Do Smartphones Increase Linkage to and Retention in Care in Newly Diagnosed HIV-positive Patients in Johannesburg, South Africa: A Multisite Randomised Controlled Trial
Phase: NA
Conditions: HIV Infections, Viral Load, Patient Compliance, Antiretroviral Therapy, Cell Phone
Sponsor: World Bank

 
Study Protocol 
Do smartphones increase linkage to and retention in 
care in newly diagnosed HIV­positive patients in 
Johannesburg, South Africa: A multisite randomised 
controlled trial  
Short title: ​Smartphone Linkage to Care (SmartLtC) 
 
Research institution 
Wits Reproductive Health & HIV Institute (RHI) 
Corner of Esselen & Klein Streets 
Hillbrow, Johannesburg 
South Africa, 2001 
Represented by: Dr. Eugene Sickle (​esickle@wrhi.ac.za​) 
 
Supported by: 
The World Bank (contract: 7173708) 
1818 H Street, N.W. 
Washington, DC 20433 
USA 
Represented by: Ms Marelize Prestidge (mgorgens@worldbank.org) 
 
Investigators 
Jesse Coleman, MSc. RHI, Principal Investigator 
Lynsey Isherwood, MSc. NHLS, Investigator 
Vincent Lau Chan, MSc. RHI, Project Coordinator 
Francois Venter, MD. RHI, Technical Advisor 
Eugene Sickle, PhD. RHI, Technical Advisor 
Sergio Carmona, FCPath (Haem). NHLS, Technical Advisor 
 
Trial sites 
 
1 

Hillbrow Community Health Centre (Hillbrow CHC), Hillbrow Health Precinct, Johannesburg 
Helen Joseph Hospital, Perth Road, Rossmore, Johannesburg 
 
 
Protocol details 
Version: 1.3 
15 May, 2015 
(this protocol is reviewed regularly and updated as new/relevant mobile lab technology &
 
 
 
 
 
 
 
 
 
 
 
 
 
research is released. 
 
 
     
 
 
2 

Contents 
Full title 
Short title: Smartphone Linkage to Care (SmartLtC) 
Research institution 
Sponsor 
Investigators 
Trial sites 
Protocol details 
Contents 
List of abbreviations & definitions 
Rationale & background 
Study goals & objectives 
Study goal 
Primary objective 
Secondary objectives 
Study design 
Population 
Intervention 
Inclusion criteria 
Exclusion criteria 
Methodology 
Pre­recruitment 
Recruitment 
Cost­Effectiveness analysis 
Sample Size 
App specifications 
Patient follow­up 
Participant opt­out 
Safety considerations 
Data management & statistical analysis 
Data management 
Analysis plan 
Regulatory compliance 
Ethics 
Informed consent forms 
Expected outcomes 
Dissemination of results and publication policy 
Duration 
Problems anticipated 
Potential risks 
Limitations 
Project management 
Budget 
References 
Appendix I: Informed Consent 
Appendix II: Participant survey tools 
Appendix III: App specifications 
Appendix IV: App Mockup Screens 
 
3 

List of abbreviations & definitions 
●
Adherence
​(to
medication)
­
Following
a
medicine
regimen
according
to
the
 
 
 
 
 
 
 
 
 
 
 
recommended dosage and frequency. 
●
Android ​­ A free and open­source smartphone operating system created by Google. 
●
App ​­ An application created for a smartphone. An app can be made for Android, iPhone
   
 
 
 
   
 
 
 
 
 
 
 
 
 
(iOS), BlackBerry or Windows Phone. 
●
CD4 ​­ Also known as CD4+ T helper cells, which are an essential part of the human
   
 
 
 
   
 
 
 
 
 
 
 
 
 
 
immune system. The number of CD4 cells found per cubic millimetre determines if an
 
 
 
 
 
 
 
 
 
 
 
   
 
HIV­positive individual should be on ARV medication. 
●
Linkage (to care) ­ Attendance to follow­up HIV care by an HIV­positive patient. In the
 
 
   
 
 
 
 
 
 
 
 
 
 
 
current study linkage to care is defined as attendance to a follow up clinical visit and
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
laboratory test within 6 months of HIV diagnosis. 
●
mHealth ​­ The use of mobile devices to support health care. 
●
Retention (in care) ­ Attending to regular follow­up medical visits once receiving HIV
 
 
   
 
 
 
 
 
 
 
 
 
care. In the current study, retention in care is defined as continuation of HIV care
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(regular clinic visits with laboratory tests and/or medicine pickup) after the linkage to
 
 
 
 
 
 
 
 
 
 
 
 
 
care visit. 
●
Smartphone ​­ A mobile phone that runs an operating system that allows the installation
     
 
 
 
 
 
 
 
 
 
 
 
of apps. Most phones that cost $50 USD or more are smartphones as are all Android,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Apple, and Windows Phone devices. 
Rationale & background 
South African HIV testing rates are high, with almost 50% of adults knowing their status
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(Shisana et al, 2014). However, immediate linkage to the next levels of care of newly
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
diagnosed HIV­positive individuals is very low throughout the region (Rosen, 2011).
 
 
 
 
 
 
 
 
 
 
 
Improved access to point of care CD4 counts, widely anticipated to have improved linkage to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
care, have yielded disappointingly limited success, suggesting other interventions are
 
 
 
 
 
 
 
 
 
 
required (Larson, 2013; Faal, 2011). Linkage to care and adherence to medication is higher
 
 
 
 
 
 
 
 
 
 
 
 
 
 
in HIV than in most other chronic illnesses, and this is widely ascribed to widespread HIV
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
patient education programmes within communities; further patient empowerment and
 
 
 
 
 
 
 
 
 
involvement in care may additionally improve retention. Current demographic data on those
 
 
 
 
 
 
 
 
 
 
 
 
specifically accessing antiretroviral (ART) care, however, suggests that younger people and
 
 
 
 
 
 
 
 
 
 
 
men are disproportionately less likely to make this link (Takuva et al 2015), again suggesting
 
 
 
 
 
 
 
 
 
 
   
 
 
 
that these two groups would benefit from more focus. 
Previous research has suggested that mobile phones (mHealth) can improve antiretroviral
 
 
 
 
 
 
 
 
 
 
 
adherence rates in low­resource settings (Lester, 2010; Pop­Eleches, 2011). However, there
 
 
 
 
 
 
 
 
 
 
 
is a dearth of literature looking at the use of mHealth to encourage patient linkage to care
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
before initiation of ART, and retention through the continuum of care. 
A study in Niger tested whether a simple monitoring system, implemented via the mobile
 
 
 
 
 
   
 
 
 
 
 
 
 
phone, can improve student learning as part of an adult education program (Aker & Ksoll,
 
 
 
 
 
 
 
 
 
 
 
 
   
 
2015). Using a randomized control trial in 163 villages in Niger, the investigators randomly
 
   
 
 
 
 
 
 
 
 
 
 
 
4 

assigned half of the villages to a mobile phone monitoring program, whereby teachers,
 
 
 
 
 
 
 
 
 
 
 
 
 
students and the village chief were called on a weekly basis. There was no incentive
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
component to the program. The program dramatically affected student reading and maths
 
 
 
 
 
 
 
 
 
 
 
 
test performance already during the first year of the program.  
South Africa is a middle­income country that has seen a large increase in mobile phone
 
 
   
 
 
 
 
   
 
 
 
 
 
ownership over the past few years, with significant growth in smartphone ownership. Since
 
 
 
 
 
 
 
 
 
 
 
 
 
early 2014, most phones sold every month in South Africa have been smartphones, due in
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
large part to price drops (currently under R500/<$50 per phone), with sales projected to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
continue to increase as the prices decrease further (Techcentral, 2014). This proliferation of
 
 
 
 
 
 
 
 
 
 
 
 
 
smartphones in South Africa provides an excellent opportunity to introduce mHealth
 
 
 
 
 
 
 
 
 
 
 
interventions. Data from a Khayelitsha (a very poor suburb of Cape Town) research project
 
 
   
 
 
 
 
 
 
 
 
 
 
from late 2014 shows regular use of internet (56%), WhatsApp (60%) and e­mail (30%) by
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
health care patients. Anecdotally there has been a significant increase in the use of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Smartphones and internet in South Africa over the last year. In one of the study sites the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
study team noticed a 40­50% use of smartphone during an observation of individuals waiting
 
 
   
 
 
 
 
 
 
 
 
 
 
in line for HIV testing and the phones they were using to pass time. 
South Africa has a National Health Laboratory System (NHLS) within the state sector, with a
 
 
   
 
 
 
 
 
 
 
 
 
   
sophisticated information infrastructure that can link patient laboratory results across health
 
 
 
 
 
 
 
 
 
 
 
facilities and provinces. In 2013, the National Department of Health agreed to use a single
 
 
 
 
 
 
 
 
 
 
 
 
   
 
patient identifier across the country, meaning that individualised longitudinal monitoring of
 
 
 
 
 
 
 
 
 
 
 
patients will be made easier. The use of the unique number will also increase the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
confidentiality of patient results as an ID book (or passport/refugee card) will be required to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ascertain patient identification. 
This study proposes providing individual patient laboratory results to newly­diagnosed
 
 
 
 
 
 
 
 
 
 
HIV­positive smartphone users through a secure application (app) as a method to get them
 
 
 
   
 
 
 
   
 
 
 
 
linked to and retained in care, and engage with educational materials purposefully developed
 
 
 
   
 
 
 
 
 
 
 
 
to explain their results. Message prompts will also be used to alert patients that their results
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
are ready and provide information on how to link to care, and assistance to relink to care if
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
they fall out of the health system for any reason. Finally, prompts will be sent to patients to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
remind health care workers if they are due for repeat laboratory monitoring. 
NHLS, has begun a similar programme with a TB­app, which allows for clinician TB­patient
 
 
   
 
 
   
 
 
 
 
 
 
monitoring and follow­up, launched in December 2014. Early feedback from piloting the
 
 
 
 
 
 
 
 
 
 
 
 
TB­app show that clinicians value the ability to have a live database to access patient
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
laboratory results. The app for this intervention will be HIV and patient­focused, but will be
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
created based on the experience of the NHLS. It is expected that patients will also value the
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
ability to monitor their laboratory results and learn more about their condition using their own
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
smartphone. 
RHI has been sending SMS­based maternal health messages to pregnant women and new
 
 
 
 
 
 
 
 
 
 
 
 
 
mothers since mid­2012 as part of the MAMA South Africa project. Based on the success of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MAMA, starting in August 2014, the National Department of Health (NDoH) launched
 
 
 
 
 
 
 
 
 
 
 
 
MomConnect, a national SMS­based maternal health registration and information project.
   
