Mobile Behavioral Ecological Momentary Assessment and Intervention in Rakai, Uganda: A Pilot Study
Phase: NA
Conditions: Ecological Momentary Assessment and Intervention
Sponsor: Johns Hopkins University

 
 
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Study Protocol:  
Mobile Behavioral Ecological Momentary Assessment and Intervention in Rakai, Uganda 
 
Protocol Date: 30th March 2015 
 
ClinicalTrials.gov Identifier: NCT04375423 

Date: March 30, 2015    
Principal Investigator: Larry W Chang, MD, MPH 
Application Number: IRB00065934 
 
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JHM IRB - eForm A – Protocol 
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Mobile Behavioral Ecological Momentary Assessment 
 and Intervention in Rakai, Uganda: A Pilot Study 
 
1. 
Abstract 
 
Ecological Momentary Assessment and Intervention (EMAI) is an emerging technique for 
gathering richer and more relevant data through repeated, longitudinal sampling of participants in their 
natural setting in order to deliver real-time interventions. Challenges with instilling healthy behaviors 
are well documented. These challenges are magnified in low and middle income countries (LMICs) 
where significant social and structural barriers to care often exist. The rapid emergence of mHealth 
(mobile technologies for health), including growing access to low-cost smartphones, now allows for 
unprecedented advancements in and novel research on mHealth applications in LMICs. We therefore 
propose a pilot EMAI study of health behavior in Rakai, Uganda.  
This study aims to demonstrate that it is feasible and acceptable to use smartphones in a LMIC to 
collect near real-time, geolocated behavioral information and to send tailored health messages based 
upon this data. This proposal will provide unique insights into the geospatial/temporal epidemiology of 
health behaviors, generate preliminary estimates of intervention impact, and establish an evidence-base 
for future large-scale, randomized EMAI mHealth trials. This study will be nested within the Rakai 
Health Sciences Program’s (RHSP) ongoing Rakai Community Cohort Study (RCCS).  
Our main study objective is to conduct a pilot EMAI study among current RCCS study 
participants. Participants will be given a smartphone with an application that will collect GPS-based 
geolocations and ask assessment questions (e.g. diet/alcohol, smoking, and sexual behaviors). Using 
participants’ responses, the application can deliver tailored intervention health messaging to 
participants using pre-programmed algorithms. During Days 1-30 of follow-up, all participants will 
receive assessment questions only to establish baseline behaviors. During Days 31-90, participants will 
be randomized to either continuing with assessment questions only (control arm) or to also begin 
receiving intervention messaging (intervention arm). The randomized design will allow for calculation 
of an estimate of EMAI effect on diet/alcohol, smoking, and sexual behaviors which will be used to 
design future, large-scale randomized controlled trials of EMAI.  
Secondary objectives of this study proposal are to assess processes, facilitators, and barriers to 
EMAI using a mixed methods (quantitative and qualitative) approach. Also, to assess EMAI validity 
and relevance, we will describe and compare EMAI-collected behavioral data with traditional 
questionnaire-collected data.  
Study hypotheses are as follows: EMAI can be successfully implemented in Uganda, and 
participants receiving intervention messaging will have improved self-reported health behaviors 
compared to controls; EMAI will be feasible and acceptable by this population; and, EMAI-
collected data will correlate with traditional questionnaire-collected data. 
This is the first study to our knowledge of EMAI in sub-Saharan Africa. If this novel data 
collection and intervention method is proven to be robust, feasible and acceptable, it could serve as an 
innovative platform for the future delivery of real-time, tailored, geolocated mHealth interventions, a 
potentially profound method for improving health. 
 

Date: March 30, 2015    
Principal Investigator: Larry W Chang, MD, MPH 
Application Number: IRB00065934 
 
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2. 
Objectives 
 
Primary Objective: To conduct a pilot EMAI study in Rakai, Uganda. 
 
Secondary Objective: To assess processes, facilitators, and barriers to EMAI. 
 
