A Mobile Phone Game to Prevent HIV Among Young Africans
Phase: NA
Conditions: HIV/AIDS
Sponsor: Emory University

 
 
 
 
 
Title:  
A Mobile Phone Game to Prevent HIV among 
Young Africans 
 
Sponsor:   
National Institute of Mental Health 
 
Date:  
 
July 20th, 2018 Version: 1.4  
 
NCT Number:  NCT03054051 
 
Investigators:  Dr. Kate Winskell, Rollins School of Public Health,  
Dr. Victor Mudhune, KEMRI-CGHR 
Page 1 of 127 
 

Investigators Roles and Responsibilities: 
 
Kate Winskell Principal Investigator,  
Associate 
Professor 
in 
Global Health, at the Rollins 
School of Public Health  
Will oversee all scientific and managerial 
aspects of the project, including the final 
design and executive production of the 
game and the development of the final pilot 
study protocol. Dr. Winskell will oversee 
the writing of game content; approve 
successive modules of the game, and 
review concept and pre-testing data. Dr. 
Winskell will participate in the analysis of 
data collected and collaborate with other 
key 
personnel 
on 
the 
writing 
of 
manuscripts. 
Victor 
Mudhune 
Principal Investigator, 
Principal Research Officer, 
HIV Research Branch, 
KEMRI-CGHR, 
Kisumu, Kenya 
Will lead all Kenya-based research. He 
will 
oversee 
KEMRI 
project 
staff, 
contribute to the development of the 
final study protocol, and ensure strict 
adherence to that protocol. He will 
participate in data analysis and in the 
preparation of manuscripts. 
Victor Akelo 
Co-Investigator, 
 
Epidemic Intelligence 
Service (EIS) Officer, 
Centers for Disease 
Control and Prevention 
Atlanta, Georgia 
Substantial input into the protocol 
development. He will participate in data 
analysis 
and 
in 
the 
preparation 
of 
manuscripts. 
Chris 
Obong’o 
 
Co-Investigator, 
Graduate 
Assistant 
and 
Doctoral Student, 
Substantial 
input 
into 
study 
design, 
protocol development and assessment tools 
including being responsible for providing 
Page 2 of 127 
 

School of Public Health 
University of Memphis 
Memphis TN, 38111 
 
Regional M&E Specialist, 
PATH 
East and Southern Africa 
Region 
Kisumu, Kenya 
consultation 
on 
parent-child 
communication and pre-risk prevention in 
Kenya during the game development phase. 
Will 
provide 
input 
for 
study 
implementation and report writing.  
Rob 
Stephenson 
 
 
Co-Investigator,  
Professor in the 
Department of Health 
Behavior and Biological 
Sciences at the University 
of Michigan School of 
Nursing  
 
Substantial input on the development of 
survey measures and game content. He will 
oversee validity and reliability testing of 
the survey instruments and analyze pilot 
test data. He will provide statistical 
consultation 
on 
the 
sampling 
and 
randomization processes, including the 
design of the proposed efficacy trial to be 
developed from this formative work.   
Ken 
Ondeng’e 
 
Co-Investigator,  
Behavioral scientist 
HIV Research Branch 
KEMRI Center for Global 
Health 
and 
Research 
Collaboration (CGHR) 
Kisumu-Busia Road 
P.O. Box 1578-40100 
Kisumu, Kenya 
Substantial 
input 
into 
the 
protocol 
development. Will oversee data collection, 
qualitative data analysis and provide input 
for report writing. 
Gaelle 
Sabben 
Co-Investigator, 
Public Health Program 
Associate 
Hubert Department of 
Substantial input into study protocol 
manual development and assessment 
tools. Will participate in data analysis 
Page 3 of 127 
 

Global Health 
Rollins School of Public 
Health 
Emory University 
and in the preparation of manuscripts. 
David 
Schnabel 
Co-Investigator, 
Director and Senior 
Technical Advisor 
CDC-Kenya, HIV 
Research Program 
Kisumu, Kenya 
Substantial input into study protocol 
manual development and assessment 
tools. Will provide input for study 
implementation and report writing. 
 
Page 4 of 127 
 

TABLE OF CONTENTS 
1.0 
LAY SUMMARY ............................................................................................................................ 7 
2.0 
BACKGROUND ............................................................................................................................ 8 
2.1 
Aims of the feasibility study ................................................................................................... 8 
2.2 
Preliminary studies that support this stage of the research ..................................................... 9 
2.3 
Significance/justification for current study ............................................................................ 9 
2.4 
Sample .................................................................................................................................. 11 
2.5 
Setting ................................................................................................................................... 12 
2.6 
Recruitment .......................................................................................................................... 12 
2.7 
Procedures ............................................................................................................................ 13 
2.8 
Measures ............................................................................................................................... 14 
2.9 
Risks to participation ............................................................................................................ 18 
2.10 
Benefits to subject or future benefits .................................................................................... 18 
2.11 
Data analysis ......................................................................................................................... 18 
3.0 
TRAINING .................................................................................................................................. 20 
3.1 
Description of training for research personnel ..................................................................... 20 
4.0 
PLANS FOR DATA MANAGEMENT AND MONITORING ............................................................. 20 
4.1 
Description of data safety and monitoring plan .................................................................... 20 
5.0 
CONFIDENTIALITY ..................................................................................................................... 21 
5.1 
Plans to protect privacy of subjects and confidentiality of data ........................................... 21 
5.2 Description of plans to link data to identifiers ........................................................................... 21 
5.3 Description of how linkage will be protected ............................................................................ 22 
6.0 INFORMED CONSENT ..................................................................................................................... 22 
6.1 How and where will informed consent be obtained? Oral or written? ...................................... 22 
6.2 
Plans to inform participants of new findings or research results that might affect health .... 22 
7.0 REFERENCES ................................................................................................................................... 23 
APPENDICES ......................................................................................................................................... 27 
Appendix 1: Study Budget ............................................................................................................... 27 
Appendix 2B: Assent Formative Research - Swahili ....................................................................... 31 
Appendix 2C: Assent Formative Research - Luo ............................................................................ 35 
Appendix 3A: Parental Consent Formative Research - English ...................................................... 39 
Appendix 3B: Parental Consent Formative Research - Swahili ...................................................... 43 
Appendix 3C: Parental Consent Formative Research - Luo ............................................................ 47 
Appendix 4A: Assent Intervention - English ................................................................................... 51 
Appendix 4B: Assent Intervention - Swahili ................................................................................... 55 
Appendix 4C: Assent Intervention - Luo ......................................................................................... 60 
Appendix 5A: Parental Consent Intervention - English ................................................................... 65 
Appendix 5B: Parental Consent Intervention - Swahili ................................................................... 69 
Appendix 5C: Parental Consent Intervention - Luo ......................................................................... 73 
Appendix 6A: Parent Consent Formative Research- English .......................................................... 77 
Appendix 6B: Parent Consent Formative Research - Swahili ......................................................... 80 
Appendix 6C: Parent Consent Formative Research - Luo ............................................................... 83 
Appendix 7A: Parent Consent Self Post-Intervention FGD - English ............................................. 86 
Appendix 7B: Parent Consent Self Post-Intervention FGD - Swahili ............................................. 89 
Appendix 7C: Parent Consent Self Post-Intervention FGD - Luo ................................................... 92 
Appendix 8A: FGD Guide for Formative Research with Preadolescents - English ........................ 95 
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Appendix 8B: FGD Guide for Formative Research with Preadolescents – Swahili .................Error! 
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Appendix 8C: FGD Guide for Formative Research with Preadolescents - Luo ... Error! Bookmark 
not defined. 
Appendix 9A: Follow-Up FGD Guide for Preadolescents - English .............. Error! Bookmark not 
defined. 
Appendix 9B: Follow-Up FGD Guide for Preadolescents – Swahili ............. Error! Bookmark not 
defined. 
Appendix 9C: Follow-Up FGD Guide for Preadolescents – Luo .... Error! Bookmark not defined. 
Appendix 10A: FGD Guide for Formative Research with Parents/Caregivers - English .........Error! 
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Appendix 10B: FGD Guide for Formative Research with Parents/Caregivers - Swahili .........Error! 
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Appendix 10C: FGD Guide for Formative Research with Parents/Caregivers - Luo ...............Error! 
Bookmark not defined. 
Appendix 11A: Follow-Up FGD Guide for Parents - English ......... Error! Bookmark not defined. 
Appendix 11C: Follow-Up FGD Guide for Parents - Luo ............... Error! Bookmark not defined. 
Appendix 12A: FGD Guide to Assess Acceptability of Behavioral Measures with 
Parents/Caregivers - English ............................................................ Error! Bookmark not defined. 
Appendix 13A: Focus Group Discussion Guide on Survey Preadolescents - English .............Error! 
Bookmark not defined. 
Appendix 14A: Draft Behavioral Survey for Preadolescents - English .......... Error! Bookmark not 
defined. 
Appendix 15A: Recruitment Script for Participation in Feasibility Test - English ..................Error! 
Bookmark not defined. 
Appendix 15B: Recruitment Script for Participation in Feasibility Test - Swahili ..................Error! 
Bookmark not defined. 
Appendix 15C: Recruitment Script for Participation in Feasibility Test - Luo .... Error! Bookmark 
not defined. 
Appendix 16A: Recruitment Script for Focus Group Discussions with Preadolescent and 
Parent/Caregiver - English ............................................................... Error! Bookmark not defined. 
Appendix 16B: Recruitment Script for Focus Group Discussions with Preadolescent and 
Parent/Caregiver - Swahili ............................................................... Error! Bookmark not defined. 
Appendix 16C: Recruitment Script for Focus Group Discussions with Preadolescent and 
Parent/Caregiver - Luo ..................................................................... Error! Bookmark not defined. 
Appendix 17: Study Identification card for Preadolescent Participants ......... Error! Bookmark not 
defined. 
Appendix 18: Sibling screening questions= English ....................... Error! Bookmark not defined. 
Appendix 19: Recruitment Script for Participation in Additional Study Activities - English ..Error! 
Bookmark not defined. 
Appendix 20: Other adolescents screening questions= English ...... Error! Bookmark not defined. 
Appendix 21: Assent Followup= English ........................................................................................ 96 
Appendix 22: Parental Consent Followup= English ........................................................................ 99 
Appendix 23: Assent Followup (Siblings)= English ..................................................................... 103 
Appendix 24: Parental Consent Followup (Sibling) - English ...................................................... 106 
Appendix 25: Assent Followup (Adolescents)= English ............................................................... 110 
Appendix 26: Parental Consent Followup (Adolescent) - English ................................................ 113 
Appendix 27: Parent Consent Self Additional Evaluation - English ............................................... 117 
Appendix 28: Draft FGD guide Followup Intervention – English ................................................ 120 
Page 6 of 127 
 

Appendix 29: Draft FGD guide Followup Older Adolescents – English ....... Error! Bookmark not 
defined. 
Appendix 30: Draft FGD guide Followup Parents – English .......... Error! Bookmark not defined. 
Appendix 31: Draft Social Networks Survey – English .................. Error! Bookmark not defined. 
Appendix 32 Draft Behavioral Survey for Parental App Evaluation .............. Error! Bookmark not 
defined. 
 
Page 7 of 127 
 

1.0 LAY SUMMARY 
A Mobile Phone Game to Prevent HIV among Young Africans 
Rationale and Objectives: This project, funded by the National Institute of Mental Health, will 
design, develop and pilot test an electronic game to prevent HIV among African preadolescents 
(aged 11-14), delivered via inexpensive Android smart phones. In order to collect feasibility data 
for a future randomized controlled trial, this study involves the development and subsequent 
pilot-testing of the intervention with a sample of young people in Nyanza region, Kenya, where 
11.4% of young women ages 15-24 are HIV-infected. This feasibility study will be carried out 
with the Kenya Medical Research Institute (KEMRI).  
 
Population: The population to be studied are minors, male and female, aged 11-14 (n = 108; 48 
participating in formative research and 60 in intervention), their older siblings and friends, and 
their parents or caregivers.  
 
Recruitment and Informed Consent/Assent: Participants will be recruited by KEMRI via 
schools and community-based organizations (CBOs). Parents/caregivers will be invited to attend 
an informational meeting at which study staff will describe the nature of the study and ask for 
volunteers. Written informed consent/assent will be required. Study enrollment will take place at 
the homes of participants.  
 
Data collection:  
1. Formative Research: Focus Group Discussions (FGDs) will be held with preadolescents and 
their parents/caregivers at KEMRI offices or those of a local CBO. FGD participants will 
provide feedback on game design documents and successive modules; they will also review the 
behavioral survey to establish face validity and acceptability. Respondent burden will be 
approximately 1 hour (preadolescent) or 1.5 hours (adult) per FGD.  
2. Intervention: Preadolescents in the intervention and control group will complete 3 behavioral 
surveys over a 12-week period via audio computer-assisted self-interview (ACASI) technology. 
Respondent burden per survey will be approximately 45 minutes. Participants in the intervention 
arm and their parents will also take part in post-intervention FGDs. Respondent burden will be 
approximately 1 hour (preadolescent) or 1.5 hours (adult) per FGD. Participants enrolled in the 
intervention arm will engage in 10 hours of game play over a two-week period. The game will 
automatically collect for analysis data related to all of participants’ in-game behavior, e.g. time 
spent playing, scores on knowledge-based mini-games, decisions made in role-playing games. 
 
Confidentiality: Identification numbers will be the sole identifier included on the survey, FGD 
transcripts, and in analysis datasets. Only consent/assent forms and the participant list will have 
participant names. The participant list that links participant names and study identification 
numbers will be kept in a locked file drawer, and only authorized study team members will have 
access to that list.  
 
The game will address issues related to sexual and reproductive health. The behavioral survey 
will assess behaviors and behavioral mediators that we propose will be influenced by the game. 
These include sexual behavior and intent and perceived readiness to have sex; knowledge, 
attitudes, perceived social norms, and self-efficacy related to targeted behaviors. Using ACASI 
technology, we will ask “gate” questions (“Have you ever had sex?”) that introduce skip patterns 
Page 8 of 127 
 

determining whether study participants are asked more detailed questions. Participants who 
answer “no” to the gate question will not be asked more detailed questions about their sexual 
behavior. These safeguards will protect participants from questions that could cause discomfort. 
2.0 BACKGROUND 
In sub-Saharan Africa, around 45% of new HIV infections occur in young people between the 
ages of 15 and 24.1 Youth need information and skills prior to sexual debut to protect themselves 
from HIV. Reaching preadolescents ages 11-14 with the knowledge and skills to support healthy 
behaviors prior to sexual debut may help establish lifelong patterns of safer sexual behavior and 
avert high-risk behaviors in the future.2-5  
 
New mobile technologies provide unprecedented opportunities to deliver culturally-relevant 
skills-building interventions at scale.6 Increasingly ubiquitous mobile phone technologies in 
Africa will, with time, make it possible to engage youth – at scale and at low cost – in culturally-
adapted prevention interventions that require little manpower to implement with consistent 
quality, have high entertainment and motivation appeal, and incorporate automated data 
collection. If appropriately grounded in behavioral theory and evidence-based practice, electronic 
games delivered via mobile phones have the potential to become valuable tools in HIV 
prevention efforts.  
 
This project, funded by the National Institute of Mental Health, will design, develop and pilot 
test Tumaini, an electronic game for preadolescents, delivered via inexpensive Android smart 
phones. The game will be informed by socio-behavioral and pedagogical theories, evidence-
based practice, and Dr. Winskell’s unique formative research on youth sexual culture in sub-
Saharan Africa. It will be designed to: educate young players, ages 11-14, about sexual health 
and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs 
and unintended pregnancy; challenge harmful gender norms and HIV stigma; and foster dialogue 
with parents and caregivers.  
 
In order to collect feasibility data for a future randomized controlled trial (RCT), this study 
involves the development of the electronic game intervention and pilot-testing of the intervention 
with a sample of 60 young people in Kisumu town and in a rural site in Nyanza region, Kenya, 
where 11.4% of young women ages 15-24 are HIV-infected.7 Males and females ages 11-14 
enrolled in the intervention arm will engage in 10 hours of game play over a two-week period.  
 
The feasibility study will be carried out with the Kenya Medical Research Institute (KEMRI), 
Kisumu, Kenya.  
 
2.1 Aims of the feasibility study 
 
The specific aims for our proposed 3-year study are: 
 
Aim 1: To design and develop a theory-based, empirically grounded mobile phone game for 
young Kenyans aged 11-14 focused on increasing age at sexual debut and condom use at first 
sex; 
 
Page 9 of 127 
 

Aim 2: To pilot test the game with a sample of 60 preadolescents aged 11-14 in rural and urban 
Western Kenya focusing on data needed for a larger efficacy trial, including assessments of 
feasibility, acceptability, willingness, and safety.  
 
We also have the following secondary aim:  
 
Secondary Aim 1: To provide preliminary data on the impact of the game on mediators of 
behaviors (knowledge, attitudes, perceived social norms, behavioral intentions, and related self-
efficacy) to inform the development of an R01 focused on establishing efficacy of the game.  
 
2.2 Preliminary studies that support this stage of the research  
The proposed project draws on several years of formative research conducted by Dr. Kate 
Winskell on young Africans’ – including young Kenyans’ – HIV-related narratives. The 
narratives were submitted by tens of thousands of young Africans to Global Dialogues/Scenarios 
from Africa8 (GD/SfA) scriptwriting competitions. Analysis of this data has provided insights 
into youth sexual culture and youth sense-making9 around subjects including condoms,10 
stigma,11,12 abstinence,13 testing,14 gender norms, sexual violence, relationships, peer influence, 
and antiretroviral therapy (ART). The narratives also provide a goldmine of authentic and 
relevant storylines, dialogue, characters and environments, which are essential to the 
development of culturally adapted curricula focusing on skills-building. Research findings and 
narratives are currently being applied in the enhancement and cultural adaptation of evidence-
based youth prevention curricula for CDC’s Division of Global HIV/AIDS (DGHA).15-17 The 
game will be tailored to 11-14 year-old males and females, drawing on the youth-authored 
narratives and based on concept- and pre-testing data. 
 
In 2013, additional preliminary research was conducted with funding from Emory’s Hubert 
Department of Global Health to inform the development of the current proposal. Anonymous 
online surveys were launched via Facebook with young people aged 15-19 in Nigeria and Kenya 
and four Focus Group Discussions (FGDs), segmented by sex and by time spent playing games, 
were conducted with young people in Imo State, South-East Nigeria. Although clearly not 
representative of the youth population, our online survey data revealed high levels of game-
playing and broad enthusiasm for the game concept in both countries. FGDs likewise revealed 
great enthusiasm for games from male and female participants and “game-players” and “non-
game-players” (determined by hours of weekly game-play) alike, and was also reported among 
their younger siblings. Participants expressed particular enthusiasm for the idea of a role-playing 
game framed in terms of protecting one’s future and preparing for life challenges. 
 
A developmental R03 award from the Emory Center for AIDS Research (CFAR) allowed us to 
conceptualize the proposed project in dialogue with a range of partners; identify and engage in 
regular dialogue around game design with our game development partner; and review relevant 
literature and curricula of youth prevention evidence-based interventions (EBIs), including EBIs 
culturally adapted for Kenyan youth. This unique combination of preliminary data sources 
ensures the proposed intervention and feasibility trial are grounded in the realities of African 
youth experience. 
 
2.3 Significance/justification for current study  
Recent meta-analyses have noted the need for more effective behavioral prevention interventions 
Page 10 of 127 
 

for African youth, highlighting the stark mismatch between the HIV burden in youth and efforts 
to conceptualize and rigorously evaluate interventions targeting this population.5 There is a 
pressing need in youth HIV prevention to develop and test approaches that show potential for 
increased size and sustainability of effects. Youth prevention interventions have focused on 
young people ages 15-19, many of whom are already sexually active, despite the well-
documented challenges of trying to change established risk behaviors.4,5 Reaching 
preadolescents ages 11-14 with the knowledge, adolescents and skills to support healthy 
behaviors prior to sexual debut may help establish lifelong patterns of safer sexual behavior and 
avert high-risk behaviors in the future.2-5 
 
While many youth HIV prevention programs are successful in increasing awareness and 
knowledge, they have shown little effect on sexual risk behavior.5 They often lack skills-building 
or practice activities and have too often provided information that is decontextualized from 
young people’s lived reality and which fails to engage with the structural and normative factors 
that constrain individual agency.18 Future interventions must promote skills for preventing HIV 
infection that are relevant to the prevailing socio-cultural context6,18-21 and grounded in scenarios 
which young people perceive as authentic and relevant. 
 
There is a need to pursue approaches characterized by catalytic innovation,22 i.e. that are more 
affordable, easier to deliver, and have superior scalability, and that thereby have the potential to 
dramatically increase reach, while ensuring fidelity to intervention design. Such approaches can 
help meet the ethical obligation to ensure that youth in high HIV-prevalence settings are 
optimally prepared for a safe sexual debut in the most cost-effective way.  
 
New mobile technologies provide unprecedented opportunities to deliver culturally relevant 
skills-building interventions at scale. Increasingly affordable basic Chinese-manufactured 
smartphones offer the possibility to engage youth in culturally-relevant skills-building 
interventions that require little manpower to implement with consistent quality, have high 
entertainment and motivation appeal, and incorporate automated data collection, facilitating 
monitoring, evaluation and theory-building. 
 
Electronic games are extremely popular among young people. They have potential to impact 
youth HIV prevention in sub-Saharan Africa if they are (a) appropriately grounded in behavioral 
and instructional theory23,24 and informed by evidence-based practice and (b) use technologies 
that will be accessible to players at the time of future dissemination.25 Clinical26-29 and military30 
training provide examples of the benefits of video game technology for learning and skills 
development, while a small but growing body of evidence31-37 supports the effectiveness of 
games for health outcomes related to diabetes38 and asthma39 management, diet40 and physical 
activity,41 and adherence to medication.42 In addition to health outcomes, studies report positive 
effects on a range of mediators of health behaviors, including knowledge, self-efficacy, and 
health-related dialogue. To date, few games have been designed with solid theoretical grounding 
and rigorously evaluated.31-37 There is therefore a pressing need to expand our understanding of 
and the evidence base for the use of game technology for health and to assess their feasibility in 
low-resource settings. If proved efficacious in the eventual trial, the proposed intervention has 
the potential to be highly scalable, cost-effective, and culturally adaptable to individual sub-
Saharan countries.  
 
Page 11 of 127 
 

2.4 Sample  
 
Population:  
• Preadolescents, male and female, aged 11-14, in Nyanza region, Kenya (n = 108) 
• Parents of preadolescents aged 11-14, in Nyanza region, Kenya (n = 54) 
• 
Adolescents, including older siblings of enrolled intervention arm preadolescents, aged 15-
25, in Nyanza region, Kenya (n=75) 
 
Vulnerable population: A proportion of this population will be minors (<18 years old). 
Safeguards to protect this vulnerable population are described in detail below.  
 
Inclusion criteria (preadolescents):  
• Aged 11-14 at time of recruitment 
• Resident in Nyanza region, Kenya 
• Having basic literacy in English (Grade 3-4 on the Flesch-Kincaid Reading Scale). 
This criteria is not expected to greatly limit generalizability of findings for our 11-14 
year-old target audience as primary school education (ages 6/7 through 13/14+) has 
been free and compulsory in Kenya since 2003; all school subjects are taught in 
English from Standard Year 4 (age 10+) onwards.  
• Only one child per family 
 
Exclusion criteria (preadolescents): 
• Aged <11 or >14 
• Not resident in Nyanza region, Kenya 
• Without basic literacy in English 
• 
Sibling to a child already enrolled in the study 
• 
Participant in formative research to inform the study 
 
 
Inclusion criteria (parents): 
• Parent/primary caregiver of child aged 11-14 at time of recruitment 
• Resident in Nyanza region, Kenya 
 
Exclusion criteria:  
• Not parent/primary caregiver of child aged 11-14 at time of recruitment 
• Not resident in Nyanza region, Kenya 
• 
Participant in formative research to inform the study 
 
 
Inclusion criteria (siblings): 
• Older sibling of intervention arm child aged 11-14 at time of recruitment, currently 
aged 15-25 
• Resident in Nyanza region, Kenya 
• With basic English literacy 
 
 
Exclusion criteria (siblings): 
• Not older sibling of intervention arm child aged 11-14 at time of recruitment 
Page 12 of 127 
 

• Older than 25 
• Not resident in Nyanza region, Kenya 
• Without basic English literacy 
 
Inclusion criteria (other adolescents): 
• Currently aged 15-25  
• Resident in Nyanza region, Kenya 
• With basic English literacy 
 
 
Exclusion criteria (other adolescents): 
 
• Older than 25  
• Not resident in Nyanza region, Kenya 
• Without basic English literacy 
 
2.5 Setting 
The proposed pilot test will be conducted in rural Western Kenya, where the Kenyan Medical 
Research Institute (KEMRI)/CDC Health and Demographic Surveillance System (HDSS) is 
located, and in Kisumu town, Kenya’s third largest city. KEMRI has established community 
advisory boards (CABs) in the HDSS sites and in Kisumu town, which will be available to the 
proposed study.  
 
Data collection will take place at KEMRI offices, health clinics, or in the meeting room of a 
local community-based organization (CBO). In addition, data on game-play will be 
automatically collected on mobile phones given to preadolescent study participants.  
 
2.6 Recruitment 
Site of and/or procedures for recruitment: Participants will be recruited through schools, CBOs, 
clinics, churches and social events in Kisumu town and rural communities. KEMRI will provide 
a list of all schools, CBOs, clinics, churches and upcoming social events in each area. Research 
staff will arrange meetings with leaders of these venues to describe the nature of the research.  
 
Description of recruitment methods: In schools, information will be sent out to parents 
describing the study and inviting them to an informational meeting. At the informational 
meeting, study staff will describe the nature of the study and answer questions from attendees. 
The meetings will ask for parents/ caregivers to volunteer for participation. We expect to hold 
around 10 of these informational meetings. Contact information will be collected from 
parents/caregivers selected and a research assistant will then arrange to meet interested families 
at their homes or another preferred location, provide a brief description of the project, answer 
any remaining questions, and screen for eligibility, prior to securing parental consent and 
preadolescent assent. Siblings will be recruited through phone contact with previously enrolled 
families. Additional adolescents will be recruited through snowball sampling, by asking 
previously enrolled families to distribute letters describing the study to friends and family, and 
having interested individuals contact the study team directly; by asking secondary school 
teachers to distribute these letters to creative and engaged students, and having interested 
individuals contract the study team directly; and by asking CAB and YAB (youth advisory 
board) members and local youth-friendly clinics and CBOs to distribute these same letters 
Page 13 of 127 
 

to young people and having interested individuals contact the study team Consent and 
assent for additional participants under age 18 will be carried out in the same way as for 
preadolescent participants. Participants aged 18 and over will meet with a research 
assistant at home or another preferred location, receive a brief description of the project, 
ask any remaining questions, and be screened for eligibility prior to providing consent for 
participation. 
 
Equitable recruitment of subjects: The youth sample will be gender-balanced and efforts will be 
made to ensure that participation is evenly distributed across the 11-14 age range. No more than 
8 volunteers will be recruited from each informational meeting to avoid overrepresentation by 
site. If more than 8 parents/caregivers volunteer, they will be selected randomly from names 
placed in a bowl. If there is more than one eligible child in the household, study staff will 
randomly select a child for enrollment by placing the children’s names in a bowl. Recruitment 
materials and consent/assent forms will be available in English and Luo to ensure comprehension 
(these will be translated into Luo and Swahili and back translated to English by two groups of in-
house translators at KEMRI to ensure accuracy). Parents choosing not to enroll will be asked to 
complete a brief questionnaire identifying reasons for non-participation. 
The sibling sample will not be held to the same even gender and age distribution. The additional 
adolescents recruited through snowball sampling will be selected in order to ensure age and 
gender balance the group of 15-25 year old participants. 
 
2.7 Procedures 
Study Design and Data Collection Procedures:  
 
The study design falls into four parts. Data collection procedures and total respondent burden for 
each part are specified below: 
 
i) Game Development and Validation of Behavioral Measures 
a. Focus Group Discussions with preadolescents [34 FGDs x 6-8 participants; there 
will be overlap in participants in the focus groups, i.e. the same individual may 
take part in several different rounds of focus groups ]. Total respondent burden: 1 
hour per FGD and/or Cognitive Interviews with preadolescents [9 Interviews; 
participants will be the same individuals as those involved in FGDs]. Total 
respondent burden: 1 hour per interview  
 
b. Focus Group Discussions with parents/caregivers [14 FGDs x 6-8 participants; ; 
there will be overlap in participants in the focus groups, i.e. the same individual 
may take part in more than one round of focus groups]. Total respondent burden: 
1.5 hours per FGD. 
 
ii) Intervention 
c. Intervention: Independent game-play [30 preadolescents]. Total respondent 
burden: 10 hours of game-play over 2-3 weeks.  
 
iii) Behavioral Survey 
d. Survey of preadolescents [60 preadolescents]. Total respondent burden: 45 
minutes x 3 (at baseline, post-intervention, and endline) 
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iv) Follow-up Evaluation 
e. Focus Group Discussions with preadolescents [14 FGDs x 6-8 participants]. Total 
respondent burden per FGD: 1 hour and/or In-Depth Interview (IDI) with 
preadolescents [12 Interviews; participants may be the same individuals as those 
involved in FGDs]. Total respondent burden: 1 hour per interview  
f. Focus Group Discussions with parents [8 FGDs x 6-8 participants]. Total 
respondent burden: 1.5 hours. and/or In-Depth Interview (IDI) with parents [8 
Interviews; participants may be the same individuals as those involved in FGDs]. 
Total respondent burden: 1 hour per interview 
g. Focus Group Discussions with adolescents [16 FGDs x 6-8 participants]. Total 
respondent burden: 1 hour and/or In-Depth Interview (IDI) with siblings [16 
Interviews; participants may be the same individuals as those involved in FGDs]. 
Total respondent burden: 1 hour per interview 
h. Survey on social networks with preadolescents and adolescents [1 survey x 120 
participants]. Total respondent burden: 15 minutes. 
i. Cognitive interviews with preadolescents and adolescents [12 interviews]. Total 
respondent burden: 1 hour 
j. Cognitive interviews with parents [9 interviews]. Total respondent burden: 1 hour 
k. Survey of adolescents [20 preadolescents and adolescents]. Total respondent 
burden: 1 hour 
l. Survey of parents [20 parents]. Total respondent burden: 1 hour 
 
 
2.8 Measures 
i) 
Game Development and Validation of Behavioral Measures 
 
A draft game design document and successive modules will be reviewed by young people and 
their parents in Kenya via FGDs. Game development will be iterative, with ten rounds of FGDs 
with preadolescents and parents/caregivers staggered across the 8-month process. A total of 48 
preadolescents and 24 parents will be recruited to participate in the FGDs. There will be overlap 
in participants in the focus groups, i.e. the same individual may take part in several different 
rounds of focus groups. The first two rounds will comprise 3 FGDs with preadolescents (6-8 per 
FGD) and 3 FGDs with parents (6-8 per FGD). Their purpose will be to fine-tune the game 
concept and design, graphic design elements, and narrative. Rounds 3-10 will pre-test successive 
modules of the game in FGDs with preadolescents. FGD questions will focus on perceived 
acceptability (liking, appropriateness), usability (ease of play), comprehension of concepts, 
relevance to their daily lives, entertainment and immersive appeal of the game. In addition, 
suggestions will be elicited on how to improve the game design. The same participants will not 
participate in every round of FGD. 
 