 
 
 
 
 
 
 
 
Like MAMA, MomConnect sends stage­based maternal health information to pregnant
 
 
 
 
 
 
 
 
 
 
women and new mothers from their first ANC visit until their baby is one year old and as of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5 

mid­March 2015 over 325,000 women have received maternal health messages through
 
 
 
 
 
 
 
 
 
 
 
MomConnect. RHI assisted the NDoH with setting up MomConnect and is providing ongoing
 
 
 
 
 
 
 
 
 
   
 
 
technical assistance. Recently the NDoH has been investigating sending MomConnect
 
 
 
 
 
 
 
 
 
 
messages using IP­based messaging services (Such as the smartphone apps WhatsApp,
 
 
 
 
 
 
 
 
 
 
 
WeChat, etc.), which signals a shift to accepting that smartphones could play a role within
 
 
 
   
 
 
 
 
 
 
   
 
 
NDoH activities.  
The use of smartphones as a method for patients to receive laboratory results has never
 
 
 
 
   
 
 
 
 
 
 
 
 
 
been published previously. We hope that this study will show that this method is both
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
acceptable and increases patient engagement. The study uses a patient­centered approach
 
 
 
 
 
 
 
   
 
 
to care and treatment that aims to increase patient empowerment. If this concept of an app
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
increasing linkage to HIV care is proven to work in HIV clients in Johannesburg, it will provide
 
 
 
 
   
 
 
   
 
 
 
   
 
 
important evidence for potential programmatic roll­out of such an mHealth strategy.
 
 
 
 
 
 
 
 
 
 
 
Additionally, publishing the findings from this study will encourage other research teams to
 
 
 
 
 
 
 
 
 
 
 
 
 
conduct similar research building on what we have done and learnt. 
The decision to use a smartphone­based app for the current study is based on inexpensive
 
 
 
   
 
 
 
 
 
   
 
 
 
data costs (for both provider and patient), the privacy/security of an app, the ability to send
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
immediate and secure notifications and high (and increasing) levels of smartphone
 
 
 
 
 
 
 
 
 
 
 
ownership in South Africa, particularly among urban dwellers. Even in more rural settings
 
 
 
 
 
 
 
 
 
 
 
 
 
smartphone ownership is expected to reach over 70% in a few years as smartphone prices
 
 
 
 
 
 
 
 
   
 
 
 
 
 
reach $20 USD each (current smartphone’s, such as the MTN Steppe, cost as little as R450
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
or about $35 USD). Based on learnings from the MomConnect program (described above)
 
 
 
 
 
 
 
 
 
 
 
 
 
an SMS­based strategy is not scalable due to the current (relatively) high cost of sending
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SMSs in South Africa. Additionally, SMS is not secure or private as they can be read by
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
anyone with access to the phone. 
While designing the study, the team was conscious of the limited resources of the potential
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
participants. The app will be installed by the research team using a USB connection,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
negating the need of data charges to download/install it. Additionally, all of the app’s
 
 
 
 
 
 
 
 
 
 
 
 
 
 
background HIV information and computational logic will be built­in, meaning that any new
 
 
 
 
 
 
 
 
 
 
 
 
 
CD4 count/viral load result sent to the app will only be a few kilobytes each, including the
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
data used for logging into the app. This translates to a maximum cost of R0.02 (or $0.0017
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
USD) on Vodacom’s out­of­bundle data rates (which is currently the most expensive data
 
 
 
 
 
 
 
 
 
 
 
 
 
option, out­of­bundle or in­contract, in South Africa ) per laboratory result received. Another
 
 
 
 
 
 
 
 
 
 
 
 
1
option for the study was a secure website which works similarly to the app. Such a website
 
 
 
 
   
 
 
 
 
 
 
 
 
   
 
would increase data costs for the patient (since everything on the site would have to be
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
downloaded each time it was visited) and would not allow for notifications. For these
 
 
 
 
 
 
 
 
 
 
 
 
 
 
reasons, a smartphone app was chosen for the study. 
1
For
details
of
Vodacom’s
out­of­bundle
(read:
most
expensive)
data
pricing,
please
see:
 
 
 
 
 
 
 
 
 
 
 
 
 
http://www.vodacom.co.za/vodacom/shopping/data/prepaid­data 
6 

Study goals & objectives 
Study goal 
To determine if a smartphone app that provides laboratory results (CD4 count and viral load)
 
     
 
 
 
 
 
 
 
 
 
 
 
and health information relating to HIV to patients is acceptable to individuals who are newly
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
diagnosed with HIV (will they use it?), increases linkage to and retention in care (do they
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
attend follow up visits at a higher rate?) and can be feasibly implemented in a clinical setting.  
Primary objective 
To test whether linkage to HIV care is improved by providing clients with access to a
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
smartphone­enabled application (app) when compared to standard of care around 6 months
 
 
 
 
 
 
 
 
 
   
 
post­diagnosis. 
Secondary objectives 
1.
To compare ART initiation rates between intervention and control arms. 
2.
To assess the feasibility and acceptability of receiving laboratory results to a personal
 
 
 
 
 
 
 
 
 
 
   
 
smartphone. 
3.
To assess secondary effects from improved patient information, including return rates
 
 
 
 
 
 
 
 
 
 
 
after falling out of care (assessed through routine patient record reviews), patient
 
 
 
 
 
 
 
 
 
 
 
 
satisfaction (through face­to­face surveys at the 6­month follow­up visit and end of the
 
 
 
 
 
 
 
 
 
 
 
 
 
study), and rates of additional blood tests (especially CD4 count, viral load). 
4.
To assess patient knowledge levels of their laboratory results. 
5.
To specifically look at 2 subgroups – men and young adults (18 to 25 years of age), who
 
 
 
   
   
 
 
 
 
 
 
 
 
 
 
 
would particularly benefit from improved linkage to care. 
6.
To assess the performance of the app in clients with different levels of education and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
standard of living, and see if there are differences in clinical and usage outcomes 
7.
To evaluate differences in linkage­to­care, HIV­knowledge, adherence to medication
 
 
 
 
 
 
 
 
 
(treatment patients only) and reported quality of life between wellness and treatment
 
 
 
 
 
 
 
 
 
 
 
 
patients. 
8.
To assess the financial and economic costs of providing the SmatLtC smartphone app. 
9.
To determine the incremental cost, and cost­effectiveness of ART initiation link to the
 
 
 
 
 
 
 
 
 
 
 
 
 
smartphone app (receiving laboratory results and linkage­to­care) as compared to the
 
 
 
 
 
 
 
 
 
 
 
standard ART initiation. 
Study design 
Population 
The study was designed to take place in two high­volume HIV testing sites in Johannesburg,
 
 
 
 
 
 
   
 
 
 
 
   
 
South Africa. To ensure a sufficient sample size for the study results to be statistically
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
significant, the study sites required a minimum of 1000 new HIV­positive patients per month.
 
 
 
 
   
 
 
 
 
 
 
 
 
According to the District Health Information System, there are three possible sites within the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
province of Gauteng, where Johannesburg is situated; Chris Hani Baragwanath Hospital,
 
 
 
 
 
 
 
 
 
 
 
Hillbrow Community Health Centre (CHC), and Helen Joseph Hospital. The study team
 
 
 
 
 
 
 
 
 
 
 
 
selected Hillbrow CHC and Helen Joseph Hospital due to their proximity to each other, ease
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
of access and the fact that no similar research activities are ongoing in either site. 
7 

Hillbrow CHC is an inner­city clinical site which provides primary, HIV, antenatal care (ANC)
 
   
 
 
 
 
 
 
 
 
 
 
 
and postnatal care (PNC) care to patients. Johannesburg’s inner­city is characterised by high
 
 
 
 
 
 
 
 
   
 
 
 
density living, a large immigrant population and high rates of poverty and unemployment.
 
   
 
 
 
 
 
 
 
 
 
 
While official population estimates cite Johannesburg’s population as 400,000 individuals,
 
 
 
 
 
 
 
 
 
 
unofficial population estimates suggest that over 900,000 individuals currently live in the area
 
 
 
 
 
 
 
 
 
 
 
 
 
(O’Connor et al, 2011). The official catchment population for Hillbrow CHC is approximately
 
 
 
 
 
 
 
 
 
 
   
 
220,000 from around Hillbrow and surrounding neighbourhoods. Despite the poverty,
 
 
 
 
 
 
 
 
 
 
smartphone ownership for those attending care at Hillbrow CHC is approximately 40­50%.
 