Secondary Objective: To compare EMAI-collected with traditional questionnaire-collected data. 
 
3. 
Background  
 
Smartphone-based mHealth is a potentially transformative technology in low and middle-
income countries (LMIC). The growth of mobile phones in LMIC has been remarkable.1 Initial 
mobile growth primarily began with “dumb” or feature phones, i.e. mobile devices with limited 
features and internet connectivity. These devices were rapidly leveraged for health care purposes as part 
of a “first wave” of applications based primarily on SMS (short message service) technology.2,3 Mobile 
infrastructure has progressively expanded in LMICs and more recently, smartphones have been steadily 
increasing in number with an estimated 19.8% penetration in 2013, up from 1.6% in 2008.4 With the 
increasing adoption of smartphones in LMICs, a “second wave” of mHealth innovation based upon 
networked, data-driven applications is possible.  
EMAI may outperform traditional methods of data collection and behavioral intervention. 
Ecological Momentary Assessment and Intervention (EMAI) is an emerging technique for gathering 
richer and more relevant data through repeated, longitudinal sampling of participants and intervening in 
real-time in their natural setting.5 Compared to traditional assessment of human behavior, e.g. 
questionnaires and interviews, Ecological Momentary Assessment (EMA) appears to reduce recall bias, 
improve validity by collecting data in the real world, and enable capture of dynamic processes over 
time,5 which has also been supported by our own studies which have collected reliable data on geo-
located, sensitive behaviors such as drug use, mood, alcohol intake, and sexual behaviors.6-8 Ecological 
Momentary Intervention (EMI) has benefits beyond traditional interventions by allowing for more 
temporally and spatially appropriate interventions, extending care beyond traditional health facilities 
and into the individual’s natural setting. Smartphones have revolutionized access to EMAI and provide 
a growing platform for health-related assessment and intervention in LMICs.   
A disease and prevention/treatment agnostic EMAI platform could be highly scalable. This 
study proposes to test a disease and prevention/treatment agnostic EMAI platform. We will test this 
platform by targeting three behavioral areas of high public health significance, i.e. smoking, 
diet/alcohol, and sexual activity, which contribute to smoking-related cancers, obesity, and HIV 
transmission. This agnostic platform could be adapted for most health care conditions, making it highly 
scalable and increasing potential impact. 
Preliminary studies. Our group has done extensive and pioneering work in mHealth (including 
EMAI), mixed methods research, and longitudinal surveillance of health behaviors. emocha-We have 
experience in the design, development, implementation, and evaluation of mHealth as founders of 
emocha,10-12 an mHealth software platform. We have conducted a number of EMAI studies 
domestically, including The EXposure Assessment in Current Time (EXACT) study (5U01DA023832; 
PI: Gregory Kirk) assessed drug use and psychosocial stress in injection drug users (IDUs) in urban 
Baltimore. We developed a EMA application for this study which was successfully implemented with 
excellent participant response and demonstrated validity.6,7 Another EMAI application developed by 

Date: March 30, 2015    
Principal Investigator: Larry W Chang, MD, MPH 
Application Number: IRB00065934 
 
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our group to assess HIV care engagement (clinic attendance and adherence), drug cravings, and 
psychosocial stress to improve retention in care and adherence to medications for out-of-care, HIV-
infected IDUs has also been successfully implemented (R34DA033181; PIs: Kirk, Westergaard). 
Finally, we have developed an EMA application to assess alcohol use and sexual behaviors in men who 
have sex with men in Baltimore which successfully recruited participants (P30AI094189; PI: Cui 
Yang). 
 
4. 
Study Procedures 
 
Primary Objective: To conduct a pilot EMAI study with smartphones in Rakai, Uganda. 
 
Study design. This pilot study will be nested within the Rakai Community Cohort Study (RCCS, 
WIRB #20031318), an ongoing, population-based, prospective, observational study which surveys 
Rakai District communities in Uganda every ~12-18 months. 
 