FGDs will be conducted to establish face validity and comprehension of the behavioral survey 
questions among preadolescents and their acceptability among parents. In cognitive interviews 
and FGDs, preadolescent participants will be asked questions relating to specific survey items 
and what specific survey questions mean to them. Parents will be asked to read the survey and 
identify questions they consider unacceptable. 
 
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ii) 
Intervention  
The 60 pilot study participants (youth ages 11-14) will be randomized to the intervention or 
control arm upon completion of the baseline survey. The assignments will be generated with the 
use of a pseudo-random-number generator with permuted blocks, used to ensure balance 
between the numbers of participants assigned to each arm. Those randomized to the intervention 
arm will be given a low-cost (<$50) Android phone on which the game is programmed and 
invited to play the game for one hour each day for 10 days over a two-week period. While we 
anticipate that access to smartphones will be widespread at time of roll-out of an efficacious 
game, this is not yet the case: for the purposes of the feasibility test, phones need to be provided 
in order to ensure consistency of technology and avoid SES bias. All other phone functions will 
be disabled for safety reasons. The phone will be programmed to issue regular reminders to 
encourage game-play. The game will automatically record the time spent playing and the choices 
made in the context of game play. Those randomized to the control arm will receive the current 
standard of care i.e. no intervention beyond routine exposure to local community-based and mass 
media interventions and exposure to life skills education for those in school.  
 
The game, Tumaini, will be a scenario-based role-playing game, optimized for use on low-cost 
Android smartphones that uses comic book-style graphics. It will be downloaded onto the phone 
as an app so that it can be played without Internet access. The game will be tailored to 11-14 
year-old males and females, drawing on the youth-authored narratives and based on concept- and 
pre-testing data.  
 
The game will be available first in English, produced with locally-sourced voice talent. A Luo 
version would follow if feasibility for conducting an efficacy trial in Nyanza were established. In 
order to maximize access to the game for those with limited literacy levels (and increase its 
youth entertainment appeal), all game content will be delivered via both audio and text. Eligible 
participants in the feasibility study will need to demonstrate basic literacy in English (Grade 3-4 
on the Flesch-Kincaid Reading Scale) to ensure that they are able to link response options that 
are heard in English with the same response options shown in text format on screen (for 
example, “Option 1: Leave. Option 2: Stay and see what happens…”). Audio effects will be used 
to maximize immersion.  
 
The proposed game will be designed to: educate young players, ages 11-14, about sexual health 
and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs 
and unintended pregnancy; challenge HIV stigma and harmful gender norms; nurture awareness 
of and positive attitudes towards health services; and promote parent-child dialogue. The 
Information-Motivation-Behavioral Skills (IMB) model43 elucidates the triple-layered structure 
of the game: 
 
1. Information – mini-games. Information that is relevant to HIV transmission and prevention 
will be conveyed by a series of mini-games, i.e. short, simple electronic games contained 
within the larger, more complex game.  
 
2. Behavioral skills and related self-efficacy – scenarios. Built around GD/SfA data, the 
central role-playing element of the game invites the player to take over male and female 
avatars and navigate through a series of scenarios in which s/he makes decisions and 
develops skills and related self-efficacy. The game will include skills-building scenarios from 
Page 16 of 127 
 

preadolescence through the teen years addressing subjects including: realizing future plans 
and dreams; healthy romantic relationships; puberty; harmful gender norms and expectations; 
gender-based violence, including sexual violence, child sexual abuse, and early marriage; 
positive and negative peer influence; alcohol and drugs; peer, partner and adult pressure to 
have sex; intergenerational and transactional sex; unintended pregnancy; STIs; living with 
HIV - testing, treatment and disclosure; and parent/caregiver-child communication. 
 
3. Motivation – meta-narrative linking virtual and real worlds. A motivational meta-
narrative will also link the virtual world with the player’s real world.  
 
iii) 
Behavioral Survey 
 
A survey will be implemented with the preadolescents at baseline (1-2 weeks prior to the 
intervention), post-intervention (1-2 weeks after the intervention), and follow-up (6 
weeks after the intervention), assessing mediators of sexual behavior. We anticipate that 
the assessment will take no more than 45 minutes to complete. All assessments will be 
conducted via audio computer-assisted self-interview (ACASI) technology in which the 
computer will read questions to the participants. Previous research has successfully used 
the ACASI system in Kenya.44 Prior to using the ACASI system, its feasibility and 
acceptability will be pilot tested with a sample of 10 preadolescents. Each participant will 
wear headphones to ensure privacy while answering the questions. Study staff will be 
available to orient participants to the computer system and to answer any questions that 
arise during the interview. Research assistants will administer the questionnaire face to 
face for those participants who are not comfortable using the computer. The data will be 
directly entered into the computer. Surveys will be conducted using ACASI with a view 
to protecting participant confidentiality and reducing social desirability bias.  
 
The survey measures will focus on behaviors and behavioral mediators that we propose 
will be influenced by the game. The proposed measures reflect Social Cognitive Theory45 
and the Information-Motivation-Behavioral Skills model in which the intervention is 
grounded. We will measure sexual behavior, intent to have sex and readiness to have sex. 
We will also assess parent-child dialogue about sex. These primary behavioral mediators 
have already been validated and used with this a similar youth population in the Nyanza 
region HDSS site as part of the evaluation of the Families Matter! Program (FMP) and/or 
with a similar youth population in Botswana as part of an RCT of Project AIM46 
conducted by CDC’s DGHA.47 FMP is a CDC-sponsored intervention for parents and 
caregivers of 9-12 year-olds that promotes effective parent-child communication about 
sexuality and sexual risk reduction.2 In addition, the validity and reliability of many of 
the questions had been established in prior research with US populations.48,49 The FMP 
measures will be supplemented with additional measures drawn from existing literature 
and adapted to be culturally and age-appropriate.50 The survey will assess knowledge, 
attitudes, perceived social norms, along with self-efficacy related to targeted behaviors 
(e.g. rejection of peer, partner and adult pressure to have sex).51 Attitudinal measures and 
measures of perceived social norms will address HIV stigma, gender norms, violence 
against women, intergenerational sex and transactional sex, alcohol and drugs, and 
condoms. Examples of source literature for these measures include: the questionnaire 
from the Guttmacher Institute’s Protecting the Next Generation Project, used with 
Page 17 of 127 
 

adolescents in Uganda; Kalichman et al.’s brief HIV stigma scale, validated in South 
Africa;52 IMB sub-scales (including, for example, the Perceived Effectiveness of AIDS 
Preventive Behavior sub-scale),53 used with adolescents in South Africa;54 the Gender 
Equitable Men Scale,55 and CARE’s Gender Equity Index (modeled after the GEM scale 
for 10-14 year-olds and tested and implemented in Kenya).56  
 
ACASI allows us to introduce “gate” questions (“Have you ever had sex?”) that 
introduce skip patterns determining whether study participants are asked more detailed 
questions. Participants who answer “no” to the gate question will not be asked the more 
detailed questions about their sexual behavior. These safeguards will protect participants 
from questions that could cause discomfort and should help allay unease parents may feel 
about their children being asked questions about sexual behaviors. The survey will collect 
demographic data (age, sex, years in school, residency, etc) and include questions about 
computer access, hours of game play per week, personal phone ownership, household 
phone ownership. The follow-up surveys will be identical to the baseline, with the 
exception that those exposed to the intervention arm will also be asked questions on how 
long and how they used the game. They will also be asked to rate individual modules, the 
game’s usability, entertainment appeal, etc. 
 
iv) 
Follow-up Evaluation 
Following the intervention, four FGDs will be conducted with the 30 preadolescents in the 
intervention arm, and four FGDs will be conducted with their parents/caregivers, for a total of 8 
FGDs, each with 6-8 participants. Equal numbers of FGDs will take place at the two locations 
(Kisumu town and the rural site). The FGDs will be held at KEMRI offices or a CBO meeting 
room and will be conducted in Luo and/or English. The purpose of the FGD will be to provide 
deeper contextual data on the experience of exposure to the game. Questions will focus on: 
acceptability; dose received; barriers to playing the game as instructed; usability; appeal; 
immersion; relevance; safety; and suggestions for improving the experience.  
Additional FGDs and/or IDIs will be conducted with the preadolescents, with some of their older 
siblings, other older adolescents, and with parents, for a total of 30 additional FGDs, each with 6-
8 participants, and/or 36 IDIs. These will also be held at KEMRI officers or a CBO meeting 
room and conducted in DhoLuo, Swahili, and/or English. The purpose of these additional FGDs 
will be to provide additional data on particular aspects of game appeal, recommendations for 
revisions, and suggestions for future game expansions. 
An additional short survey will be conducted with control and intervention arm participant 
preadolescents, their siblings, and other older adolescents. For those who attend FGDs, these 
surveys will be done in person. For others, they can be carried out by phone. The purpose of this 
survey is to provide additional data on social networks and information sharing networks among 
youths in our target demographic. 
Parents will be invited to review and provide feedback on the acceptability of edits to the 
behavioral survey questions. Further cognitive interviews and pilot tests will be conducted with 
preadolescents, their older siblings and other older adolescents to assist revisions to the 
behavioral survey, for a total of 12 interviews and 20 pilot tests. Parents will also participate in 9 
cognitive interviews and 20 pilot tests to assist with the development of an additional parental 
survey.  
Page 18 of 127 
 

Unlike feasibility test behavioral surveys, these modified surveys are intended to be delivered via 
ODK (Open Data Kit), using mobile devices. Piloting of the survey will including piloting the 
new platform for usability and for feasibility of this form of survey delivery. 
 
2.9 Risks to participation 
Potential risks consist of being uncomfortable or emotionally upset as a result of the questions 
asked in the FGDs or the assessment survey, or topics addressed in intervention sessions. It is 
possible that certain assessment questions regarding sexual behavior may make participants feel 
uncomfortable. In addition, participants may have concerns about their personal safety associated 
with being in possession of the mobile phone.  
 
Procedures to reduce risk: Questions will be vetted by the KEMRI community advisory board, 
by parents/guardians, and by preadolescent participants in focus group discussions and cognitive 
interviews prior to being administered. Participants are free to refuse to answer any question and 
may terminate participation in the study at any time. To minimize the risk of participants feeling 
uncomfortable about answering personal questions, we will use a self-administered ACASI 
survey. We will make every effort to create a secure environment (ensuring privacy) prior to 
conducting baseline, post-intervention, and endline assessments. One objective of the feasibility 
study will be to ensure that providing participants with low-cost smartphones will not result in 
risks to their safety. Non-game-related functions on the phone will be disabled in the interests of 
participants’ safety. In addition, participants will be instructed not to tell others about the phone 
or to use it in public. Because of these risk reduction procedures, we expect there would be 
minimal psychological harm to participants. In the event any participant experiences 
psychological harm due to study participation, participant will be evaluated, adequate 
psychological support including referral for further management will be provided by the study 
team. 
 
2.10 
Benefits to subject or future benefits 
Participants in the intervention arm will have the opportunity to experience the use of an 
electronic game to promote safer sexual health for youth in Africa. Others will benefit because 
the study will result in increased knowledge about how video games could be used for HIV 
prevention efforts in Africa. The study will provide important new information to inform the 
development of an efficacy trial of an electronic game and its impact on sexual health among 
youth in Africa. Given the very high burden of HIV among youth in Africa, this has the potential 
to offer an exciting new opportunity for intervention. 
 
2.11 
Data analysis 
Rationale for proposed number of subjects: We propose to enroll a total of 168 Kenyan 
preadolescents. Forty eight children will participate in concept-testing and pre-testing of the 
game and in fine-tuning and ensuring face validity of the survey instrument. Sixty of the 
remaining 90 will participate in the pilot intervention, 30 in the study arm, and 30 in the control 
group. The last 75 will be recruited after the intervention is tested, and only participate in focus 
group discussions and review of survey instruments. 
 
Twenty-four parents or caregivers of 11-14 year-olds will participate in concept-testing and pre-
testing of the game and in determining acceptability of the survey instrument. In addition, one 
Page 19 of 127 
 

parent or guardian of each study participant in the intervention arm (n = 30) will be recruited to 
participate in post-intervention focus group discussions. 
 
We propose, then, to consent and enroll a sample of 60 youth for the intervention component of 
the study. Previous KEMRI based studies suggest approximately 15% loss to follow-up (LFU) in 
cohort studies. We allow for 20% LFU in our sample, producing a sample of 48 youth with 
complete data. As with most pilot studies, we are not adequately powered to show efficacy of the 
game in the study population.  The purpose of the proposed pilot study is to collect data on the 
feasibility of conducting a larger efficacy trial of the game. However, we are interested in 
showing that the game “trends” in the correct direction.  
 
Formal sample calculations: We found that our study design (30 participants using the game 
versus 30 control participants, yielding data on 48 participants) would have 77% statistical power 
to detect a 32% change in a binary attitude measure using a two-sided level-0.1 test of two 
independent binomial proportions.  If we use a level-0.2 test, then we have 77% statistical power 
to detect a change in attitudes of about 26%.  
 
Based on prior pre-testing experience, we are confident that this number of FGDs is sufficient to 
achieve data saturation for our purposes. 
 
Plans for data management and statistical analysis: For each measure we will examine 
univariate properties (frequency and range) and compare prevalence/ mean (range) by age, 
gender, urban/rural location and study arm using appropriate statistical tests for significance. We 
will conduct additional analysis to the prevalence and mean (ranges) of these variables across 
control and experimental arms, focusing on identifying significant differences in changes in 
these variables pre and post intervention. Although the pilot study is not powered to detect 
changes, this analysis will provide more data on the context of behaviors in this population and 
will suggest the possible directions of effects for a larger efficacy trial. 
 
The game will automatically collect data related to all of participants’ in-game behavior, 
including but not limited to: time they spend playing; their scores on knowledge-based mini-
games; the decisions they make in the role-playing games, including how they solve problems, 
accomplish tasks, and overcome obstacles; and the life goals their choose in the meta-narrative 
component. We will generate descriptive statistics from the in-game data. Analysis will present 
descriptive statistics of time spent playing the game (times per week, minutes per session, 
minutes per week), time devoted to different game components, number of players using each 
phone, scores on knowledge-based mini-games, and choices made during game play. Using 
appropriate tests for significance, we will examine differences in these outcomes by age, gender, 
urban/ rural location, and in relation to other survey measures. 
 
Data from the FGDs and IDIs will be audio-recorded, transcribed and entered into MaxQDA 
software. A codebook of deductive themes, focusing on domains addressed in discussion guide, 
and inductive themes emerging from the transcripts, will be used to label the data. We will 
conduct grounded theory-based, thematic analysis of the transcripts with particular focus on 
linkages between thematic domains, patterns by age and gender, and issues that could inform the 
successful design of a future efficacy trial. 
 
Page 20 of 127 
 

Inclusion of stopping rules as appropriate: Not applicable.  
3.0 TRAINING 
3.1 Description of training for research personnel  
All research personnel have completed CITI training. The PIs (Winskell, Mudhune) or one of the 
Co-Is (Stephenson, Breiman) will hold a pre-training preparation meeting at the individual sites 
with local staff to cover the goals, purpose and design of the study and briefly introduce the 
intervention and underlying philosophy of the intervention. Staff will receive study-specific 
training on data collection procedures (including ACASI and ODK data collection) and related 
confidentiality issue ethics. They will be trained to be sensitive to preadolescent and 
parent/caregiver discomfort with certain themes or questions, and to people’s differing opinions 
about sexual education for children. Additionally, all staff will be trained on recognition and 
documentation of any unusual events or circumstances that occur during data collection. Staff 
will be monitored closely by the PIs and Kenya-based Project Coordinator. Staff deficient in any 
aspect of performance will be re-trained, closely monitored for proficiency, and if not adhering 
to established protocols and procedures, will be terminated.  
4.0 PLANS FOR DATA MANAGEMENT AND MONITORING 
4.1 Description of data safety and monitoring plan 
In accordance with the National Institutes of Health (NIH) requirements, we will adopt a Data 
and Safety Monitoring Plan to ensure participants’ safety as well as the data’s validity and 
integrity. The PIs will provide close monitoring and oversight of all study procedures and quality 
assurance checks.  All records pertaining to the study and all of the original and electronic files 
containing collected data will be securely stored by the PIs. Paper copies will be stored in a 
locked metal file cabinet housed in an off-site office location while electronic files will have 
encryption and strong password protection. Completed and signed consent forms will be stored 
in a different locked file cabinet also off-site. 
 
Because there are minimal risks involved in this study, the chances of adverse events are low. 
The most likely adverse event is participant discomfort with some of the subject matter in the 
intervention or the assessments. Interventionists and assessment staff will be trained to be 
sensitive to this discomfort, and to people’s differing opinions about sexual education for 
children. Participants who are not comfortable with the content of the intervention or the 
assessment questionnaires will be reminded that they can choose not to participate for any 
reason.  
A second area of discomfort is that parents may be uncomfortable with their child being asked 
questions about sexual behaviors and attitudes. The consent form will indicate that children will 
be asked questions about sex. Parents will be invited to review the child’s assessment instrument, 
and paper forms will be available for parents’ review. We will point out to parents that for 
questions about sexual behavior, there is a “gate” question that determines whether children are 
asked more detailed questions about sexual intercourse, condom use, and sex partners. Children 
who answer “no” to the gate question will not be asked the more detailed questions about their 
sexual behavior. Parents who object to their children being asked these questions can choose not 
to participate. Parents who accept their children to participate in the study will have reviewed the 
questions their children will be asked. However, the parents will not be able to identify their 
children’s specific choices. 
 
Page 21 of 127 
 

In the event that a minor reports neglect and/ or sexual abuse, the study team (in line with 
conventional best practices) plans to document such cases, report to the local IRB and most 
importantly, refer the victim to the nearest gender based violence center (GBV) for psycho-social 
counseling, medical care and paralegal advice. Interviewers will be trained to offer referrals for 
counseling or social services, trained to discuss sensitively the adolescent’s disclosed experience 
and to monitor for emotional upset or anxiety during or as a result of the interview among any of 
the participants (adolescent or parent) and to offer support and referrals for counseling and other 
services to those participants. Additionally, interviewers will receive training in protection of 
human subjects.  
 
Staff will be trained to report any adverse events that concern them immediately to the Project 
Coordinator at the local field site, via telephone. Should a serious adverse event occur, the 
Project Coordinator will immediately inform Drs. Winskell and Mudhune who, in turn, will 
immediately inform the Emory University IRB and KEMRI IRB. If an adverse event appears to 
be research-related, it will be reported to the OHRP and the NIMH project officer, along with 
summaries of discussions concerning the event. The funding institution project officer will be 
informed of any IRB action taken concerning any adverse event.   
 
Dr. Winskell’s Program Officer at NIMH has indicated that a Data Safety and Monitoring Board 
is not required for this study.  
5.0 CONFIDENTIALITY 
5.1 Plans to protect privacy of subjects and confidentiality of data 
Study surveys will be self-administered via ACASI and will be completed by preadolescents in a 
private space. Access to data collected through these surveys (without associated identifiers) will 
be limited to Drs. Winskell and Mudhune, and relevant staff, all of whom will be training in the 
importance of data privacy. No PHI will be collected. At enrollment, we will collect at least 2 
forms of information to facilitate re-contact of participants, including a home address and a cell 
phone number. Re-contact information will be stored in the study's retention database and will 
only be accessible to study staff with a study-related need for access to these identifiers. Re-
contact information will not be linked to the survey data. 
 
The Principal Investigators and Co-Investigators will be responsible for dissemination of study 
findings through presentations and publications. Dr. Winskell will also be solely responsible for 
handling any requests from other investigators to examine the data collected during this study. 
 
To minimize risks to confidentiality, we will provide study data with all appropriate physical and 
operational security protections. Data will be stored in a physically secure environment, and all 
electronic data files will have encryption and strong password protection. Only those study staff 
who require access to identifying data to complete their study-related roles will be allowed 
access. All study staff will be trained in security and confidentiality procedures, and will sign a 
confidentiality agreement before receiving access to any participant data. Focus group 
participants will be reminded that the confidentiality of any information they provide cannot be 
guaranteed and that they should not say anything that they do not want others outside the group 
to hear. 
 
 
5.2 Description of plans to link data to identifiers 
Page 22 of 127 
 

 
Identification numbers will be developed for participants and noted on study identification cards 
handed out to participants. These will be the sole identifiers included on the survey, FGD 
transcripts, and in analysis datasets. A list will be kept linking the study identification 
 numbers to the identifying participant information. Only consent/assent forms and the 
participant list will have participant names.  
 
5.3 Description of how linkage will be protected  
The participant list that links participant names and study identification numbers will be kept in a 
locked file drawer, and only authorized study team members will have access to that list.  
6.0 INFORMED CONSENT 
6.1 How and where will informed consent be obtained? Oral or written? 
 
Informed consent/assent will consist of a written document, which the participant may read 
himself, or which can be read to the participant by study staff. Written documentation of 
informed consent/assent will be required. Recruitment materials and consent/assent forms will be 
available in English, Swahili and DhoLuo to ensure comprehension (these will be translated into 
Swahili and Luo and back translated to English by two groups of in-house translators at KEMRI 
to ensure accuracy). Parents choosing not to enroll will be asked to complete a brief 
questionnaire identifying reasons for non-participation. 
 
Parents/ primary caregivers will provide informed consent for their child’s participation if the 
child is under 18; in order to avoid any pressure to participate, children will simultaneously be 
invited to provide informed assent in a separate room. Siblings and other adolescents over 18 
will provide informed consent for participation in follow-up FGDs on their own behalf. 
Children and parents will be informed that participation is voluntary, that they do not have to 
answer questions that make them uncomfortable, and that all information will be kept private. 
Information on participants’ experimenting with sex will not be made available to parents for 
participants’ to maintain participants’ own privacy. The game is however meant to promote safer 
sexual health for youth in Africa and for participants. 
 
Unless another location is preferred by participants, study enrollment will take place at the home 
of participants so that they can be easily located in the event of potential attrition. To encourage 
retention, study staff will make regular house calls to the parents/ caregivers of the enrolled 
youth (once per week), and reminders for follow-up study assessments will be made – via phone 
calls – one week and the day before study assessments. 
 
6.2 Plans to inform participants of new findings or research results that might affect health 
 
This preliminary study is unlikely to uncover information that would directly impact 
participants’ health.  
 
  
Page 23 of 127 
 

 
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Page 27 of 127 
 

 
APPENDICES 
Appendix 1: Study Budget 
Redacted 
Appendix 2A: Assent Formative Research - English 
 
ASSENT FORM FOR MINOR SUBJECTS 
 
Study Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators: Kate Winskell, PhD, and Victor Mudhune, MBA MPH 
______________________________________________________________________________ 
This page to be filled in by research team at the time assent is obtained: 
 
Subject’s Age: _____ years (If the child is younger than 6 years old, assent is not required.) 
 
Subject’s Name: ______________________________________________________________ 
 
Check one box: 
______________________________________________________________________________ 
 This child is 6 to 10 years old — must obtain subject’s verbal assent (subject’s signature not 
required) 
       
__________________________________________________ 
____________ 
__/__ 
Signature of person soliciting assent of 6 to 10-year-old subject    Date 
 
 
Time 
______________________________________________________________________________ 
 This child is 11 to 17 years old — must obtain subject’s signature on assent form to 
document assent 
        
______________________________________________________________________________ 
 In my opinion, this child is unable to provide informed assent for non-age-related reasons, 
and the PI for this study has been informed of this determination. 
• Reason(s): 
_____________________________________________________________________
_____________________________________________________________________ 
 
__________________________________________________ 
____________ 
__/__ 
Signature of person soliciting assent (if above box is checked)      Date 
 
 
Time 
 
 
 
Page 28 of 127 
 

 
ASSENT FORM FOR MINOR SUBJECTS 
 
Study Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators: Kate Winskell, PhD and Victor Mudhune, MBA MPH 
 
INFORMATION ABOUT THIS STUDY: 
 
Introduction  
You are being invited to take part in a research study conducted by Emory University in Atlanta 
and the Kenya Medical Research Institute (KEMRI). The study will help us develop a new way 
for children to learn about HIV using a game on a mobile phone.  
  
You only have to take part in the study if you want to. The purpose of this form is to help you 
decide if you want to be in the study. If you are going to be in the study, your parent/caregiver 
also has to agree. But if you do not wish to be in the study, you do not have to, even if your 
parent/caregiver has agreed. Your parent/caregiver cannot force you. 
 
You can leave the study at any time. If you join the study and then change your mind, it is okay 
for you to leave the study. No one will be upset with you. You can skip any questions that you do 
not wish to answer. 
 
This form may contain words that you do not understand. Please ask the study staff to explain 
any word or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
The research team wants to develop a new way for children to learn about HIV using a game on 
a mobile phone. We would like you to tell us what you think of their ideas, plans, and designs. 
We would also like you to help us decide what questions to ask children in order to find out if the 
game is helping them learn about HIV.  
 
What will happen if I take part in this study? 
If you agree to be in the study, here is what will happen:   
 
Focus Group Discussion: We will show you our ideas, plans and designs for the game and ask 
you to discuss them with a group of 6-10 children of about your age. We will also ask you to tell 
us what you think about certain topic areas and about certain questions that we plan to ask other 
children who play the game. We will ask you to take part in these discussion groups around 3-5 
times over a period of 8 months, but you can refuse to participate in any of these discussion 
groups you don’t want to take part in. The group discussions will be recorded to make sure we 
do not miss anything that participants say. Each group discussion will last about an hour. 
 
What are the good (benefits) and bad (risks) things that could happen to me if I agree to be 
in the study? 
 
Benefits:  You will not receive direct benefit by taking part. However, when you take part, you 
are helping us to make a game about HIV that you like and would like to play. You are also 
Page 29 of 127 
 

 
helping us learn if the questions we plan to ask children make sense. You will not be offered 
payment for being in this study.  However, you will be reimbursed Kshs 500 for your time and 
transport costs and refreshments provided as per standard requirements during FGDs. 
 
Risks:  Parts of the game and some of the questions may embarrass you or make you feel 
uncomfortable. If you feel uncomfortable with any questions you are asked, you may refuse to 
answer them. 
 
What about my confidentiality? 
You are being asked to take part in a group discussion. We cannot promise that children in the 
group will not share what you say with others. You shouldn’t say anything in the discussion 
group that you would not want others outside the group to hear.  
 
Your information will be kept private.  All information will be stored safely on a computer 
protected by passwords. No one will be able to trace your answers to you.  
 
This assent form will be kept in a safe locked cabinet. We will use a study number in place of 
your name on all study forms. Your name will never be shared with others. Your name will 
never be used for analysis.  
 
Disclosure of Child Sexual Abuse and Neglect 
Your privacy is very important to us, but so is your health and safety. In cases where abuse, 
neglect or a child’s desire to harm themselves or others is suspected or disclosed during the 
study, our staff are required to report this information. 
 
What if I have questions?  
You can ask any questions you have at any time. If you have any questions about the study now 
or later, you may contact: 
 
Name:  Dr. Victor Mudhune, Principal Investigator, KEMRI 
Email: VMudhune@kemricdc.org   
 
 
Phone: 057 2022929/02 
 
If you have any questions about your rights as a research participant, or have concerns or 
complaints, or if you feel you have been harmed by taking part in this study, please contact: the  
secretary, KEMRI Scientific and Ethics Review Unit (SERU), (P. O. Box 54840-00200, Nairobi) 
at telephone 020-2722541 or cell phone 0722205901 or 0733400003 or 
 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 2022929/02 
Or  
Name:  Emory University Institutional Review Board 
Email: irb@emory.edu  
Phone: +1 404 712 0720 
 
Page 30 of 127 
 

 
The above numbers are not for emergencies. If you are having an emergency, please go to the 
nearest clinic/place you can get help.  
Do you have any questions? 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the 
study and what will happen in the study. I understand the risks and benefits for me. I have been 
given the opportunity to consider my decision and have had all my questions answered. I 
understand that: 
 
1) I can choose to join this study or not. It is up to me. 
2) My parent/caregiver must also agree for me to participate in the study. I cannot participate in 
the study if my parent/caregiver does not agree. 
3) Even if my parent/caregiver agrees, I do not have to participate in the study if I do not want 
to. 
4) If I refuse to join the study, no one will be upset with my parent/caregiver and me. 
5) I can decide to stop being in this study at any time.  
6) My parent/guardian can choose for me to stop being in the study at any time. 
Assent 
By signing this document, I agree to take part in this study as explained in this assent form. 
 
__________________________________________________ 
____________ 
__/__ 
Signature of 11 to 17-year-old Subject 
 
 
         Date 
    
 
Time 
 
__________________________________________________ 
____________ 
__/__ 
Signature of person soliciting assent of 11-17 year old Subject    
Date 
    
 
Time 
 
 
 
Page 31 of 127 
 

 
Appendix 2B: Assent Formative Research - Swahili 
 
Informed Consent Forms 
 
ASSENT FORM FOR MINOR SUBJECTS 
 
Study Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators: Kate Winskell, PhD, and Victor Mudhune, MBA MPH 
______________________________________________________________________________ 
This page to be filled in by research team at the time assent is obtained: 
 
Subject’s Age: _____years (If the child is younger than 6 years old, assent is not required.) 
 
Subject’s Name: _______________________________________________________________ 
 
Check one box: 
______________________________________________________________________________ 
 This child is 6 to 10 years old — must obtain subject’s verbal assent (subject’s signature not 
required) 
 
__________________________________________________ 
____________ 
__/__                           
Signature of person soliciting assent of 6 to 10-year-old subject    Date 
 
 
Time 
 
______________________________________________________________________________ 
 This child is 11 to 17 years old — must obtain subject’s signature on page 2 of assent form 
to document assent 
        
______________________________________________________________________________ 
 In my opinion, this child is unable to provide informed assent for non-age-related reasons, 
and the PI for this study has been informed of this determination. 
• Reason(s): 
• __________________________________________________________________
__________________________________________________________________ 
 
 
__________________________________________________ 
____________ 
__/__ 
Signature of person soliciting assent (if above box is checked)      Date 
 
 
Time 
 
 
 
Page 32 of 127 
 

 
ASSENT FORM FOR MINOR SUBJECTS 
 
Study Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators: Kate Winskell, PhD and Victor Mudhune, MBA MPH 
 
MAELEZO/HABARI KUHUSU UTAFITI HUU 
 
Utangulizi 
.  
Unakaribishwa ushiriki katika utafiti unaofanywa na chuo kikuu cha Emory Atlanta na Kenya 
Medical Research Institute (KEMRI). utafiti huu utatusaidia kuunda njia mpya ya watoto 
kujifunza kuhusu Virusi Vya Ukimwi  kwa kutumia mchezo kwenye simu ya mkono. 
 
