  
22.  
Engle PL, Fernald LCH, Alderman H, Behrman J, O’Gara C, Yousafzai A, et al. Strategies for 
reducing inequalities and improving developmental outcomes for young children in low-
income and middle-income countries. Lancet. 2011;378(9799):1339–53.  
23.  
Sharma R, Gaffey MF, Alderman H, Bassani DG, Bogard K, Darmstadt GL, et al. Prioritizing 
research for integrated implementation of early childhood development and maternal, 
newborn, child and adolescent health and nutrition platforms. J Glob Health. 2017;7(1).  
24.  
Murray J, Head R, Sarrassat S, Hollowell J, Remes P, Lavoie M, et al. Modelling the effect of a 
mass radio campaign on child mortality using facility utilisation data and the Lives Saved Tool 
(LiST): findings from a cluster randomised trial in Burkina Faso. BMJ Glob Heal. 
2018;3(4):e000808.  
25.  
Taiwo L, Idris S, Abubakar A, Nguku P, Nsubuga P, Gidado S, et al. Factors affecting access to 
information on routine immunization among mothers of under 5 children in Kaduna state 
Nigeria, 2015. Pan Afr Med J. 2017;27:1–8.  
26.  
Mwambete KD, Mtaturu Z. Knowledge of sexually transmitted diseases among secondary 
school students in Dar es Salaam, Tanzania. Afr Health Sci. 2006;6(3):165–9.  
27.  
Rogers EM, Vaughan PW, Swalehe RM, Rao N, Svenkerud P, Sood S. Effects of an 
entertainment-education radio soap opera on family planning behavior in Tanzania. Stud Fam 
Plann. 1999 Sep;30(3):193–211.  
28.  
Demilew YM. Factors associated with mothers’ knowledge on infant and young child feeding 
recommendation in slum areas of Bahir Dar City, Ethiopia: cross sectional study. BMC Res 
Notes. BioMed Central; 2017;10(1):1–7.  
29.  
Muchie KF, Alemu K, Tariku A, Tsegaye AT, Abebe SM, Yitayal M, et al. Rural households at 
risk of malaria did not own sufficient insecticide treated nets at Dabat HDSS site: Evidence 
from a cross sectional re-census. BMC Public Health. 2017;17(1):1–9.  

________________________________________________________________________________________________ 
Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 41 of 42 
30.  
Negussie A, Girma G. Is the role of Health Extension Workers in the delivery of maternal and 
child health care services a significant attribute? the case of Dale district, southern Ethiopia. 
BMC Health Serv Res. 2017;17(1):1–8.  
31.  
Sarrassat S, Meda N, Badolo H, Ouedraogo M, Some H, Bambara R, et al. Effect of a mass 
radio campaign on family behaviors and child survival in Burkina Faso: a repeated cross-
sectional, cluster-randomised trial. Lancet. 2018;6(3):e330–41.  
32.  
Higgs ES, Goldberg AB, Labrique AB, Cook SH, Schmid C, Cole CF, et al. Understanding the role 
of mhealth and other media interventions for behavior change to enhance child survival and 
development in low-and middle-income countries: An evidence review. J Health Commun. 
2014;19:164–89.  
33.  
Coetzee B, Kohrman H, Tomlinson M, Mbewu N, Le Roux I, Adam M. Community health 
workers’ experiences of using video teaching tools during home visits-A pilot study. Health 
Soc Care Community. 2018 Mar;26(2):167–75.  
34.  
Roess AA, Di Peppi R, Kinzoni EA, Molouania M, Kennedy E, Ibata SR, et al. Knowledge Gained 
and Retained from a Video-Centered, Community-Based Intervention for Ebola Prevention, 
Congo. J Health Commun. 2017 Nov;22(11):913–22.  
35.  
Muro F, Meta J, Renju J, Mushi A, Mbakilwa H, Olomi R, et al. “it is good to take her early to 
the doctor” - Mothers’ understanding of childhood pneumonia symptoms and health care 
seeking in Kilimanjaro region, Tanzania. BMC Int Health Hum Rights. 2017;17(1):1–8.  
36.  
Mwidunda SA, Carabin H, Matuja WBM, Winkler AS, Ngowi HA. A school based cluster 
randomised health education intervention trial for improving knowledge and attitudes 
related to Taenia solium cysticercosis and taeniasis in Mbulu district, northern Tanzania. PLoS 
One. 2015;10(2):1–17.  
37.  
National Bureau of Statistics, United Nations Children’s Fund. Child Poverty in Tanzania. 2016.  
38.  
Ministry of Health, Community Development, Gender, Elderly and Children (Tanzania 
Mainland), Ministry of Health (Zanzibar), National Bureau of Statistics, Office of the Chief 
Government Statistician  and I. Tanzania Demographic and Health Survey and Malaria 
Indicator Survey (TDHS-MIS) 2015-16 [Internet]. 2016. Available from: 
https://dhsprogram.com/pubs/pdf/fr321/fr321.pdf 
39.  