Study setting and population. Rakai District (~2200 km2) is a mostly rural district 
(population~400,000) in Uganda bordered by Tanzania and Lake Victoria. RHSP has been conducting 
community-based research in Rakai since 1988 including large, prospective health behavior studies.26 
RHSP survey results of demographic and behavioral characteristics are similar to those reported for 
southwestern Uganda in Demographic and Health Surveys,27 suggesting that despite long-term 
surveillance and health education, the population is typical of rural/semi-rural Uganda.28  
 
Rakai Community Cohort Study (RCCS): RHSP’s ongoing 54 community (n~20,000) longitudinal HIV 
surveillance study provides >20 years of data on HIV prevalence/incidence, health behaviors, sexual 
networks, and mobility/migration in Rakai District, Uganda.  
 
Eligibility. We will aim to recruit 120 total adults (age >=18 years) from current, literate RCCS study 
participants.29 We will purposely recruit a sample that has a broad range of participant characteristics in 
our study to optimize diversity of responses and increase study generalizability. Specific variables for 
which we will target sampling include: gender (~50% female), age (at least 20% among age groups 18-
25, 26-35, >50), and occupation (at least 20% traders and farmers). 
 
Recruitment. As part of a detailed written informed procedure, RCCS participants have consented to 
be contacted for future studies. We will enumerate a list of current RCCS participants with key 
demographics, and, as described above, we will purposively select participants meeting our study 
population composition goals. We will begin with recruitment via RCCS in locations where it is 
actively conducting its continual surveys of the Rakai community, asking participants as they undergo 
the RCCS survey if they would also like to participate in this nested study. If we are unable to 
conveniently obtain our desired sample via ongoing survey activities of RCCS, we will send trained 
staff to recruit RCCS participants from communities in which RCCS has recently conducted surveys. 
Eligible participants will be asked to complete a written informed consent procedure (see Section 8 
below) in order to enter this specific study. 
 
Participant-related Procedures. Participant training. After recruitment, participants will undergo a 
~30-60 minute training session. A brief training curriculum will be used consisting of basic phone use, 

Date: March 30, 2015    
Principal Investigator: Larry W Chang, MD, MPH 
Application Number: IRB00065934 
 
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contacting the study team, and detailed instruction on EMAI application use. Participants will be 
required to demonstrate proficiency with the EMAI interface prior to receiving a study smartphone. The 
first 48 hours after the participant has the phone will be a “run-in” period to allow for troubleshooting 
of device problems and to allow participants to become familiar with the EMAI application procedures.  
Follow-up (Days 1-30, Baseline Behaviors). After the run-in period, all participants will receive 
assessment questions only for a 30 day period in order to establish baseline behaviors. After completing 
this initial 30 day period, participants will be required to return to the study office to complete a short 
questionnaire (see Aim 3) and to be randomized to the second phase of follow-up.  
Follow-up (Days 31-90, Randomized Evaluation). After completing the Day 30 questionnaire, 
participants will be randomized using a computerized random number generator, in a 1:1 ratio, to either 
continue receiving assessment questions only (control arm) or to also begin receiving intervention 
messages (intervention arm). After reaching 60 and 90 days of follow-up, participants will return to the 
study office to complete a brief questionnaire on behaviors and experiences with the phone. After 90 
days of follow-up participants will also return their phones to study staff. 
Logistics. Phones will be preloaded with airtime. If additional airtime is needed, participants can 
“beep” (call and hang up, no cost to caller) study staff to transfer airtime to phones using locally 
available services.  
Smartphone loss/theft. Installed software will allow for GPS-locating of lost/stolen phones and 
can remotely wipe data on phones as needed. Participants will be notified that they will not be eligible 
for their incentives if they lose or have their phones stolen. These participants will remain in all study 
analyses (intention-to-treat) but will not receive a second phone.  
Smartphone malfunction. Participants will be asked to communicate with study staff either in-
person or remotely should their smartphone malfunction. Malfunctioning phones will be returned to 
study staff if necessary. IT support will be available to troubleshoot phones during regular business 
hours throughout the study. Study staff will record all instances of malfunctioning phones as part of 
process evaluations.          
 