Utashiriki tu kwa utafiti ikiwa unataka. Sababu ya hii karatasi/fomu ni kukusaidia kuamua kama 
unataka kuwa katika utafiti.kama unaenda kushiriki katika utafiti, mzazi wako /mlezi pia lazima 
akubali. Lakini kama hutaki kushiriki kwenye utafiti, si lazima hata kama mzazi/mlezi wako 
amekubali. Mzazi /mlezi wako hawezi kukulazimisha. 
 
Unaweza kuacha utafiti wakati wowote. Kama umejiunga na utafiti kisha ubadili fikira zako, ni 
sawa kuacha utafiti.Hakuna atakaye kasirika na wewe. Unaweza ruka maswali yoyote ambayo 
hutaki kujibu. 
 
Fomu hii inaweza kuwa na maneno ambayo huelewi. Tafadhali uliza mfanyikazi wa utafiti 
aeleze neno lolote au maelezo ambayo si wazi kwako. Unaweza kuuliza maswali wakati wowote. 
 
Ni kwa nini tunafanya utafiti huu? 
Timu ya utafiti inataka kuunda njia mpya ya watoto kujifunza kuhusu virusi vya ukimwi kwa 
kutumia mchezo kwenye simu ya mkono/rununu. Tungependa utuambie kile ambacho unafikiria 
kuhusu mawazo, mipango na miundo yao. Tungependa pia utusaidie kuamua maswali ya kuuliza 
watoto ili kujua kama mchezo inawasaidia kujifunza kuhusu virusi vya ukimwi, 
 
Ni nini itafanyika kama nimeshiriki katika utafiti huu? 
kama umekubali kushiriki katika  utafiti ,haya ndiyo yatakayofanyika/yatakayotendeka: 
 
Mahojiano/majadiliano ya kikundi: tutakuonyesha mawazo, mipango na miundo yetu ya mchezo 
na kukuuliza uzijadili na kundi la watoto 6-10 ambao wanakaribia umri sawa na wako. 
Tutakuuliza pia utuambie unachofikiria kuhusu mada nyingine na kuhusu maswali fulani 
ambayo tunapanga kuuliza watoto wengine wanaocheza mchezo. Tutakuuliza ushiriki katika 
makundi ya majadiliano karibu mara 3-5 kwa kipindi cha miezi 8, lakini unaweza kukataa 
kushiriki kwenye makundi ya majadiliano yoyote ambayo hutaki kushiriki. Majadiliano ya 
makundi yatarekodiwa ili kuhakikisha hatujakosa chochote ambacho mshiriki atasema.kila 
majadiliano ya kikundi itakaa karibu saa moja. 
 
Ni nini manufaa na hatari ambayo inaweza kunifanyikia kama nimekubali kushiriki 
kwenye utafiti? 
 
Page 33 of 127 
 

 
Manufaa: hutapata manufaa ya moja kwa moja kwa kushiriki. Hata hivyo, ukishiriki, unatusaidia 
kuunda mchezo kuhusu virusi vya ukimwi ambayo unapenda na ungependa kucheza. 
Unatusaidia pia kujifunza kama maswali tunayopanga kuuliza watoto ni ya maana/mantiki. 
Hutapewa malipo kwa kushiriki katika utafiti huu. Utapewe pesa kiasi cha $6 za kugaramia 
wakati na nauli yako pamoja na vinyuaji kulingana na kanuni inayo kubaliwa saa ya 
mazungumzo ya vikundi. 
 
Hatari: Sehemu ya mchezo na baadhi ya maswali yanaweza kukuaibisha au kukufanya usihisi 
kuwa huru. Kama unahisi huko huru na maswali yoyote umeulizwa, unaweza kukataa kuyajibu 
 
Ni nini kuhusu siri yangu?  
Unaulizwa ushiriki katika majadiliano ya kikundi. Hatuwezi kuahidi kwamba watoto katika 
kikundi hawataeleza wengine utakachosema. Hufai kusema chochote katika maadiliano ya 
kikundi ambayo hungetaka wengine nje ya kikundi wasikie. 
 
Maelezo yako yatawekwa siri. Maelezo/taarifa yote yatahifadhiwa kwa salama kwenye 
tarakilishi/kompyuta ambayo imelindwa na neno la siri. Hakuna atakayeweza fuatilia majibu 
yako  kwako 
 
Fomu hii ya afikio itawekwa salama kwenye kabati iliyofungwa. Tutatumia nambari ya utafiti 
badala ya jina lako kwenye fomu zote za utafiti. Jina lako kamwe halitaelezwa wengine. Jina 
lako kamwe halitatumika kwa uchambuzi 
 
Kutoa taarifa ya unyanyasaji wa watoto kimapenzi na Kutelekezwa 
Siri yako ni muhimu sana kwetu lakini pia, afya na usalama yako.katika hali ambapo 
unyanyasaji, kutelekezwa au hamu ya mtoto kujiumiza au wengi imeshukiwa au kusemwa 
wakati wa utafiti, wafanyi kazi wa utafiti wetu wanahitajika kuripoti taarifa/habari hii. 
 
Je, kama nina maswali ? 
Unaweza kuuliza maswali yoyote ambayo uko nayo wakati wowote. Kama uko na maswali 
yoyote kuhusu utafiti saa hii au baadaye, unaweza wasiliana: 
 
Jina:  Dr. Victor Mudhune, Principal Investigator, KEMRI 
Barua pepe:VMudhune@kemricdc.org  
 
 
 
Nambari ya simu: 057 2022929/02 
 
Kama uko na maswali yoyote kuhusu haki zako kama mshiriki wa utafiti au uko na wasiwasi 
wowote au malalamishi, au kama unahisi umeumizwa kwa kushiriki katika utafiti huu. Tafadhali 
wasiliana na:  
 
Katibu, KEMRI Scientific and Ethics Review Unit (SERU), (sanduku la posta 54840-00200, 
Nairobi) kwenye nambari ya simu 020-2722541 au simu ya rununu 0722205901 au 0733400003 
au 
 
Jina: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Barua pepe:  SMunga@kemri.org 
:Simu :057 2022929/02 
Page 34 of 127 
 

 
 au 
Jina: Emory University Institutional Review Board 
 
Barua pepe: irb@emory.edu  
 Simu: +1 404 712 0720 
 
Nambari hapo juu si ya dharura. Kama uko na dharura, tafadhali enda kwenye kliniki /pahali 
karibu  ambapo unaweza pata usaidizi. 
Je uko na maswali yoyote? 
 
Kauli ya idhini/Kukubali 
Nimesoma (au nimeelezewa) na naelewa hii fomu. Naelewa sababu ya utafiti na kile ambacho 
kitatendeka kwa utafiti. Naelewa hatari na manufaa kwangu. Nimepewa nafasi ya kufikiria 
uamuzi wangu na maswali yangu yote yamejibiwa. Naelewa kwamba: 
 
a) Ninaweza chagua kujiunga na huu utafiti au la . ni juu yangu.  
b) Mzazi /mlezi wangu lazima pia akubali ili niweze kushiriki katika utafiti. Siwezi kushiriki 
katika utafiti kama mzazi/mlezi wangu hajakubali. 
c) Hata kama mzazi/mlezi wangu amekubali, si lazima nishiriki kwa utafiti kama sitaki. 
d)  
e) kama nimekataa kujiunga na utafiti, hakuna atakaye kasirika na mzazi/mlezi wangu na mimi. 
f) Ninaweza amua kuacha kuwa katika utafiti wakati wowote. 
g) Mzazi/mlezi anaweza nichagulia ili niache kuwa/kushiriki katika utafiti wakati wowote.  
 
Afikio 
Kwa kuweka sahihi katika karatasi, nakubali kushiriki katika huu utafiti kama ilivyoelezwa 
katika fomu hii ya afikio. 
 
__________________________________________________ 
____________ 
__/__ 
Sahihi ya mshiriki wa umri 11-17 
 
          
 
Tarehe  
 
Saa 
 
        
 
__________________________________________________ 
____________ 
__/__ 
Sahihi ya mtu anayekusanya/kuchukua            
 
 
Tarehe   
 
Saa 
 afikio ya mshiriki wa umri 11-17 
 
Page 35 of 127 
 

 
Appendix 2C: Assent Formative Research - Luo 
 
Oboke Mar Ayie Mar Nonro ma Dwaro Wach 
 
Informed Consent Forms 
Oboke Mag Ayie 
ASSENT FORM FOR MINOR SUBJECTS 
OBOKE MAR AYIE MAR NYITHINDO MATINDO MA JOCHIWRE 
 
Study Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 Nying Nonro: Tugo mani e simb ong’we yamo mar gengo landruok mar kute mag  ayaki 
kuom joma tindo ma  jorotenge. 
 
Jochung ne Nonro: Kate Winskell, PhD, and Victor Mudhune, MBA MPH 
______________________________________________________________________________ 
Oboke ibiro pog gi jatij nonro sama ikao ayie: 
 
Hik jachiwre: ______________higni (ka nyathi tin ne higni 6, oboke mar ayie ok dwarre) 
Nying Jachiwre: _______________________________________________________________ 
 
Rwak/go tik achiel kuom box gi: 
______________________________________________________________________________ 
 Nyathini  en  jahigni 6 nyaka 10- nyaka ochiw ayie gi  dhoge (seyi mar  jachiwre) 
 
 
__________________________________________________ 
____________ 
__/__ 
Seyi mar jalno ma kao ayie kuom nyathi ma jahigni 6-10.    
Tarik     
 
Saa 
 
 
_____________________________________________________________________________ 
 Nyathini en jahigni 11-17- nyaka seyi mar  jachiwre kau e  oboke mar 2 mar  oboke mar  
ayie 
        
______________________________________________________________________________ 
 
  Gi pacha, nyathini ok nyal chiwo ayie nikech gigo ma ok otenore gi hike, to jachung mar 
nonroni onyis wachni/duokoni. 
• Gigomomiyo: 
____________________________________________________________
____________________________________________________________ 
 
 
__________________________________________________ 
____________ 
__/__ 
Seyi mar jalno ma kao ayie (ka orwak/ogo tik box)   
 
Tarik   
 
Saa 
 
 
Page 36 of 127 
 

 
ASSENT FORM FOR MINOR SUBJECTS 
OBOKE MAR AYIE NE NYITHINDO MA JOCHIWRE 
 
Study Title: A Mobile Phone Game to Prevent HIV among Young Africans 
Nying Nonro: Tugo mani e simb ong’we yamo mar gengo landruok mar kute mag ayaki 
kuom joma tindo ma jorotenge. 
 
Jochung ne Nonro: Kate Winskell, PhD and Victor Mudhune, MBA MPH 
 
WECHE KUOM/E WI NONRO: 
 
Chakruok 
 
Waruaki donjo e nonro ma itimo gi mbalariany mar Emory, Atlanta gi migao mar Kenya 
Medical Research Institute (KEMRI). Nonroni biro konyowa loso yoo manyien ne nyithindo 
mondo opunjore kuom kute mag ayaki e yor tugo man e simb ongwe yamo. 
  
Ibiro mana donjo e nonro ka idwaro/diher.    Fomni biro konyi ng’ado paro  ka idwaro  bedo  e 
nonro. Ka ibiro bedo e nonro, janyuolni/jaritni nyaka bende yie/chiw thuolo. To ka ok idwar 
bedo e nonro, ok ochuno ibedie, kata ka janyuolni/jaritni oyie/ochiwo  thuolo. Janyuolni /Jaritni 
ok nyal chuni. 
 
Inyalo wuok e nonro e saa asaya. Ka idonjo e  nonro to  kendo  iloko paro, en kare mondo 
iwuogi e nonro. Onge ng’ato ma biro chuanyore kodi. Inyalo kadho penjo ma ok idwar duoko. 
 
Fomni nyalo tigo weche ma ok winjireni. Bed thuolo mar penjo jatij nonro mondo  olerni wach 
kata weche mak ok winjireni. Inyalo penjo saa a saya. 
 
Ang’o momiyo  watimo  nonro? 
 
Jononro dwaro loso yoo manyien ne nyithindo  mondo puonjore  e wi kute  mag ayaki e  yor  
tugo mani e  simb ong’we  yamo. Dwar mondo unyiswa gima uparo kuom wachni, chenro   gi 
kido gi. 
 
Ang’o ma biro timore ka adonjo a nonro?  
 
Ka iyie bedo e nonro, mae  e  gima  biro  timore: 
 
Wuoyo/Twak  ma kanyakla/grup: Wabiro nyisi paro ma wan go, chenro gi  kido mag tugo kaeto 
wakwayi  mondo  wawuoye e kanyakla/grup mar nyithindo 6-10 ma uromgo  e  higni/ ma  
mbaseni. Bende wabiro penji mondo inyiswa gima iparo kuom wuoyowa gi e wi penjo moko ma 
wachano penjo  nyithindo mamoko ma biro tugo tugoni. Wabiro kwayi mondo idonjo e twag mar 
kanyakla   ndalo 3-5 kuom thuolo ma dweche 8, to inyalo tamori chiwruok e   wuoyo/twak moro 
amora ma ok idwar donjoe. Twak mar kanyakla/grup ibiro mak gi nyakalondo. 
 
Ang’o  maber (ber)  gi  marach ( rach) manyalo timore ne an ka  ayie bedo e  nonro? 
 
Page 37 of 127 
 

 
 
Ohala/ber: Ok ibi yudo ohala/ ber moriere kuom donjo e nonroni. To, ka idonjo, ikonyowa loso 
tugo e kuom kute mag ayaki ma ihero kendo diher tugo. Bende ikonyowa puonjore ka penjo ma 
wachano penjo nyithindo bende winjore. Ok bi miyi chudo ne bedo e nonro. Kata kamano 
wabiro miyi Kshs 500 ne secheni, gi pes wuoth gi math ibiro chiw kaka chick dwaro seche twak. 
 
Hinyruok/ Rach: Moko kuom tukegi gi penjo moko nyalo  miyo ine  wichkuot kata  mi ibed  ma 
ok ini thuolo. Ka  iwinjo ka  ok ini thuolo gi  penjo moro amora ma openji, inyalo tamori  duoko  
penjogo. 
 
Ang’o  kuom  kano  weche mopondo/maling ling 
 
Ikwayi mondo  idonji e  wuoyo/ twak mar  kanyakla/grup.Ok  wanyal singo ni nyithindo  mani e   
wuoyo/twak mar  grup/kanyakla ok  nyal wacho weche  ma  owach gi joma moko. Ok onego 
iwach wach moro e  wuoyo/ twak mar  kanyakla/grup ma ok  idwar  joma  moko oko  mar  grup  
owinji/ong’e. 
 
Wecheni ibiro kan mopondo. Weche duto ibiro kan  mopondo e komputa mag  gi nying ma aling 
ling. Onge ng’ato ma  biro luo  duokogi 
 
Oboke mar ayieni ibiro kan mopondo e kabat ma olor. Wabiro tiyo gi namba kar nying e foms 
duto  mag  nonro.Nyingi ok bi mi joma moko. Nyingi ok bi ti godo e yudo  duoko mag  nonro. 
 
Wacho ka ng’ato ojwang’o kata omulo, oterore gi nyathi e  yo  ma  ok  owinjore 
 
Ritni en gima duong ne wan, bende ngimani gi ritni. E thuolo ma ng’ato omul, oterore gi nyathi 
kata ojwange mondo ohinye, jotijwa onego ochiw wachni. 
 
Ang’o ma timore ka an  gi  penjo? 
 
Inyalo penjo penjo  mora ma  ingo saa a saya. Ka  ini gi  penjo e  wi nonro sani kata  bange, 
inyalo  tudori gi: 
 
Nying: Dr. Victor Mudhune, Principal Investigator, KEMRI 
 
Oboke mar  mbui: VMudhune@kemricdc.org  
 
 
 
Simu: 057 2022929/02 
 
Ka  eni gi penjo mora mora e wi  ratiro mari kaka  jachiwre  e nonro, kata  ini gi ngur kata  
ywagruok, kata iwinjo ka  iyudo  hinyruok kuom chiwruok  e nonro, yie  itudri gi: jagoro 
 KEMRI Scientific and Ethics Review Unit (SERU), (P. O. Box 54840-00200, Nairobi) simu 
020-2722541 kata ong’we yamo 0722205901 kata 0733400003 kata 
 
Nying: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Oboke  mar  mbui: SMunga@kemri.org 
Simu: 057 2022929/02 
Kata 
Page 38 of 127 
 

 
Nying: Emory University Institutional Review Board 
: Oboke mar  mbui:irb@emory.edu  
Phone: simu: +1 404 712 0720 
 
Nembni mani malo ka ok gini mag dwaro kony mapiyo piyo . Ka in gi chandruok ma  dwaro  
kony mapiyo piyo, wakwayi mondo idhi e  klinik/kama chiegni kodi mondoiyud kony. 
Be eni  gi  penjo? 
Wach mar Chiwo  Thuolo 
 
Asesomo(kata oselerna) kendo owinjo gima  fomni wacho. Ang’eyo gima omiyo itimo  nonro gi  
gima  biro  timore  e  nonro. Ang’eyo  hinyruok/ rach gi ohala/ber ne an. Omiya thuolo mar 
ng’ado paro kendo  penjo  ga duto oseduoki. Ang’eyo ni: 
 
7) Anyalo  yiero donjo e  nonro kata ok tamora. En herona. 
8) Jonyuolna/jaritna nyaka bende yie mondo achiwra e nonro. Ok anyal chiwra  ka  jonyuol/jarit 
odagi. 
9) Kata ka janyuolna/jaritna oyie.  Ok ochuno ni nyaka  achiwra e  nonro ka  ok adwar. 
10) Ka  adagi donjo  e nonro, onge ng’ato ma biro chwanyore gi janyuolna/jaritna kendo  koda. 
11) Anyalo wuok bedo e  nonroni e saa a saya. 
12) Janyuolna/jaritna nyalo yiero mondo  awe  bedo e nonro e saa a saya. 
 
Ayie 
Ka  agoyo seyi obokeni, ayie donjo e  nonro kaka oler e form mar  ayie. 
 
 
__________________________________________________ 
____________ 
__/__ 
Seyi mar jachiwre ma  jahigni 11-17                                           
Tarik            
 
Saa 
 
        
__________________________________________________ 
____________ 
__/__ 
Seyi mar jalno ma kao ayie mar Jachiwre ma  jahigni 11-17        
Tarik        
 
Saa 
 
 
 
Page 39 of 127 
 

 
Appendix 3A: Parental Consent Formative Research - English 
 
Consent for Child to be a Research Subject 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Introduction  
Your child is being invited to take part in a research study conducted by Emory University in 
Atlanta and the Kenya Medical Research Institute (KEMRI). The study will help us develop a 
new way for children to learn about HIV using a game on a mobile phone.  We plan to recruit a 
total of 162 people for this study. 
 
This form is to help you decide if you want to allow your child to be in the study. Your child can 
only take part in the study if you agree. Your child will also be asked if they want to take part in 
the study. Nothing bad will happen to you or your child if you or they say ‘no’.  
 
If you decide to allow your child to join the study and then change your mind, it is okay for 
him/her to leave the study. You can remove him/her from the study at any time. No one will be 
upset with you or your child. 
 
This form may contain words that you do not understand. Please ask the study staff to explain 
any word or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
The research team wants to develop a new way for children to learn about HIV using a game on 
a mobile phone. We would like your child to tell us what he or she thinks of the research team’s 
ideas, plans, and designs. We would also like your child to help us decide what questions to ask 
children in order to find out if the game is helping them learn about HIV. 
 
What will happen if my child takes part in this study? 
 
If both you and your child agree for your child to take part in the study, here is what will happen:   
 
Focus Group Discussion: We will show your child our ideas, plans and designs for the game and 
ask him or her to discuss them with a group of 6-10 children of about the same age. We will also 
ask your child to tell us what they think about certain topic areas and about certain questions that 
we plan to ask other children who play the game. We will ask your child to take part in these 
discussion groups 3-5 times over a period of 8 months. He or she can refuse to participate in any 
of these discussion groups. The group discussions will be recorded to make sure we do not miss 
anything that participants say. Each group discussion will last about 1 hour. 
 
Page 40 of 127 
 

 
What are the good (benefits) and bad (risks) things that could happen to my child if I agree 
for him/her to be in this study?  
 
Benefits:  Your child will not receive direct benefit by taking part. However, when your child 
takes part, he or she is helping us to make a game about HIV that children like him or her like 
and would like to play. He or she is also helping us learn if the questions we plan to ask children 
are clear and relevant. You will not be offered payment for being in this study. However, you 
will be reimbursed Kshs 500 for your time and transport costs and refreshments. 
 
Risks:  Parts of the game and some of the questions may embarrass your child or make him or 
her feel uncomfortable. If your child feels uncomfortable with any questions, he or she may 
refuse to answer them. 
 
What about my child’s confidentiality?   
 
Your child is being asked to take part in a group discussion. We cannot promise that children in 
the group will not share what he or she say with others. Your child shouldn’t say anything in the 
discussion group that he or she would not want others outside the group to hear.  
 
Your child’s information will be kept private. All information will be stored safely on a 
computer protected by passwords. No one will be able to trace your child’s answers to him or 
her.  
 
This consent form will be kept in a safe locked cabinet. We will use a study number in place of 
your child’s name on all study forms. Your child’s name will never be shared with others. Your 
child’s name will never be used for analysis.  
 
Does my child have to participate? What will happen if we change our minds? 
 
You can choose for your child to not be in this study. Your child can choose not to be in the 
study. If you and your child agree for him/her to be in the study, he/she can still refuse to answer 
any question. You or your child can stop their participation in the study at any time. Nothing bad 
will happen to you or your child if they refuse to answer questions or want to stop taking part in 
the study.  
 
Disclosure of Child Sexual Abuse and Neglect 
 
Your child’s privacy is very important to us, but so are his/her health and safety. In cases where 
abuse, neglect or the desire to harm themselves or others is suspected or disclosed during the 
study, our staff are required to report this information. 
 
What if I have questions?  
You can ask any questions you have at any time. If you have any questions about the study now 
or later, you may contact: 
 
Name:  Dr. Victor Mudhune  
  
Email: VMudhune@kemricdc.org   
 
 
Page 41 of 127 
 

 
Phone: 057 2022929/02 
 
 
  
If you have any questions about your or your child’s rights as a research participant, or have 
concerns or complaints, or if you feel you have been harmed by taking part in this study, please 
contact: the secretary, KEMRI Scientific and Ethics Review Unit (SERU), (P. O. Box 54840-
00200, Nairobi) at telephone 020-2722541 or cell phone 0722205901 or 0733400003 or 
 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 2022929/02 
Or  
Name:  Emory  University Institutional Review Board 
Email: irb@emory.edu  
Phone: +1-404-712-0720 
 
The above numbers are not for emergencies. If you are having an emergency, please go to the 
nearest clinic/place you can get help.  
 
Do you have any questions? 
 
Page 42 of 127 
 

 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the 
study and what will happen in the study. I understand the risks and benefits for my child. I have 
been given the opportunity to consider my decision and have had all my questions answered. I 
understand that: 
 
1) I can choose to allow my child to join this study or not. It is up to me. 
2) My child can choose to join the study or not. It is up to him or her. 
3) Even if I agree, my child does not have to participate in the study if he/she does not want to. 
4) If I refuse or my child chooses not to join the study, nothing bad will happen to me or my 
child as a result. 
5) I can decide to stop my child from being in this study at any time.  
6) My child can stop being in the study at any time. 
Consent 
By signing this document, I agree to let my child participate in the study as explained in this 
form. 
 
Date 
 
 
 
 
     Signature of Parent/Guardian 
 
 
 
 
 
 
 
 
     Printed Name of Parent/Guardian 
 
 
Child’s Name  
 
 
      
 
 
 
Date 
 
 
 
 
      Signature of Project Staff 
 
 
 
   
 
 
 
 
      Printed Name of Project Staff 
 
 
Page 43 of 127 
 

 
Appendix 3B: Parental Consent Formative Research - Swahili 
 
Consent for Child to be a Research Subject 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Utangulizi 
Mtoto wako anakaribishwa kushiriki katika utafiti unaofanywa na chuo kikuu cha Emory Atlanta 
na Kenya Medical Research Institute (KEMRI). utafiti huu utatusaidia kuunda njia mpya ya 
watoto kujifunza kuhusu Virusi Vya Ukimwi  kwa kutumia mchezo kwenye simu ya mkono.tuko 
na mpango wa kusajili jumla ya watu 162 kwa hii utafiti. 
 
Fomu hii ni ya kukusaidia kuamua kama unataka kukubalia mtoto wako ashiriki katika utafiti. 
Mtoto wako anaweza shiriki katika utafiti kama umekubali tu. Mtoto wako pia ataulizwa kama 
anataka kushiriki katika utafiti.Hakuna kitu kibaya kitakachokufanyikia au mtoto wako kama 
wewe au mtoto wako amesema la 
 
Kama umeamua kukubalia mtoto wako ajiunge na utafiti na kisha ubadilishe fikira, ni sawa 
kuacha utafiti.unaweza kumtoa kwenye utafiti wakati wowote.hakuna atakaye kasirika na wewe 
au mtoto wako.  
 
Hii fomu inaweza kuwa na maneno ambayo huelewi. Tafadhali uliza mfanyikazi wa utafiti 
aeleze neno lolote au taarifa/maelezo ambayo si wazi kwako. Unaweza kuuliza maswali wakati 
wowote. 
 
Ni kwa nini tunafanya utafiti huu? 
Timu ya utafiti inataka kuunda njia mpya ya watoto kujifunza kuhusu virusi vya ukimwi kwa 
kutumia mchezo kwenye simu ya mkono/rununu. Tungependa mtoto wako atuambie kile 
ambacho anafikiria kuhusu mawazo, mipango na miundo yao. Tungependa pia mtoto wako 
atusaidie kuamua maswali ya kuuliza watoto ili kujua kama mchezo inawasaidia kujifunza 
kuhusu virusi vya ukimwi, 
 
Ni nini itafanyika/tendeka kama mtoto wangu ameshiriki katika utafiti huu? 
 
Kama wewe na mtoto wako mmekubali ili mtoto wako ashiriki katika utafiti,   
 
Mahojiano/majadiliano ya kikundi: tutaonyesha mtoto wako mawazo, mipango na miundo yetu 
ya mchezo na kumuuliza azijadili na kundi la watoto 6-10 ambao wanakaribia umri sawa na 
yake. Tutauliza mtoto wako pia atuambie anachofikiria kuhusu mada Fulani na kuhusu maswali 
fulani ambayo tunapanga kuuliza watoto wengine wanaocheza mchezo. Tutauliza mtoto wako 
ashiriki katika mahojiano ya kikundi karibu mara 3-5 kwa kipindi cha miezi 8.  Anaweza kukataa 
kushiriki kwenye mahojiano/majadiliano ya kikundi. Majadiliano ya makundi yatarekodiwa ili 
Page 44 of 127 
 

 
kuhakikisha hatujakosa chochote ambacho mshiriki amesema.kila mahojiano ya kikundi itakaa 
karibu saa moja. 
 
Ni nini manufaa na hatari ambayo inaweza kufanyikia mtoto wangu kama nimekubali 
ashiriki kwenye utafiti? 
 
Manufaa: mtoto wako hatapata manufaa ya moja kwa moja kwa kushiriki. hata hivyo,mtoto 
wako akishiriki, anatusaidia kuunda mchezo kuhusu virusi vya ukimwi ambayo watoto kama  
yeye wanapenda na wangependa kucheza.anatusaidia pia kujifunza kama maswali tunayopanga 
kuuliza watoto ni wazi na ya maana/mantiki. Hutapewa malipo kwa kushiriki katika utafiti huu. 
Utapewe pesa kiasi cha Kshs 500 za kugaramia wakati na nauli yako pamoja na vinyuaji 
kulingana na kanuni inayo kubaliwa saa ya mazungumzo ya vikundi. 
 
Hatari: sehemu ya mchezo na baadhi ya maswali yanaweza kuaibisha mtoto wako au kumfanya 
asihisi kuwa huru. Kama mtoto wako anahisi hako huru na maswali yoyote, anaweza kukataa 
kuyajibu 
 
Ni nini kuhusu siri ya mtoto wangu? 
Mtoto wako anaulizwa ashiriki katika mahojiano/majadiliano ya kikundi. Hatuwezi kuahidi 
kwamba watoto katika kikundi hawataeleza wengine atakachosema. Mtoto wako hafai kusema 
chochote katika mahojiano/majadiliano ya kikundi ambayo hangetaka wengine nje ya kikundi 
wasikie. 
 
Maelezo ya mtoto wako yatawekwa siri. Maelezo/taarifa yote yatahifadhiwa kwa salama kwenye 
tarakilishi/kompyuta ambayo imelindwa na neno la siri. Hakuna atakayeweza fuatilia majibu ya 
mtoto wako kwake. 
 
Fomu hii ya afikio itawekwa salama kwenye kabati iliyofungwa. Tutatumia nambari ya utafiti 
badala ya jina la mtoto kwenye fomu zote za utafiti. Jina la mtoto wako kamwe halitaelezwa 
wengine. Jina la mtoto wako kamwe halitatumika kwa uchambuzi 
 
Ni lazima mtoto wangu ashiriki? Ni nini itafanyika/itatendeka kama tumebadili fikira? 
 
Unaweza kuchagua kama mtoto wako atashiriki katika utafiti. Mtoto wako anaweza kuchagua 
kushiriki katika utafiti. Kama wewe na mtoto wako mmekubali akuwe katika utafiti, bado 
anaweza kukataa kujibu swali lolote. Wewe na mtoto wako mnaweza kushiriki katika utafiti 
wakati wowote. Hakuna kitu kibaya ambacho kitafanyika /kitatendeka kama amekataa kujibu 
maswali au kupeana damu au anataka kuacha kushiriki kwenye utafiti.  
 
Kutoa taarifa ya unyanyasaji wa watoto kimapenzi na Kutelekezwa 
 
Siri ya mtoto wako ni muhimu sana kwetu lakini pia, afya na usalama wake.katika hali ambapo 
unyanyasaji, kutelekezwa au hamu ya kujiumiza au wengine imeshukiwa au kusemwa wakati wa 
utafiti,wafanyi kazi wa utafiti wetu wanahitajika kuripoti taarifa hii. 
 
Je, kama nina maswali yoyote? 
 
Page 45 of 127 
 

 
Unaweza kuuliza maswali yoyote ambayo uko nayo wakati wowote. Kama uko na maswali 
yoyote kuhusu utafiti saa hii au baadaye, unaweza wasiliana: 
 
Jina: Dr. Victor Mudhune 
  
Barua pepe 
VMudhune@kemricdc.org   
 
 
Simu 057 2022929/02  
 
  
Kama uko na maswali yoyote kuhusu haki zako kama mshiriki wa utafiti au uko na wasiwasi 
wowote au malalamishi, au kama unahisi umeumizwa kwa kushiriki katika utafiti huu. Tafadhali 
wasiliana:  
 
Katibu, KEMRI Scientific and Ethics Review Unit (SERU), (sanduku la posta 54840-00200, 
Nairobi) kwenye nambari ya simu 020-2722541 au simu ya rununu 0722205901 au 0733400003 
au 
 
Jina Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Barua pepe SMunga@kemri.org 
Simu057 2022929/02 
Jina:  Emory  University Institutional Review Board 
Barua pepe 
irb@emory.edu  
Simu +1-404-712-0720 
 
Nambari hapo juu si ya dharura. Kama uko na dharura, tafadhali enda kwenye kliniki /pahali 
karibu ambapo unaweza pata usaidizi. 
Je uko na maswali yoyote? 
 