 
 
 
 
 
 
 
 
 
 
 
HIV prevalence levels are approximately 22%. 
Helen Joseph Hospital is approximately 4 km west of Johannesburg’s inner­city in the suburb
 
 
   
   
 
 
 
 
 
 
 
 
of Auckland Park. As a tertiary clinical site, the hospital provides a number of clinical services
 
 
 
   
 
 
 
 
 
   
 
 
 
 
including HIV, ANC, PNC, and specialised care services to patients and has a connection
 
 
 
 
 
 
 
 
 
 
 
   
 
with the University of Witwatersrand’s Department of Medicine. The area surrounding Helen
 
 
 
 
 
 
 
 
 
 
 
 
Joseph Hospital is comprised of mostly black South African middle­income families living in
 
 
 
 
 
 
 
 
 
 
 
 
 
single unit residential dwellings. Helen Joseph Hospital has a catchment population of
 
 
 
 
 
 
 
 
 
 
 
 
around 250,000 and an HIV prevelence of approximately 15­20%. 
Linkage­to­care rates for all newly diagnosed HIV­positive individuals in both sites are
 
 
 
 
 
 
 
 
 
 
 
 
50­55%. Women have slightly higher linkage rates, at 60%, while men have slightly lower
 
 
 
 
 
 
 
 
 
 
 
 
 
 
rates, close to 45%. Exact linkage­to­care figures for young adults, those aged between 18
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and 25, in this area are unknown. However, previous research has suggested linkage rates
 
 
 
 
 
 
 
 
 
 
 
 
 
 
for young adults to be 40­45% (Takuva et al 2015). Due to South African laws that protect
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
exploitation of children and the resulting difficulty in including them in research studies, all
 
 
 
 
 
 
 
 
 
 
 
 
 
 
participants will be 18 years of age or older. 
Intervention 
This is a multi­site randomised controlled trial in which newly diagnosed HIV­positive
 
 
 
 
 
 
 
 
 
 
 
 
patients, fulfilling all inclusion criteria, will be randomised to either receive the intervention
 
 
 
 
 
 
 
 
 
 
 
 
 
(installation of a password­protected laboratory result and HIV­information app on their
 
 
 
 
 
 
 
 
 
 
 
smartphone) or the standard of care. All patients will be provided with their unique identifier,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
to present to the clinic, and asked for permission to access their results on the computer, as
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
a means to assess follow up, to phone them and ask them about their experience of HIV
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
care (at the end of the study) and to verify their clinic attendance throughout the study.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participants will be able to provide feedback about the study to the study team by phone or
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SMS at any time. In return for their time all study participants will receive a R50 study
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
participation allowance, in the form of a mobile phone credit voucher, at the end of their
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
recruitment visit. Participants will be informed that no additional funds will be provided for
 
 
 
 
 
 
 
 
 
 
 
 
 
 
subsequent appointments. 
Patients randomised to the intervention arm will be assisted with downloading and installing
 
 
 
 
 
 
 
 
 
 
 
 
 
the app, and setting up their accounts with a username, password and PIN. How to use the
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
app including accessing laboratory data and HIV support information will also be explained.
 
 
 
 
 
 
 
 
 
 
 
 
 
All patients will be recruited at first CD4 count test as the classification into ‘wellness’ or
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
‘treatment’ will not occur until their return to the clinic. As standard of care, both wellness and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
treatment patients are requested to return after 6 months for a follow­up phlebotomy and
 
 
 
 
 
 
   
 
   
 
 
 
CD4 count (for wellness patients) or viral load (for patients on ART) testing. All study
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8 

participants will be assumed to be linked to care if they attend for the follow up laboratory
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
tests by the end of the 8​th month after joining the study. The study team is aware that some
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
patients will need ART bloods at 3 months, and some will need a follow­up VL due to not
 
 
 
 
 
   
 
 
 
 
   
 
 
 
 
 
being suppressed at 6 months. With this in mind, the app will notify the study participant to
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
go for an appointment 6 and 12 months after recruitment irrespective of their initial CD4
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
count (both wellness and treatment groups). To provide additional support to study
 
 
 
 
 
 
 
 
 
 
 
 
participants in the treatment arm, the app will monitor the first viral load result and notify
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
participants with a viral load of >1000 copies/mm​3 to go to the clinic in two months, while
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
notifying participants with a viral load of <1000 copies/mm​3 to go to the clinic after six
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
months. This logic will be built into the app and is per current South African HIV Guidelines
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
published 24 December 2014 by the National Department of Health.  
The intervention arm will not receive additional or different individualised or real time care,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
other than at the installation and use of the app; we want to demonstrate the performance of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the app in as ‘real­world’ an environment as possible. Any appointment reminder message
 
 
 
 
 
 
 
 
 
 
 
 
 
sent to the patient will be automated and based on algorithms developed from national
 
 
 
 
 
 
 
 
 
 
 
 
 
 
guidelines. Use of the app by patients is expected to add to their understanding of HIV and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the role of laboratory tests (specifically CD4 counts and viral loads) and ARV medicine as the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
treatment ensuring their wellbeing. If visits are missed, or monitoring protocols are not
 
 
 
 
 
 
 
 
 
 
 
 
 
followed, this will be noted when the final data are analysed. The team will also monitor use
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
of the app by patients throughout the study to get an understanding which parts of the app
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
were regularly used and how long patients spent reviewing their results or reading other
 
 
 
 
 
 
 
 
 
 
 
 
 
 
information within the app. 
Inclusion criteria 
●
Newly diagnosed HIV­positive, clients presenting at selected public health facilities,
 
 
 
 
 
 
 
 
 
 
irrespective of CD4 count 
●
Access to an Android smartphone with data (estimated to be 40­50% of current Hillbrow
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Community Health Centre (CHC) population) 
●
Willing to pay the (small) cost to access their laboratory result 
●
Age – 18 years and older 
●
Proof of ID/passport/refugee number (for identification/security, and to confirm the single
 
 
 
 
 
 
 
 
 
 
 
patient identifier) 
●
Can read English or Zulu 
●
Ability and willingness to sign informed consent 
Exclusion criteria 
●
Clients presenting for ANC services, as these women will be enrolled in the national
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MomConnect program 
●
Refusal to participate 
Note that success of the primary objective is not ART initiation, but linkage to care as defined
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
above i.e. ​attending for a CD4 count measurement PLUS one other HIV­related NHLS test
 
 
 
   
 
 
 
 
 
 
 
 
 
within 8 months of HIV diagnosis​. This allows the study team to assess linkage to care of
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
patients who are both eligible and not eligible for ART. Traditionally, non­ART eligible
 
 
 
 
 
 
 
 
 
 
 
 
 
patients have been disproportionately lost to follow up and have therefore been included in
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9 

this study. 
 
 
Figure 1: Adapted from Health Resources and Services Administration, HIV/AIDS Bureau.
 
 
 
 
 
 
 
 
 
 
 
Continuum of engagement in HIV care. Cheever LW. Engaging HIV­infected patients in care:
 
 
   
 
 
 
 
 
 
 
 
 
their
lives
depend
on
it.
Clin
Infect
Dis
2007;44(11):1500­02.
Available
from
 
 
 
 
 
 
 
 
 
 
 
http://www.cdc.gov/hiv/prevention/programs/pwp/linkage.html 
Methodology 
Pre­recruitment 
Prior to recruitment the study team will test study feasibility through potential user
 
 
 
 
 
 
 
 
 
 
 
 
 
one­on­one interviews and focus groups to test the usability and language of the app, the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
information contained within it, the informed consent document and an HIV quiz to ensure
 
 
 
 
 
 
 
 
 
 
 
 
 
 
these tools are understandable by potential study participants. Additionally, the study team
 
 
 
 
 
 
 
 
 
 
 
 
will host a meeting with Wits RHI’s HIV­positive Community Advisory Group (CAG) to garner
 
   
 
 
 
 
 
 
 
 
 
 
 
feedback, gauge interest in the app and test usability. This qualitative feedback on app use
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and interpretation of data will be used to improve the app design and client information. Due
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
to the proof­of­concept nature of the study, we will not conduct a pilot, but we will monitor
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
and review progress regularly, and act on any feedback received from app users.  
Recruitment 
Study participants will be recruited at HIV clinics after receiving a confirmatory HIV test and
 
 
 
 
 
 
 
 
 
   
 
 
 
 
following the drawing of CD4 count bloods. A trained and GCP­certified research staff
 
 
 
 
 
 
 
 
 
 
 
 
 
member will approach patients and inform them about the study, and invite them to get
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
pre­screened for participating in the study. The study team is aware this can be a traumatic
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
time for individuals, but previous research has provided RHI staff with useful experience to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ensure that the research staff are appropriately sensitive to the patient’s feelings and needs.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The recruitment site will be organised for efficient flow of potential participants which will
 
 
 
 
 
 
 
 
 
 
 
 
 
 
include a private space for consenting to the study, collecting patient information and app
 
 
 
 
 
 
 
 
 
 
 
 
 
 
installation/training. Two recruiters will work at each site, minimising the waiting time for
 
 
 
 
 
 
 
 
 
 
 
 
 
potential participants. 
10 

If interest is shown, the study recruiter will first inquire about their age and pregnancy status
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
as the study only allows those who are 18 years of age and older and not currently pregnant.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Upon finding individuals who are under 18 or are pregnant the recruiter will inform them they
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
are not eligible, thank them for their time, and record the reason for non­participation in the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
study database. For individuals who are 18 or older and are not pregnant, the recruiter will
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
invite them to a private space where they will be asked (non­identifying) demographic and
 
 
   
 
 
 
 
 
 
 
 
 
 
socioeconomic questions. ​The demographic and socioeconomic questions asked to all
 
 
 
 
 
 
 
 
 
 
potential participants will allow the study team to perform a comparison later to determine
 
 
 
 
 
 
 
 
   
 
 
 
 
what differences there are between smartphone owners and non­owners, and how
 
 
 
 
 
 
 
 
 
 
 
generalisable the results are. Following the demographic and socioeconomic questions will
 
 
 
 
 
 
 
 
 
 
 
be a number of inclusion and exclusion criteria questions to confirm the remaining eligibility
   
 
 
 
 
 
 
 
 
 
 
 
 
criteria
(smartphone
ownership,
literacy,
photo
proof of identification, willingness to
 
 
 
 
 
 
 
 
 
 
participate). If an individual is found to be ineligible the recruiter will inform them they are not
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
eligible, thank them for their time, and record the reason for non­participation in the study
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
database. If the reason for exclusion is that they do not own an Android phone with data, the
   
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
type of phone will also be noted.  
Patients who fit the study eligibility criteria will be invited to participate, provided a broad
 
 
 
 
 
 
 