EMAI Application. The EMAI application for this study will be programmed following user centered 
design principles on the emocha platform.30  
Prompts. The EMAI application will send prompts (audible alert and text message asking them 
to complete a specific form,  no specific health information revealed in prompts) to participants at 3 
times: daily, random, weekly. Daily prompts will occur once a day at a scheduled time, a random 
prompt occurs once a day at an unscheduled time, and a weekly prompt occurs once a week at a 
scheduled time. The diversity of prompts allows for a range of response patterns.5 Participants will be 
allowed to respond to read form and respond to prompts only after entering a password.  
Event-contingent reporting. In addition to prompts, participants will also be able to report 
behaviors on an event-contingent basis, i.e. within an hour after they engage in a specific behavior. A 
password will again be required to input data. 
Data collection forms. The EMAI application will automatically launch the appropriate 
password-protected forms with each prompt, or they can be launched by the participant for event-
contingent reporting. Forms will be completed using touchscreen input. Simple yes/no and multiple-
choice check list questions will be used. Forms are designed to be typically completed in <1 minute. 
Specific form content is shown in Table 1.  
Geolocation. The EMAI application will automatically record participant geolocation via GPS 
approximately hourly and each time a form is completed.  

Date: March 30, 2015    
Principal Investigator: Larry W Chang, MD, MPH 
Application Number: IRB00065934 
 
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Data transfer. All participant-entered and geolocated data will be initially stored in encrypted 
format on the phones. When cellular network or WiFi coverage is detected by the application, the data 
will be synced to a server for study staff to monitor responses. Updates to forms and algorithms will be 
sent from the server to phones as needed.  
 
Table 1: EMA application sample questions. 
Forms 
Behavior Domains 
Questions 
Daily 
Smoking, 
Diet/Alcohol Use, 
Sexual Activity 
Did you smoke today/this week? (yes/no) If so, how many items 
did you smoke today? (#); Did you eat any vegetables today/this 
week? (yes/no); Did you use any alcohol today/this week? 
(yes/no); Did you have any sex with anyone who was not your 
marital or long-term partner today/this week? (yes/no) If so, did 
you use condoms? (yes/no) 
Random 
Weekly 
Event-
contingent 
Smoking, 
Diet/Alcohol Use, 
Sexual Activity 
Checklist Format: Within the past hour, I smoked, ate vegetables, 
drank alcohol and/or had sex with someone who was not my 
marital or long-term partner. 
 
In response to data entered by participants, the EMAI application will be programmed with 
algorithms to provide real-time feedback, i.e. EMI, through tailored health text messages. Only patients 
randomized to the EMI arm will receive these messages. We will use general health as well as behavior-
specific messaging. Examples are shown in Table 2. 
 
Table 2: Examples of EMI responses. 
EMA Data Collected 
EMI Response 
Any “negative” health behavior 
entered. 
“Today is a great day to start being healthy.” “You can make a 
difference in your health.” “You have people around you who care 
about you.” 
Did you eat any vegetables? NO 
“Eating a mixed diet (meats and vegetables) is a healthy way to 
go.” 
Participant enters a geolocation 
previously associated with smoking. 
“There are better things to spend money on than cigarettes.” 
“Smoking causes lung cancer.” 
 
Cultural Adaption, Language, and Literacy Formative Work. Prior to beginning formal 
recruitment, we will test the appropriateness of our questions and messaging in terms of cultural 
adaptation, clarity, and meeting literacy requirements. Specifically, we will use our initial list of 
proposed questions and messages and then ask potential participants (~10) in the study whether the 
questions and messaging are clear, acceptable, and correctly understood by them. We will then refine 
questions and messaging as needed.   
   