Kauli ya idhini/kukubali 
Nimesoma (au nimeelezewa) na naelewa hii fomu. Naelewa sababu ya utafiti na kile ambacho 
kitatendeka kwa utafiti. Naelewa hatari na manufaa kwa mtoto wangu. Nimepewa nafasi ya 
kufikiria uamuzi wangu na maswali yangu yote yamejibiwa. Naelewa kwamba: 
 
Ninaweza chagua kukubalia mtoto wangu ajiunge na utafiti huu au la, ni juu yangu.  
Mtoto wangu anaweza kuchagua kujiunga na utafiti au la. Ni juu yake. 
 
1. Hata kama nimekubali, si lazima mtoto wangu ashiriki katika utafiti kama hataki 
2. Kama nimekataa na mtoto wangu amechagua kutojiunga na utafiti, hakuna kitu kibaya 
ambacho kitanifanyikia au mtoto wangu juu ya hii. 
2. Ninaweza amua kukataza mtoto wangu kushiriki katika huu utafiti wakati wowote. 
3. Mtoto wangu anaweza kataa kushiriki kwenye utafiti wakati wowote. 
 
Page 46 of 127 
 

 
Afikio 
Kwa kusahihi karatasi hii, nakubali kuacha mtoto wangu ashiriki katika utafiti vile imeelezwa 
kwa hii fomu. 
 
_________________________ 
 
__________________________________________ 
Tarehe  
 
 
 
 
Sahihi ya mzazi/msimamizi/mlezi 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________ 
 
 
 
 
 
      
Jina chapisho la mzazi /msimamizi/mlezi 
 
__________________________ 
Jina la mtoto  
 
      
 
 
 
__________________________ 
 
_________________________________________ 
Tarehe  
 
 
 
 
Sahihi ya afisa wa mradi. 
 
 
 
 
 
 
 
 
_________________________________________ 
   
 
 
 
 
 
Jina chapisho la afisa wa mradi 
 
Page 47 of 127 
 

 
Appendix 3C: Parental Consent Formative Research - Luo 
 
Consent for Child to be a Research Subject 
Title:  A Mobile Phone Game to Prevent HIV among Young Africans 
Nying Nonro: Tugo mani e simb ong’we yamo mar gengo landruok mar kute mag ayaki 
kuom joma tindo ma jorotenge. 
 
Jochung ne Nonro: 
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Omuom Owuok: U.S. National Institute of Mental Health 
 
Chakruok 
 
Nyathini iruako mondo odonji e nonro ma itimo gi Mbalariany mar Emory, Atlanta gi  migawo 
mar  Kenya Medical Research Institute (KEMRI). Nonroni biro konyowa loso yoo manyien ne 
nyithindo puonjore kuom kute mag ayaki  e yor  tugo e simb ong’we yamo. Wachano rwako 
madirom ji 162 e nonroni. 
 
Fomni  biro konyi ng’ado paro ka idwaro yiene nyathini mondo odonj e nonro. Nyathini nyalo 
mana donjo e  nonro ka iyie. Nyathini bende ibiro penj ka odwaro donjo e nonro. Onge  gima 
rach ma  biro  timore ne  ini kata  nyathini ka ini  kata nyathini  owacho  ‘ooyo’. 
 
Ka ing’ado yiene nyathini donjo e nonro kendo bange iloko  paro, en kare ne en wuok e nonro. 
Inyalo golo nyathini e nonro  saa a saya. Onge ng’ato ma biro chwanyore kodi kata gi nyathini. 
 
Fomni nyalo bedo  gi  weche ma ok  winjire.Yie ipenj jotij nonro olerni wach kata weche ma ok 
winjire ne ini. Inyalo penjo  penjo  saa a saya. 
 
Ang’o momiyo watimo  nonroni? 
 
Jotij nonro dwaro loso yoo manyien ma nyithindo nyalo puonjore e wi kute  mag  ayaki e yor  
tugo ma e  simb  ong’we  yamo. Dwaher nyathini onyiswa gima oparo kuom paro, chenro gi kido 
mag tugo mag jotij nonro. Bende  dwaher nyathini okonywa ng’ado  paro e wi penjo ma  
wapenjo nyithindo mondo  wang’e  ka tugoni konyogi puonjore e  wi  kute mag ayaki. 
 
Ang’o  ma  biro  timore ka  nyathini ochiwore e  nonroni? 
 
Ka ute,ini gi nyathini uyie nyathini odonji e  nonro, mae  e  gima  biro  timo: 
 
Twak mar kanyakla/grup: Wabiro nyiso nyathini pachwa, chenrowa gi kit tuke kendo penje/ 
wuoyo  kanyakla/grup mar  nyithindo 6-10 manigi higni ma rom kode/mbesene. Bende  wabiro 
penjo nyathini mondo onyiswa gima giparo  e  wi  wuoyowa gi penjo  moko ma wachano miyo  
nyithindo moko ma tugo tugo.Wabiro  kwayo  nyathini mondo odonji e wuoyo/ twak mag  
kanyakla /grup  ndalo  3-5 kuom thuolo mar dweche  8. Nyathini nyalo  tamore chiwre e   
wuoyo/twak  mag  kanykla/grup.  Wuoyo/Twak mag kanyakla/grup ibiro mak  gi nyakalondo 
Page 48 of 127 
 

 
mondo kik  gimoro obawa ma jachiwre owacho. Twak mag kanyakla/grup biro kao ma  dirom  
saa 1. 
 
Ang’o maber (ohala) gi rach (hinyruok) gigo ma nyalo timore ka nyathini oyie  donjo e 
nonro? 
 
Ohala/ Ber: Nyathini ok bi yudo ohala/ber moriere kuom donjo e nonro. To, ka  nyathini odonjo, 
obiro konyowa loso tugo e  wi  kute  mag  ayaki ma  nyithindo ka en kata machal kode diher  
tugo. Nyathini bende konyowa puonjore ka penjo ma  wachano  penjo winjore kendo ni kare. Ok 
bi miyi chudo kuom bedo e nonro. Kata kamano wabiro miyi Kshs 500 ne secheni, gi pes wuoth 
gi math ibiro chiw kaka chick dwaro seche twak 
 
Hinyruok/rach 
Moko  kuom tugo gi  penjo  moko  nyalo kuodo  wiy nyathini kata mi  obedi  ma  ok thuolo. Ka  
nyathini  obedo  ma  ok thuolo  gi penjo  moko, nyathini nyalo tamore  duoko penjo. 
 
Ang’o kuom kano  mopondo/maling ling weche nyathina? 
 
Ikwayi nyathini mondo idonji e twak mar kanyakla/grup.Ok wanyalo singo ni nyithindo manie  
twak mar  grup/kanyakla ok  nyalo wacho/pimo weche  ma  owach gi joma moko. Ok onego 
iwach wach moro e twak mar kanyakla/grup ma ok  idwar  joma  moko oko  mar  grup  
owinji/onge. 
 
Wecheni mag nyathini ibiro kan mopondo. Weche duto ibiro kan  mopondo e komputa mag  gi 
nying ma aling ling. Onge ng’ato ma  biro luo  duoko mag nyathini  
 
Oboke mar ayieni ibiro kan mopondo e kabat ma olor. Wabiro tiyo gi namba kar nying nyathini e 
foms  duto  mag  nonro.Nying nyathini ok bi miyi joma moko. Nying nyathini ok bi ti  godo e 
yudo  duoko mag  nonro. 
 
Bende nyathina nyaka chiwre? Ang’o ma biro timore ka waloko paro? 
 
Inyalo  yiero mondo nyathini  kik donj  e nonro. Nyathini nyalo yiero mondo kik odonj  e nonro. 
Ka  ini gi nyathini uyie mondo odonj  e nonro nyathini podi nyalo  tamore duoko  penjo. Ini kata  
nyathini  nyalo weyo chiwruok e nonro e  saa a saya. Onge gima rach ma nyalo timore ne ini 
kata nyathini ka  gi otamore duoko penjo kata tamore donjo e nonro. 
 
Wacho  ka  ng’ato  ojwang’o kata omulo, oterore gi  nyathi e  yo  ma  ok  owinjore 
 
Ritni en gima duong ne wan, bende ngimani gi ritni. E thuolo ma ng’ato omul, oterore gi nyathi 
kata ojwange mondo ohinye, jotijwa onego ochiw wachni. 
 
Ang’o ma timore ka an gi penjo? 
Inyalo penjo penjo  mora ma  ingo saa a saya. Ka  ini gi  penjo e  wiy nonro sani kata  bange, 
inyalo  tudori gi: 
 
Nying: Dr. Victor Mudhune, Principal Investigator, KEMRI 
Page 49 of 127 
 

 
Oboke  mar  mbui: 
VMudhune@kemricdc.org   
 
 
Simu: 057 2022929/02 
 
Ka eni gi penjo mora mora e wi  ratiro mari kaka  jachiwre  e nonro, kata  ini gi ngur kata  
ywagruok, kata iwinjo ka  iyudo  hinyruok kuom chiwruok  e nonro, yie  itudri gi: jagoro 
KEMRI Scientific and Ethics Review Unit (SERU), (P. O. Box 54840-00200, Nairobi) simu 
020-2722541 kata ong’we yamo 0722205901 kata 0733400003 kata 
 
Nying: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Oboke  mar  mbui: SMunga@kemri.org 
Simu: 057 2022929/02 
Kata 
Nying:  
Emory University Institutional Review Board 
Oboke mar  mbui: 
irb@emory.edu  
Simu: +1 404 712 0720 
 
Nembni mani malo  ka ok  gini mag dwaro  kony  ma piyo piyo. Ka  eni  gi chandruok ma  
dwaro kony ma piyo piyo. Wakwayi idhi e  klinik/kama chiegni kodi mondo iyudi kony. 
Be eni  gi  penjo? 
 
Wach mar Chiwo Thuolo 
 
Asesomo (kata oselerna) kendo owinjo gima  fomni wacho. Ang’eyo gima omiyo itimo  nonro gi  
gima  biro  timore  e  nonro. Ang’eyo  hinyruok/ rach gi  ber ne an. Omiya thuolo mar ng’ado 
paro kendo  penjo  g a duto oseduoki. Ang’eyo ni: 
 
1. Anyalo yiero mondo nyathina odonji e  nonro kata  atamora. En herona 
2. Nyathina nyalo  yiero donjo e nonro kata tamruok.  En herone 
3. Kata  ka ayie,  nyathina  ok onego odonji e  nonro ka ok idwar. 
4. Ka  atamora kata  ka nyathina otamore donjo e nonro, onge gima rach ma  biro  timore ne an 
kata  ne  nyathina nikech mano. 
5. Anyalo  chungo nyathina  kik  ibed  e  nonro saa asaya 
6. Nyathina  nyalo  weyo  bedo e  nonro saa asaya 
 
Page 50 of 127 
 

 
Ayie 
Ka agoyo seyi obokeni. Ayie mondo nyathina ochiwre e nonroni kaka oler e fomni 
 
_____________________________  
______________________________________ 
Tarik  
 
 
 
       
Seyi mar janyuol/jarit 
                                                     
  
 
 
 
 
 
 
 
 
 
 
 
_______________________________________ 
 
 
 
 
 
      
Ndik Nying janyuol/jarit 
 
 
 
Nying Nyathi  
 
      
 
 
 
 
Tarik  
 
 
                   Seyi mar  Jatij Nonro 
 
 
 
   
 
 
 
 
      Ndik Nying Jatij Nonro 
 
Page 51 of 127 
 

 
 
Appendix 4A: Assent Intervention - English 
 
 
ASSENT FORM FOR MINOR SUBJECTS 
 
Study Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators: Kate Winskell, PhD, and Victor Mudhune, MBA MPH 
______________________________________________________________________________ 
This page to be filled in by research team at the time assent is obtained: 
 
Subject’s Age: _____years (If the child is younger than 6 years old, assent is not required.) 
 
Subject’s Name: ______________________________ 
 
Check one box: 
______________________________________________________________________________ 
 This child is 6 to 10 years old — must obtain subject’s verbal assent (subject’s signature not 
required) 
       
__________________________________________________ 
____________ 
__/__ 
Signature of person soliciting assent of 6 to 10-year-old subject    Date 
 
 
Time 
 
______________________________________________________________________________ 
 This child is 11 to 17 years old — must obtain subject’s signature on assent form to 
document assent 
        
______________________________________________________________________________ 
 In my opinion, this child is unable to provide informed assent for non-age-related reasons, 
and the PI for this study has been informed of this determination. 
• Reason(s): 
_____________________________________________________________________
_____________________________________________________________________ 
 
 
__________________________________________________ 
____________ 
__/__ 
Signature of person soliciting assent (if above box is checked)      Date 
 
 
Time 
 
 
 
Page 52 of 127 
 

 
ASSENT FORM FOR MINOR SUBJECTS 
 
Study Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD 
Victor Mudhune, MBA MPH 
 
INFORMATION ABOUT THIS STUDY: 
 
Introduction  
You are being invited to take part in a research study conducted by Emory University in Atlanta 
and the Kenya Medical Research Institute (KEMRI). The study will help us develop a new way 
for children to learn about HIV using a game on a mobile phone. About 108 preadolescents, male 
and female will be asked to join the study. 
  
You only have to take part in the study if you want to. The purpose of this form is to help you 
decide if you want to be in the study. If you are going to be in the study, your parent/caregiver 
also has to agree. But if you do not wish to be in the study, you do not have to, even if your 
parent/caregiver has agreed. Your parent/caregiver cannot force you. 
 
You can leave the study at any time. If you join the study and then change your mind, it is okay 
for you to leave the study. No one will be upset with you. You can skip any questions that you do 
not wish to answer. 
 
This form may contain words that you do not understand. Please ask the study staff to explain 
any word or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
The research team wants to find out how a game about HIV that children play on a mobile phone 
may affect their behavior. The study will help us understand whether the game helps children 
learn about HIV and helps keep them healthy.  
 
What will happen if I take part in this study? 
If both you and your parent/caregiver agree for you to take part in the study, here is what will 
happen:   
 
Survey: You will sit in front of a computer wearing headphones. You will hear questions through 
the headphones and will enter your answers on the computer (this is called a survey). You will 
complete the survey three times (about 12 weeks apart). Each survey will take about 45 minutes. 
Some questions will be about you, your health, and your goals. Other questions will be  about 
sexual behavior and alcohol use. If you feel uncomfortable with any of the questions, you may 
refuse to answer them. You can also stop taking part in the survey at any time. 
 
Game: You may or may not be selected to complete this part of the study. If you are selected, we 
will lend you a mobile phone. The only thing you will be able to do on the phone is play the 
game: all other functions of the phone will be disabled. We will ask you to play the game for 10 
Page 53 of 127 
 

 
hours over a 2-3 week period. At the end of this time, we will collect the phone from you. We 
will be able to see from the phone how you played the game. 
Focus Group Discussion: After we have collected the phone, we will ask you to take part in a 
group discussion to tell us about your experiences playing the game. The group discussion will 
be recorded to make sure we do not miss anything that participants say. The group discussion 
will last about 1 hour. 
 
What are the good (benefits) and bad (risks) things that could happen to me if I agree to be 
in the study? 
 
Benefits:  You will not get direct benefit by taking part. However, when you take part, you are 
helping us to find out if the game helps children learn about HIV and stay healthy. You will not 
be offered payment for being in this study. However, you will be reimbursed Kshs 500 for your 
time and transport costs and refreshments. 
 
Risks:  Parts of the game and some of the questions may embarrass you or make you feel 
uncomfortable. If you feel uncomfortable with any questions, you may refuse to answer them. 
You can return the phone to us and stop being in the study at any time.  
 
What about my confidentiality? 
Your information will be kept private.  All information will be stored safely on a computer 
protected by passwords. No one will be able to trace your answers to you.  
 
This assent form will be kept in a safe locked cabinet. We will use a study number in place of 
your name on all study forms. Your name will never be shared with others. Your name will 
never be used for analysis.  
 
You are being asked to take part in a group discussion. We cannot promise that children in the 
group will not share what you say with others. You shouldn’t say anything in the discussion 
group that you would not want others outside the group to hear. 
 
Disclosure of Child Sexual Abuse and Neglect 
Your privacy is very important to us, but so is your health and safety. In cases where abuse, 
neglect or a child’s desire to harm themselves or others is suspected or disclosed during the 
study, our staff are required to report this information. 
 
What if I have questions?  
 
You can ask any questions you have at any time. If you have any questions about the study now 
or later, you may contact: 
 
Name:  Dr. Victor Mudhune  
  
Email: VMudhune@kemricdc.org   
 
 
Phone: 057 2022929/02 
 
 
  
If you have any questions about your rights as a research participant, or have concerns or 
complaints, or if you feel you have been harmed by taking part in this study, please contact: the 
Page 54 of 127 
 

 
secretary, KEMRI Scientific and Ethics Review Unit (SERU), (P. O. Box 54840-00200, Nairobi) 
at telephone 020-2722541 or cell phone 0722205901 or 0733400003 or 
 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 2022929/02 
Or  
Name:  Emory  University Institutional Review Board 
Email: irb@emory.edu  
Phone: +1-404-712-0720 
The above numbers are not for emergencies. If you are having an emergency, please go to the 
nearest clinic/place you can get help.  
 
Do you have any questions? 
 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the 
study and what will happen in the study. I understand the risks and benefits for me. I have been 
given the opportunity to consider my decision and have had all my questions answered. I 
understand that: 
 
1. I can choose to join this study or not. It is up to me. 
2. My parent/caregiver must also agree for me to participate in the study. I cannot participate in 
the study if my parent/caregiver does not agree. 
3. Even if my parent/caregiver agrees, I do not have to participate in the study if I do not want 
to. 
4. If I refuse to join the study, no one will be upset with my parent/caregiver and me. 
5. I can decide to stop being in this study at any time.  
6. My parent/guardian can choose for me to stop being in the study at any time. 
Assent 
By signing this document, I agree to take part in this study as explained in this assent form. 
 
 
__________________________________________________ 
____________ 
__/__ 
Signature of 11 to 17-year-old Subject 
 
 
         Date 
    
 
Time 
 
        
 
__________________________________________________ 
____________ 
__/__ 
Signature of person soliciting assent of 11-17 year old Subject    
Date 
    
 
Time 
 
 
Page 55 of 127 
 

 
 
Appendix 4B: Assent Intervention - Swahili 
 
 
ASSENT FORM FOR MINOR SUBJECTS 
 
Study Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators: Kate Winskell, PhD, and Victor Mudhune, MBA MPH 
______________________________________________________________________________ 
This page to be filled in by research team at the time assent is obtained: 
 
Subject’s Age: _____years (If the child is younger than 6 years old, assent is not required.) 
 
Subject’s Name: _______________________________________________________________ 
 
Check one box: 
______________________________________________________________________________ 
 This child is 6 to 10 years old — must obtain subject’s verbal assent (subject’s signature not 
required) 
       
__________________________________________________ 
____________ 
__/__ 
Signature of person soliciting assent of 6 to 10-year-old subject    Date 
 
 
Time 
 
 
______________________________________________________________________________ 
 This child is 11 to 17 years old — must obtain subject’s signature on page 2 of assent form 
to document assent 
        
______________________________________________________________________________ 
 In my opinion, this child is unable to provide informed assent for non-age-related reasons, 
and the PI for this study has been informed of this determination. 
• Reason(s): 
_____________________________________________________________________
_____________________________________________________________________ 
 
 
 
__________________________________________________ 
____________ 
__/__ 
Signature of person soliciting assent (if above box is checked)      Date 
 
 
Time 
 
 
 
 
 
 
Page 56 of 127 
 

 
ASSENT FORM FOR MINOR SUBJECTS 
 
Study Title: A Mobile Phone Game to Prevent HIV among Young Africans 
Principal Investigators:  
Kate Winskell, PhD 
Victor Mudhune, MBA MPH 
MAELEZO KUHUSU UTAFITI  HUU 
 
Utangulizi  
Unakaribishwa ushiriki katika utafiti unaofanywa na chuo kikuu cha Emory Atlanta na Kenya 
Medical Research Institute (KEMRI). utafiti huu utatusaidia kuunda njia mpya ya watoto 
kujifunza kuhusu Virusi Vya Ukimwi  kwa kutumia mchezo kwenye simu ya mkono. Karibu 
vijana 108 ,wa  kiume na kike wataulizwa wajiunge na utafiti. 
Utashiriki tu kwa utafiti ikiwa unataka. Sababu ya hii karatasi/fomu ni kukusaidia kuamua kama 
unataka kuwa katika utafiti.kama unaenda kushiriki katika utafiti, mzazi wako /mlezi pia lazima 
akubali. Lakini kama hutaki kushiriki kwenye utafiti,si lazima hata kama mzazi/mlezi wako 
amekubali. Mzazi /mlezi wako hawezi kukulazimisha. 
 
Unaweza kuacha utafiti wakati wowote. Kama umejiunga na utafiti kisha ubadili fikira zako, ni 
sawa kuacha utafiti.Hakuna atakaye kasirika na wewe. Unaweza ruka maswali yoyote ambayo 
hutaki kujibu. 
 
Fomu hii inaweza kuwa ma maneno ambayo huelewi. Tafadhali uliza mfanyikazi wa utafiti 
aeleze neno lolote au maelezo ambayo si wazi kwako. Unaweza kuuliza maswali wakati wowote. 
 
Ni kwa nini tunafanya huu utafiti 
Timu ya utafiti inataka kujua ni vipi mchezo kuhusu virusi vya ukimwi ambayo watoto 
wanacheza kwenye simu ya mkono inaweza athiri tabia yao.utafiti utatusaidia kuelewa kama 
mchezo inasaidia watoto kujifunza kuhusu virusu vya ukimwi na inawasaidia kuendelea kuwa na 
afya bora. 
 
Ni nini itafanyika kama nimeshiriki katika utafiti huu? 
 
Kama 
umekubali 
pamoja 
na 
mzazi/mlezi 
kushiriki 
kwenye 
utafiti 
,haya 
ndiyo 
yatakayofanyika/yatakayotendeka: 
 
Uchunguzi: utakaa mbele ya kompyuta ukiwa umevaa vifaa vya kusikiza sauti. Utasikia maswali 
kupitia vifaa vya kusikiza sauti na utaweka majibu kwa kompyuta (hii inaitwa uchunguzi) 
utakamilisha utafiti mara tatu (kama tofauti ya wiki 12). Kila uchunguzi utachukua karibu dakika 
45. Maswali mengine yatakuwa kukuhusu, afya yako na malengo yako. Maswali mengine 
Page 57 of 127 
 

 
yatakuwa kuhusu tabia ya kingono na matumizi ya pombe. Kama unahisi huko huru na maswali 
yoyote, unaweza kataa kuzijibu. Unaweza pia kuacha kushiriki katika uchunguziwakati wowote. 
 
Mchezo: unaweza au huwezi kuchaguliwa kushiriki katika utafiti. Kama umechaguliwa, 
tutakusaidia na simu ya mkono. Kile ambacho utaweza kufanya kwenye simu ni kucheza mchezo 
pekee: sehemu nyingine yote ya simu itafungwa isifanye kazi.tutakuuliza ucheze mchezo kwa 
masaa 10 kwa muda wa wiki 2-3.mwisho wa wakati huu, tutakusanya simu kutoka kwako. 
Tutaweza kuona kwenye simu vile ambavyo ulicheza mchezo 
 
Mahojiano /majadiliano ya kikundi: baada ya kukusanya simu, tutakuuliza ushiriki katika 
mahojiano ya kikundi ili utuambie kuhusu uliyoyapitia kucheza mchezo. Mahojiano ya kikundi 
yatarekodiwa ili kuhakikisha katujakosa chochote ambacho mshiriki amesema. Mahojiano ya 
kikundi itakaa karibu saa moja. 
 
Ni nini manufaa na hatari ambayo inaweza kunifanyikia kama nimekubali kushiriki 
kwenye utafiti? 
 
Manufaa: hutapata manufaa ya moja kwa moja kwa kushiriki. Hata hivyo, ukishiriki, unatusaidia 
kujua kama mchezo inasaidia watoto kujifunza kuhusu virusi vya ukimwi na kukuwa na afya 
bora.hutapewa malipo kwa kushiriki katika utafiti huu. Utapewe pesa kiasi cha Kshs 500 za 
kugaramia wakati na nauli yako pamoja na vinyuaji kulingana na kanuni inayo kubaliwa saa ya 
mazungumzo ya vikundi. 
 
Hatari: sehemu ya mchezo na baadhi ya maswali yanaweza kukuaibisha au kukufanya usihisi 
kuwa huru. Kama unahisi huko huru na maswali yoyote umeulizwa, unaweza kukataa kuyajibu. 
Unaweza rudisha simu kwetu na kuacha kushiriki kwenye utafiti wakati wowote. 
 
Ni nini kuhusu siri yangu?  
Maelezo yako yatawekwa siri. Maelezo/taarifa yote yatahifadhiwa kwa salama kwenye 
tarakilishi/kompyuta ambayo imelindwa na neno la siri. Hakuna atakayeweza kufuatilia majabu 
yako kwako 
 
Fomu hii ya afikio itawekwa salama kwenye kabati iliyofungwa. Tutatumia nambari ya utafiti 
badala ya jina lako kwenye fomu zote za utafiti. Jina lako kamwe halitaelezwa wengine. Jina 
lako kamwe halitatumika kwa uchambuzi 
 
Unaulizwa ushiriki katika majadiliano ya kikundi. Hatuwezi kuahidi kwamba watoto katika 
kikundi hawataeleza wengine utakachosema. Hufai kusema chochote katika maadiliano ya 
kikundi ambayo hungetaka wengine nje ya kikundi wasikie. 
 
Kutoa taarifa ya unyanyasaji wa watoto kimapenzi na Kutelekezwa 
Siri yako ni muhimu sana kwetu lakini pia, afya na usalama yako.katika hali ambapo 
unyanyasaji, kutelekezwa au hamu ya mtoto kujiumiza au wengi imeshukiwa au kusemwa 
wakati wa utafiti, wafanyi kazi wa utafiti wetu wanahitajika kuripoti taarifa hii. 
 
Je, kama nina maswali? 
Page 58 of 127 
 

 
 
Unaweza kuuliza maswali yoyote ambayo uko nayo wakati wowote. Kama uko na maswali 
yoyote kuhusu utafiti saa hii au baadaye, unaweza wasiliana na: 
 
Jina:  Dr. Victor Mudhune  
  
Barua pepe:  VMudhune@kemricdc.org   
 
 
Simu:  057 2022929/02 
 
 
  
Kama uko na maswali yoyote kuhusu haki zako kama mshiriki wa utafiti au uko na wasiwasi 
wowote au malalamishi, au kama unahisi umeumizwa kwa kushiriki katika utafiti huu. Tafadhali 
wasiliana na:  
Katibu, KEMRI Scientific and Ethics Review Unit (SERU), (sanduku la posta 54840-00200, 
Nairobi) kwenye nambari ya simu 020-2722541 au simu ya rununu 0722205901 au 0733400003 
au 
 
Jina: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Barua pepe: SMunga@kemri.org 
Simu: 057 2022929/02 
 au 
Jina:   Emory  University Institutional Review Board 
Barua pepe:  irb@emory.edu  
Simu: +1-404-712-0720 
Nambari hapo juu si ya dharura. Kama uko na dharura, tafadhali enda kwenye kliniki /pahali 
karibu  ambapo unaweza pata usaidizi. 
 
Je uko na maswali yoyote? 
 
Kauli ya idhini/kukubali 
Nimesoma (au nimeelezewa) na naelewa hii fomu. Naelewa sababu ya utafiti na kile ambacho 
kitatendeka kwa utafiti. Naelewa hatari na manufaa kwangu. Nimepewa nafasi ya kufikiria 
uamuzi wangu na maswali yangu yote yamejibiwa. Naelewa kwamba: 
 
1. Ninaweza chagua kujiunga na huu utafiti au la . ni juu yangu 
2. Mzazi /mlezi wangu lazima pia akubali ili niweze kushiriki katika utafiti. Siwezi kushiriki 
katika utafiti kama mzazi/mlezi wangu hajakubali. 
3. Hata kama mzazi/mlezi wangu amekubali, si lazima nishiriki kwa utafiti kama sitaki. 
4. Kama nimekataa kujiunga na utafiti, hakuna atakaye kasirika na mzazi/mlezi wangu na mimi. 
5. Ninaweza amua kuacha kuwa katika utafiti wakati wowote 
6. Mzazi/mlezi anaweza nichagulia ili niache kuwa/kushiriki katika utafiti wakati wowote.  
 
Page 59 of 127 
 

 
Afikio 
 
Kwa kuweka sahihi katika hii karatasi, nakubali kushiriki katika huu utafiti kama ilivyoelezwa 
katika fomu hii ya afikio. 
 
 
__________________________________________________ 
____________ 
__/__ 
Sahihi ya mshiriki wa umri 11 hadi 17 
 
 
         Tarehe  
 
Saa 
 
 
        
 
__________________________________________________ 
____________ 
__/__ 
Sahihi ya mtu anayekusanya/kuchukua     
  
 
 
Tarehe           
Saa 
afikio ya mshiriki wa umri 11-17    
 
    
 
 
Page 60 of 127 
 

 
Appendix 4C: Assent Intervention - Luo 
 
ASSENT FORM FOR MINOR SUBJECTS 
 
Study Title: A Mobile Phone Game to Prevent HIV among Young Africans 
Nying Nonro: Tugo mani e simb ong’we yamo mar  gengo landruok mar kute  mag  ayaki 
kuom  joma tindo ma  jorotenge. 
 
 
Jochung  ne nonro: Kate Winskell, PhD, and Victor Mudhune, MBA MPH 
______________________________________________________________________________ 
 
Oboke  ibiro  pog  gi jatij  nonro sama  ikao  ayie: 
 
Hik jachiwre: _____ higni (ka nyathi tin ne higni 6, oboke mar ayie ok dware) 
 
Nying jachiwre: ______________________________ 
 
Rwak/go tik achiel kuom  box gi: 
______________________________________________________________________________ 
 Nyathini  en  jahigni 6 nyaka 10- nyaka chiw ayie gi  dhoge ( seyi mar  jachiwre) 
       
                                          
 
__________________________________________________ 
____________ 
__/__ 
Seyi mar  jalno ma kao ayie kuom nyathi ma jahigni 6-10.    
Tarik      
 
Saa 
 
_____________________________________________________________________________ 
 Nyathini en jahigni 11-17- nyaka seyi mar  jachiwre kau e  oboke mar 2 mar  oboke mar  
ayie 
        
______________________________________________________________________________ 
 Gi pacha, nyathini ok nyal chiwo ayie nikech gigo ma ok otenore gi  hike,  to  jachung mar  
nonroni onyis wachni/duokoni. 
Gigo momiyo: 
___________________________________________________________________________ 
___________________________________________________________________________ 
 
 
__________________________________________________ 
____________ 
__/__ 
Seyi mar jalno ma kao ayie ( ka orwak/go tik box)   
 
Tarik            
 
Saa 
 
 
 
 
Page 61 of 127 
 

 
ASSENT FORM FOR MINOR SUBJECTS 
 
Study Title: A Mobile Phone Game to Prevent HIV among Young Africans 
Nying Nonro:Tugo mani e simb ong’we yamo mar gengo landruok mar kute mag ayaki 
kuom joma tindo ma jorotenge. 
 