UNICEF. Tanzania Education Fact Sheet. 2017.  
40.  
National Bureau of Statistics O of the CGS. Tabora Region: Basic Demographic and Socio-
Economic Profile; 2012 Population and Housing Census. Dar es Salaam, Tanzania; 2016.  
41.  
Fishbein M, Yzer MC. Using Theory to Design Effective Health Behavior Interventions. 
Commun Theory. 2003;13(2):164–83.  
42.  
UNICEF. Collecting data on foundational learning skills and parental involvement in 
education: Division of Data , Research and Policy. 2017;  
43.  
UNICEF. Development of the Early Childhood Development Index in MICS surveys. 2017.  
44.  
Obradovic J, Portilla XA, Tirado-Strayer N, Siyal S, Rasheed MA, Yousafzai AK. Maternal 
scaffolding in a disadvantaged global context: The influence of working memory and cognitive 
capacities. J Fam Psychol. 2017 Mar;31(2):139–49.  

________________________________________________________________________________________________ 
Malezi II protocol V4.0 (3 August 2020)                                                                                                                Page 42 of 42 
45.  
Rochat TJ, Houle B, Stein A, Pearson RM, Newell ML, Bland RM. Psychological morbidity and 
parenting stress in mothers of primary school children by timing of acquisition of HIV 
infection: a longitudinal cohort study in rural South Africa. J Dev Orig Health Dis. 2018 
Feb;9(1):41–57.  
46.  
Maguire-Jack K, Wang X. Pathways from neighborhood to neglect: The mediating effects of 
social support and parenting stress. Child Youth Serv Rev [Internet]. 2016;66:28–34. Available 
from: https://www.sciencedirect.com/science/article/pii/S0190740916301293 
47.  
Ravens J, Ravens J CJ. Raven’s Standard Progressive Matrices (SPM). Bloomington, Indiana, 
USA: Pearson’s; 2000.  
48.  
Wicherts JM, Dolan CV, Carlson JS  van de MH. Raven’s test performance of sub-Saharan 
Africans: Average performance, psychometric properties, and the Flynn Effect. Learn Individ 
Differ. 2010;20(3):135–51.  
49.  
Abidin R. Parenting Stress Index (PSI). Charlottesville VA: Pediatric Psychology Press; 1990.  
50.  
Haskett ME, Ahern LS, Ward CS, Allaire JC. Factor structure and validity of the parenting 
stress index-short form. J Clin Child Adolesc Psychol. 2006 Jun;35(2):302–12.  
51.  
Smith Fawzi MC, Ngakongwa F, Liu Y, Rutayuga T, Siril H, Somba M, et al. Validating the 
Patient Health Questionnaire-9 (PHQ-9) for screening of depression in Tanzania. Neurol 
Psychiatry Brain Res. Elsevier; 2019;31(April 2018):9–14.  
52.  
DSM-III and the transformation of American psychiatry: a history. Am J Psychiatry [Internet]. 
1993;150(3):399–410. Available from: https://doi.org/10.1176/ajp.150.3.399 
53.  
Kroenke K, Spitzer RL, Williams JBW, Lowe B. The Patient Health Questionnaire Somatic, 
Anxiety, and Depressive Symptom Scales: a systematic review. Gen Hosp Psychiatry. 
2010;32(4):345–59.  
54.  
Chibanda D, Benjamin L, Weiss HA, Abas M. Mental, neurological, and substance use 
disorders in people living with HIV/AIDS  in low- and middle-income countries. J Acquir 
Immune Defic Syndr. United States; 2014 Sep;67 Suppl 1:S54-67.  
55.  
Guo N, Bindt C, Te Bonle M, Appiah-Poku J, Tomori C, Hinz R, et al. Mental health related 
determinants of parenting stress among urban mothers of young children--results from a 
birth-cohort study in Ghana and Cote d’Ivoire. BMC Psychiatry. 2014 May;14:156.  
56.  
Mayston R, Patel V, Abas M, Korgaonkar P, Paranjape R, Rodrigues S, et al. Symptoms of 
common mental disorder and cognitive associations with seropositivity among a cohort of 
people coming for testing for HIV/AIDS in Goa, India: A cross-sectional survey. BMC Public 
Health. 2013;13(1):1.  
57.  
Pefura-Yone EW, Soh E, Kengne AP, Balkissou AD, Kuaban C. Non-adherence to antiretroviral 
therapy in Yaounde: prevalence, determinants and the concordance of two screening criteria. 
J Infect Public Health. 2013 Aug;6(4):307–15.  
58.  
Barber TJ, Bradshaw D, Hughes D, Leonidou L, Margetts A, Ratcliffe D, et al. Screening for HIV-
related neurocognitive impairment in clinical practice: challenges and opportunities. AIDS 
Care. 2014 Feb;26(2):160–8.