Secondary Objective: To assess processes, facilitators, and barriers to EMAI-These results will 
inform future EMAI implementation, scale-up, and sustainability questions. We will utilize a mixed 
methods (quantitative and qualitative) approach involving process indicator analyses, in-depth 
interviews (IDI), and focus group discussions (FGD).33  
 
Quantitative Methods and Analytic Plan for Process Measures. We will gather process data during 
EMAI implementation to include: EMA prompt response rate, form completion rates, out-of-network 
time, malfunctions, down time, and device retention. Process measures analyses will be exploratory in 
nature. We will use descriptive statistics, as well as explore associations with moderating/mediating 

Date: March 30, 2015    
Principal Investigator: Larry W Chang, MD, MPH 
Application Number: IRB00065934 
 
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factors  such as gender and age using Chi-square, Fisher’s exact test, and multivariate regression 
methods as appropriate.  
 
Qualitative Methods. Study Population. All participants will take part in IDIs (n=120) which will 
explore individual experiences with the EMAI application. IDIs will occur immediately after completion 
of the 90 day follow-up period. Smaller groups (6-8 each) will participate in 2 FGDs after Day 30 and 
Day 90 of the study (4 FGDs total, ~24-32 participants total) to create a more dynamic and interactive 
forum for additional insights. Data Collection. RHSP has an experienced Qualitative Research 
Department to help ensure high quality data collection.34-36 Semi-structured interview guides will be 
used for qualitative data collection with open-ended questions on EMAI processes, barriers, facilitators, 
confidentiality, satisfaction, challenges, suggestions for improvement, and perceived effect of EMI on 
behaviors. We will also explore issues regarding long-term adoption of this type of technology, gender-
specific considerations, and how EMAI is or is not integrated in relation to current everyday use of 
mobile phones in this setting. All IDIs and FGDs will be conducted in the participants’ preferred 
language and digitally recorded. Translation and transcription will be done in a single step by trained 
staff. Analytic Plan. Data will be entered into ATLAS.ti software (GmbH, Germany) to facilitate coding 
and analysis. Following an iterative approach, transcript review will begin while IDIs and FGDs are still 
underway and participant responses will be used to shape questions for future interviews. Initial line-by-
line coding will be completed on a sample of transcripts to develop a codebook, which will then be used 
to categorize responses into thematic categories. Quotes from coded transcripts will be triangulated with 
the original transcripts to ensure appropriate contextualization. The study team will meet and discuss 
identified themes and come to consensus on what modifications, if any, need to be incorporated into the 
EMAI application in future iterations. These modifications will be carefully documented.  
 
Secondary Objective: To compare EMAI-collected with traditional questionnaire-collected data-
We will describe and compare EMAI versus traditional questionnaire-collected data.  
 
Methods. All study participants will be administered a traditional paper-based questionnaire at the 
completion of the 30 day follow-up period and a similar questionnaire after the 60 and 90 day follow-up 
periods. This questionnaire will assess satisfaction and acceptability of the participant’s experience 
using EMAI. Additionally, the questionnaire will ask the same behavioral questions as the EMAI 
application, but ask participants to recall these behaviors over the past 30 days, e.g. over the past 30 
days, how many days did you drink alcohol? 
 
Analytic Plan. Responses to traditional questionnaire data will be compared with EMAI collected data 
using descriptive statistics such as percent agreement, Kappa statistic, scatter plot correlation graphs, 
mean within-pair differences, coefficient of variation, and Bland-Altman plots.37 Successful completion 
of this aim will generate important preliminary evidence on EMAI acceptability and reliability to 
support future NIH studies.  
 