Jochung ne Nonro 
Kate Winskell, PhD 
Victor Mudhune, MBA MPH 
 
WECHE KUOM/E WI NONRO 
 
Chakruok  
 
Iruaki mondo idonj e nonro mitimo gi Mbalariany mar Emory, Atlanta gi migawo mar Kenya 
Medical  Research Institute(KEMRI). Nonroni biro konyowa loso yoo manyien ma nyithindo 
nyalo puonjore e wi  kute mag ayaki ka gi tugo man e  simb ong’we yamo. Ma dirom nyithindo 
108, machuo gi nyiri ibiro kwa mondo odonj e nonro. 
  
Ibiro mana  donjo e  nonro  ka  idwaro. Fomni  ichiwo mondo  okonyi ng’ado  paro ka idwaro  
donjo  e  nonro. Ka  ibiro  bet the  nonro,janyuolni/jaritni nyaka  yie.To ka ok idwar  bet  e  
nonro, ok  ochuno, kata ka janyuolni/jaritni oyie. Janyuolni/jaritni ok  nyal  chuni. 
 
Inyalo wuok  e nonro saa asaya.  Ka idonjo e nonro to bange iloko paro,  en kare mondo iwuog  e 
nonro. Onge ng’ato ma  ibiro  chwanyo.Inyalo  kadho penjo ma  ok  idwar  duoko. 
 
Fomni nyalo bedo gi  weche ma  ok  winjire. Wakwayi mondo ipenj jatij nonro mondo olerni 
wach kata  weche ma ok winjireni.Inyalo  penjo  penjo  saa a saya. 
 
Ang’o momiyo watimo  nonro? 
 
Jotij  Nonro dwaro ng’eyo kaka tugo e  wi  kute mag  ayaki ma  nyithindo  tugo e  simb  ong’we  
yamo nyalo chocho/loko timbegi.Nonroni biro konyowa ng’eyo kaponono tugoni konyo  
nyithindo puonjore  e wi kute mag  ayaki kendo konyogi bedo  mangima. 
 
Ang’o ma  biro  timore ka  adonjo  e  nonroni? 
 
Ka ute ini gi janyuolni/jaritni oyie mondo idonji e nonro, mae e gima biro timore: 
 
Survey/Penjo: Ibiro  bet  mbele/ e nyim  komputa ka  iruako  gir  winjo wach/headphones.Ibiro 
winjo  penjo  kokalo e   gir winjo wach/headphones kendo  ibiro  ruako duoko e  komputa( mae 
iluongo survey/ penjo).Ibiro tieko penjo/survey ndalo  adek(kuom wige 12 mopogore). 
Penji/survey ka penji/survey biro kao dakika maromo 45. Penjo moko biro bedo kuomi iwuon, 
ngimani gi dwaroni. Penjo moko biro bedo e timbeni mag terruok gi tiyo gi kongo. Ka iwinjo k 
ok ini thuolo gi penjo moro amora, inyalo tamori duokogi. Inyalo wuok e penjini/survey saa 
asaya. 
 
Page 62 of 127 
 

 
 
Tugo: Inyalo yieri kata ok nyal yieri tieko bath nonroni.Ka oyier wabiro miyi simb ong’we 
yamo. Gima  ibiro  nyalo  timo e simb ong’we  yamo  en mana  tugo tugo: tije  mamoko mag 
simb ong’we  yamo ibiro ket mondo  kik  tii. Wabiro kwayi mondo itug tugo kuom seche 10 
kuom thuolo mar wige 2-3. E giko mar thuoloni, wabiro choko simb ong’we koa kuomi. Wabiro 
neno e yie simb ong’we yamo kaka ne itugo tugo. 
 
Wuoyo/Twak mar kanyakla/grup: Ka  wasechoko simbe mag  ong’we yamo, wabiro kwayi 
mondo idonj e  twak mar  kanyakla/grup mondo inyiswa e  wiy gig wa  iparo kata ikadhe sama 
ne itugo tugo. Wuoyo mar  kanykla/grup ibiro mak  gi nyakalondo mondo  mi  kik wawe wach 
moro oko ma  jachiwre  owacho. Twak mar  kanyakla/grup biro  kao  madirom saa 1. 
 
Ang’o maber (ohala) gi rach (hinyruok) gigo ma nyalo timore ka nyathini oyie donjo e 
nonro? 
 
Ohala/ Ber: Ok ibi yudo ber moriere kuom donjo  e nonroni. To, ka idonjo, ikonyowa  loso  tugo 
e kuom  kute  mag  ayaki ma ihero kendo diher  tugo.Bende ikonyowa puonjruok ka  penjo ma  
wachano  penjo nyithindo bende winjore. Ok  bi  miyi chudo ne  bedo  e nonro. Kata kamano 
wabiro miyi Kshs 500 ne secheni, gi pes wuoth gi math ibiro chiw kaka chick dwaro seche twak 
 
Hinyruok/ Rach: Moko kuom tukegi gi penjo moko nyalo  miyo ine  wichkuot kata  mi ibed  ma 
ok ini thuolo. Ka iwinjo ka ok ini thuolo gi  penjo moro amora ma openji, inyalo tamori  duoko  
penjogo. 
 
Ang’o kuom kano  mopondo/maling ling? 
 
Wecheni ibiro kan mopondo. Weche duto ibiro  kan  mopondo e komputa mag  gi nying ma 
aling ling. Onge ng’ato ma  biro luo  duokogi. 
 
Oboke  mar  ayieni ibiro kan mopondo e kabat ma olor. Wabiro  tiyo  gi namba kar  nying nyath 
e foms  duto  mag  nonro.Nyingi ok bi mi joma moko. Nyingi ok  be  ti  godo e yudo  duoko mag  
nonro. 
 
Ikwayi nyathini mondo idonji e wuoyo/ twak mar kanyakla/grup.Ok wanyalo singo ni nyithindo  
manie  wuoyo/twak mar  grup/kanyakla ok  nyalo wacho/pimo weche  ma  owach gi joma moko.  
 
Ok onego iwach wach moro e  wuoyo/twak mar  kanyakla/grup ma ok  idwar  joma  moko oko  
mar  grup  owinji/ong’e. 
 
Wacho  ka  ng’ato  ojwang’o kata omulo, oterore gi  nyathi e  yo  ma  ok  owinjore 
 
Ritni en gima duong ne wan,bende ngimani gi ritni. E thuolo ma ng’ato omul,oterore gi nyathi 
kata ojwange mondo ohinye,jotijwa onego ochiw wachni. 
 
Ang’o ma timore ka an  gi  penjo? 
 
Page 63 of 127 
 

 
Inyalo penjo penjo  mora ma  ingo saa asaya. Ka  ini gi  penjo e  wiy nonro sani kata  bange, 
inyalo  tudori gi: 
 
Nying: Dr. Victor Mudhune, Principal Investigator, KEMRI 
Oboke  mar  mbui:VMudhune@kemricdc.org  
 
 
 
Simu: 057 2022929/02 
 
Ka  ini gi penjo mora mora e wi  ratiro mari kaka  jachiwre  e nonro, kata  ini gi ngur kata  
ywagruok, kata iwinjo ka  iyudo  hinyruok kuom chiwruok  e nonro, yie  itudri gi: jagoro 
 KEMRI Scientific and Ethics Review Unit (SERU), (P. O. Box 54840-00200, Nairobi) simu 
020-2722541 kata ong’we yamo 0722205901 kata 0733400003 kata 
 
Nying: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Oboke  mar  mbui: SMunga@kemri.org 
Simu: 057 2022929/02 
Or  Kata 
Nying: Emory University Institutional Review Board 
Oboke mar  mbui:irb@emory.edu  
Simu: +1 404 712 0720 
 
Nembni mani malo  ka ok  gini mag dwaro  kony  ma piyo piyo. Ka  eni  gi chandruok ma  
dwaro kony ma piyo piyo. Wakwayi idhi e  klinik/kama chiegni kodi mondo iyudi kony. 
Be eni  gi  penjo? 
 
Wach mar Chiwo  Thuolo 
 
Asesomo (kata oselerna) kendo owinjogima  fomuni wacho. Ang’eyo gima  omiyo itimo  nonro 
gi  gima  biro  timore  e  nonro. Ang’eyo  hinyruok/ rach gi  ber/ohala ne an. Omiya thuolo mar 
ng’ado paro kendo  penjo  ga duto oseduoki. Ang’eyo ni: 
 
1) Anyalo  yiero donjo e  nonro kata ok adonj. En herona. 
2) Jonyuolna/jaritna nyaka bende yie mondo achiwra e  nonro. Ok  anyal  chiwora  ka  
jonyuol/jarit odagi. 
3) Kata  ka  janyuolna/jaritna  oyie.  Ok ochuno ni  nyka  achiwra e  nonro ka  ok adwar. 
4) Ka  adagi donjo  e nonro, onge ng’ato ma biro  chwanyore  gi janyuolna/jaritna kendo  koda. 
5) Anyalo weyo  bedo e  nonroni e saa a saya. 
6) Janyuolna/jaritna nyalo yiero mondo  awe  bedo e nonro e saa a saya. 
 
Ayie 
Ka  agoyo seyi obokeni, ayie donjo e  nonro kaka oler e form mar  ayie. 
 
       
________________________________________________________________________ 
 
Seyi mar jachiwre  ma  jahigni 11-17     Tarik      Saa 
 
        
 
Page 64 of 127 
 

 
_______________________________________________________________________ 
 
Seyi mar  jalno ma kao  ayie mar Jachiwre ma  jahigni 11-17  Tarik      Saa 
 
 
 
Page 65 of 127 
 

 
Appendix 5A: Parental Consent Intervention - English 
 
Consent for Child to be a Research Subject 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Introduction  
 
Your child is being invited to take part in a research study conducted by Emory University in 
Atlanta and the Kenya Medical Research Institute (KEMRI). The study will help us develop a 
new way for children to learn about HIV using a game on a mobile phone.  We plan to recruit a 
total of 162 people for this study.  
 
This form is to help you decide if you want to allow your child to be in the study. Your child can 
only take part in the study if you agree. Your child will also be asked if they want to take part in 
the study. Nothing bad will happen to you or your child if you or they say ‘no’.  
 
If you decide to allow your child to join the study and then change your mind, it is okay for 
him/her to leave the study. You can remove him/her from the study at any time. No one will be 
upset with you or your child. 
 
This form may contain words that you do not understand. Please ask the study staff to explain 
any word or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
 
The research team wants to find out how a game about HIV that children play on a mobile phone 
may affect their behavior. The study will help us understand whether the game helps children 
learn about HIV and helps keep them healthy.  
 
What will happen if my child takes part in this study? 
 
If both you and your child agree for your child to take part in the study, here is what will happen:   
 
Survey: Your child will sit in front of a computer wearing headphones. She or he will hear 
questions through the headphones and will enter his or her answers on the computer (this is 
called a survey). Your child will complete the survey three times (about 12 weeks apart).   
 
Each survey will take about 45 minutes. Some questions will be about your child, his or her 
health, and goals. Other questions will be about sexual behavior and alcohol use.  
 
Page 66 of 127 
 

 
If your child feels uncomfortable with any of the questions, he or she may refuse to answer them. 
Your child can also stop taking part in the survey at any time. 
 
Game: Your child may or may not be selected to complete this part of the study. If your child is 
selected, we will lend him or her a mobile phone. The only thing your child will be able to do on 
the phone is play the game: all other functions of the phone will be disabled. We will ask your 
child to play the game for 10 hours over a 2-3 week period. At the end of this time, we will 
collect the phone from your child. We will be able to see from the phone how your child played 
the game. 
 
Focus Group Discussion: After we have collected the phones, we will ask your child to take part 
in a group discussion to tell us about his or her experiences playing the game. The group 
discussion will be recorded to make sure we do not miss anything that participants say. The 
group discussion will last about 1 hour.  
 
What are the good (benefits) and bad (risks) things that could happen to my child if I agree 
for him/her to be in this study?  
 
Benefits:  Your child may not get direct benefits by taking part. However, when your child takes 
part, he or she is helping us to find out if the game helps children learn about HIV and stay 
healthy. You will not be offered payment for being in this study.  However, you will be 
reimbursed Kshs 500 for your time and transport costs and refreshments. 
 
Risks:  Parts of the game and some of the questions may embarrass your child or make him or 
her feel uncomfortable. If your child feels uncomfortable with any questions, he or she may 
refuse to answer them. Your child can return the phone to us and stop being in the study at any 
time.  
 
What about my child’s confidentiality?   
 
Your child’s information will be kept private.  All information will be stored safely on a 
computer protected by passwords. No one will be able to trace your child’s answers to him or 
her.  
This consent form will be kept in a safe locked cabinet. We will use a study number in place of 
your child’s name on all study forms. Your child’s name will never be shared with others. Your 
child’s name will never be used for analysis.  
 
Your child is being asked to take part in a group discussion. We cannot promise that children in 
the group will not share what he or she say with others. Your child shouldn’t say anything in the 
discussion group that he or she would not want others outside the group to hear. We will remind 
him or her about this. 
 
Does my child have to participate? What will happen if we change our minds? 
 
You can choose for your child to not be in this study. Your child can choose not to be in the 
study. If you and your child agree for him/her to be in the study, he/she can still refuse to answer 
any question. You or your child can stop their participation in the study at any time. Nothing bad 
Page 67 of 127 
 

 
will happen to you or your child if they refuse to answer questions or want to stop taking part in 
the study.  
 
Disclosure of Child Sexual Abuse and Neglect 
 
Your child’s privacy is very important to us, but so are his/her health and safety. In cases where 
abuse, neglect or the desire to harm themselves or others is suspected or disclosed during the 
study, our staff are required to report this information. 
 
What if I have questions?  
You can ask any questions you have at any time. If you have any questions about the study now 
or later, you may contact:  
 
Name:  Dr. Victor Mudhune  
  
Email: VMudhune@kemricdc.org  
 
 
Phone: 057 2022929/02 
 
 
  
If you have any questions about your or your child’s rights as a research participant, or have 
concerns or complaints, or if you feel you have been harmed by taking part in this study, please 
contact: the secretary, KEMRI Scientific and Ethics Review Unit (SERU), (P. O. Box 54840-
00200, Nairobi) at telephone 020-2722541 or cell phone 0722205901 or 0733400003 or 
 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 2022929/02 
Or  
Name:  Emory  University Institutional Review Board 
Email: irb@emory.edu 
Phone: +1-404-712-0720 
 
The above numbers are not for emergencies. If you are having an emergency, please go to the 
nearest clinic/place you can get help.  
Do you have any questions? 
 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the 
study and what will happen in the study. I understand the risks and benefits for my child. I have 
been given the opportunity to consider my decision and have had all my questions answered. I 
understand that: 
 
1) I can choose to allow my child to join this study or not. It is up to me. 
2) My child can choose to join the study or not. It is up to him or her. 
3) Even if I agree, my child does not have to participate in the study if he/she does not want to. 
4) If I refuse or my child chooses not to join the study, nothing bad will happen to me or my 
child as a result. 
Page 68 of 127 
 

 
5) I can decide to stop my child from being in this study at any time.  
6) My child can stop being in the study at any time. 
Consent 
By signing this document, I agree to let my child participate in the study as explained in this 
form. 
 
Date 
 
 
 
 
     Signature of Parent/Guardian 
 
 
 
 
 
 
 
 
     Printed Name of Parent/Guardian 
 
 
 
Child’s Name  
 
 
      
 
 
 
 
Date 
 
 
 
 
      Signature of Project Staff 
 
 
 
   
 
 
 
 
      Printed Name of Project Staff 
 
Page 69 of 127 
 

 
Appendix 5B: Parental Consent Intervention - Swahili 
 
Consent for Child to be a Research Subject 
 
Mada: Mchezo wa simu ya rununu ili kuzuia virusi vya ukimwi kwa vijana wa Afrika 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Utangulizi 
 
Mtoto wako anakaribishwa kushiriki katika utafiti unaofanywa na chuo kikuu cha Emory Atlanta 
na Kenya Medical Research Institute (KEMRI). utafiti huu utatusaidia kuunda njia mpya ya 
watoto kujifunza kuhusu Virusi Vya Ukimwi  kwa kutumia mchezo kwenye simu ya mkono.tuko 
na mpango wa kusajili jumla ya watu 162 kwa hii utafiti. 
 
Fomu hii ni ya kukusaidia kuamua kama unataka kukubalia mtoto wako ashiriki katika utafiti. 
Mtoto wako anaweza shiriki katika utafiti kama umekubali tu. Mtoto wako pia ataulizwa kama 
anataka kushiriki katika utafiti.hakuna kitu kibaya kitakachokufanyikia au mtoto wako kama 
wewe au mtoto wako amesema la 
 
Kama umeamua kukubalia mtoto wako ajiunge na utafiti na kisha ubadilishe fikira, ni sawa 
kuacha utafiti.unaweza kumtoa kwenye utafiti wakati wowote.hakuna atakaye kasirika na wewe 
au mtoto wako.  
 
Hii fomu inaweza kuwa na maneno ambayo huelewi. Tafadhali uliza mfanyikazi wa utafiti 
aeleze neno lolote au taarifa/maelezo ambayo si wazi kwako. Unaweza kuuliza maswali wakati 
wowote. 
 
Ni kwa nini tunafanya utafiti huu? 
 
Timu ya utafiti inataka kujua jinsi mchezo kuhusu virusi vya ukimwi ambayo watoto wanacheza 
kwa simu ya mkono inaweza kuathiri tabia yao.utafiti utatusaida kuelewa kama michezo 
inasaidia watoto kujifunza kuhusu virusi vya ukimwi na inawasadia kuendelea kuwa na afya 
bora. 
Ni nini itafanyika/tendeka kama mtoto wangu ameshiriki katika utafiti huu 
Kama umekubali 
pamoja 
na 
mtoto 
wako 
kushiriki 
kwenye 
utafiti, 
haya ndiyo 
yatakayofanyika/yatakayotendeka: 
 
Uchunguzi: mtoto wako atakaa mbele ya kompyuta akiwa umevaa vifaa vya kusikiza sauti. 
atasikia maswali kupitia vifaa vya kusikiza sauti  na ataweka majibu kwa kompyuta (hii inaitwa 
uchunguzi) mtoto wako atakamilisha uchunguzi mara tatu (kama tofauti ya wiki 12). Kila 
uchunguzi utachukua karibu dakika 45. Maswali mengine yatakuwa kuhusu mtoto wako, afya 
yake na malengo yake. Maswali mengine yatakuwa kuhusu tabia ya kingono na matumizi ya 
Page 70 of 127 
 

 
pombe. Kama mtoto wako anahisi hayuko huru na maswali yoyote, anaweza kataa kuzijibu. 
Mtoto wako anaweza pia kuacha kushiriki katika uchunguziwakati wowote. 
 
Mchezo: mtoto wako anaweza au hawezi kuchaguliwa kushiriki katika utafiti. Kama mtoto wako 
amechaguliwa, tutamsaidia na simu ya mkono. Kile ambacho mtoto wako ataweza kufanya 
kwenye simu ni kucheza mchezo pekee: sehemu nyingine yote ya simu itafungwa isifanye 
kazi.tutauliza mtoto wako acheze mchezo kwa masaa 10 kwa muda wa wiki 2-3.mwisho wa 
wakati huu, tutakusanya simu kutoka kwa mtoto wako.. Tutaweza kuona kwenye simu vile 
ambavyo mtoto wako alicheza mchezo. 
 
Mahojiano/majadiliano ya kikundi: baada ya kukusanya simu, tutauliza mtoto wako ashiriki 
katika mahojiano ya kikundi ili atuambie kuhusu aliyoyapitia kucheza mchezo. Mahojiano ya 
kikundi yatarekodiwa ili kuhakikisha katujakosa chochote ambacho mshiriki amesema. 
Mahojiano ya kikundi itakaa karibu saa moja. 
 
Ni nini manufaa na hatari ambayo inaweza fanyikia mtoto wangu  kama nimekubali 
ashiriki kwenye utafiti? 
 
Manufaa: hutapata manufaa ya moja kwa moja kwa kushiriki. Hata hivyo, ukishiriki, unatusaidia 
kukua kama mchezo inasaidia watoto kujifunza kuhusu virusi vya ukimwi na kukuwa na afya 
bora.hutapewa malipo kwa kushiriki katika utafiti huu. Utapewe pesa kiasi cha Kshs 500 za 
kugaramia wakati na nauli yako pamoja na vinyuaji kulingana na kanuni inayo kubaliwa saa ya 
mazungumzo ya vikundi. 
 
Hatari: sehemu ya mchezo na baadhi ya maswali  yanaweza kukuaibisha au kukufanya usihisi 
kuwa huru. Kama unahisi huko huru na maswali yoyote umeulizwa, unaweza kukataa kuyajibu. 
Unaweza rudisha simu kwetu na kuacha kushiriki kwenye utafiti wakati wowote. 
 
Ni nini kuhusu siri ya mtoto wangu?  
Maelezo ya mtoto wako yatawekwa siri. Maelezo/taarifa yote yatahifadhiwa kwa salama kwenye 
tarakilishi/kompyuta ambayo imelindwa na neno la siri. Hakuna atakayeweza  kufuatilia majibu 
ya mtoto wako yake 
 
Fomu hii ya afikio itawekwa salama kwenye kabati iliyofungwa. Tutatumia nambari ya utafiti 
badala ya jina la mtoto wako kwenye fomu zote za utafiti. Jina la mtoto wako kamwe 
halitaelezwa wengine. Jina lako kamwe halitatumika kwa uchambuzi 
 
Mtoto wako anaulizwa  ashiriki katika majadiliano ya kikundi. Hatuwezi kuahidi kwamba 
watoto katika kikundi hawataeleza wengine atakachosema. Hufai kusema chochote katika 
mahojiano ya kikundi ambayo hangetaka wengine nje ya kikundi waskie. Tutamkumbusha 
kuhusu hii. 
 
Ni lazima mtoto wangu ashiriki? Ni nini itafanyika/itatendeka  kama tumebadili fikira? 
 
Unaweza kuchagua kama mtoto wako atashiriki katika utafiti. Mtoto wako anaweza kuchagua 
kushiriki katika utafiti. Kama wewe na mtoto wako mmekubali akuwe katika utafiti, bado 
anaweza kukataa kujibu swali lolote. Wewe na mtoto wako mnaweza kushiriki katika utafiti 
Page 71 of 127 
 

 
wakati wowote. Hakuna kitu kibaya ambacho kitafanyika /kitatendeka kama amekataa kujibu 
maswali au kupeana damu au anataka kuacha kushiriki kwenye utafiti.  
 
Kutoa taarifa ya unyanyasaji wa watoto kimapenzi na Kutelekezwa 
Siri ya mtoto wako ni muhimu sana kwetu lakini pia, afya na usalama yake.katika hali ambapo 
unyanyasaji, kutelekezwa au hamu ya kujiumiza au wengine imeshukiwa au kusemwa wakati wa 
utafiti, wafanyi kazi wa utafiti wetu wanahitajika kuripoti taarifa hii. 
 
Je, kama nina maswali ? 
Unaweza kuuliza maswali yoyote ambayo uko nayo wakati wowote. Kama uko na maswali 
yoyote kuhusu utafiti saa hii au baadaye, unaweza wasiliana na : 
 
Name:  Dr. Victor Mudhune  
  
Barua pepe: 
VMudhune@kemricdc.org  
 
 
Simu:  057 2022929/02 
 
 
  
Kama uko na maswali yoyote kuhusu haki zako kama mshiriki wa utafiti au uko na wasiwasi 
wowote au malalamishi, au kama unahisi umeumizwa kwa kushiriki katika utafiti huu. Tafadhali 
wasiliana na:  
Katibu, KEMRI Scientific and Ethics Review Unit (SERU), (sanduku la posta 54840-00200, 
Nairobi) kwenye nambari ya simu 020-2722541 au simu ya rununu 0722205901 au 0733400003 
au 
 
Jina: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
 Barua pepe: SMunga@kemri.org 
Simu: 057 2022929/02 
 au 
Name:  Emory  University Institutional Review Board 
 
irb@emory.edu 
+1-404-712-0720 
Nambari hapo juu si ya dharura. Kama uko na dharura, tafadhali enda kwenye kliniki /pahali 
karibu ambapo unaweza pata usaidizi. 
Je uko na maswali yoyote? 
 
kauli ya idhini/kukubali 
Nimesoma (au nimeelezewa) na naelewa hii fomu. Naelewa sababu ya utafiti na kile ambacho 
kitatendeka kwa utafiti. Naelewa hatari na manufaa kwa mtoto wangu. Nimepewa nafasi ya 
kufikiria uamuzi wangu na maswali yangu yote yamejibiwa. Naelewa kwamba: 
 
1. Ninaweza chagua kukubalia mtoto wangu ajiunge na utafiti huu au la . ni juu yangu 
2. Mtoto wangu anaweza kuchagua kujiunga na utafiti au la. Ni juu yake. 
3. hata kama nimekubali, si lazima mtoto wangu ashiriki katika utafiti kama hataki 
4. Kama nimekataa na mtoto wangu amechagua kutojiunga na utafiti, hakuna kitu kibaya 
ambacho kitanifanyikia au mtoto wangu juu ya hii. 
Page 72 of 127 
 

 
5. Ninaweza amua kukataza mtoto wangu kushiriki katika huu utafiti wakati wowote. 
6. Mtoto wangu anaweza kata kushiriki kwenye utafiti wakati wowote. 
Afikio  
Kwa kusahihi karatasi hii, nakubali kuacha mtoto wangu ashiriki katika utafiti vile imeelezwa 
kwa hii fomu. 
 
 
 
___________________________ 
 
 
Tarehe  
 
 
      
 
Sahihi ya mzazi/msimamizi/mlezi 
 
 
 
 
 
 
 
     
 
 
 Jina chapisho la  mzazi /msimamizi/mlezi 
 
 
 
 
Jina la mtoto  
     
 
 
 
 
 
Tarehe  
 
 
 
 
 
      Sahihi ya afisa wa mradi. 
 
 
   
 
 
 
 
      Jina chapisho la afisa wa mradi 
Page 73 of 127 
 

 
Appendix 5C: Parental Consent Intervention - Luo 
Consent for Child to be a Research Subject 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 Nying Nonro: Tugo mani e simb ong’we yamo mar gengo landruok mar kute  mag  ayaki 
kuom  joma tindo ma  jorotenge. 
 
Jochung ne Nonro:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Omuom Owuok:  U.S. National Institute of Mental Health 
 
Chakruok 
Iruako nyathini mondo odonji e nonro ma itimo gi Mbalariany mar Emory, Atlanta gi migawo 
ma Kenya  Medical  Research Institute (KEMRI).  
Nonroni biro konyowa loso yoo  manyien  ma  nyithindo puonjore e  wi kute  mag  ayaki  e  yor  
tugo e  simb ongw’we yamo. Wachano ruako ji 162 e nonroni. 
 
Fomni en mar konyi ng’ado paro ka idwar yieni nyathini donjo e nonroni.Nyathini nyalo donjo e 
nonro mana ka  iyiene. Nyathini bende ibiro penj ka odwaro donjo e nonro. Onge gima rach ma 
biro  timore ne  ini kata nyathini  ka  ini kata  nyathini owacho ‘ooyo’ 
 
Ka  ing’ado  yiene  nyathini  donjo  e nonro to  iloko  paro, en kare ne  en weyo  nonro.Inyalo  
gole e  nonro saa asaya. Onge  ng’ato ma  biro  chwanyore gi  ini  kata nyathini. 
Fomni otingo weche moko ma ok  winjre. Wakwayi ipenji jotij  nonro mondo  olerni wach  kat  
weche  ma ok winjreni. Inyalo penjo  penjo saa a saya. 
 
Ang’o ma  watimo  e nonroni? 
 
Jotij  nonro dwaro ng’eyo kaka tugo e  wi kute  mag  ayaki ma  nyithindo  tugo e  simb ong’we 
yamo nyalo  chocho  timbe gi. Nonroni biro konyowa ng’eyo kaponono tugo gi konyo nyithindo 
puonjore e wi  kute  mag  ayaki kendo konyo gi bedo mangima. 
 
Ang’o  ma  biro  timore ka  nyathina odonjo e  nonroni? 
 
Ka  ute ini  gi nyathini oyie ne  nyathini donjo  e nonro, mae  e  gima  biro  timore: 
 
Survey/Penjo: Ibiro  bet  e mbele/nyim  komputa ka  iruako gir winjo wach/ headphones.Ibiro 
winjo  penjo  kokalo e  gir winjo wach/ headphones kendo  ibiro  ruako duoko e  komputa( mae 
iluongo survey/ penjo).Ibiro tieko penjo/survey ndalo  adek(kuom wige 12 mopogore). 
Penji/survey ka penji/survey biro kao dakika maromo 45. Penjo moko biro  bedo kuomi iwuon, 
ngimani gi dwaroni. Penjo  moko biro  bedo e timbeni mag  terruok gi tiyo  gi  kongo. Ka iwinjo 
ka ok  ini  thuolo gi  penjo moro amora, inyalo  tamori  duokogi. Inyalo wuok e penjini/survey 
saa a saya. 
 
Page 74 of 127 
 

 
Tugo: Inyalo yieri kata ok nyal yieri tieko bath nonroni.Ka oyier wabiro  miyi simb  ong’we  
yamo. Gima  ibiro  nyalo  timo e simb ong’we  yamo  en mana  tugo tugo: tije  mamoko mag 
simb ong’we  yamo ibiro ket mondo  kik  tii. Wabiro kwayi mondo itug tugo kuom seche 10 
kuom thuolo mar wige 2-3. E giko mar thuoloni, wabiro choko simb ong’we koa  kuomi. Wabiro 
neno e  simb ong’we  yamo kaka  ne  itugo  tugo. 
 
Wuoyo/Twak mar kanyakla/grup: Ka wasechoko simbe mag ong’we yamo, wabiro kwayi mondo 
idonj e  twak mar  kanyakla/grup mondo inyiswa e  wiy gig wa  iparo kata ikadhe sama ne itugo 
tugo. Wuoyo mar kanykla/grup ibiro mak gi nyakalondo mondo  mi  kik wawe wach moro oko 
ma  jachiwre  owacho. Twak mar kanyakla/grup biro  kao  madirom saa 1. 
 
 
Ang’o maber (ohala) gi rach (hinyruok) gigo ma nyalo timore ka nyathini oyie donjo e 
nonro? 
 
Ohala/ ber: Ok ibi yudo ber moriere kuom donjo e nonroni. To, ka idonjo, ikonyowa  loso  tugo e 
kuom  kute  mag  ayaki ma ihero kendo diher  tugo.Bende ikonyowa puonjruok ka  penjo ma  
wachano  penjo nyithindo bende winjore. Ok bi  miyi chudo ne  bedo  e nonro. Kata kamano 
wabiro miyi Kshs 500 ne secheni, gi pes wuoth gi math ibiro chiw kaka chick dwaro seche twak. 
 