 
 
 
 
 
   
 
overview
of
the
study,
explained
the
randomisation,
read
the
informed
consent
 
 
 
 
 
 
 
 
 
 
 
documentation, and asked to sign it after being told that participating requires them to allow
 
 
 
 
   
 
 
 
 
 
 
 
 
 
the study team to monitor their laboratory results throughout the study and contact them with
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
a follow­up questionnaire about their experiences of the study and HIV care they received. At
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
any time, if an individual decides they do not want to participate, the recruiter will thank them
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
for their time, and record the reason for non­participation in the study database.  
Upon signing informed consent, their personal details including name, surname, ID number,
 
 
 
 
 
 
 
 
 
 
 
 
and a baseline survey which consists of a HIV/CD4 count knowledge questionnaire (all tools
   
 
 
 
 
   
 
 
 
 
 
 
listed in appendix II) will be recorded into REDCap (Harris et al, 2009), ​an electronic data
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
capture tool hosted at Wits University , using a tablet device by trained research staff. At the
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
2
end of the recruitment process all patients will be provided their R50 participation allowance.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patients in both study arms will be encouraged to return to the clinic as per the clinic
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
guidelines to receive their CD4 result and attend wellness or HIV care follow­up. 
REDCap will randomise the participant to the standard of care or intervention arm through
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the device without informing the participant. Participants randomised to the standard of care
 
 
 
 
 
 
 
 
 
 
 
 
 
arm will be provided with a copy of their signed informed consent document and thanked for
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
their time.  
Participants randomised to the intervention arm will be told about the smartphone app and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
told how it works. The study staff member will install the app on the participant’s phone and
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
assist the participant in setting up an account with a username, password and PIN number
 
 
 
 
 
 
 
 
   
 
 
 
 
 
and provide an overview of how the app and notification system works. Participants will be
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 ​REDCap (Research Electronic Data Capture) is a secure, web­based application designed to support data
 
 
 
 
 
 
   
 
 
 
 
 
 
 
capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
data manipulation and export procedures; 3) automated export procedures for seamless data downloads to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
common statistical packages; and 4) procedures for importing data from external sources. 
11 

informed that they are welcome to use the app at any time, and it will notify them when a
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
   
laboratory result has arrived. As mentioned above, the cost per laboratory result received is
 
 
 
 
 
 
 
 
 
 
 
 
   
approximately R0.02. Patients will be informed of this cost prior to participating. 
The aim of the study is to show that smartphone apps work for that proportion of the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
population that currently have Android smartphones, not that it works for the general
 
 
 
 
 
 
 
 
 
 
 
 
 
population. Smartphone purchase is rapidly increasing in South Africa, with 75% of new cell
 
 
   
 
 
 
 
 
 
 
 
 
 
phones sold in South Africa currently being smart phones. We expect that randomization and
 
   
 
 
 
 
 
 
 
 
 
 
 
a large sample size will enable us to have a reasonable balance between the arms, unless
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
participants randomized to the control group request study withdrawal due to not getting the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
app. 
Sample Size 
Based on a primary endpoint of a second HIV­linked laboratory test (CD4, viral load) being
 
   
 
 
   
 
 
 
 
 
 
 
 
performed at a clinical facility, within 8 months after the HIV­positive result, suggesting
 
 
 
 
 
 
 
 
 
 
 
 
 
successful attendance and entry into HIV care, we anticipate at least 1000 patients in each
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
arm will be needed. The study team expects to see a 20% difference in linkage to care levels
 
 
 
 
 
 
 
 
 
   
 
   
 
 
 
 
through the app (using a second HIV­linked laboratory test as an indicator for linkage to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
care). The sample size is calculated based on 80% power, 0.05 significance with a
 
 
 
 
 
 
 
 
 
 
 
 
 
 
loss­to­follow­up rate of approximately 27% (Hillbrow CHC data). Both ART and pre­ART
 
 
 
 
 
 
 
 
 
 
 
 
patients will be expected to return for a follow­up laboratory test around 6 months after
 
 
 
 
 
 
   
 
 
 
   
 
 
diagnosis; ART patients for a viral load, and pre­ART for a follow­up CD4 count. 
In South Africa, both younger and male clients have lower linkage to care rates than females
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and individuals over 25. In order to conduct subgroup analysis on these higher­risk
 
 
 
 
 
 
 
 
 
 
 
 
 
populations (young people and men), there will be an over­sampling of male patients and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
those between the ages of 18 (the age of majority) and 25 for both the intervention and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
control arms given that it has been shown that these groups are less likely to access health
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
services efficiently (Kranzer, 2010). These populations will be recruited until 250 of these
 
 
 
 
 
 
 
 
 
 
 
 
 
individuals are included in both arms to ensure the study is powered to analyse the effect in
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
these key subgroups. Based on a 20% difference in linkage to care for the intervention/app
 
 
 
 
   
 
 
 
 
 
 
 
 
 
arm with an 80% power, a significance level of 0.05 and a loss­to­follow­up rate of 40% a
 
 
 
 
   
 
 
 
 
   
 
 
 
   
sample size of 97 per arm is required. Again, the study team will over­sample based on the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
proof­of­concept nature of the study. 
 
 
 
12 

Figure 2:​ Recruitment flow chart 
 
App specifications 
The application will be able to be quickly installed by the study staff, at no cost to the patient,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and once installed, will consume minimal network data, as patients are very conscious of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
cost of data bundles. For the study the app will be available on Android only (the type of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
phone potential participants with non­Android smartphones have will be recorded). The app
 
 
 
 
 
 
 
 
 
 
 
 
icon and name on the phone will be non­descript and not suggestive of a health application.
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
Username, password and PIN requirements will prevent any unauthorized access to this
 
 
 
 
 
 
 
 
 
 
 
 
data. App­based push­notification reminders will notify patient when a new result is present
 
 
 
 
 
 
 
   
 
   
 
by stating “​There is updated information for you. Please use the app to access it​”. The
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
notification will give no detail about the nature of the information, ensuring all detail is only
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
displayed within the password­protected section of the app. 
Within the app, laboratory result data will be presented clearly, with simple explanations on
 
 
 
 
 
 
 
 
 
 
 
 
 
 
every screen, in English and Zulu with a grade 4 reading level (as per WHO guidelines on
 
 
 
 
 
 
   
   
 
 
 
 
 
 
 
literacy). Laboratory results will not be shown in isolation, but will be supplemented with
 
 
 
 
 
 
 
 
 
 
 
 
 
 
13 

informative and relevant information explaining the result that has been shown
and the
 
 
 
 
 
 
 
 
 
 
 
 
 
3
recommended action for the patient to take. Patients will also be able to view additional
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV­related information and a Frequently Asked Questions (FAQ) through the app. This
 
 
 
 
 
 
 
 
 
 
 
 
information will be created with support from HIV clinicians and psychosocial teams and
 
 
 
 
 
 
 
 
 
 
 
 
 
focus on information that is relevant for newly diagnosed HIV­positive individuals. Links to
 
 
 
 
 
 
 
 
 
 
 
 
 
external sites (e.g.: National Department of Health HIV site, LoveLife, etc.), to get further HIV
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
support/information will be provided (to be opened in the smartphone web browser) and
 
 
 
 
 
 
 
 
 
 
 
 
 
access to them will be monitored by the app. Automated prompts will be built­in to the app,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
triggered automatically at five and a half months, six months and 12 months after the app
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
has been installed. These triggers will inform the patient that it is (almost) time to attend a
 
 
 
 
 
 
 
 
 
     
 
 
 
   
further laboratory test. 
The app will measure the number of times and dates/times that it is opened, relative to the
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
sending of the push notifications, so as to understand usage. In addition, we will be able to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
tell if the app is opened during a clinic visit (as measured by a laboratory request), marking a
   
 
   
 
   
 
 
 
 
   
 
 
   
possible showing of the result to a health care worker. Health care workers in the study sites
 
 
 
 
 
   
 
 
 
 
 
   
 
 
 
will be briefed about and explained how the app works. Patients will be encouraged to use
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the call back facility if they have linked to care but are still receiving reminder notifications to
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
do so; this should allow us to evaluate the accuracy of the single patient identifier use. Note
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
that patients who have been linked to care at the study sites will automatically stop receiving
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the reminder notifications until the next time they are required to attend the clinic. An
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
overview of app specifications can be seen below (Appendix III). 
Prior to study recruitment, the study team will conduct at least two focus group discussions
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(FGD’s) with potential study participants. These FGD’s will test the ease of installation and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
use of the app, language level of the content, understanding of the laboratory test results,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and satisfaction of the participants. Feedback from the FGD participants will be shared with
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the app developers who will make improvements to the app. 
Patient follow­up 
Patients will be followed up for a minimum of one year and maximum of 18 months to
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
monitoring linkage to care and retention in care. We anticipate recruitment taking 3 months
 
 
 
 
 
 
 
 
 
 
 
   
 
resulting in data spanning 15­18 months, over the 2 year lifetime of the project (if funding is
 
 
 
 
 
 
 
   
 
 
 
 
 
 
   
secured, as per issues cited in the “Risks” section, below). The outcome of the primary
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
objective (linkage to care) will be analysed 8 months after recruitment of the last participant
 
 
 
 
 
 
   
 
 
 
 
 
 
 
to allow for patients link to care slightly delayed. 
3 For example, if a CD4 count of 250 is returned, the number will be shown in red with an informative note
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
explaining that that CD4 value is abnormally low and request that the patient attend to the clinic for further care as
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
soon as possible. Alternatively, if the a CD4 count result of 700 is returned, the number will be shown in amber (a
 
 
 
   
   
 
 
 
 
   
 
 
 
 
 
   
 
 
warning colour) with an informative note explaining that the CD4 count value is within the normal range and they
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
should return to the clinic for wellness counselling and then have another CD4 count test in 6 months. For any
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
result (CD4 or viral load) the patient will be able to get more information about HIV/AIDS, CD4 counts and viral
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
loads within the app, see a list of frequently asked questions (FAQ), given clickable links to get external (web)
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
information or provided contact numbers for the study team (for study or app­related questions) or the National
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV/AIDS helpline (for HIV­related questions). 
14 