Timeline for proposed study. 
Activity                                                   Study Month→ 
1-2 
3-4 
5-6 
6-7 
7-8 
9-10 11-12 13-14 15-16 17-18 19-20 21-22 23-24 
Formative work on messaging 
 
 
 
 
 
 
 
 
 
 
 
 
mHealth EMAI Software Programming and Testing 
 
 
 
 
 
 
 
 
 
 
 
 
 
EMAI Recruitment and Implementation (90 days total 
per participant, follow-up periods will be asynchronous)  
 
 
 
 
 
 
 
 
 
 
 
 
 
Mixed Methods Evaluations 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final Analyses and Dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 

Date: March 30, 2015    
Principal Investigator: Larry W Chang, MD, MPH 
Application Number: IRB00065934 
 
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Table 3: Power calculations. 
5. 
Inclusion/Exclusion Criteria-See above. 
 
6. 
Drugs/ Substances/ Devices-Not applicable. 
 
7. 
Study Statistics (for Primary Objective) 
 
Sample Size/Power Calculations. This is an exploratory study 
powered not to assess intervention efficacy but to provide preliminary 
estimates of effect. As an example, Table 3 shows power calculations 
for alcohol use based on different estimates of intervention impact. 
Prior data indicate that approximately 50% of the Rakai population uses 
alcohol on a weekly basis. If there is a 50% reduction in alcohol use 
following EMAI, the study will have 81.5% percent power to detect this 
difference.  
 
Change in health behaviors following EMAI. We hypothesize that EMAI results in improved health 
behaviors. We will use data on health behaviors obtained prior to the start of the randomized phase, 
Days 1-30, to characterize baseline behaviors for each participant. Changes in baseline behaviors will 
be assessed from 30-90 days relative to baseline in intervention and control arms. The relative change 
from baseline to follow-up (e.g. change in proportion of yes responses to daily alcohol use over Days 1-
30 compared to Days 31-90), will be compared between intervention and controls arms using mixed 
effects models. Temporal trends in behaviors in each arm over the entire 90 day period also will be 
identified and characterized. 
 
Mobility patterns and health outcomes. The extent to which individuals travel local and long 
distances is likely a significant predictor of health outcomes We will use EMAI data to characterize 
participants’ mobility patterns and the associations between these patterns and health behaviors in 
intervention and control arms.31 All GPS data will be cleaned using standardized methods,32 with 
emphasis on identification in coordinate outliers and missing coordinate data. Individuals in each arm 
will be classified into 3 groups based on their mobility data: low mobility (limited local movement), 
high local mobility (frequent local movement only), and high long distance mobility (frequent local and 
longer distance travel or long distance travel only). Spatial travel kernels at daily, weekly, and monthly 
intervals will be estimated using maximum likelihood methods and GPS data fit to various statistical 
distributions. The best fit spatial kernels will be used to determine the extent of local and longer 
distance movement and to establish cutoffs for the appropriate categorization of mobility patterns, 
where individuals’ primary residential location will serve as the anchor location from which distance of 
movements are measured. Mobility patterns will be correlated with participant demographics and self-
report of behaviors obtained via the EMAI using random effects regression models for binary and 
ordinal outcomes in intervention and control arms. Data on mobility patterns and their association with 
health outcomes will be informative to health behavior programs and for a wide variety of modelling 
studies on infectious disease transmission, including HIV.  
 
8. 
Risks 
 
% Reduction 
In Behavior 
Power 
20 
0.195 
30 
0.381 
40 
0.611 
50 
0.815 

Date: March 30, 2015    
Principal Investigator: Larry W Chang, MD, MPH 
Application Number: IRB00065934 
 
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Potential risks/harms. Risks from this study include the loss of confidentiality in reporting potentially 
sensitive health information. Having a smartphone in their possession may also make participant targets 
for theft or exploitation. All smartphones will require an unlocking password and will be inaccessible 
without that password. Each participant and project personnel will be allocated a password to 
authenticate correspondence and prevent unauthorized parties from accessing information or providing 
false information. The health advice participants receive through the EMAI application may not be 
accurate, relevant, and may cause unintended harm. There is also risk of embarrassment, personal 
discomfort, and sensitivity to discussing and answering questions related to sexual behaviors and other 
sensitive subjects. Subjects may also become fatigued from interviews and meetings. The likelihood of 
these risks is small based upon previous RHSP studies and experiences. 
 