Hinyruok/rach: Moko  kuom tukegi gi  penjo moko nyalo  miyo ine  wichkuot kata  mi ibedi  ma 
ok ini thuolo. Ka iwinjo ka  ok eni thuolo gi  penjo moro amora ma openji, inyalo tamori  duoko  
penjogo. 
 
Ang’o kuom kano  mopondo/maling ling weche nyathina?  
 
Wecheni nyathini ibiro  kan mopondo. Weche duto ibiro  kan  mopondo e komputa mag  gi 
nying ma aling ling. Onge ng’at ma  biro luo  duokogi 
 
Oboke  mar  ayieni ibiro  kan mopondo e kabat ma olor. Wabiro  tiyo  gi namba kar  nying e 
fomus  duto  mag  nonro.Nying ok bi miyi joma moko. Nying  ok  bi  ti  godo e yudo  duoko mag  
nonro. 
 
Ikwayi  nyathini mondo  idonj e  wuoyo/twak mar  kanyakla/grup.Ok  wanyal singo ni nyithindo  
mantie e wuoyo/ twak mar  grup/kanyakla ok  nyal wacho weche  ma  owach gi joma moko. Ok 
oneg iwach wach moro e  wuoyo/twak mar  kanyakla/grup ma ok  idwar  joma  moko oko  mar  
grup  owinji/ong’e. Wabiro parone mano. 
 
Bende nyathina nyaka chiwre? Ang’o ma biro timore ka waloko paro? 
 
Inyalo  yiero mondo nyathini  kik donj  e nonro. Nyathini nyalo yiero mondo kik odonj  e nonro. 
Ka  ini gi nyathini uyie mondo odonj  e nonro nyathini podi nyalo  tamore duoko  penjo. Ini kata  
nyathini nyalo wuok chiwruok e nonro e  saa a saya. Onge  gima  rach ma nyalo timore ne ini 
kata nyathini ka  gi tamore duoko penjo kata chiwo remo kata tamore donjo e nonro. 
 
Wacho ka ng’ato ojwang’o kata omulo, oterore gi  nyathi e  yo  ma  ok  owinjore 
Page 75 of 127 
 

 
Ritni en gima duong ne wan,bende ngimani gi ritni. E thuolo ma ng’ato omul,oterore gi nyathi 
kata ojwange mondo ohinye,jotijwa onego ochiw wachni. 
 
Ang’o ma timore ka an  gi  penjo? 
Inyalo penjo penjo  mora ma  ingo saa asaya. Ka  ini gi  penjo e  wiy nonro sani kata  bange, 
inyalo  tudori gi: 
 
Nying: Dr. Victor Mudhune, Principal Investigator, KEMRI 
 Oboke  mar  mbui: 
VMudhune@kemricdc.org   
 
 
Simu: 057 2022929/02 
 
Ka  eni gi penjo mora mora e wi  ratiro mari kaka  jachiwre  e nonro, kata  ini gi ngur kata  
ywagruok, kata iwinjo ka  iyudo  hinyruok kuom chiwruok  e nonro, yie  itudri gi: jagoro 
 KEMRI Scientific and Ethics Review Unit (SERU), (P. O. Box 54840-00200, Nairobi) simu 
020-2722541 kata ong’we yamo 0722205901 kata 0733400003 kata 
 
Nying: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Oboke  mar  mbui: SMunga@kemri.org 
Simu: 057 2022929/02 
Or  Kata 
Nying:  
Emory University Institutional Review Board 
Oboke mar  mbui: irb@emory.edu  
Simu: +1 404 712 0720 
 
Nembni mani malo  ka ok  gini mag dwaro  kony  ma piyo piyo. Ka  eni  gi chandruok ma  
dwaro kony ma piyo piyo. Wakwayi idhi e  klinik/kama chiegni kodi mondo iyudi kony. 
Be eni  gi  penjo? 
Wach mar chiwo thuolo 
 
Asesomo(kata oselerna) kendo owinjo gima  fomni wacho. Ang’eyo gima  omiyo itimo  nonro gi  
gima  biro  timore  e  nonro. Ang’eyo  hinyruok/ rach gi  ber/ohala ne an. Omiya thuolo mar 
ng’ado paro kendo  penjo  ga duto oseduoki. Ang’eyo ni: 
 
1) Anyalo yiero mondo nyathina odonji e  nonro kata  atamora. En herona 
2) Nyathina nyalo  yiero donjo e nonro kata tamruok.  En herone 
3) Kata ka ayie,  nyathina ok onego odonji e  nonro ka ok idwar. 
4) Ka atamora kata  ka nyathina otamore donjo e nonro, onge gima rach ma  biro  timore ne an 
kata  ne  nyathina nikech mano. 
5) Anyalo  chungo nyathina  kik  ibed  e  nonro saa a saya 
6) Nyathina  nyalo  weyo  bedo e  nonro saa a saya 
Page 76 of 127 
 

 
Ayie 
Ka agoyo seyi obokeni. Ayie mondo nyathina ochiwre e nonroni kaka  oler e  fomni 
 
 
 
 
Tarik  
 
 
                  Seyi mar  janyuol/jarit 
  
 
 
 
 
 
 
 
 
 
 
 
    
 Ndik Nying janyuol/jarit 
 
 
 
Nying Nyathi  
 
      
 
 
 
 
Tarik  
 
 
       
 
Seyi mar  Jatij Nonro 
 
 
 
   
 
 
 
 
       
Ndik Nying Jatij Nonro 
 
 
Page 77 of 127 
 

 
Appendix 6A: Parent Consent Formative Research- English 
 
Consent to Be a Research Subject 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Introduction  
You are being invited to take part in a research study conducted by Emory University in Atlanta 
and the Kenya Medical Research Institute (KEMRI). The study will help us develop a new way 
for children to learn about HIV using a game on a mobile phone.  We plan to recruit a total of 
162 people for this study. 
 
You only have to take part in the study if you want to. The purpose of this form is to help you 
decide if you want to be in the study. If you do not wish to be in the study, you do not have to. If 
you join the study and then change your mind, it is okay for you to leave the study. No one will 
be upset with you.  
 
This form may contain words that you do not understand. Please ask the study staff to explain 
any word or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
The research team wants to develop a new way for children to learn about HIV using a game on 
a mobile phone. We would like you to tell us what you think of their ideas, plans, and designs. 
We would also like you to help us decide what questions to ask children in order to find out if the 
game is helping them learn about HIV. 
  
What will happen if I take part in this study? 
If you agree to be in the study, here is what will happen:   
 
Focus Group Discussion: We will show you our ideas, plans and designs for the game and ask 
you to discuss them with a group of 6-10 other parents. We will also read to you or ask you to 
look at questions we plan to ask children who play the game. We will ask you to tell us how you 
feel about these questions and to discuss them with a group of other parents. We will ask you to 
take part in these discussion groups up to 4 times over a period of 8 months. Each group 
discussion will last about 90 minutes. The group discussions will be recorded to make sure we do 
not miss anything that participants say. 
 
What are the good (benefits) and bad (risks) things that could happen to me if I agree to be 
in the study? 
 
Page 78 of 127 
 

 
Benefits:  You will not receive direct benefit by taking part. However, when you take part, you 
are helping us to make a game about HIV that you like and would feel comfortable with your 
child playing. You are also helping us learn if the questions we plan to ask children are 
acceptable to you. You will not be offered payment for being in this study.  However, you will 
be reimbursed Kshs 500 for your time and transport costs and refreshments. 
 
Risks:  Parts of the game and some of the questions may embarrass you or make you feel 
uncomfortable. If you feel uncomfortable with any questions you are asked, you may refuse to 
answer them. 
 
What about my confidentiality? 
You are being asked to take part in a group discussion. We cannot promise that others in the 
group will not share what you say with others. You shouldn’t say anything in the discussion 
group that you would not want others outside the group to hear.  
 
Your information will be kept private.  All information will be stored safely on a computer 
protected by passwords. No one will be able to trace your answers to you.  
 
This consent form will be kept in a safe locked cabinet. We will use a study number in place of 
your name on all study forms. Your name will never be shared with others. Your name will 
never be used for analysis.  
 
What if I have questions?  
You can ask any questions you have at any time. If you have any questions about the study now 
or later, you may contact: 
 
Name:  Dr. Victor Mudhune, Principal Investigator, Kenya Medical Research Institute 
Email: VMudhune@kemricdc.org   
 
 
Phone: 057 2022929/02 
 
 
  
If you have any questions about your rights as a research participant, or have concerns or 
complaints, or if you feel you have been harmed by taking part in this study, please contact: the 
secretary, KEMRI Scientific and Ethics Review Unit (SERU), (P. O. Box 54840-00200, Nairobi) 
at telephone 020-2722541 or cell phone 0722205901 or 0733400003 or 
 
Name: Dr. Stephen Munga, Center Director, Kenya Medical Research Institute, Center for 
Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 2022929/02 
 
Or  
 
Name:  Emory University Institutional Review Board 
Email: irb@emory.edu  
Phone: +1-404-712-0720 
 
Page 79 of 127 
 

 
The above numbers are not for emergencies. If you are having an emergency, please go to the 
nearest clinic/place you can get help.  
 
 
Do you have any questions? 
 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the 
study and what will happen in the study. I understand the risks and benefits for me. I have been 
given the opportunity to consider my decision and have had all my questions answered. I 
understand that: 
 
1) I can choose to join this study or not. It is up to me. 
2) If I refuse to join the study, no one will be upset with me or my child. 
3) I can decide to stop being in this study at any time.  
4) I can refuse to answer any questions I choose.  
 
Consent 
By signing this document, I agree to take part in this study as explained in this assent form. 
 
               
Date 
 
 
 
 
     Signature of Adult 
 
 
 
 
 
 
 
 
     Printed Name of Adult 
 
 
 
Date 
 
 
 
 
      Signature of Project Staff 
 
 
 
   
 
 
 
 
      Printed Name of Project Staff 
Page 80 of 127 
 

 
Appendix 6B: Parent Consent Formative Research - Swahili 
 
Consent to Be a Research Subject 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Introduction Utangulizi 
Unakaribishwa kushiriki katika utafiti unaofanywa na chuo kikuu cha Emory Atlanta na Kenya 
Medical Research Institute (KEMRI). utafiti huu utatusaidia kuunda njia mpya ya watoto 
kujifunza kuhusu Virusi Vya Ukimwi  kwa kutumia mchezo kwenye simu ya mkono.tuko na 
mpango wa kusajili jumla ya watu 162 kwa hii utafiti. 
 
Unafaa ushiriki katika huu utafiti kama unataka tu. Sababu ya hii fomu ni kukusaidia amua kama 
unataka kushiriki katika utafiti.kama hutaki kushiriki kwenye utafiti, si lazima. Kama umejiunga 
na utafiti na kasha ubadilishe fikira, ni sawa kuacha utafiti.hakuna atakaye kasirika nawe. 
 
Fomu hii inaweza kuwa na maneno ambayo huelewi. Tafadhali uliza mfanyikazi wa utafiti 
akueleza neno lolote au maelezo ambayo si wazi kwako. Unaweza uliza maswali wakati wowote. 
 
Ni kwa nini tunafanya utafiti? 
Timu ya utafiti inataka kuunda njia mpya ya watoto kujifunza kuhusu virusi vya ukimwi kwa 
kutumia mchezo kwenye simu ya mkono.tungependa utuambie kile ambacho unafikiria kuhusu 
mawazo, mipango na miundo yao, tungependa pia utusaidie kuamua ni maswali gani ya kuiliza 
watoto ili tuweze kujua kama mchezo inawasaidia kujifunza kuhusu virusi vya ukimwi. 
  
Ni nini itatendeka kama nimeshiriki katika utafiti? 
Kama umekubali kushiriki katika utafiti, haya ndio yatatendeka: 
 
Mahojiano/majadiliano ya kikundi: tutakuonyesha mawazo, mipango na miundo yetu ya mchezo 
na kukuuliza uzijadili na kundi la wazazi 6-10 . Tutakusomea pia au kukuuliza uangalie maswali 
ambayo tunapanga kuuliza watoto ambao wanacheza mchezo.tutakuuliza utuambie jinsi 
unavyohisi kuhusu maswali haya na kuzijadili na kundi la wazazi wengine. Tutakuuliza ushiriki 
katika makundi ya mahojiano karibu mara 4 kwa kipindi cha miezi 8. Kila mahojiano ya kikundi 
itakaa karibu dakika 90.Mahojiano ya kikundi yatarekodiwa ili kuhakikisha hatujakosa chochote 
ambacho washiriki watasema. 
 
Ni nini manufaa na hatari ambayo inaweza kunifanyikia kama nimekubali kushiriki 
kwenye utafiti? 
 
Manufaa: hutapata manufaa ya moja kwa moja kwa kushiriki. Hata hivyo, ukishiriki, unatusaidia 
kuunda mchezo kuhusu virusi vya ukimwi ambayo unapenda na ungehisi huru mtoto wako 
Page 81 of 127 
 

 
akicheza.unatusaidia pia kujifunza kama maswali tunayopanga kuuliza watoto yanakubalika na 
wewe. Hutapewa malipo kwa kushiriki katika utafiti huu. Utapewe pesa kiasi cha Kshs 500 za 
kugaramia wakati na nauli yako pamoja na vinyuaji kulingana na kanuni inayo kubaliwa saa ya 
mazungumzo ya vikundi. 
 
Hatari: sehemu ya mchezo na baadhi ya maswali yanaweza kukuaibisha au kukufanya usihisi 
kuwa huru. Kama unahisi huko huru na maswali yoyote umeulizwa, unaweza kukataa kuyajibu 
 
Ni nini kuhusu siri yangu?  
 
Unaulizwa ushiriki katika majadiliano ya kikundi. Hatuwezi kuahidi kwamba wengine katika 
kikundi hawataeleza wengine utakachosema. Hufai kusema chochote katika maadiliano ya 
kikundi ambayo hungetaka wengine nje ya kikundi waskie. 
 
Maelezo yako yatawekwa siri. Maelezo/taarifa yote yatahifadhiwa kwa salama kwenye 
tarakilishi/kompyuta ambayo imelindwa na neno la siri. Hakuna atakayeweza fuatilia majibu 
yako kwako 
 
Fomu hii ya afikio itawekwa salama kwenye kabati iliyofungwa. Tutatumia nambari ya utafiti 
badala ya jina lako kwenye fomu zote za utafiti. Jina lako kamwe halitaelezwa wengine. Jina 
lako kamwe halitatumika kwa uchambuzi 
 
Je Kama nina maswali? 
 
Unaweza kuuliza maswali yoyote ambayo uko nayo wakati wowote. Kama uko na maswali 
yoyote kuhusu utafiti saa hii au baadaye, unaweza wasiliana na : 
 
Jina: 
Dr. Victor Mudhune, Principal Investigator, Kenya Medical Research Institute 
Barua pepe: 
VMudhune@kemricdc.org   
 
 
Simu: 057 2022929/02 
 
 
  
Kama uko na maswali yoyote kuhusu haki zako kama mshiriki wa utafiti au uko na wasiwasi 
wowote au malalamishi, au kama unahisi umeumizwa kwa kushiriki katika utafiti huu. Tafadhali 
wasiliana na :  
Katibu, KEMRI Scientific and Ethics Review Unit (SERU), (sanduku la posta 54840-00200, 
Nairobi) kwenye nambari ya simu 020-2722541 au simu ya rununu 0722205901 au 0733400003 
au 
 
Jina: Dr. Stephen Munga, Center Director, Kenya Medical Research Institute, Center for Global 
Health Research 
Barua pepe: SMunga@kemri.org 
Simu:057 2022929/02 
 
 au 
 
Jina: Emory University Institutional Review Board 
Barua pepe: 
irb@emory.edu  
Page 82 of 127 
 

 
Simu: +1-404-712-0720 
 
Nambari hapo juu si ya dharura. Kama uko na dharura, tafadhali enda kwenye kliniki /pahali 
karibu ambapo unaweza pata usaidizi 
ko na maswali yoyote? 
 
Kauli ya idhini/kukubali  
Nimesoma (au nimeelezewa) na naelewa hii fomu. Naelewa sababu ya utafiti na kile ambacho 
kitatendeka kwa utafiti. Naelewa hatari na manufaa kwangu. Nimepewa nafasi ya kufikiria 
uamuzi wangu na maswali yangu yote yamejibiwa. Naelewa kwamba: 
 
1. Ninaweza chagua kujiunga na huu utafiti au la . Ni juu yangu. 
2. Kama nimekataa kujiunga na utafiti, hakuna atakaye kasirika nami au mtoto wangu. 
3. Ninaweza kuamua kuacha kuwa katika utafiti wakati wowote. 
4. Ninaweza kata kujibu maswali yoyote ambayo nimechagua. 
 
Afikio 
 
Kwa kuweka sahihi katika karatasi, nakubali kushiriki katika huu utafiti kama ilivyoelezwa 
katika fomu hii ya afikio. 
 
 
              
 
Tarehe  
 
 
     sahihi ya mtu mzima 
 
 
 
 
 
 
 
 
     Jina chapisho la mtu mzima 
 
 
 
 
Tarehe  
 
 
      Sahihi ya mfanyikazi wa mradi 
 
 
 
   
 
 
 
 
      Jina chapisho la mfanyi kazi wa mradi. 
 
Page 83 of 127 
 

 
Appendix 6C: Parent Consent Formative Research - Luo 
 
Consent to Be a Research Subject 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
Nying Nonro: Tugo mani e simb ong’we yamo mar gengo landruok mar  kute  mag  ayaki 
kuom  joma tindo ma  jorotenge. 
 
Jochung ne nonro: 
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Omuom Owuok:U.S. National Institute of Mental Health 
 
Chakruok 
 
Iruaki mondo  idonji e  nonro  ma itimo  gi Mbalariany mar  Emory, Atlanta gi migawo ma 
Kenya  Medical  Research Institute(KEMRI). Nonroni biro konyowa loso yoo  manyien  ma  
nyithindo puonjore e  wi kute  mag  ayaki  e  yor  tugo e  simb ongw’we yamo. Wachano ruako 
koriwore ji 162 e nonroni. 
 
Oneg idonj e nonroni mana ka idwaro.Fomni en mar konyi ng’ado paro ka idwar donjo e 
nonroni. Fomni biro konyi ng’ado paro ka idwaro donjo nonro. Ka ok idwaro donjo e nonro, ok 
ochuno ibedie.  Ka idonjo e nonro kendo iloko pachi, en kare mondo iwuog e nonro. Onge 
ng’ama biro chwanyoreFomni otingo weche moko ma ok  winjre. Wakwayi ipenji jotij  nonro 
mondo  olerni wach  kata  weche  ma ok winjreni. Inyalo penjo  penjo saa a saya. 
 
Ang’o  momiyo watimo nonroni? 
 
Jotij nonro dwaro loso yoo manyien ma nyithindo nyalo puonjore e wi kute mag  ayaki e yor  
tugo man  e  simb  ong’we  yamo. Dwaher nyathini onyiswa gima oparo kuom pache, chenro gi 
kido mag tugo mag jotij nonro. Bende  dwaher nyathini okonywa ng’ado  paro e wi penjo ma  
wapenjo nyithindo mondo  wang’e  ka tugoni konyogi puonjore e  wi  kute  mag ayaki. 
  
Ang’o ma  biro  timore ka adonjo  enonroni? 
 
Ka  iyie  donjo e nonro, mae  e  gima biro timore: 
 
Wuoyo/Twak ma Kanyakla/grup: Wabiro  nyisou  pachwa, chenrowa gi kit tuke  kendo  penji 
wuoye  kanyakla/grup mar  jonyuol 6-10. Bende wabiro  somou kendo kwayou  mondo ung’I 
penjo ma  wachano penjo nyithindu mondo otugie. Wabiro kwayou mondo unyiswa gima uparo  
e wi  weche ma  wawuoye gi,  gi penjo  moko ma  wachano miyo  nyithindu moko  ma tugo 
tugo. Kendo wuoye  gi jonyuol ma moko.Wabiro  kwayou  mondo udonji e twak mag  kanyakla 
/grup  ndalo 4 kuom thuolo mar dweche  8. Twak mag  kanyakla/group ibiro  kao dakika 90. 
Wuoyo/Twak ibiro mak  gi nyakalondo mondo kik  gimoro obawa ma jochiwre  owacho.  
 
Page 84 of 127 
 

 
Ang’o maber (ohala) gi rach (hinyruok) gigo ma nyalo timore ka nyathini oyie donjo e 
nonro? 
 
Ohala/ ber: Ok ibi yudo ohala/ber moriere kuom donjo  e nonroni. To, ka idonjo, ikonyowa  loso  
tugo e kuom  kute  mag  ayaki ma ihero kendo diher  tugo.Bende ikonyowa puonjruok ka  penjo 
ma  wachano  penjo nyithindo bende winjore. Ok bi  miyi chudo ne bedo  e nonro. Kata kamano 
wabiro miyi Kshs 500 ne secheni, gi pes wuoth gi math ibiro chiw kaka chick dwaro seche twak. 
 
Hinyruok/rach: Moko  kuom tukegi gi  penjo moko nyalo  miyo ine  wichkuot kata  mi ibedi  ma 
ok ini thuolo. Ka  iwinjo ka  ok ini thuolo gi  penjo moro amora ma openji, inyalo tamori  duoko  
penjogo. 
 
Ang’o kuom kano  mopondo/maling ling?  
 
Ikwayi mondo  idonji e twak mar kanyakla/grup.Ok wanyalo singo ni jomoko mantie  e twak 
mar  grup/kanyakla ok  nyalo wacho/pimo weche  ma  owach gi joma moko. Ok onego iwach 
wach moro e  twak mar  kanyakla/grup ma ok  idwar  joma  moko oko  mar  grup  owinji/ong’e. 
 
Wecheni ibiro  kan mopondo. Weche duto ibiro kan  mopondo e komputa mag  gi nying ma 
aling ling. Onge ng’ato ma  biro luo  duokogi.  
 
Oboke mar ayieni ibiro kan mopondo e kabat ma olor. Wabiro tiyo gi namba e foms duto  mag  
nonro.Nyingi  ok bi mi joma moko. Nyingi ok bi ti godo e yudo  duoko mag  nonro. 
 
Ang’o ma timore ka an  gi  penjo?Inyalo penjo penjo  mora ma  ingo saa asaya. Ka  ini gi  
penjo e  wiy nonro sani kata  bange, inyalo  tudori gi: 
 
Nying: Dr. Victor Mudhune, Principal Investigator, KEMRI 
Oboke  mar  mbui:VMudhune@kemricdc.org  
 
 
 
Simu: 057 2022929/02 
 
Ka  ini gi penjo mora mora e wi  ratiro mari kaka  jachiwre  e nonro, kata  ini gi ngur kata  
ywagruok, kata iwinjo ka  iyudo  hinyruok kuom chiwruok  e nonro, yie  itudri gi: jagoro 
 KEMRI Scientific and Ethics Review Unit (SERU), (P. O. Box 54840-00200, Nairobi) simu 
020-2722541 kata ong’we yamo 0722205901 kata 0733400003 kata 
 
Nying: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Oboke  mar  mbui: SMunga@kemri.org 
Simu: 057 2022929/02 
Or  Kata 
Nying: Emory University Institutional Review Board 
Oboke mar  mbui:irb@emory.edu  
Phone: simu: +1 404 712 0720 
 
Nembni mani malo  ka ok  gini mag dwaro  kony  ma piyo piyo. Ka  eni  gi chandruok ma  
dwaro kony ma piyo piyo. Wakwayi idhi e  klinik/kama chiegni kodi mondo iyudi kony. 
Be eni  gi  penjo? 
Page 85 of 127 
 

 
Wach mar Chiwo  Thuolo 
 
Asesomo (kata oselerna) kendo owinjo gima  fomni wacho. Ang’eyo gima  omiyo itimo  nonro 
gi  gima  biro  timore  e  nonro. Ang’eyo  hinyruok/ rach gi  ber/ohala ne an. Omiya thuolo mar 
ng’ado paro kendo  penjo  g a duto oseduoki. Ang’eyo ni: 
 
1. Anyalo yiero donjo e  nonroni kata tamora  ma ok adonjo 
2. Ka  atamora  donjo e  nonroni, onge  ng;ato  ma  biro  chwanyore koda  kata gi nyathina 
3. Anyalo ng’ado mondo  awuog enonroni saa asaya 
4. Anyalo tamora duoko penjo  ka ayiero. 
 
Ayie 
Ka  agoyo  seyi obokeni. Ayie mondo adonji e  nonroni kaka  olerna e  fom mar ayie 
 
 
 
 
Tarik  
 
 
 
     Seyi mar  Janyuol 
 
 
 
 
 
 
 
 
 
 
 
 
     Ndik nying janyuol 
 
 
 
 
Tarik  
 
 
       
 
Seyi mar  Jatij Nonro 
 
 
 
   
 
 
 
 
       Ndik Nying Jatij Nonro 
 
Page 86 of 127 
 

 
Appendix 7A: Parent Consent Self Post-Intervention FGD - English 
 
Consent to be a Research Subject 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Introduction  
You are being invited to take part in a research study conducted by Emory University in Atlanta 
and the Kenya Medical Research Institute (KEMRI). The study will help us develop a new way 
for children to learn about HIV using a game on a mobile phone.  We plan to recruit a total of 
162 people for this study. 
 
You only have to take part in the study if you want to. The purpose of this form is to help you 
decide if you want to be in the study. If you do not wish to be in the study, you do not have to. If 
you join the study and then change your mind, it is okay for you to leave the study. No one will 
be upset with you.  
 
This form may contain words that you do not understand. Please ask the study staff to explain 
any word or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
 
The research team wants to develop a new way for children to learn about HIV using a game on 
a mobile phone. Your child is participating or has participated in a study in which he or she was 
invited to play a game on a mobile phone for 10 hours over a 2-3 week period. We would like 
you to tell us about your family’s experience with this study.  
 
What will happen if I take part in this study? 
If you agree to be in the study, here is what will happen:   
 
Focus Group Discussion: After your child has played the game and returned the phone, we will 
ask you to take part in a group discussion to tell us about your experiences as the parent of a 
child taking part in this study. The group discussion will be recorded to make sure we do not 
miss anything that participants say. The group discussion will last about 90 minutes. 
 
What are the good (benefits) and bad (risks) things that could happen to me if I agree to be 
in the study? 
 
Benefits:  You will not receive direct benefit by taking part. However, when you take part, you 
are helping us to learn how we can make the game as valuable as possible for children and their 
parents. You will not be offered payment for being in this study. You will not be offered 
Page 87 of 127 
 

 
payment for being in this study. However, you will be reimbursed Kshs 500 for your time and 
transport costs and refreshments provided as per standard requirements during FGDs. 
 
Risks:  Some of the questions may embarrass you or make you feel uncomfortable. If you feel 
uncomfortable with any questions you are asked, you may refuse to answer them. 
 
What about my confidentiality? 
You are being asked to take part in a group discussion. We cannot promise that others in the 
group will not share what you say with others. You shouldn’t say anything in the discussion 
group that you would not want others outside the group to hear.  
 
Your information will be kept private. All information will be stored safely on a computer 
protected by passwords. No one will be able to trace your answers to you.  
 
This consent form will be kept in a safe locked cabinet. We will use a study number in place of 
your name on all study forms. Your name will never be shared with others. Your name will 
never be used for analysis.  
 
What if I have questions?  
You can ask any questions you have at any time. If you have any questions about the study now 
or later, you may contact: 
 
Name:  Dr. Victor Mudhune, Principal Investigator, KEMRI 
Email: VMudhune@kemricdc.org   
 
 
Phone: 057 2022929/02 
 
If you have any questions about your rights as a research participant, or have concerns or 
complaints, or if you feel you have been harmed by taking part in this study, please contact: the 
secretary, KEMRI Scientific and Ethics Review Unit (SERU), (P. O. Box 54840-00200, Nairobi) 
at telephone 020-2722541 or cell phone 0722205901 or 0733400003. 
Or 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 2022929/02 
Or  
Name:  Emory University Institutional Review Board 
Email: irb@emory.edu  
Phone: +1 404 712 0720 
 
The above numbers are not for emergencies. If you are having an emergency, please go to the 
nearest clinic/place you can get help.  
 
Do you have any questions? 
 
Page 88 of 127 
 

 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the 
study and what will happen in the study. I understand the risks and benefits for me. I have been 
given the opportunity to consider my decision and have had all my questions answered. I 
understand that: 
 
1) I can choose to join this study or not. It is up to me. 
2) If I refuse to join the study, no one will be upset with me or my child. 
3) I can decide to stop being in this study at any time.  
4) I can refuse to answer any questions I choose.  
 
Consent 
By signing this document, I agree to take part in this study as explained in this assent form. 
 
               
Date 
 
 
 
 
     Signature of Adult 
 
 
 
 
 
 
 
 
     Printed Name of Adult 
 
 
 
Date 
 
 
 
 
      Signature of Project Staff 
 
 
 
   
 
 
 
 
      Printed Name of Project Staff 
 
 
 
Page 89 of 127 
 

 
Appendix 7B: Parent Consent Self Post-Intervention FGD - Swahili 
 
Consent to be a Research Subject 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Utangulizi 
Unakaribishwa kushiriki katika utafiti unaofanywa na chuo kikuu cha Emory Atlanta na Kenya 
Medical Research Institute (KEMRI). utafiti huu utatusaidia kuunda njia mpya ya watoto 
kujifunza kuhusu Virusi Vya Ukimwi  kwa kutumia mchezo kwenye simu ya mkono.tuko na 
mpango wa kusajili jumla ya watu 162 kwa hii utafiti. 
 
Unafaa ushiriki katika huu utafiti kama unataka tu. Sababu ya hii fomu ni kukusaidia amua kama 
unataka kushiriki katika utafiti.kama hutaki kushiriki kwenye utafiti, si lazima. Kama umejiunga 
na utafiti na kasha ubadilishe fikira, ni sawa kuacha utafiti.hakuna atakaye kasirika nawe. 
 
Fomu hii inaweza kuwa na maneno ambayo huelewi. Tafadhali uliza mfanyikazi wa utafiti 
akueleza neno lolote au maelezo ambayo si wazi kwako. Unaweza uliza maswali wakati wowote. 
 
Ni kwa nini tunafanya huu utafiti? 
 
Timu ya utafiti inataka kuunda njia mpya ya watoto kujifunza kuhusu virusi vya ukimwi kwa 
kutumia mchezo kwenye simu ya mkono. Mtoto wako anashiriki au ameshiriki katika utafiti 
ambayo alikaribishwa acheze mchezo kwa simu ya mkono kwa masaa 10 kwa muda wa wiki 2-
3. Tungependa utuambie kuhusu vitu ambavyo familia yako wamepitia/kuona kwa hii utafiti. 
 
Ni nini itatendeka kama nimeshiriki katika utafiti? 
 
Kama umekubali kushiriki katika utafiti, haya ndio yatatendeka: 
 
Mahojiano/majadiliano ya kikundi: baada ya mtoto wako amecheza mchezo na kurudisha simu, 
tutakuuliza ushiriki kwa mahojiano ya kikundi na utuambie kuhusu uliyoyapitia kama mzazi wa 
mtoto anayeshiriki katika huu utafiti. Mahojiano ya kikundi itakaa karibu dakika 90. 
 