Baseline recruitment will include questions on basic demographics. Throughout the study the
 
 
 
 
 
 
 
 
 
 
 
 
team will monitor the number of times the app is accessed to view laboratory results and/or
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
support information by the user; and loss­to­ follow­up. Healthcare monitoring, measured by
 
 
 
 
 
 
 
 
 
 
 
 
appropriate laboratory adherence to treatment guidelines, will be monitored through the
 
 
 
 
 
 
 
 
 
 
 
NHLS database; in particular, we will monitor whether providing information to the patient to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
prompt the health care worker improves compliance with guidelines. All patients who exit
 
 
 
 
 
 
 
 
 
 
 
 
 
from the trial will be given a survey that includes questions to assess CD4 count and HIV
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
knowledge, health status, health care access, and patient satisfaction with the app, as well
 
 
 
 
 
 
 
 
 
 
 
 
 
 
as with the health care services. This will allow us to compare how much the app has
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
contributed to linkage to and retention in care, as well as to patient understanding of their
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
health management. 
After 8 months of participating in the study the research team will monitor participant
 
 
 
 
 
 
 
 
 
 
 
 
 
 
attendance to a follow­up laboratory test through the NHLS test database. The patient will
 
   
 
 
 
 
 
 
 
 
 
 
 
not be contacted at this point. Data will be analysed comparing the standard of care arm with
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the intervention arm. 
With additional funding the study will include a patient follow­up 12 months after recruitment.
 
 
 
 
 
 
   
 
 
 
 
 
 
Patients will be contacted by phone and asked to complete the WHO Quality Of Life BREF
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV tool (WHOQOL­BREF HIV ), those on ARVs will be given the ACTG ARV adherence
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4
tool while all participants will be asked to provide their feedback through an end­of­study
 
 
 
 
 
 
 
 
 
 
 
 
 
 
questionnaire. The end of study questionnaire includes questions regarding their experiences
 
 
 
 
 
 
 
 
 
 
 
during the study, their health status, their experience of HIV care, actual and opportunity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
costs, as well as a follow­up HIV/CD4 count knowledge questionnaire (tools can be found in
 
 
 
   
 
 
 
 
 
 
 
 
 
 
appendix II). All responses will be recorded into REDCap on a mobile device by research
 
 
 
 
 
 
 
 
 
   
 
 
 
 
staff. 
Cost­Effectiveness analysis 
A cost­effectiveness analysis will be conducted and compare the intervention arm with the
 
 
 
 
 
 
 
 
 
 
 
 
 
standard of care arm from the societal perspective. Financial and economic costs will be
 
 
 
 
 
 
 
 
 
 
 
 
 
 
assessed, which include ART costs, incremental health systems costs, and patient
 
 
 
 
 
 
 
 
 
 
 
productivity loss due to morbidity and mortality. A potential for cost savings due to a
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
reduction in low CD4 count results, Adverse Event (AE) and Opportunistic Infection (OI) will
 
 
 
 
 
 
 
 
 
 
 
 
 
 
also be incorporated into the cost­effectiveness analysis. 
  
Populations under consideration: 
●
General population 
●
General population categorised by 5 year age groups 
●
Specific populations: 18 to 25, over 25, men 
  
Epidemiology outcomes: 
●
HIV mortality by 5 year age groups 
●
HIV incidence by 5 year age groups 
4 The WHOQOL­BREF HIV is a cross­cultural quality of life assessment tool based on the WHO­QOL100 and the
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
WHO­QOL­BREF. The WHO­QOL­BREF HIV measures quality of life for those with HIV over 31 questions. 
15 

●
HIV prevalence by 5 year age groups 
●
Rate of progression to death through four equal durations 
●
HIV stages defined by mean CD4 count 
Economic outcomes (to be obtained through the patient chart review include): 
●
ARV drug costs 
●
Treatment literacy level 
●
Clinic consultations (for ART delivery and OI and AE treatment) 
●
Laboratory tests (including CD4, viral load and routine monitoring tests) 
●
X­rays 
●
Diagnostic procedures 
●
Personnel training costs 
●
Number of consultations with i) doctors; ii) nurses consultations; iii) other health care
 
 
 
   
 
 
 
 
 
 
 
 
personnel 
●
Number of home visits 
●
Number of counsellor consultations 
●
Total annual per patient cost of providing a comprehensive model of ART linkage to
 
 
 
 
 
 
   
 
 
 
 
 
 
care using the smartphone app (receiving laboratory results and linkage­to­care) plus
 
 
 
 
 
 
 
 
 
 
 
cost over 10 years 
  
Cost­effectiveness analysis involves the comparison of two or more competing methods in
 
 
 
 
 
 
 
 
 
 
 
 
terms of both their costs and consequences. The outcome measure of the cost­effectiveness
 
 
 
 
 
 
 
 
 
 
 
 
 
work will be the cost of ART initiation with a particular intervention in South African Rand
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
(ZAR) per disability adjusted life year (DALY) averted. The lower the cost per DALY averted,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the more cost­effective the intervention. It will be based on a 5% discount rate. 
  
For each target and cost scenario, this analysis will be able to provide the estimated impact
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
in terms of OI and AE averted, impact in HIV stage defined by CD4 count and treatment
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
costs and deaths averted due to ART linkage to care of those using the smartphone app.  
Participant opt­out 
All participants will be provided with contact information for the study team and will be
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
informed that they can drop out of the study at any time with no consequences (as per Good
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical Practice guidelines). Should a participant request to withdraw from the study the
 
 
 
   
 
 
 
 
 
 
 
 
team will identify their informed consent sheet and mark it accordingly, remove the patient’s
 
 
 
 
 
 
 
 
   
 
 
 
 
data from REDCap and notify the NHLS if they are part of the intervention arm to ensure they
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
will not receive additional notifications of laboratory results. The participant will be asked if
 
 
 
 
 
 
 
 
 
 
 
 
   
they would like to keep their username and password active to access the app in the future;
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
their account will be deleted or kept accordingly. 
Safety considerations 
Accidental disclosure (through phone loss/theft/borrowing or any other method) will be limited
 
 
 
 
 
 
 
 
 
 
 
 
by the study team as much as possible. This will be done actively by having a username,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
password AND PIN code for app use. Additionally, the recruitment team will inform
 
 
 
 
 
 
 
 
 
 
 
 
 
participants of the sensitive information on the app and request that they don’t share it with
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
16 

anyone. Lastly, the app icon and name will not relate to health or HIV in any way; only after
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the username and password is entered will health­related terminology be used. 
Should a participant have any issues regarding their diagnosis or the study they will be able
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
to access help. At recruitment they will be told that for HIV­related queries they can call the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV/AIDS helpline numbers that are shown in the app. For study­related queries, they can
 
 
 
 
 
 
 
 
 
 
 
 
 
 
call the study team on the phone numbers that are listed in the study documentation. 
Data management & statistical analysis 
Data management 
Patient recruitment, demographic, baseline and follow­up survey data will be collected by a
 
 
 
 
 
 
 
 
 
 
 
   
trained and GCP certified researcher using a mobile device (tablet) connected to the
 
 
 
 
 
 
 
 
 
 
 
 
 
REDCap database. REDCap is a secure web­based application designed for virtually
 
 
 
 
 
 
 
 
 
 
 
collecting clinical research data and is used by over 150,000 projects around the world (more
 
 
 
 
   
 
 
 
 
 
 
 
 
 
information at: ​http://project­redcap.org/​). The REDCap Android app, which will be installed
 
 
 
 
 
 
 
 
 
 
 
on the tablets, allows for off­line data collection if there is no internet connection available. 
Laboratory results will be added to the NHLS laboratory database as they are received and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
pushed to the participant through an application layer that is part of the smartphone app. The
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
REDCap database will be connected to the NHLS laboratory database using an API
 
 
 
 
 
 
 
 
 
 
 
 
 
(application programming interface). All HIV­related NHLS laboratory results will be recorded
 
 
 
 
 
 
 
 
 
 
 
as part of the study to monitor the total number and frequency of laboratory tests on study
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
participants. All data transmission between electronic databases/servers will be secured and
 
 
 
 
 
 
 
 
 
 
 
encrypted. 
Paper records (completed informed consent) will be in the control of study staff for the day
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
they are collected. At the end of each day they will be returned to a centralised location (e.g.:
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
RHI offices) where they will be scanned and archived in a data storage room. Once archived
 
 
 
 
 
 
 
 
     
 
 
 
 
 
the paper records will only be accessed under special circumstances (e.g.: a patient
 
 
 
 
 
 
 
 
 
 
 
 
 
withdraws or a confirmation of a patient's acceptance to be in the study is required). 
Data analysis will be conducted by research staff with all identifying participant data
 
 
 
 
 
 
 
 
 
 
 
 
 
de­identified. 
Analysis plan 
The primary outcome, linkage to care around 6 months after initial diagnosis, will be available
 
 
 
 
 
 
   
 
 
 
 
 
 
 
after the final patient recruited has reached the 8 month mark, allowing immediate
 
 
 
 
 
 
 
 
 
 
 
 
 
assessment of the feasibility and immediate impact of the app on initial linkage to care.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Thereafter, retention in care, defined as continuation of HIV care (regular clinic visits with
 
 
 
 
 
 
 
 
 
 
 
 
 
 
laboratory tests and/or medicine pickup) after the linkage to care visit will be assessed 12
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
months after linkage to care had been made. 
Analysis will be done by the study team using STATA. Intention­to­treat will be the primary
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
approach
of
the
analysis
and
all
missing
data
points
will
be
considered
to
be
 
 
 
 
 
 
 
 
 
 
 
 
 
 
loss­to­follow­up. Analysis of the primary outcome will be based on a chi­squared test
 
 
 
 
 
 
 
 
 