Protection against risks. Recruitment and informed consent: Recruitment and informed consent: 
Participants provide written informed consent for RCCS, the parent study within which this study is 
nested. RCCS participants provide consent for recontact for other unspecified studies. Potential 
participants for this study will be approached by trained research staff. Staff will read, review, and 
discuss the study purpose, subject involvement, risks, potential benefits, and new consent forms 
specific to this study with potential subjects. All discussions and written material will be in the native 
language of the region (Luganda). All translations will be certified by a nationally recognized 
organization (Makerere University). If the participant agrees and is able to express a summary and 
understanding of the study, they will sign the consent form and be given a copy. Signed consent forms 
will be secured at the RHSP offices in Rakai. 
 
Protection of confidentiality: Research materials: Materials will include the interviews, consent forms, 
and mobile phone logs of all activity conducted through the mHealth application. In order to preserve 
confidentiality, informed consent documents – which by definition include the participant’s name - are 
retained in locked filing cabinets and secure store rooms, accessible only to senior investigators or 
designated staff. No personal identifiers will be attached to the questionnaire or samples. Electronic 
data sets and clinical readouts are downloaded into password protected computers, and individual 
identifiers are stripped. Names linked to study IDs are stored in a separate, password protected 
electronic file, on a computer and server accessible only to authorized senior personnel. All RHSP 
research staff  have received extensive human subjects/research ethics training, including the need for 
complete confidentiality. Participant entered EMAI data will be encrypted at all times, be it on the 
phone, with data transfer, or sitting on the server. The application and server access will be password 
protected. If a phone is lost or stolen, we will have the ability to remotely wipe the phone of all data 
and render it inoperable. All interviews will be conducted in private or, if appropriate, as a focus group. 
If a breach of confidentiality occurs, we will report to the appropriate IRBs according to NIH 
guidelines. The principal investigator will discuss any breaches of confidentiality and intervene as 
necessary to decrease the risk of future breaches. 
 
Avoidance of social harm: We will counsel participants on the need to be discrete with their 
smartphones to avoid risk of being targeted for theft or exploitation. We will attempt to use locally 
available smartphones to minimize the novelty of participants using these devices. We will teach 
participants to immediately contact study staff if they have any negative experiences and they will be 
able to return the phones and quit the study at any time. 
 

Date: March 30, 2015    
Principal Investigator: Larry W Chang, MD, MPH 
Application Number: IRB00065934 
 
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Protection from discomfort, embarrassment, and fatigue: To mitigate these concerns, the following 
procedures will be implemented: (i) Training of research staff will emphasize caring, non-judgmental, 
and non-threatening approaches to the questioning, counseling, and teaching of patients; (ii) Research 
staff will be trained to stop their tasks if the patient appears to be in distress and to contact higher-
trained staff if any distress is noted; (iii) Participants will be informed that they have the right to 
withdraw from the study at any time without any adverse consequences. 
 
Protection from unintended consequences: Participants may encounter a variety of complex and 
unanticipated situations in the field once they begin this pilot study. Study team members will be 
available at all times via mobile phone for any situations which may arise. Participants may be 
confused by health messaging or have unintended harm from health messaging this is incorrect or 
inappropriate. RHSP health facilities are and will continue to be available to all participants free of 
charge and participants will be instructed to seek the advice of a health provider should there be any 
confusion or health concern. Overall, the EMAI is more likely to provide benefit rather than unintended 
harm. Additionally, our current and published experiences with EMAI have not found significant 
instances of harm. 
 
mHealth-Specific Concerns: Special mention is made here regarding the ethical issues around EMAI, 
particularly the “tracking” aspects and use of geolocated data which will be linked to sensitive 
behaviors. In addition to full informed consent, the application, phones, and server will use rigorous 
security methods (passwords, encryption, remote data wiping, user controls, etc.) to help protect 
subjects. All geolocation data will be presented in anonymized and de-identified fashions (e.g. blurring 
specific locations to prevent identification). In the secondary objectives, we will specifically ask 
participants for their perspectives on the ethical issues of EMAI. 
 