Ni nini manufaa na hatari ambayo inaweza kunifanyikia kama nimekubali kushiriki 
kwenye utafiti? 
 
Manufaa: hutapata manufaa ya moja kwa moja kwa kushiriki. Hata hivyo, ukishiriki, unatusaidia 
kujifunza jinsi ya kuunda mchezo ikuwe ya thamani iwezekanavyo kwa watoto na wazazi wao. 
Hutapewa malipo kwa kushiriki katika utafiti huu. Utapewe pesa kiasi cha Kshs 500 za 
Page 90 of 127 
 

 
kugaramia wakati na nauli yako pamoja na vinyuaji kulingana na kanuni inayo kubaliwa saa ya 
mazungumzo ya vikundi. 
 
Hatari: sehemu ya mchezo na baadhi ya maswali  yanaweza kukuaibisha au kukufanya usihisi 
kuwa huru. Kama unahisi huko huru na maswali yoyote umeulizwa, unaweza kukataa kuyajibu 
 
Ni nini kuhusu siri yangu?  
 
Unaulizwa ushiriki katika majadiliano ya kikundi. Hatuwezi kuahidi kwamba wengine katika 
kikundi hawataeleza wengine utakachosema. Hufai kusema chochote katika maadiliano ya 
kikundi ambayo hungetaka wengine nje ya kikundi waskie. 
 
Maelezo yako yatawekwa siri. Maelezo/taarifa yote yatahifadhiwa kwa salama kwenye 
tarakilishi/kompyuta ambayo imelindwa na neno la siri. Hakuna atakayeweza fuatilia majibu 
yako kwako 
 
Fomu hii ya afikio itawekwa salama kwenye kabati iliyofungwa. Tutatumia nambari ya utafiti 
badala ya jina lako kwenye fomu zote za utafiti. Jina lako kamwe halitaelezwa wengine. Jina 
lako kamwe halitatumika kwa uchambuzi 
 
Je kama nina maswali? 
 
Unaweza kuuliza maswali yoyote ambayo uko nayo wakati wowote. Kama uko na maswali 
yoyote kuhusu utafiti saa hii au baadaye, unaweza wasiliana na: 
 
Jina:   Dr. Victor Mudhune, Principal Investigator, KEMRI 
Barua pepe: 
VMudhune@kemricdc.org   
 
 
Simu: 057 2022929/02 
 
Kama uko na maswali yoyote kuhusu haki zako kama mshiriki wa utafiti au uko na wasiwasi 
wowote au malalamishi, au kama unahisi umeumizwa kwa kushiriki katika utafiti huu. Tafadhali 
wasiliana na:  
Katibu, KEMRI Scientific and Ethics Review Unit (SERU), (sanduku la posta 54840-00200, 
Nairobi) kwenye nambari ya simu 020-2722541 au simu ya rununu 0722205901 au 0733400003  
 
au 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Barua Pepe: SMunga@kemri.org 
 
Simu: 057 2022929/02 
 Au 
Jina:  Emory University Institutional Review Board 
 
Barua pepe: irb@emory.edu  
Simu:  +1 404 712 0720 
 
Nambari hapo juu si ya dharura. Kama uko na dharura, tafadhali enda kwenye kliniki /pahali 
karibu ambapo unaweza pata usaidizi 
Page 91 of 127 
 

 
 
Uko na maswali yoyote? 
 
Kauli ya idhini/kukubali 
Nimesoma (au nimeelezewa) na naelewa hii fomu. Naelewa sababu ya utafiti na kile ambacho 
kitatendeka kwa utafiti. Naelewa hatari na manufaa kwangu. Nimepewa nafasi ya kufikiria 
uamuzi wangu na maswali yangu yote yamejibiwa. Naelewa kwamba: 
 
1. Ninawza chagua kujiunga na utafiti au la. Ni juu yangu 
2. Kama nimekataa kujiunga na utafiti, hakuna atakaye kasirika na mimi au mtoto wangi 
3. Ninaweza amua kuacha kuwa katika huu utafiti wakati wowote. 
4. Ninaweza kukataa kujibu maswali yoyote nimechagua. 
 
Afikio 
Kwa kutia sahihi kwenye hii karatasi, nakubali kushiriki katika utafiti hii kama ilivyoelezwa 
katika fomu hii ya afikio. 
 
               
 
 
 
 
 
Sahihi ya mtu mzima 
Tarehe 
 
 
 
 
 
 
 
     Jina chapisho la mtu mzima 
 
 
 
 
Tarehe  
 
 
      sahihi ya mfanyikazi wa mradi 
 
 
 
   
 
 
 
 
       
                                                              Jina chapisho la mfanyi kazi wa mradi 
Page 92 of 127 
 

 
Appendix 7C: Parent Consent Self Post-Intervention FGD - Luo 
Consent to be a Research Subject 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 Nying Nonro:Tugo mani e  simb ong’we yamo mar  gengo landruok mar kute mag  ayaki 
kuom  joma tindo ma  jorotenge. 
 
Jochung ne Nonro:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Omuom Owuok: U.S. National Institute of Mental Health 
 
Chakruok 
Iruaki mondo  idonji e  nonro  ma itimo  gi Mbalariany mar  Emory, Atlanta gi migawo ma 
Kenya  Medical  Research Institute(KEMRI). Nonroni biro konyowa loso yoo  manyien  ma  
nyithindo puonjore e  wi kute  mag  ayaki  e  yor  tugo e  simb ongw’we yamo. Wachano ruako 
koriwore ji 162 e nonroni. 
 
Oneg idonj e nonroni mana ka idwaro.Fomni en mar konyi ng’ado paro ka idwar donjo e 
nonroni. Fomni biro konyi ng’ado paro ka idwaro donjo nonro. Ka ok idwaro donjo e nonro, ok 
ochuno ibedie.  Ka idonjo e nonro kendo iloko pachi, en kare mondo iwuog e nonro. Onge 
ng’ama biro chwanyore. 
 
Fomni otingo weche moko ma ok  winjre. Wakwayi ipenji jotij  nonro mondo  olerni wach  kata  
weche  ma ok winjreni. Inyalo penjo  penjo saa a saya. 
 
Ang’o momiyo watimo nonroni? 
 
Jotij  Nonro dwaro loso yoo ma  nyithindo nyalo puonjore e wi  kute  mag ayaki ka tiyo gi simb 
ong’we yamo. Nyathini ochiwre kata  chiwre e nonroni ma oruake  mondo otug tugo mar  simb 
ong’we yamo kuom seche 10 kuom thuolo mar  wige 2-3. Dwaher mondo inyiswa kaka family 
mar paro e wi nonroni. 
 
Ang’o ma  biro timore ka adonjo e nonroni? 
Ka iyie donjo e nonroni,mae e gima biro timore: 
 
Tugo:  Bang ka nyathini osetugo ma oduoko simb ong’we yamo, wabiro kwayi mondo ibedie e  
wuoyo/twak mar kanyakla/grup mondo inyiswa pachi kuom mae kaka janyuol mar nyathi mantie 
e nonro. Wuoyoni/twak mag kanyakla/grup ibiro mak gi nyakalondo ok wadwak  gimoro  obawa 
ma jachiwre owacho. Wuoyoni/twakni mar kanyakla/grup biro kao dakika 90. 
 
Ang’o maber (ohala) gi  rach (hinyruok) gigo ma nyalo timore ka  nyathini oyie  donjo e 
nonro? 
 
Ohala/ ber: Ok ibi yudo ohala/ber moriere kuom donjo e nonroni. To, ka idonjo, ikonyowa  loso  
tugo e kuom  kute  mag  ayaki ma ihero kendo diher  tugo. Bende ikonyowa puonjruok ka  penjo 
Page 93 of 127 
 

 
ma  wachano  penjo nyithindo bende winjore. Ok bi  miyi chudo ne bedo  e nonro. Kata kamano 
wabiro miyi Kshs 500 ne secheni, gi pes wuoth gi math ibiro chiw kaka chick dwaro seche twak. 
 
Hinyruok/rach:Moko  kuom tukegi gi  penjo moko nyalo  miyo ine  wichkuot kata  mi ibedi  ma 
ok ini thuolo. Ka  iwinjo ka  ok ini thuolo gi  penjo moro amora ma openji, inyalo tamori  duoko  
penjogo. 
 
Ang’o kuom kano mopondo/maling ling? 
 
Ikwayi mondo  idonji e twak mar kanyakla/grup.Ok wanyalo singo ni jomoko mantie  e wuoyo/ 
twak mar  grup/kanyakla ok  nyalo wacho/pimo weche  ma  owach gi joma moko. Ok onego 
iwach wach moro e  twak mar  kanyakla/grup ma ok  idwar  joma  moko oko  mar  grup  
owinji/ong’e. 
 
Wecheni ibiro  kan mopondo. Weche duto ibiro kan  mopondo e komputa mag  gi nying ma 
aling ling. Onge ng’ato ma  biro luo  duokogi.  
 
Oboke  mar  ayieni ibiro  kan mopondo e kabat ma olor. Wabiro  tiyo  gi namba kar  nying e 
fomus  duto  mag  nonro.Nying ok bi miyi joma moko. Nying  ok  be  ti  godo e yudo  duoko 
mag  nonro. 
 
Ang’o ma timore ka an  gi  penjo? 
 
Inyalo penjo penjo mora ma ingo saa a saya. Ka ini gi penjo e wi nonro sani kata  bange, inyalo  
tudori gi: 
 
Nying: Dr. Victor Mudhune, Principal Investigator, KEMRI 
Oboke  mar  mbui: 
VMudhune@kemricdc.org   
 
 
Simu: 057 2022929/02 
 
Ka  ini gi penjo mora mora e wi  ratiro mari kaka  jachiwre  e nonro, kata  ini gi ngur kata  
ywagruok, kata iwinjo ka  iyudo  hinyruok kuom chiwruok  e nonro, yie  itudri gi: jagoro 
 KEMRI Scientific and Ethics Review Unit (SERU), (P. O. Box 54840-00200, Nairobi) simu 
020-2722541 kata ong’we yamo 0722205901 kata 0733400003 kata 
 
Nying: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Oboke  mar  mbui: SMunga@kemri.org  
Simu: 057 2022929/02 
Kata 
Nying: Emory University Institutional Review Board 
Oboke mar  mbui:irb@emory.edu  
Simu: +1 404 712 0720 
 
Nembni mani malo  ka ok  gini mag dwaro  kony  ma piyo piyo. Ka  ini  gi candruok ma  dwaro 
kony ma piyo piyo, wakwayi mondo idhi e  klinik/kama chiegni kodi mondo iyud kony. 
Be ini  gi  penjo? 
 
Page 94 of 127 
 

 
Wach mar chiwo  thuolo  
Asesomo (kata oselerna) kendo owinjo gima fomni wacho. Ang’eyo gima omiyo itimo nonro gi  
gima  biro  timore  e  nonro. Ang’eyo hinyruok/ rach gi ber/ohala ne an. Omiya thuolo mar 
ng’ado paro kendo penjo ga duto oseduoki. Ang’eyo ni: 
 
1) Anyalo yiero donjo e  nonroni kata tamora  ma ok adonjo 
2) Ka  atamora  donjo e  nonroni, onge  ng;ato  ma  biro  chwanyore koda  kata gi nyathina 
3) Anyalo ng’ado mondo  awuoK e nonroni saa a saya 
4) Anyalo tamora duoko penjo ka ayiero. 
 
Ayie 
Ka  agoyo  seyi obokeni. Ayie mondo adonji e  nonroni kaka  olerna e  fom mar ayie 
 
 
 
Tarik  
 
 
                 Seyi mar  Janyuol 
                                                    
 
 
 
 
 
 
 
     Ndik Nying Janyuol 
 
 
 
      
 
 
 
Tarik  
 
 
                  Seyi mar  Jatij Nonro 
 
 
   
 
 
 
 
      Ndik Nying Jatij Nonro 
Page 95 of 127 
 

 
Appendix 8A through Appendix 21 redacted 
Page 96 of 127 
 

 
Appendix 22: Assent Followup= English 
 
EMORY UNIVERSITY 
ASSENT FORM FOR MINOR SUBJECTS 
 
Study Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Emory University Rollins School of Public Health 
Victor Mudhune, MBA, MPH, KEMRI Center for Global Health Research 
 
 
INFORMATION ABOUT THIS STUDY: 
 
Introduction  
You were invited to take part in a research study conducted by Emory University in Atlanta and the 
Kenya Medical Research Institute (KEMRI). The study will help us develop a new way for children to 
learn about HIV using a game on a mobile phone. We have recruited 162 people for this study (108 
young people, and 54 of their parents) and are recruiting an additional 45 people. 
  
You only have to take part in the study if you want to. The purpose of this form is to help you decide if 
you want to continue to be in the study. If you are going to be in the study, your parent/caregiver also 
has to agree. But if you do not wish to be in the study anymore, you do not have to, even if your 
parent/caregiver has agreed. Your parent/caregiver cannot force you. 
 
You can leave the study at any time. If you join the study and then change your mind, it is okay for you 
to leave the study. No one will be upset with you. You can skip any questions that you do not wish to 
answer. 
 
This form may contain words that you do not understand. Please ask the study staff to explain any word 
or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
The research team wants to find out how a game about HIV that children play on a mobile phone may 
affect their behavior. The study will help us understand whether the game helps children learn about 
HIV and helps keep them healthy.  
 
What will happen if I take part in this study? 
If both you and your parent/caregiver agree for you to take part in the study, here is what will happen:   
 
Focus Group Discussion: After we collected the phone, we asked those who played to take part in a 
group discussion to tell us about their experiences playing the game. For this stage of the study, we are 
asking you to take part in another group discussion to give additional information about your experience 
and to share your suggestions on what topics and stories this kind of game could be about. The group 
discussion will be recorded to make sure we do not miss anything that participants say. The group 
discussion will last about 1 hour. 
 
In-Depth Interview: We may ask you to take part in a one-on-one interview to tell us about your 
experience playing the game, and your suggestions on what other topics and stories this game could be 
Page 97 of 127 
 

 
about. The interview will be recorded to make sure we do not miss anything you say. It will last about 60 
minutes. 
 
Game Play: We may ask you to play an updated version of the game and to give your feedback about 
the changes that have been made since last year during a focus group dicussion. The discussion will last 
no more than 2 hours. 
 
Cognitive Interview/ Discussion: We may ask you to read questions we plan to ask children who play the 
game in the future. This interview/ discussion will last no more than 1 hour. 
 
Survey Pilot: We may ask you to answer the questions we plan to ask children who play the game in the 
future so we can test the questions. This will last no more than 1 hour. 
 
Survey: We will ask you to answer a few questions about how you share information with others and 
who you share information with. This survey will take no more than 15 minutes. 
 
 
What are the good (benefits) and bad (risks) things that could happen to me if I agree to be in the 
study? 
 
Benefits:  You will not get direct benefit by taking part. However, when you take part, you are helping us 
to find out if the game helps children learn about HIV and stay healthy. You will not be offered payment 
for being in this study. 
 
Risks:  Some of the questions may embarrass you or make you feel uncomfortable. If you feel 
uncomfortable with any questions, you may refuse to answer them. You can stop being in the study at 
any time.  
 
 
What about my confidentiality? 
Your information will be kept private.  All information will be stored safely on a computer protected by 
passwords. No one will be able to trace your answers to you.  
 
This assent form will be kept in a safe locked cabinet. We will use a study number in place of your name 
on all study forms. Your name will never be shared with others. Your name will never be used for 
analysis.  
 
You are being asked to take part in a group discussion. We cannot promise that children in the group will 
not share what you say with others. You shouldn’t say anything in the discussion group that you would 
not want others outside the group to hear. 
 
Disclosure of Child Sexual Abuse and Neglect 
Your privacy is very important to us, but so is your health and safety. In cases where abuse, neglect or a 
child’s desire to harm themselves or others is suspected or disclosed during the study, our staff are 
required to report this information. 
 
What if I have questions?  
Page 98 of 127 
 

 
You can ask any questions you have at any time. If you have any questions about the study now or later, 
you may contact: 
 
Name:  Dr. Victor Mudhune, Principal Investigator, KEMRI 
Email: vmudhune@kemricdc.org  
 
 
 
Phone: 0722-687430 
 
 
  
If you have any questions about your rights as a research participant, or have concerns or complaints, or 
if you feel you have been harmed by taking part in this study, please contact: the secretary, KEMRI 
Ethical Review Committee, (P. O. Box 54840-00200, Nairobi) at telephone 020-2722541 or cell phone 
0722205901 or 0733400003 or 
 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 22923/24 
Or  
Name:  Emory  University Institutional Review Board 
Email: irb@emory.edu  
Phone: +1-404-712-0720 
 
The above numbers are not for emergencies. If you are having an emergency, please go to the nearest 
clinic/place you can get help.  
 
Do you have any questions? 
 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the study 
and what will happen in the study. I understand the risks and benefits for me. I have been given the 
opportunity to consider my decision and have had all my questions answered. I understand that: 
 
1) I can choose to join this study or not. It is up to me. 
2) My parent/caregiver must also agree for me to participate in the study. I cannot participate in the 
study if my parent/caregiver does not agree. 
3) Even if my parent/caregiver agrees, I do not have to participate in the study if I do not want to. 
4) If I refuse to join the study, no one will be upset with my parent/caregiver and me. 
5) I can decide to stop being in this study at any time.  
6) My parent/guardian can choose for me to stop being in the study at any time. 
 
Assent 
By signing this document, I agree to take part in this study as explained in this assent form. 
 
       ________________________________________________________________________ 
 
Signature of 11 to 17-year-old Subject  
 
        Date 
   Time 
 
        
 
       ________________________________________________________________________ 
 
Signature of person soliciting assent of 11-17 year old Subject   Date 
   Time
Page 99 of 127 
 

 
Appendix 23: Parental Consent Followup= English 
 
Emory University 
Consent for Child to be a Research Subject 
 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Emory University Rollins School of Public Health 
Victor Mudhune, MBA, MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Introduction  
 
Your child was invited to take part in a research study conducted by Emory University in Atlanta and the 
Kenya Medical Research Institute (KEMRI). The study is helping us develop a new way for children to 
learn about HIV using a game on a mobile phone.  We have recruited 162 people for this study (108 
young people, and 54 of their parents) and are recruiting an additional 45 people. 
 
This form is to help you decide if you want to allow your child to be in the next step of the study. Your 
child can only take part if you agree. Your child will also be asked if they want to take part in the study. 
Nothing bad will happen to you or your child if you or they say ‘no’.  
 
If you decide to allow your child to join the study and then change your mind, it is okay for him/her to 
leave the study. You can remove him/her from the study at any time. No one will be upset with you or 
your child. 
 
This form may contain words that you do not understand. Please ask the study staff to explain any word 
or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
 
The research team wants to find out how a game about HIV that children play on a mobile phone may 
affect their behavior. The study is helping us understand whether the game helps children learn about 
HIV and helps keep them healthy.  
 
What will happen if my child takes part in this study? 
 
If both you and your child agree for your child to take part in the study, here is what will happen:   
 
Focus Group Discussion: After we collected the phones, we may have asked your child to take part in a 
group discussion to tell us about his or her experiences playing the game. For this stage of the study we 
may ask your child to take part in another group discussion to give additional information about his or 
her experience, and his or her suggestions on what other topics and stories this kind of game could be 
about. The group discussion will be recorded to make sure we do not miss anything that participants 
say. The group discussion will last about 1 hour.  
Page 100 of 127 
 

 
 
In-Depth Interview: We may ask your child to take part in a one-on-one interview to tell us about his or 
her experience playing the game, and his or her suggestions on what other topics and stories this game 
could be about. The interview will be recorded to make sure we do not miss anything you say. It will last 
about 60 minutes. 
 
Game Play: We may ask your child to play an updated version of the game and to give his or her 
feedback about the changes that have been made since last year during a focus group dicussion. The 
discussion will last no more than 2 hours. 
 
Cognitive Interview/Discussion: We may ask your child to read questions we plan to ask children who 
play the game in the future so we can make sure the questions are understandable for young people. 
This interview or group discussion will last no more than 1 hour. 
 
Survey Pilot: We may ask your child to answer the questions we plan to ask children who play the game 
in the future so we can test the questions. This will last no more than 1 hour. 
 
Survey: We will ask your child to answer a few questions about how he or she shares information with 
others and who he or she shares information with. This survey will take no more than 15 minutes. 
 
 
What are the good (benefits) and bad (risks) things that could happen to my child if I agree for 
him/her to be in this study?  
 
Benefits:  Your child may not get direct benefits by taking part. However, when your child takes part, he 
or she is helping us to find out if the game helps children learn about HIV and stay healthy. You will not 
be offered payment for being in this study.   
 
Risks:  Parts of the game and some of the questions may have embarrassed your child or made him or 
her feel uncomfortable. If your child feels uncomfortable with any questions now, he or she may refuse 
to answer them. Your child can stop being in the study at any time.  
 
What about my child’s confidentiality?   
 
Your child’s information will be kept private.  All information will be stored safely on a computer 
protected by passwords. No one will be able to trace your child’s answers to him or her.  
 
This consent form will be kept in a safe locked cabinet. We will use a study number in place of your 
child’s name on all study forms. Your child’s name will never be shared with others. Your child’s name 
will never be used for analysis.  
 
Your child is being asked to take part in a group discussion. We cannot promise that children in the 
group will not share what he or she say with others. Your child shouldn’t say anything in the discussion 
group that he or she would not want others outside the group to hear. We will remind him or her about 
this. 
 
Does my child have to participate? What will happen if we change our minds? 
 
Page 101 of 127 
 

 
You can choose for your child to not be in this study. Your child can choose not to be in the study. If you 
and your child agree for him/her to be in the study, he/she can still refuse to answer any question. You 
or your child can stop their participation in the study at any time. Nothing bad will happen to you or 
your child if they refuse to answer questions or want to stop taking part in the study.  
 
Disclosure of Child Sexual Abuse and Neglect 
Your child’s privacy is very important to us, but so are his/her health and safety. In cases where abuse, 
neglect or the desire to harm themselves or others is suspected or disclosed during the study, our staff 
are required to report this information. 
 
What if I have questions?  
You can ask any questions you have at any time. If you have any questions about the study now or later, 
you may contact:  
 
Name:  Dr. Victor Mudhune, Principal Investigator, KEMRI 
Email: vmudhune@kemricdc.org  
 
 
 
Phone: 0722-687430 
  
If you have any questions about your or your child’s rights as a research participant, or have concerns or 
complaints, or if you feel you have been harmed by taking part in this study, please contact: the 
secretary, KEMRI Ethical Review Committee, (P. O. Box 54840-00200, Nairobi) at telephone 020-
2722541 or cell phone 0722205901 or 0733400003 or 
 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 22923/24 
Or  
Name:  Emory  University Institutional Review Board 
Email: irb@emory.edu 
Phone: +1-404-712-0720 
 
The above numbers are not for emergencies. If you are having an emergency, please go to the nearest 
clinic/place you can get help.  
 
Do you have any questions? 
 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the study 
and what will happen in the study. I understand the risks and benefits for my child. I have been given the 
opportunity to consider my decision and have had all my questions answered. I understand that: 
 
1) I can choose to allow my child to join this study or not. It is up to me. 
2) My child can choose to join the study or not. It is up to him or her. 
3) Even if I agree, my child does not have to participate in the study if he/she does not want to. 
4) If I refuse or my child chooses not to join the study, no one will be upset with me or my child as a 
result. 
5) I can decide to stop my child from being in this study at any time.  
6) My child can stop being in the study at any time. 
Page 102 of 127 
 

 
Consent 
By signing this document, I agree to let my child participate in the study as explained in this form. 
               
Date 
 
 
 
 
     Signature of Adult 
 
 
 
 
 
 
 
     Printed Name of Adult 
 
 
Date 
 
 
 
 
      Signature of Project Staff 
 
 
 
   
 
 
 
 
      Printed Name of Project Staff 
Page 103 of 127 
 

 
Appendix 24: Assent Followup (Siblings)= English 
 
Emory University 
Assent to be a Research Subject 
 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Introduction  
You are being invited to take part in a research study conducted by Emory University in Atlanta and the 
Kenya Medical Research Institute (KEMRI). The study will help us develop a new way for children to 
learn about HIV using a game on a mobile phone.  We have recruited 162 people for this study (108 
young people, and 54 of their parents) and are recruiting an additional 45 people. 
 
You only have to take part in the study if you want to. The purpose of this form is to help you decide if 
you want to be in the study. If you do not wish to be in the study, you do not have to. If you join the 
study and then change your mind, it is okay for you to leave the study. No one will be upset with you.  
 
This form may contain words that you do not understand. Please ask the study staff to explain any word 
or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
 
The research team wants to develop a new way for children to learn about HIV using a game on a 
mobile phone. Your brother or sister participated in a study in which he or she was invited to play a 
game on a mobile phone for 10 hours over a 2-3 week period. We would like you to tell us about your 
experience with this study.  
 
What will happen if I take part in this study? 
If you agree to be in the study, here is what may happen:   
 
Focus Group Discussion: We may ask you to take part in a group discussion to tell us about your 
experiences as the brother or sister of a child taking part in this study,any experience you had playing 
the game, and your suggestions on what other topics and stories this kind of game could be about. The 
group discussion will be recorded to make sure we do not miss anything that participants say. The group 
discussion will last about 60 minutes. 
 
In-Depth Interview: We may ask you to take part in a one-on-one interview to tell us about your 
experience playing the game, and your suggestions on what other topics and stories this game could be 
about. The interview will be recorded to make sure we do not miss anything you say. It will last about 60 
minutes. 
 
Page 104 of 127 
 

 
Game Play: We may ask you to play an updated version of the game and to give your feedback about 
the changes that have been made since last year during a focus group dicussion. The discussion will last 
no more than 2 hours. 
 
Cognitive Interview/ Discussion: We may ask you to read questions we plan to ask children who play the 
game in the future. This interview or discussion will last no more than 1 hour. 
 
Survey Pilot: We may ask you to answer the questions we plan to ask children who play the game in the 
future so we can test the questions. This will last no more than 1 hour. 
 
Survey: We will ask you to answer a few questions about how you share information with others and 
who you share information with. This survey will take you no more than 15 minutes. 
 
What are the good (benefits) and bad (risks) things that could happen to me if I agree to be in the 
study? 
Benefits:  You will not receive direct benefit by taking part. However, when you take part, you are 
helping us to learn how we can make the game as valuable as possible for children and their parents. 
You will not be offered payment for being in this study.  
 
Risks:  Some of the questions may embarrass you or make you feel uncomfortable. If you feel 
uncomfortable with any questions you are asked, you may refuse to answer them. 
 
 
What about my confidentiality? 
You are being asked to take part in a group discussion. We cannot promise that others in the group will 
not share what you say with others. You shouldn’t say anything in the discussion group that you would 
not want others outside the group to hear.  
 
Your information will be kept private. All information will be stored safely on a computer protected by 
passwords. No one will be able to trace your answers to you.  
 
This consent form will be kept in a safe locked cabinet. We will use a study number in place of your 
name on all study forms. Your name will never be shared with others. Your name will never be used for 
analysis.  
 
What if I have questions?  
You can ask any questions you have at any time. If you have any questions about the study now or later, 
you may contact: 
 
Name:  Dr. Victor Mudhune, Principal Investigator, KEMRI 
Email: VMudhune@kemricdc.org  
 
 
 
Phone: 0722-687430 
 
If you have any questions about your rights as a research participant, or have concerns or complaints, or 
if you feel you have been harmed by taking part in this study, please contact: the secretary, KEMRI 
Ethical Review Committee, (P. O. Box 54840-00200, Nairobi) at telephone 020-2722541 or cell phone 
0722205901 or 0733400003. 
Or 
Page 105 of 127 
 

 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 22923/24 
Or  
Name:  Emory University Institutional Review Board 
Email: irb@emory.edu  
Phone: +1 404 712 0720 
 
The above numbers are not for emergencies. If you are having an emergency, please go to the nearest 
clinic/place you can get help.  
 
Do you have any questions? 
 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the study 
and what will happen in the study. I understand the risks and benefits for me. I have been given the 
opportunity to consider my decision and have had all my questions answered. I understand that: 
 
1) I can choose to join this study or not. It is up to me. 
2) My parent/ caregiver must also agree for me to participate in the study. I cannot participate in the 
study if my parent/caregiver does not agree. 
3) Even if my parent/caregiver agrees. I do not have to participate in the study if I do not want to. 
4) If I refuse to join the study, no one will be upset with me. 
5) I can decide to stop being in this study at any time.  
6) My parent/ guardian can choose for me to stop being in the study at any time. 
7) I can refuse to answer any questions I choose.  
 
Consent 
By signing this document, I agree to take part in this study as explained in this assent form. 
 
 
               
Date 
 
 
 
 
     Signature of 15-17 year old subject 
 
 
Date 
 
 
 
 
      Signature of person soliciting assent of 15-17 year old 
subject 
 
Page 106 of 127 
 

 
Appendix 25: Parental Consent Followup (Sibling) - English 
 
Emory University 
Consent to be a Research Subject 
 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Introduction  
Your child is being invited to take part in a research study conducted by Emory University in Atlanta and 
the Kenya Medical Research Institute (KEMRI). The study will help us develop a new way for children to 
learn about HIV using a game on a mobile phone.  We have recruited 162 people for this study (108 
young people, and 54 of their parents) and are recruiting an additional 45 people. 
 
The purpose of this form is to help you decide if you want allow your child to be in the study. Your child 
can only take part in the study if you agree. Your child will also be asked if they want to take part in the 
study. Nothing bad will happen to you or your child if you or they say “no”.  
 
If you decide to allow your child to join the study and then you or your child change your mind, it is okay 
for him/her to leave the study. No one will be upset with you or your child.  
 
This form may contain words that you do not understand. Please ask the study staff to explain any word 
or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
 
The research team wants to develop a new way for children to learn about HIV using a game on a 
mobile phone. Your younger child has participated in a study in which he or she was invited to play a 
game on a mobile phone for 10 hours over a 2-3 week period. Your older child may also have played this 
game while the younger child was in the study. We would like your older child to tell us about his or her 
experience with this game, and to give us advice about future games we may develop, even if he or she 
has not played.  
 
What will happen if your child takes part in this study? 
If both you and your child agree to be in the study, here is what will happen:   
 
Focus Group Discussion: We may ask your child to take part in a group discussion to tell us about his/her 
experience playing the game that was part of our study in April, and his or her suggestions on what 
other topics and stories this kind of game could be about. The group discussion will be recorded to make 
sure we do not miss anything that participants say. The group discussion will last about 60 minutes. 
 
Page 107 of 127 
 

 
In-Depth Interview: We may ask your child to take part in a one-on-one interview to tell us about his or 
her experience playing the game, and his or her suggestions on what other topics and stories this game 
could be about. The interview will be recorded to make sure we do not miss anything you say. It will last 
about 60 minutes. 
 
Game Play: We may ask your child to play an updated version of the game and to give his or her 
feedback about the changes that have been made since last year during a focus group dicussion. The 
discussion will last no more than 2 hours. 
 
Cognitive Interview/ Discussion: We may ask your child to read questions we plan to ask children who 
play the game in the future. This interview or discussion will last no more than 1 hour. 
 