 
 
 
 
comparing the proportion of individuals between the study arms and within study sites. A
 
 
 
 
 
 
 
 
 
 
 
 
 
 
17 

logistic regression model, with linkage to care as the dependent variable, will be a secondary
 
 
 
 
 
 
 
 
 
 
 
 
   
 
analysis of the primary outcome. 
For
secondary
outcomes,
chi­squared
tests
will
be
used
for
binary
variables,
 
 
 
 
 
 
 
 
 
 
 
Mann­Whitney­U tests for non­normally distributed variables, and t­tests for continuous
 
 
 
 
 
 
 
 
 
 
variables. Relative risk calculations (at 95% confidence) will be used to compute binary
 
 
 
 
 
 
 
 
 
 
 
 
 
variables. Survival analysis will be conducted to determine linkage outcomes at 6 months. A
 
 
 
 
 
 
 
 
 
 
   
   
sensitivity analysis will be conducted using regression analysis to identify and adjust for
 
 
 
 
 
 
 
 
 
 
 
 
 
potential confounders. 
For the cost­effectiveness analysis, we will have data on direct costs and understand the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
resource requirements for the development of the app. We will corroborate our existing
 
 
 
 
 
 
 
 
 
 
 
 
 
estimates of the smartphone data costs of the patient. The study team will collect data on
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
clients’ opportunity cost as part of the end of the study participant interview as linkage to care
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(as opposed to non­linkage to care) actually takes more time. We will use primary data
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
collect through this study to calculate unit costs associated to providing HIV services. 
From the opportunity cost data collected from patients we will analyse clients’ time spent
 
 
 
 
 
 
 
 
 
 
 
 
 
 
travelling to and being at health facilities to assess service uptake to measure actual patient
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
opportunity cost. The team will separate costs of implementing the SmartLtC intervention and
 
 
 
 
 
 
 
 
 
 
 
 
 
standard of care into categories (e.g. ART, other medicine, laboratory & other tests, health
 
 
 
 
 
 
 
 
 
   
 
 
 
personnel time, overhead and capital costs, patient transport, and lost patient time) which will
 
 
 
 
 
 
 
 
 
 
 
 
 
 
come from the WHO CHOICE database. Additionally, we will calculate DALY’s saved based
 
 
 
 
 
 
 
 
 
 
 
 
 
on disability and deaths averted due to the intervention with weights based on the 2010
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Global Burden of Disease Study.  
Regulatory compliance 
The following methods will be employed to ensure high quality assurance throughout the
 
 
 
 
 
 
 
 
 
 
 
 
 
study period: 
●
All study staff are GCP trained and certified throughout the study period. 
●
The study will not start before it receives ethics permission from the University of
 
 
 
 
 
   
 
 
 
 
 
 
 
Witwatersrand Human Research Ethics Committee (Medical) and approval from the
 
 
 
 
 
 
 
 
 
 
district research committee. 
●
All data collected for the study will be treated sensitively and stored in a secure location
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
(for paper documents) or a secured, password and encrypted database (for electronic
 
 
 
   
 
 
 
 
 
 
 
records) 
Ethics 
As a research institute, all RHI research projects go through both internal and external
 
 
 
 
 
 
 
 
 
 
 
 
 
 
research review. The external review is done through the University of Witwatersrand’s
 
 
 
 
 
 
 
 
 
 
 
 
ethics board, the Human Subjects Research Committee (HSRC). The SmartLtC study will
 
 
 
 
 
 
 
 
 
 
 
 
not start recruiting patients before the committee has reviewed the study and has provided
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ethics clearance. 
Informed consent forms 
Informed consent form can be found at the end of this document in Appendix I. 
18 

Expected outcomes 
This study is expected to have the following outcomes by the end of the project: 
●
An analysis of the effect of the app in linkage to care for the study population and in
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
different demographic and socioeconomic subgroups 
●
An understanding of the acceptability of the laboratory result app 
●
Incremental cost­effectiveness ratio for SmartLtC compared to SOC from the societal
 
 
 
 
 
 
 
 
 
 
 
perspective and the DOH perspective 
●
One or more conference presentations on the study and outcomes 
●
One or more published academic journal articles describing the study and outcomes 
●
A study report providing recommendations to policy makers, other study teams, and
 
 
 
 
 
 
 
 
 
 
 
 
health practitioners. 
Dissemination of results and publication policy 
Study results will be presented at national and international HIV/AIDS management and
 
 
 
 
 
 
 
 
 
 
 
 
clinician conferences and meetings. Study manuscripts will be submitted to the appropriate
 
 
 
 
 
 
 
 
 
 
 
 
journals. Results outcomes will be shared at internal and external research days as well as
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
academic meetings. All these dissemination activities will be planned and carried out in close
 
 
 
 
 
 
 
 
 
 
 
   
 
collaboration with the World Bank team. 
 
 
 
19 

Duration 
Planning is currently ongoing. Recruitment is expected to start: June 1 2015 with 8 months of
 
 
 
 
   
 
 
 
   
 
   
 
 
follow up minimum. Should additional funding be found, a further 12 months of follow­up will
 
 
 
 
 
 
 
   
 
 
 
 
 
 
be conducted (ending December 2016). 
A brief overview is as follows: 
Activity 
Year 1 
Year 2​ (to be fully funded) 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10  11  12  1 
2 
3 
4 
5 
6 
7 
8 
9 
10  11  12 
Project launch 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ethics 
application 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hiring 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Training 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Educational 
development 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Smartphone 
app 
development 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient 
recruitment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis (6 
month 
outcomes at 8 
months) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participant 
follow­up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis 
(12 month 
outcomes at 
14th month) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Report/article 
writing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Problems anticipated 
Potential risks 
The largest potential risk revolves around permission from tiers of government for the project
 
 
 
 
 
 
 
 
 
 
 
 
 
 
to continue. We hope to perform this in different provinces, but are constrained by the limited
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
funding times, so we will need to assess the quickest way forward after we have submitted
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
for permission. 
20 

We have noted that funding is not currently committed for year two, and will mobilise internal
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and other funding should World Bank not be able to commit resources to completing the last
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
phase. A 12 month extension is essential as the primary outcome extends into the second
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
year. The second year will allow the team to look at the effects of the app on ongoing
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
pre­ART monitoring and on patient information concerning VL testing, VL as an adherence
 
 
 
 
 
 
 
 
 
 
 
 
 
tool, and actual viral suppression. 
Since the study is voluntary, there is a chance of bias in patient selection. It is possible that
 
 
 
 
 
     
 
 
 
 
 
   
 
 
 
more involved patients will want to participate and thus more likely to be linked to care and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
retained in care (the healthy participant effect). The randomisation process should mitigate
 
 
 
 
 
 
 
 
 
 
 
 
some of these issues ensuring the same number of ‘involved patients’ are in each arm. As
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
with all voluntary studies, there is a chance that the results might not be completely
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
representative of the general population. This is acknowledged here and will also be
 
 
 
 
 
 
 
 
 
 
 
 
 
acknowledged in any study outcomes that are published. 
As the app is not hidden from the facility nurses, there is a chance that they might change
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
the care they provide due to fear of being reported by the participant or the app. To minimise
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the chance of this, the study team will meet with the HIV nursing team prior to recruitment to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
explain exactly how the app works including what it can and cannot do. 
Finally, there is the challenge of making this app broadly available. If the primary outcome is
 
   
 
 
 
 
 
 
 
   
 
 
   
achieved, that is improved linkage to care, we will engage the government to support the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
national rollout of this application, potentially at the point of first CD4 test. 
Limitations 
The study team acknowledges that self­testing and door­to­door testing clients will not be
 
 
 
 
 
 
 
 
 
 
 
 
 
included in this trial. This is relevant as South Africa will soon have a large push on
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
home­based HIV testing. However, further studies could include these client populations. 
Project management  
The project management team is as follows: 
Name & 
organisation 
Area of expertise 
relevant to study 
Designation 
for study 
Assigned tasks 
% 
time 
Jesse Coleman, 
RHI 
mHealth project 
management & 
health care research 
Principal 
Investigator/proje
ct manager 
Project management 
50% 
Vincent Lau 
Chan, RHI 
mHealth project 
coordination 
Project 
coordinator 
Project coordination 
50% 
Mothepane 
Phatsoane, RHI 
mHealth project 
coordination 
Research 
assistant 
Research assistance 
50% 
Maano 
Nengwani, RHI 
Data management 
Data manager 
Data management 
25% 
Lynsey 
Isherwood, NHLS 
National Health 
Laboratory Service 
App development 
& project support 
App development 
management 
20% 
21 

Willem Daniel 
Francois Venter, 
RHI 
HIV technical expert 
Support to project 
Review of research design 
and conduct, as well as 
technical support on HIV 
educational materials 
10% 
Sergio Carmona, 
NHLS 
National Health 
Laboratory Service 
Support to project 
Review of research design 
and conduct 
10% 
Budget 
The total budget for the first year of the study is $200,992 (approximately R2.3 million as of 8
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
   
February, 2015). 62% ($125,108) of this will be used for staff remuneration while the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
remainder ($75,814) will be used for non­human resource study expenses including
 
 
 
 
 
 
 
 
 
 
 
contracting for app development. 
Timeline 
Detailed timeline of first year: 
●
January report submitted: 5 February 2015 
●
Study protocol complete: 11 February 2015 
●
Site selection: 13 February 2015 
●
Project start­up workshop: 19 & 20 February 2015 
●
World Bank protocol review: 24 February 2015 
●
Wits ethics submission: 6 March 2015 
●
February report: 9 March 2015 
●
Expected ethics approval: late March/early April 2015 
●
Data management system (RedCAP) setup: Feb­Mar 2015 
●
REDCap ready: March 30 2015 
●
Submission to and approval from district research team: April 2015 
●
March report: 3 April 2015 
●
App development: Feb­April 2015 (App developer sub­contract to be signed in early
 
 
 
 
 
 
 
 
 
 
 