Data and Safety Monitoring Plan 
The risks of this study are minimal compared to trials involving biomedical interventions or 
procedures. We have developed a data and safety monitoring plan in accordance with this lower level 
of risk. Primary responsibility for data and safety monitoring will be assumed by the principal 
investigator (Dr. Chang).  
 
Data risks and monitoring: The primary data risks are inadequate quality of data collection, 
unacceptable intervention acceptance rates, data security, and unintended harm of health messaging. To 
address these risks, the principal investigator will review data quality and intervention acceptance rates 
on a quarterly basis. If risks are realized, investigators will consider stopping the study and/or taking 
appropriate steps to improve study quality and ensure adequate power. Electronic data security will be 
maintained with password protected computers accessible only to relevant study staff. Transcribed data 
will be secured in designated locked facilities at RHSP. Any data risk will be reported in a timely 
fashion to the appropriate IRBs. Any possible harm reported by participants will be immediately 
addressed by the PI and study team and reported to appropriate IRBs. 
 
Safety risks and monitoring: The primary risks in this study are social harms related to loss of 
confidentiality and embarrassment and sensitivity related to discussions about sensitive topics such as 
health and sexual behaviors. To minimize these risks, we will perform informed consent and utilize a 
strong training curriculum that emphasizes strict confidentiality and protecting against inadvertent 

Date: March 30, 2015    
Principal Investigator: Larry W Chang, MD, MPH 
Application Number: IRB00065934 
 
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disclosure. Additionally, we will ensure that training emphasizes caring, non-judgmental, and non-
threatening approaches to the questioning, counseling, and teaching of participants. We will train study-
related personnel to stop their tasks if the participant appears to be in distress and to contact higher-
trained staff if distress is noted. Any breaches of confidentially will be considered an adverse event and 
immediately reported to the principal investigator. Should any adverse event occur which may be 
related to study activities, an adverse event form will be completed by study staff and the event 
immediately reported to the principal investigator. 
 
Adverse Events: Adverse events will be routinely monitored, collected, and reported by study staff and 
the principal investigator according to NIH guidelines. Staff will be trained to complete an adverse 
event form which will be filed and electronically sent to the principal investigator for review. The 
principal investigator will ensure that study staff are appropriately trained on adverse event reporting. 
Adverse events will be reported promptly to the appropriate IRBs. 
 
9. 
Benefits 
 
Probable benefits of the proposed research to participants and for society. Subjects in this study 
may benefit from positive health messaging which may modify their health behaviors in a beneficial 
direction. If this intervention is demonstrated to be beneficial, there are potential benefits to the larger 
society and public health arena. For these reasons, the potential benefits outweigh the relatively 
minimal risks of this study. 
 
Importance of knowledge to be gained. This is the first study to our knowledge of EMAI in sub-
Saharan Africa. If this novel data collection and intervention method is proven to be feasible and 
acceptable, it could serve as an innovative platform for the future delivery of real-time, tailored, 
geolocated mHealth interventions for any disease at any stage in the continuum of health care and 
prevention, a potentially profound method for improving health. 
 
10. 
Payment and Remuneration 
 
We will provide incentives, given after completing each questionnaire, to optimize response rates. 
Overall, compensation will be approximately $30 over 90 days, given in three separate increments after 
Days 30, 60, and 90. If a participant fails to complete at least 80% of the prompts, they will forfeit their 
compensation. 
 
Participants are also provided compensation for their participation in RHSP/RCCS activities and will 
receive this compensation per current RHSP/RCCS guidelines (currently a lump sum of about $4 for 
completing one survey round).  
 
11. 
Costs-Not applicable. 
 

Date: March 30, 2015    
Principal Investigator: Larry W Chang, MD, MPH 
Application Number: IRB00065934 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 12 of 12 
 
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