Survey Pilot: We may ask your child to answer the questions we plan to ask children who play the game 
in the future so we can test the questions. This will last no more than 1 hour. 
 
Survey: We will ask your child to answer a few questions about how he or she shares information with 
others and who he or she shares information with. This survey will take no more than 15 minutes. 
 
What are the good (benefits) and bad (risks) things that could happen to me if I agree to be in the 
study? 
Benefits:  Your child will not receive direct benefit by taking part. However, when your child takes part, 
he or she is helping us to learn how we can make the game as valuable as possible for children of their 
age. You will not be offered payment for being in this study.  
 
Risks:  Some of the questions may embarrass your child or make him or her feel uncomfortable. If they 
feel uncomfortable with any questions they are asked, they may refuse to answer them. 
 
What about my child’s confidentiality? 
Your child is being asked to take part in a group discussion. We cannot promise that others in the group 
will not share what he or she says with others. He or she shouldn’t say anything in the discussion group 
that he or she would not want others outside the group to hear.  
 
Your child’s information will be kept private. All information will be stored safely on a computer 
protected by passwords. No one will be able to trace their answers to your child.  
 
This consent form will be kept in a safe locked cabinet. We will use a study number in place of your 
child’s name on all study forms. Your child’s name will never be shared with others. Your child’s name 
will never be used for analysis.  
 
Does my child have to participate? What will happen if we change our minds? 
 
You can choose for your child to not be in this study. Your child can choose not to be in the study. If you 
and your child agree for him or her to be in the study, he or she can still refuse to answer any question. 
You or your child can stop their participation in the study at any time. Nothing bad will happen to you or 
your child if they refuse to answer questions or want to stop taking part in the study.  
 
Disclosure of Child Sexual Abuse and Neglect 
Page 108 of 127 
 

 
Your child’s privacy is very important to us, but so are his/her health and safety. In cases where abuse, 
neglect or the desire to harm themselves or others is suspected or disclosed during the study, our staff 
are required to report this information. 
 
What if I have questions?  
You or your child can ask any questions you have at any time. If you or your child have any questions 
about the study now or later, you may contact: 
 
Name:  Dr. Victor Mudhune, Principal Investigator, KEMRI 
Email: vmudhune@kemricdc.org  
 
 
 
Phone: 0722-687430 
 
If you have any questions about your child’s rights as a research participant, or have concerns or 
complaints, or if you feel your child has been harmed by taking part in this study, please contact: the 
secretary, KEMRI Ethical Review Committee, (P. O. Box 54840-00200, Nairobi) at telephone 020-
2722541 or cell phone 0722205901 or 0733400003. 
Or 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 22923/24 
Or  
Name:  Emory University Institutional Review Board 
Email: irb@emory.edu  
Phone: +1 404 712 0720 
 
The above numbers are not for emergencies. If you or your child are having an emergency, please go to 
the nearest clinic/place you can get help.  
 
Do you have any questions? 
 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the study 
and what will happen in the study. I understand the risks and benefits for my child. I have been given the 
opportunity to consider my decision and have had all my questions answered. I understand that: 
 
1) I can choose to allow my child to join this study or not. It is up to me. 
2) My child can choose to join the study or not. It is up to him or her. 
3) Even if I agree, my child does not have to participate in the study if he/she does not want to. 
4) If I refuse or my child chooses not to join the study, no one will be upset with me or my child as a 
result. 
5) I can decide to stop my child from being in this study at any time.  
6) My child can stop being in the study at any time. 
 
Consent 
By signing this document, I agree to take part in this study as explained in this assent form. 
 
               
Date 
 
 
 
 
     Signature of Adult 
Page 109 of 127 
 

 
 
 
 
 
 
 
 
 
     Printed Name of Adult 
 
 
 
Date 
 
 
 
 
      Signature of Project Staff 
 
 
 
   
 
 
 
 
      Printed Name of Project Staff 
 
Page 110 of 127 
 

 
Appendix 26: Assent Followup (Adolescents)= English 
 
Emory University 
Assent to be a Research Subject 
 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Introduction  
You are being invited to take part in a research study conducted by Emory University in Atlanta and the 
Kenya Medical Research Institute (KEMRI). The study will help us develop a new way for children to 
learn about HIV using a game on a mobile phone.  We have recruited 162 people for this study (108 
young people, and 54 of their parents) and are recruiting an additional 45 people. 
 
You only have to take part in the study if you want to. The purpose of this form is to help you decide if 
you want to be in the study. If you do not wish to be in the study, you do not have to. If you join the 
study and then change your mind, it is okay for you to leave the study. No one will be upset with you.  
 
This form may contain words that you do not understand. Please ask the study staff to explain any word 
or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
 
The research team wants to develop a new way for children to learn about HIV using a game on a 
mobile phone. Young people participated in a study in which they were invited to play a game on a 
mobile phone for 10 hours over a 2-3 week period. One of the families involved in this study has 
suggested that you had some experience with this study. We would like to know more about any 
experience you had with the game, and to ask your advice about future games we may develop, even if 
you have not played.  
 
What will happen if I take part in this study? 
If you agree to be in the study, here is what may happen:   
 
Focus Group Discussion: We may ask you to take part in a group discussion to tell us about any 
experience you had playing the game, and your suggestions on what other topics and stories this kind of 
game could be about. The group discussion will be recorded to make sure we do not miss anything that 
participants say. The group discussion will last about 60 minutes. 
 
In-Depth Interview: We may ask you to take part in a one-on-one interview to tell us about your 
experience playing the game, and your suggestions on what other topics and stories this game could be 
about. The interview will be recorded to make sure we do not miss anything you say. It will last about 60 
minutes. 
Page 111 of 127 
 

 
 
Game Play: We may ask you to play an updated version of the game and to give your feedback about 
the changes that have been made since last year during a focus group dicussion. The discussion will last 
no more than 2 hours. 
 
Cognitive Interview/Discussion: We may ask you to read questions we plan to ask children who play the 
game in the future. This interview or discussion will last no more than 1 hour. 
 
Survey Pilot: We may ask you to answer the questions we plan to ask children who play the game in the 
future so we can test the questions. This will last no more than 1 hour. 
 
Survey: We will ask you to answer a few questions about how you share information with others and 
who you share information with. This survey will take you no more than 15 minutes. 
 
What are the good (benefits) and bad (risks) things that could happen to me if I agree to be in the 
study? 
Benefits:  You will not receive direct benefit by taking part. However, when you take part, you are 
helping us to learn how we can make the game as valuable as possible for children and their parents. 
You will not be offered payment for being in this study.  
 
Risks:  Some of the questions may embarrass you or make you feel uncomfortable. If you feel 
uncomfortable with any questions you are asked, you may refuse to answer them. 
 
 
What about my confidentiality? 
You are being asked to take part in a group discussion. We cannot promise that others in the group will 
not share what you say with others. You shouldn’t say anything in the discussion group that you would 
not want others outside the group to hear.  
 
Your information will be kept private. All information will be stored safely on a computer protected by 
passwords. No one will be able to trace your answers to you.  
 
This consent form will be kept in a safe locked cabinet. We will use a study number in place of your 
name on all study forms. Your name will never be shared with others. Your name will never be used for 
analysis.  
 
What if I have questions?  
You can ask any questions you have at any time. If you have any questions about the study now or later, 
you may contact: 
 
Name:  Dr. Victor Mudhune, Principal Investigator, KEMRI 
Email: VMudhune@kemricdc.org  
 
 
 
Phone: 0722-687430 
 
If you have any questions about your rights as a research participant, or have concerns or complaints, or 
if you feel you have been harmed by taking part in this study, please contact: the secretary, KEMRI 
Ethical Review Committee, (P. O. Box 54840-00200, Nairobi) at telephone 020-2722541 or cell phone 
0722205901 or 0733400003. 
Page 112 of 127 
 

 
Or 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 22923/24 
Or  
Name:  Emory University Institutional Review Board 
Email: irb@emory.edu  
Phone: +1 404 712 0720 
 
The above numbers are not for emergencies. If you are having an emergency, please go to the nearest 
clinic/place you can get help.  
 
Do you have any questions? 
 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the study 
and what will happen in the study. I understand the risks and benefits for me. I have been given the 
opportunity to consider my decision and have had all my questions answered. I understand that: 
 
1) I can choose to join this study or not. It is up to me. 
2) My parent/ caregiver must also agree for me to participate in the study. I cannot participate in the 
study if my parent/caregiver does not agree. 
3) Even if my parent/caregiver agrees. I do not have to participate in the study if I do not want to. 
4) If I refuse to join the study, no one will be upset with me. 
5) I can decide to stop being in this study at any time.  
6) My parent/ guardian can choose for me to stop being in the study at any time. 
7) I can refuse to answer any questions I choose.  
 
Consent 
By signing this document, I agree to take part in this study as explained in this assent form. 
 
 
               
Date 
 
 
 
 
     Signature of 15-17 year old subject 
 
 
Date 
 
 
 
 
      Signature of person soliciting assent of 15-17 year old 
subject 
 
Page 113 of 127 
 

 
Appendix 27: Parental Consent Followup (Adolescent) - English 
 
Emory University 
Consent to be a Research Subject 
 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Introduction  
Your child is being invited to take part in a research study conducted by Emory University in Atlanta and 
the Kenya Medical Research Institute (KEMRI). The study will help us develop a new way for children to 
learn about HIV using a game on a mobile phone.  We have recruited 162 people for this study (108 
young people, and 54 of their parents) and are recruiting an additional 45 people. 
 
The purpose of this form is to help you decide if you want allow your child to be in the study. Your child 
can only take part in the study if you agree. Your child will also be asked if they want to take part in the 
study. Nothing bad will happen to you or your child if you or they say “no”.  
 
If you decide to allow your child to join the study and then you or your child change your mind, it is okay 
for him/her to leave the study. No one will be upset with you or your child.  
 
This form may contain words that you do not understand. Please ask the study staff to explain any word 
or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
 
The research team wants to develop a new way for children to learn about HIV using a game on a 
mobile phone. Young people participated in a study in which they were invited to play a game on a 
mobile phone for 10 hours over a 2-3 week period.  One of the families involved in the study has 
suggested that your child had some experience with the study. We would like your child to tell us about 
any experience he or she had with the game, and to give us advice about future games we may develop, 
even if he or she has not played.  
 
What will happen if your child takes part in this study? 
If both you and your child agree to be in the study, here is what will happen:   
 
Focus Group Discussion: We may ask your child to take part in a group discussion to tell us about any 
experience he or she had playing the game that was part of our study in April, and his or her suggestions 
on what other topics and stories this kind of game could be about. The group discussion will be recorded 
to make sure we do not miss anything that participants say. The group discussion will last about 60 
minutes. 
 
Page 114 of 127 
 

 
In-Depth Interview: We may ask your child to take part in a one-on-one interview to tell us about any 
experience playing the game, and his or her suggestions on what other topics and stories this game 
could be about. The interview will be recorded to make sure we do not miss anything you say. It will last 
about 60 minutes. 
 
Cognitive Interview/ Discussion: We may ask your child to read questions we plan to ask children who 
play the game in the future. This interview or discussion will last no more than 1 hour. 
 
Game Play: We may ask your child to play an updated version of the game and to give his or her 
feedback about the changes that have been made since last year during a focus group discussion. The 
discussion will last no more than 2 hours. 
 
Survey Pilot: We may ask your child to answer the questions we plan to ask children who play the game 
in the future so we can test the questions. This will last no more than 1 hour. 
 
Survey: We will ask your child to answer a few questions about how he or she shares information with 
others and who he or she shares information with. This survey will take no more than 15 minutes. 
 
What are the good (benefits) and bad (risks) things that could happen to me if I agree to be in the 
study? 
Benefits:  Your child will not receive direct benefit by taking part. However, when your child takes part, 
he or she is helping us to learn how we can make the game as valuable as possible for children of their 
age. You will not be offered payment for being in this study.  
 
Risks:  Some of the questions may embarrass your child or make him or her feel uncomfortable. If they 
feel uncomfortable with any questions they are asked, they may refuse to answer them. 
 
What about my child’s confidentiality? 
Your child is being asked to take part in a group discussion. We cannot promise that others in the group 
will not share what he or she says with others. He or she shouldn’t say anything in the discussion group 
that he or she would not want others outside the group to hear.  
 
Your child’s information will be kept private. All information will be stored safely on a computer 
protected by passwords. No one will be able to trace their answers to your child.  
 
This consent form will be kept in a safe locked cabinet. We will use a study number in place of your 
child’s name on all study forms. Your child’s name will never be shared with others. Your child’s name 
will never be used for analysis.  
 
Does my child have to participate? What will happen if we change our minds? 
 
You can choose for your child to not be in this study. Your child can choose not to be in the study. If you 
and your child agree for him or her to be in the study, he or she can still refuse to answer any question. 
You or your child can stop their participation in the study at any time. Nothing bad will happen to you or 
your child if they refuse to answer questions or want to stop taking part in the study.  
 
Disclosure of Child Sexual Abuse and Neglect 
Page 115 of 127 
 

 
Your child’s privacy is very important to us, but so are his/her health and safety. In cases where abuse, 
neglect or the desire to harm themselves or others is suspected or disclosed during the study, our staff 
are required to report this information. 
 
What if I have questions?  
You or your child can ask any questions you have at any time. If you or your child have any questions 
about the study now or later, you may contact: 
 
Name:  Dr. Victor Mudhune, Principal Investigator, KEMRI 
Email: vmudhune@kemricdc.org  
 
 
 
Phone: 0722-687430 
 
If you have any questions about your child’s rights as a research participant, or have concerns or 
complaints, or if you feel your child has been harmed by taking part in this study, please contact: the 
secretary, KEMRI Ethical Review Committee, (P. O. Box 54840-00200, Nairobi) at telephone 020-
2722541 or cell phone 0722205901 or 0733400003. 
Or 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 22923/24 
Or  
Name:  Emory University Institutional Review Board 
Email: irb@emory.edu  
Phone: +1 404 712 0720 
 
The above numbers are not for emergencies. If you or your child are having an emergency, please go to 
the nearest clinic/place you can get help.  
 
Do you have any questions? 
 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the study 
and what will happen in the study. I understand the risks and benefits for my child. I have been given the 
opportunity to consider my decision and have had all my questions answered. I understand that: 
 
7) I can choose to allow my child to join this study or not. It is up to me. 
8) My child can choose to join the study or not. It is up to him or her. 
9) Even if I agree, my child does not have to participate in the study if he/she does not want to. 
10) If I refuse or my child chooses not to join the study, no one will be upset with me or my child 
as a result. 
11) I can decide to stop my child from being in this study at any time.  
12) My child can stop being in the study at any time. 
 
Consent 
By signing this document, I agree to take part in this study as explained in this assent form. 
 
               
Date 
 
 
 
 
     Signature of Adult 
Page 116 of 127 
 

 
 
 
 
 
 
 
 
 
     Printed Name of Adult 
 
 
 
Date 
 
 
 
 
      Signature of Project Staff 
 
 
 
   
 
 
 
 
      Printed Name of Project Staff 
 
Page 117 of 127 
 

 
Appendix 28: Parent Consent Self Additional Evaluation - English 
 
Consent to be a Research Subject 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Introduction  
You and your child were invited to take part in a research study conducted by Emory University in 
Atlanta and the Kenya Medical Research Institute (KEMRI) last year. The study is helping us develop a 
new way for children to learn about HIV using a game on a mobile phone.  We recruited a total of 162 
people for this study and are recruiting an additional 45 people. 
 
You only have to take part in the study if you want to. The purpose of this form is to help you decide if 
you want to be in the study. If you do not wish to be in the study, you do not have to. If you join the 
study and then change your mind, it is okay for you to leave the study. No one will be upset with you.  
 
This form may contain words that you do not understand. Please ask the study staff to explain any word 
or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
 
The research team wants to develop a new way for children to learn about HIV using a game on a 
mobile phone. Your child is participating or has participated in a study in which he or she may have been 
invited to play a game on a mobile phone for 10 hours over a 2-3 week period. We would like you to tell 
us more about your experience with this study and your recommendations for future games we may 
develop for children and their parents. 
 
What will happen if I take part in this study? 
If you agree to be in the study, here is what will happen:   
 
Focus Group Discussion: After children played the game and returned the phones, we asked you to tell 
us about your experiences as the parent of a child taking part in this study. For this stage of the study, 
we are asking you to take part in another group discussion to provide additional information about your 
experience and to share your ideas on future games we may develop for children and their parents. The 
group discussion will be recorded to make sure we do not miss anything that participants say. The group 
discussion will last about 90 minutes. 
 
In-Depth Interview: We may ask you to take part in a one-on-one interview to tell us about your 
experiences with your children playing the game, and your recommendations for future games for 
parents and children. The interview will be recorded to make sure we do not miss anything you say. It 
will last about 60 minutes. 
 
Page 118 of 127 
 

 
Cognitive Interview/ Discussion: We may ask you to read questions we plan to ask parents who play 
games or whose children play the games in the future. This interview or discussion will last no more 
than 1 hour. 
 
Survey Pilot: We may ask you to answer the questions we plan to ask parents who play games or whose 
children play the games in the future so we can test the questions. This will last no more than 1 hour. 
 
 
What are the good (benefits) and bad (risks) things that could happen to me if I agree to be in the 
study? 
 
Benefits:  You will not receive direct benefit by taking part. However, when you take part, you are 
helping us to learn how we can make games as valuable as possible for children and their parents. You 
will not be offered payment for being in this study. You will not be offered payment for being in this 
study. However, you will be reimbursed Kshs 500 for your time and transport costs and refreshments 
provided as per standard requirements during FGDs. 
 
Risks:  Some of the questions may embarrass you or make you feel uncomfortable. If you feel 
uncomfortable with any questions you are asked, you may refuse to answer them. 
 
What about my confidentiality? 
You are being asked to take part in a group discussion. We cannot promise that others in the group will 
not share what you say with others. You shouldn’t say anything in the discussion group that you would 
not want others outside the group to hear.  
 
Your information will be kept private. All information will be stored safely on a computer protected by 
passwords. No one will be able to trace your answers to you.  
 
This consent form will be kept in a safe locked cabinet. We will use a study number in place of your 
name on all study forms. Your name will never be shared with others. Your name will never be used for 
analysis.  
 
What if I have questions?  
You can ask any questions you have at any time. If you have any questions about the study now or later, 
you may contact: 
 
Name:  Dr. Victor Mudhune, Principal Investigator, KEMRI 
Email: VMudhune@kemricdc.org  
 
 
 
Phone: 057 2022929/02 
 
If you have any questions about your rights as a research participant, or have concerns or complaints, or 
if you feel you have been harmed by taking part in this study, please contact: the secretary, KEMRI 
Scientific and Ethics Review Unit (SERU), (P. O. Box 54840-00200, Nairobi) at telephone 020-2722541 or 
cell phone 0722205901 or 0733400003. 
Or 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 2022929/02 
Or  
Page 119 of 127 
 

 
Name:  Emory University Institutional Review Board 
Email: irb@emory.edu  
Phone: +1 404 712 0720 
 
The above numbers are not for emergencies. If you are having an emergency, please go to the nearest 
clinic/place you can get help.  
 
Do you have any questions? 
 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the study 
and what will happen in the study. I understand the risks and benefits for me. I have been given the 
opportunity to consider my decision and have had all my questions answered. I understand that: 
 
5) I can choose to join this study or not. It is up to me. 
6) If I refuse to join the study, no one will be upset with me or my child. 
7) I can decide to stop being in this study at any time.  
8) I can refuse to answer any questions I choose.  
 
Consent 
By signing this document, I agree to take part in this study as explained in this assent form. 
 
               
Date 
 
 
 
 
     Signature of Adult 
 
 
 
 
 
 
 
 
     Printed Name of Adult 
 
 
 
Date 
 
 
 
 
      Signature of Project Staff 
 
 
 
   
 
 
 
 
      Printed Name of Project Staff 
Page 120 of 127 
 

 
Appendix 29: Consent Followup Activities (Sibling) - English 
 
Emory University 
Consent to be a Research Subject 
 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Introduction  
You are invited to take part in a research study conducted by Emory University in Atlanta and the Kenya 
Medical Research Institute (KEMRI). The study will help us develop a new way for young people to learn 
about HIV using a game on a smartphone.  We have recruited 174 people for this study (120 young 
people, and 54 of their parents) and are recruiting an additional 63 people. 
 
The purpose of this form is to help you decide if you want to be in the study. Nothing bad will happen to 
you if you say “no”. If you decide to join the study and then you change your mind, it is okay for you to 
leave the study. No one will be upset with you.  
 
This form may contain words that you do not understand. Please ask the study staff to explain any word 
or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
 
The research team wants to develop a new way for children to learn about HIV using a game on a 
smartphone. Your younger brother or sister participated in a study in which he or she was invited to play 
a game on a smartphone for 10 hours over a 2-3 week period. You may also have played this game while 
your brother or sister was in the study. We would like you to tell us about your experience with this 
game, and to give us advice about future games we may develop, even if you have not played.  
 
What will happen if you takes part in this study? 
If you agree to be in the study, here is what will happen:   
 
Focus Group Discussion: We may ask you to take part in a group discussion to tell us about any 
experience you had playing the game, and your suggestions on what other topics and stories this kind of 
game could be about. The group discussion will be recorded to make sure we do not miss anything that 
you say. The group discussion will last about 60 minutes. 
 
In-Depth Interview: We may ask you to take part in a one-on-one interview to tell us about any 
experience you had playing the game, and your suggestions on what other topics and stories this game 
could be about. The interview will be recorded to make sure we do not miss anything you say. It will last 
about 60 minutes. 
 
Page 121 of 127 
 

 
Cognitive Interview/ Discussion: We may ask you to read questions we plan to ask young people who 
play the game in the future. This interview or discussion will last no more than 1 hour. 
 
Game Play: We may ask you to play an updated version of the game and to give your feedback about 
the changes that have been made in a focus group discussion. The discussion will last no more than 2 
hours. 
 
Survey Pilot: We may ask you to answer the questions we plan to ask young people who play the game 
in the future so we can test the questions. This will last no more than 1 hour. 
 
Survey: We will ask you to answer a few questions about how you share information with others and 
who you share information with. This survey will take no more than 15 minutes. 
 
What are the good (benefits) and bad (risks) things that could happen to me if I agree to be in the 
study? 
Benefits:  You will not receive direct benefit by taking part. However, when you take part, you are 
helping us to learn how we can make the game as valuable as possible for young people and their 
parents. You will not be offered payment for being in this study.  
 
Risks:  Some of the questions may embarrass you or make you feel uncomfortable. If you feel 
uncomfortable with any questions you are asked, you may refuse to answer them. 
 
What about my confidentiality? 
You may be asked to take part in a group discussion. We cannot promise that others in the group will 
not share what you say with others. You shouldn’t say anything in the discussion group that you would 
not want others outside the group to hear.  
 
Your information will be kept private. All information will be stored safely on a computer protected by 
passwords. No one will be able to trace your answers to you.  
 
This consent form will be kept in a safe locked cabinet. We will use a study number in place of your 
name on all study forms. Your name will never be shared with others. Your name will never be used for 
analysis.  
 
Do I have to participate? What will happen if I change my mind? 
 
You can choose to not be in this study. If you agree to be in the study, you can still refuse to answer any 
question. You can stop your participation in the study at any time. Nothing bad will happen to you if you 
refuse to answer questions or want to stop taking part in the study.  
 
Disclosure of Child Sexual Abuse and Neglect 
Your privacy is very important to us, but so is your health and safety. In cases where abuse, neglect or 
the desire to harm yourself or others is suspected or disclosed during the study, our staff are required to 
report this information. 
 
What if I have questions?  
You can ask any questions you have at any time. If you have any questions about the study now or later, 
you may contact: 
 
Page 122 of 127 
 

 
Name:  Dr. Victor Mudhune, Principal Investigator, KEMRI 
Email: vmudhune@kemricdc.org  
 
 
 
Phone: 0722-687430 
 
If you have any questions about your rights as a research participant, or have concerns or complaints, or 
if you feel you have been harmed by taking part in this study, please contact: the secretary, KEMRI 
Ethical Review Committee, (P. O. Box 54840-00200, Nairobi) at telephone 020-2722541 or cell phone 
0722205901 or 0733400003. 
Or 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 22923/24 
Or  
Name:  Emory University Institutional Review Board 
Email: irb@emory.edu  
Phone: +1 404 712 0720 
 
The above numbers are not for emergencies. If you are having an emergency, please go to the nearest 
clinic/place you can get help.  
 
Do you have any questions? 
 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the study 
and what will happen in the study. I understand the risks and benefits for myself. I have been given the 
opportunity to consider my decision and have had all my questions answered. I understand that: 
 
1) I can choose to join this study or not. It is up to me. 
2) If I refuse to join the study, no one will be upset with me as a result. 
3) I can decide to stop being in this study at any time.  
4) I can refuse to answer any questions I choose. 
 
Consent 
By signing this document, I agree to take part in this study as explained in this assent form. 
 
               
Date 
 
 
 
 
     Signature of Adult 
 
 
 
 
 
 
 
 
     Printed Name of Adult 
 
 
 
Date 
 
 
 
 
      Signature of Project Staff 
 
 
   
 
 
 
 
      Printed Name of Project Staff 
Page 123 of 127 
 

 
Appendix 30: Consent Followup Activities (Other Adolescents) - English 
 
Emory University 
Consent to be a Research Subject 
 
 
Title: A Mobile Phone Game to Prevent HIV among Young Africans 
 
Principal Investigators:  
Kate Winskell, PhD, Rollins School of Public Health 
Victor Mudhune, MBA MPH, KEMRI Center for Global Health Research 
 
Funding Source: U.S. National Institute of Mental Health 
 
Introduction  
You are invited to take part in a research study conducted by Emory University in Atlanta and the Kenya 
Medical Research Institute (KEMRI). The study will help us develop a new way for young people to learn 
about HIV using a game on a smartphone.  We have recruited 174 people for this study (120 young 
people, and 54 of their parents) and are recruiting an additional 63 people. 
 
The purpose of this form is to help you decide if you want to be in the study. Nothing bad will happen to 
you if you say “no”. If you decide to join the study and then you change your mind, it is okay for you to 
leave the study. No one will be upset with you.  
 
This form may contain words that you do not understand. Please ask the study staff to explain any word 
or information that is not clear to you. You can ask questions at any time. 
 
Why are we doing this research? 
 
The research team wants to develop a new way for children to learn about HIV using a game on a 
smartphone. Young people participated in a study in which they were invited to play a game on a 
smartphone for 10 hours over a 2-3 week period. One of the families involved in this study has 
suggested that you had some experience with the study. We would like to know more about any 
experience you had with the game, and to ask your advice about future games we may develop, even if 
you have not played.  
 
What will happen if you takes part in this study? 
If you agree to be in the study, here is what will happen:   
 
Focus Group Discussion: We may ask you to take part in a group discussion to tell us about any 
experience you had playing the game, and your suggestions on what other topics and stories this kind of 
game could be about. The group discussion will be recorded to make sure we do not miss anything that 
you say. The group discussion will last about 60 minutes. 
 
In-Depth Interview: We may ask you to take part in a one-on-one interview to tell us about any 
experience you had playing the game, and your suggestions on what other topics and stories this game 
could be about. The interview will be recorded to make sure we do not miss anything you say. It will last 
about 60 minutes. 
Page 124 of 127 
 

 
 
Cognitive Interview/ Discussion: We may ask you to read questions we plan to ask young people who 
play the game in the future. This interview or discussion will last no more than 1 hour. 
 
Game Play: We may ask you to play an updated version of the game and to give your feedback about 
the changes that have been made in a focus group discussion. The discussion will last no more than 2 
hours. 
 
Survey Pilot: We may ask you to answer the questions we plan to ask young people who play the game 
in the future so we can test the questions. This will last no more than 1 hour. 
 
Survey: We will ask you to answer a few questions about how you share information with others and 
who you share information with. This survey will take no more than 15 minutes. 
 
What are the good (benefits) and bad (risks) things that could happen to me if I agree to be in the 
study? 
Benefits:  You will not receive direct benefit by taking part. However, when you take part, you are 
helping us to learn how we can make the game as valuable as possible for young people and their 
parents. You will not be offered payment for being in this study.  
 
Risks:  Some of the questions may embarrass you or make you feel uncomfortable. If you feel 
uncomfortable with any questions you are asked, you may refuse to answer them. 
 
What about my confidentiality? 
You may be asked to take part in a group discussion. We cannot promise that others in the group will 
not share what you say with others. You shouldn’t say anything in the discussion group that you would 
not want others outside the group to hear.  
 
Your information will be kept private. All information will be stored safely on a computer protected by 
passwords. No one will be able to trace your answers to you.  
 
This consent form will be kept in a safe locked cabinet. We will use a study number in place of your 
name on all study forms. Your name will never be shared with others. Your name will never be used for 
analysis.  
 
Do I have to participate? What will happen if I change my mind? 
 
You can choose to not be in this study. If you agree to be in the study, you can still refuse to answer any 
question. You can stop your participation in the study at any time. Nothing bad will happen to you if you 
refuse to answer questions or want to stop taking part in the study.  
 
Disclosure of Child Sexual Abuse and Neglect 
Your privacy is very important to us, but so is your health and safety. In cases where abuse, neglect or 
the desire to harm yourself or others is suspected or disclosed during the study, our staff are required to 
report this information. 
 
What if I have questions?  
You can ask any questions you have at any time. If you have any questions about the study now or later, 
you may contact: 
Page 125 of 127 
 

 
 
Name:  Dr. Victor Mudhune, Principal Investigator, KEMRI 
Email: vmudhune@kemricdc.org  
 
 
 
Phone: 0722-687430 
 
If you have any questions about your rights as a research participant, or have concerns or complaints, or 
if you feel you have been harmed by taking part in this study, please contact: the secretary, KEMRI 
Ethical Review Committee, (P. O. Box 54840-00200, Nairobi) at telephone 020-2722541 or cell phone 
0722205901 or 0733400003. 
Or 
Name: Dr. Stephen Munga, Center Director, KEMRI, Center for Global Health Research 
Email: SMunga@kemri.org 
Phone: 057 22923/24 
Or  
Name:  Emory University Institutional Review Board 
Email: irb@emory.edu  
Phone: +1 404 712 0720 
 
The above numbers are not for emergencies. If you are having an emergency, please go to the nearest 
clinic/place you can get help.  
 
Do you have any questions? 
 
Statement of Permission 
I have read (or have been explained) and understand this form. I understand the reason for the study 
and what will happen in the study. I understand the risks and benefits for myself. I have been given the 
opportunity to consider my decision and have had all my questions answered. I understand that: 
 
13) I can choose to join this study or not. It is up to me. 
14) If I refuse to join the study, no one will be upset with me as a result. 
15) I can decide to stop being in this study at any time.  
16) I can refuse to answer any questions I choose. 
 
Consent 
By signing this document, I agree to take part in this study as explained in this assent form. 
 
               
Date 
 
 
 
 
     Signature of Adult 
 
 
 
 
 
 
 
 
     Printed Name of Adult 
 
 
Date 
 
 
 
 
      Signature of Project Staff 
 
 
   
 
 
 
 
      Printed Name of Project Staff 
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Appendix 31 and Appendix 32 redacted 
 
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