 
March ­ Specifications can be found in Appendix III) 
●
App testing: April 2015 
●
Minimum viable product (app): 1 May 2015 
●
April report: 8 May 2015 
●
Study recruitment start: 1 June 2015 
●
May report: 5 June 2015 
●
June report: 6 July 2015 
●
July report: 6 August 2015 
●
Study recruitment end: 31 August 2015 
●
August report: 7 September 2015 (8​th monthly report summarising 8 months of
 
 
 
 
 
 
 
 
 
 
 
 
implementation and a contract deliverable) 
●
Follow­up: June­December 2015 
●
Data analysis: Nov­Dec 2015 
●
Draft study report: 11 December 2015 
●
Expiration of contract: 31 December 2015 
●
Final report & STATA database: 29 Jan 2016 
●
Academic manuscript: 1 April 2016 
22 

References 
Aker J, Ksoll, C. (2015) ​“Call Me Educated: Evidence from a Mobile Monitoring 
Experiment in Niger.” Available at 
https://www.tcd.ie/Economics/assets/pdf/Seminars/20142015/Acker%20Call%20Me%20Edu
cated_13feb2015.pdf. Accessed on 10 March, 2015. 
Cheever LW. (2007) Engaging HIV­infected patients in care: their lives depend on it. 
Clinical Infectious Disease. 44(11):1500­02. 
Shisana, O, Rehle, T, Simbayi LC, Zuma, K, Jooste, S, Zungu N, Labadarios, D, 
Onoya, D et al. (2014) South African National HIV Prevalence, Incidence and Behaviour 
Survey, 2012. Cape Town, HSRC Press. 
Faal, M., et al. (2011). Providing immediate CD4 count results at HIV testing improves 
ART initiation. J Acquir Immune Defic Syndr 58(3): e54­59. 
Harris P, Taylor R, Thielke R, Payne J, Gonzalez N, Conde J. (2009) Research 
electronic data capture (REDCap) ­ A metadata­driven methodology and workflow process 
for providing translational research informatics support, J Biomed Inform. 2009 
Apr;42(2):377­81. 
Kranzer K, Zeinecker J, Ginsberg P, Orrell C, Kalawe NN, et al. (2010) Linkage to HIV 
Care and Antiretroviral Therapy in Cape Town, South Africa. PLoS ONE5(11): e13801. doi: 
10.1371/journal.pone.0013801 
Larson BA, Schnippel K, Brennan A, Long L, Xulu T, Maotoe T, Rosen S, Sanne I, Fox 
MP. (2013) Same­Day CD4 Testing to Improve Uptake of HIV Care and Treatment in South 
Africa: Point­of­Care Is Not Enough. AIDS Res Treat. 2013:941493. 
Lester, R. T., et al. (2010). Effects of a mobile phone short message service on 
antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet 
376(9755): 1838­1845. 
O’Connor C, Osih R, Jaffer A. (2011) Loss to Follow­Up of Stable Antiretroviral 
Therapy Patients in a Decentralised Down­Referral Model of Care in Johannesburg, South 
Africa. J Aids. 58(4): 429:432. 
Pop­Eleches, C, et al. (2011). Mobile phone technologies improve adherence to 
antiretroviral treatment in a resource­limited setting: a randomized controlled trial of text 
message reminders. Aids. 25(6): 825­834. 
Rosen S, Fox MP (2011) Retention in HIV Care between Testing and Treatment in 
Sub­Saharan Africa: A Systematic Review. PLoS Med 8(7): e1001056. doi: 
10.1371/journal.pmed.1001056 
Takuva S, Brown A, Macleod W, Pillay Y, Delpech V, Puren A. (2015) Engagement 
Within HIV Care in South Africa: Implications for Prevention. Presentation from the 2015 
Conference on Retroviruses and Opportunistic Infections (CROI). 
Techcentral. (2014) And now for the R200 smartphone. Published: 12 May 2014. 
Accessed: 20 November 2014. Available at: 
http://www.techcentral.co.za/and­now­for­the­r200­smartphone/48075/ 
 
23 

Appendix I: Informed Consent 
Information Leaflet and Informed Consent 
Smartphone Linkage to Care (SmartLtC) 
  
SPONSOR:​ The World Bank 
INVESTIGATOR:​ Jesse Coleman 
CO-INVESTIGATORS:​ Vincent Lau Chan, Prof. Francois Venter 
INSTITUTION: ​Wits Reproductive Health and HIV Institute (RHI) 
DAYTIME AND AFTER HOURS TELEPHONE NUMBER(S): ​011 358 5400/072 676 9854 
  
1.  INTRODUCTION: 
Hello, my name is ___________. I am a fieldworker with the Wits Reproductive Health and HIV
 
 
  
  
  
 
 
 
 
 
 
 
 
Institute; an organisation associated with the University of the Witwatersrand I am assisting with
 
 
 
 
 
 
 
 
 
  
 
 
 
some research. We would like to invite you to consider being a part of a research study which aims
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
to test a new way to support HCT clients. I would like to take a few minutes to explain to you how
 
  
 
 
 
 
 
  
 
  
  
 
 
 
 
 
 
 
this programme works. Before agreeing to participate, it is important that you read and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
understand the following explanation of the purpose of the programme, the procedures, benefits,
 
 
 
 
 
 
  
 
 
 
 
 
and risks, and your right to withdraw from the programme at any time. This information leaflet is
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
to help you to decide if you would like to give your permission to participate. You should fully
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
understand what is involved before you decide to take part in this programme. If you have any
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
questions, do not hesitate to ask me. You should not agree to take part unless you are satisfied
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
with the information relating to all the procedures involved. If you decide to take part in this study,
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
you will be asked to sign this document to confirm that you understand what is involved. You also
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
be required to give us your cellphone number so that we can contact you at a later stage. You will
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
be given a copy of the information sheet to keep. 
  
2.   PURPOSE OF THE STUDY: 
∙
​The purpose of this study is to test a new way of improving HIV care in public health care
 
 
 
 
 
  
 
  
 
 
 
 
 
  
 
 
 
facilities. 
∙​        ​Some participants of the study will receive extra health information relating to their HIV status. 
∙​        ​If you agree to participate, please indicate your willingness to the research staff. 
  
24 

3. LOCATION OF THE PROGRAMME AND DESCRIPTION OF PARTICIPANTS: 
∙​The research will be conducted with users of Hillbrow CHC and Helen Joseph Hospital. 
∙​All participants will be older than age 18 and be receiving health services from the locations listed
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
above. 
∙​Potential participants must own an Android smartphone (e.g.: Samsung, Sony, LG) 
  
4.   PROCEDURES: 
∙ 
If you agree to participate in this programme, we will put your name and other
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
information in a secret database. No-one except me and the project team will have access to this
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
information. 
∙ 
You will continue to receive care as usual from the health care site, including blood draws,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
laboratory results, medicines, and counselling. 
∙ 
You will not be given any experimental medicines as part of this programme and there will
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
be no other procedures performed which is not part of your routine care. 
∙ 
You will have access to the same treatment regardless (even if you do not agree to
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
participate) 
∙ 
You may at any point during the study decide to withdraw. Your feedback is welcome. If
 
 
 
 
 
 
 
 
 
 
 
 
  
  
you consent to participate, and decide to withdraw at a later stage, an opt-out option will be
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
provided. 
∙ 
During the course of the study, you might be asked to give feedback about your
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
experiences with the study. Participation is optional and you will receive the same treatment and
 
 
 
 
  
 
 
 
 
 
 
 
 
 
care if you decline to participate 
· 
You have a 50% chance of falling into the group that will not be using the cell phone App 
· 
Irrespective of the group you are in, you will be provided R50 airtime 
 
  
5.   WILL ANY OF THESE STUDY PROCEDURES RESULT IN DISCOMFORT OR INCONVENIENCE? 
∙ 
We will not cause you any additional pain or discomfort beyond the routine care which
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
you will receive. 
  
6. BENEFITS & RISKS 
 Benefits  
 
By enrolling in this programme, you may receive access to additional health and wellness
 
 
 
 
 
 
 
 
 
 
 
 
 
 
information about status. The chances of you receiving access to this information is random,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
similar to flipping a coin. If you do not receive this information, you will still receive normal
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
informational and care. 
Risks 
25 

Due to the nature of this study, there is a possibility of accidental disclosure of your HIV status.
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
The study team staff will explain to you how to minimise accidental disclosure. 
 
7.​ ​RIGHTS AS A PARTICIPANT IN THIS PROGRAMME: 
§ ​Your decision to participate in this study is completely free and you can decline to be part of the
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
  
 
programme at any time, without stating any reason.  
§
​Your decision participate in this study will not affect the care you receive in the clinic or your
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
relationship to the hospital/clinic in any way. 
  
8. FINANCIAL ARRANGEMENTS: 
∙​        ​There are no costs to participate in the study. 
  
9. REIMBURSEMENT FOR STUDY PARTICIPATION: 
∙
​You will be provided with a R50 mobile phone credit voucher if you participate in this study to
 
 
 
 
 
  
 
 
 
 
  
 
  
 
 
 
say Thank You for giving us some of your time today for this research. 
  
10.  ETHICAL APPROVAL: 
∙ 
This quality improvement protocol has been submitted to the University of the
 
 
 
 
 
 
 
 
 
 
 
 
Witwatersrand, ​Human Research Ethics Committee (HREC) ​and written approval has been
 
 
 
 
 
 
 
 
 
 
 
granted by that committee. 
∙
​The programme has been structured in accordance with the ​Declaration of Helsinki (last
 
 
 
 
 
 
 
 
 
 
 
 
 
 
updated: October 2008), which deals with the recommendations guiding doctors in biomedical
 
 
 
 
 
 
 
 
 
 
 
 
research involving human participants.
A copy may be obtained from me should you wish to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
review it. 
∙
​The 24-hour telephone number through which you can reach me or another authorised person
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
– 011 358 5400/ 072 676 9854 
If you change your number during the course of the study please send a please-call-me to the
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
following number 072 676 9854. We will then contact you to get your new phone number. 
∙
​If you want any information regarding your ​rights as a research participant, or complaints
 
 
 
 
 
 
 
 
 
  
 
 
 
 
regarding this programme​, you may contact Prof. Cleaton-Jones, Chairperson of the University of
 
 
 
 
 
 
 
 
 
 
 
  
the Witwatersrand, Human Research Ethics Committee (HREC), which is an independent
 
 
 
 
 
 
 
 
 
 
 
committee established to help protect the rights of research participants at (011) 717 2301. 
  
11.  CONFIDENTIALITY: 
∙
​All information obtained during the course of this programme implementation, including
 
 
 
 
 
 
 
 
 
 
 
 
hospital records, personal data and routine programme or clinical data will be kept strictly
 
 
 
 
 
 
 
 
 
 
 
 
 
 
confidential. Data that may be reported in scientific journals will not include any information that
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
identifies you as a participant in this programme. 
26 

∙
​The information might be inspected by the University of the Witwatersrand, Human Research
 
 
 
 
 
 
 
 
  
 
 
 
 
Ethics Committee (HREC), and the South African Medicines Control Council (MCC). Therefore, you
 
 
 
 
 
 
 
 
 
 
 
 
 
hereby authorise me to release your medical records to the South African Medicines Control
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Council and the University of the Witwatersrand, Human Research Ethics Committee (HREC). 
∙
​These records will be utilised by them only in connection with carrying out their obligations
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
relating to this programme implementation. 
∙
​Any information uncovered regarding your test results or state of health as a result of your
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
participation in this programme will be held in strict confidence. This information will not be
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
disclosed to any third party in addition to the ones mentioned above without your written
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
permission. The only exception to this rule will be cases of communicable diseases where a legal
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
duty of notification of the Department of Health exists. 
 
WRITTEN PARTICIPANT INFORMED CONSENT: 
I hereby confirm that I have been informed by the ​interviewer (fieldworker’s name)
  
 
 
  
 
 
 
 
 
 
 
 
______________________​, about the nature, conduct, benefits and risks of the mobile health
 
 
 
 
 
 
 
 
 
 
 
 
programme which gives me personalised health information. 
I have also received, read and understood the above written information ​(Participant Information
 
 
 
 
 
 
 
 
 
 
 
 
 
Leaflet and Informed Consent)​ regarding the programme intervention. 
●
I am aware that the information obtained from this programme, including personal details
 
 
 
 
 
 
 
 
 
 
 
 
 
regarding my sex, age, initials and diagnosis will be anonymously processed into a report. 
●
In view of the requirements of research, I agree that the data collected during this
 
 
 
 
 
 
  
 
 
 
 
 
 
 
programme can be processed in a computerised system by the Wits Institute of University of
 
 
 
 
  
 
 
 
 
 
 
 
 
 
Witwatersrand. 
●
I may, at any stage, without prejudice, withdraw my consent and participation in the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
programme. 
∙ 
I have had sufficient opportunity to ask questions and (of my own free will) declare
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
permission to participate in this programme. 
  
PARTICIPANT​: 
 Name 
Surname 
 
_______________________________ 
________________________  
 Signature 
 
Date and Time 
 ____________________________________________________________________________ 
I​, (Interviewer) __________________, herewith confirm that the above participant has been fully
  
 
 
 
 
 
 
 
 
 
 
 
informed about the nature, conduct and risks of the above programme. 
 Interviewer (Fieldworker)​: 
 ​Printed: 
Name & Surname                         Signature                                       Date and Time 
27 

 
 
 
 
28 

VERBAL PARTICIPANT INFORMED CONSENT: 
(Applicable only when participants cannot read or write) 
  
∙
​I, the undersigned, (​interviewer​) ………..................................have read and have explained
 
 
 
 
 
 
 
 
 
 
fully to the participant, named ........................…………………………. the participant information
 
 
 
 
 
 
 
 
 
leaflet. 
∙
​The account I have given has explained both the possible risks and benefits of participating in
 
 
  
 
 
 
 
 
 
 
 
 
  
  
this programme. 
∙
​The participant indicated that he/she understands that they will be free to withdraw from the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
programme at any time for any reason and without jeopardising his/her subsequent treatment.  
 ​I hereby certify that, the participant has agreed to participate in this programme​. 
 PARTICIPANT: 
 ​Printed Name 
Printed Surname 
 
_____________________________ 
____________________________ 
Mark or Thumbprint (if applicable) 
Date and Time 
 _____________________________ 
____________________________ 
Witness Name 
 
Date and Time 
_____________________________ 
 
Witness Signature 
 
 ​_______________________________________________________________________  
Interviewer (Fieldworker): 
 
Printed Name 
Signature 
Date and Time 
 
29 

Appendix II: Participant survey tools 
 
 
Population survey 
(To be given to all newly diagnosed HIV­positive patients that have had CD4 count
 
 
 
 
 
 
 
 
 
 
 
 
 
 
bloods drawn) 
1 
Recruitment Date: 
2 
Recruitment site: 
3 
Gender: 
4 
Date of birth: 
5 
Marital status: 
6 
Suburb currently living in: 
7 
Country of birth: 
8 
Highest education received: 
9 
What is your current employment status?  
10 
Usual monthly household income: (Note: still being reviewed based on discussions
 
 
 
 
 
 
 
 
 
 
 
around Proxy Means Test method) 
11 
Preferred language for reading: 
12 
Do you share your phone with someone?: Y/N 
13 
Do you own a smartphone? Y/N 
14 
Do you use data on your smartphone (eg: WhatsApp, WeChat, Mxit, web page,
 
 
 
 
 
 
 
 
 
 
 
 
 
email)? 
 
 
 
Recruitment survey 
(To be given to all eligible and willing participants) 
1 
First name: 
2 
Last name: 
3 
Phone number: 
4 
SA ID, Passport or refugee number: 
5 
Lab Specimen ID number: 
30 

6 
WHO staging on patient chart: 1, 2, 3 or 4 
 
 
 
Reason for ineligibility survey 
(To be given to ineligible patients) 
1 
Age ­ Under 18 
2 
Phone ­ Not Android/Not working/Not active 
2a 
Type of phone: 
3 
No photo proof of identity 
4 
Cannot read English or Zulu 
5 
Not willing/unable to sign informed consent 
6 
Pregnant 
7 
Refused to participate 
 
  
HIV/CD4 Count/VL knowledge 
All answers are true/false (Correct answer in parentheses) 
(To be given at baseline and end of study for all participants) 
1 
A healthy­looking person can have HIV. (True) 
2 
Coughing and sneezing DO NOT spread HIV. (True) 
3 
A person can get HIV by sharing a glass of water with someone who has HIV.
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
(False) 
4 
A woman can get HIV if she has anal sex with an HIV positive man. (True) 
5 
Showering, or washing one’s genitals/private parts, after sex keeps a person from
 
 
 
 
 
 
 
 
   
 
 
getting HIV. (False) 
6 
A pregnant woman infected with HIV and taking medicines will always have a baby
 
 
 
 
 
 
 
 
 
 
 
   
 
born with HIV. (False) 
7 
People who have been infected with HIV quickly show serious signs of being
 
 
 
 
 
 
 
 
 
 
 
 
 
infected. (False) 
8 
A woman cannot get HIV if she has sex during her period. (False) 
9 
There is a female condom that can help decrease a woman’s chance of getting
 
   
 
 
 
 
 
   
 
 
 
 
HIV. (True) 
31 

10 
A person will NOT get HIV if she or he is taking antibiotics. (False) 
11 
A person can get HIV from oral sex. (True) 
12 
HIV can be transmitted through vaginal sex without condoms. (True) 
13 
HIV cannot be transmitted through use of public toilets. (True) 
14 
HIV cannot be transmitted through sweat. (True) 
15 
Use of birth control pills cannot prevent people from getting the HIV/AIDS virus.
 
 
 
 
 
 
 
 
 
 
 
 
 
(True) 
16 
There is no vaccine available that can keep people from getting AIDS. (True) 
17 
Antiretroviral drugs keep people living with HIV/AIDS. from getting sick or dying.
 
 
 
 
 
 
 
 
 
 
 
 
(True) 
18 
HIV can be transmitted by eating and drinking from the same plate or glass of an
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV­positive person.  (False) 
19 
HIV can be transmitted through a mosquito bite. (False) 
20 
HIV can be prevented by properly using condoms during sexual intercourse. (True) 
21 
Antiretroviral drugs can cure HIV/AIDS. (False) 
22 
Antiretroviral drugs can prolong the life of people infected with HIV/AIDS. (True) 
23 
Men and women normally have the same CD4 count. (False) 
24 
Physical activity can impact CD4 count. (True) 
25 
A lower CD4 count is better. (False) 
26 
HIV decreases CD4 count in people who don't take ARVs. (True) 
27 
A person's CD4 count helps determine if they should be on ARVs. (True) 
28 
An HIV­negative person always has the same CD4 count. (False) 
29 
People with HIV who are not on ARVs should check their CD4 count every 6
 
 
 
 
 
 
 
 
 
 
 
 
 
   
months. (True) 
30 
People with HIV are more likely to get other diseases like TB. (True) 
31 
A viral load test determines how much HIV is in the blood. (True) 
32 
CD4 counts and viral load tests don't help HIV infected people at all. (False) 
33 
A higher viral load is better. (False) 
34 
Someone who takes their ARV medicine regularly will likely end up with an
 
 
 
 
 
 
 
 
 
 
 
 
 
'undetectable' viral load. (True) 
32 

 
 
WHOQOL­BREF HIV 
(To be given at end of study for all participants) 
1 
What is your marital status? 
2 
How is your health (Very poor/Poor/Neither Poor nor Good/Good/Very Good) 
3 
Do you consider yourself currently ill? Yes/No 
4 
If there is something wrong with you, what do you think it is? 
5 
In what year did you first test positive for HIV? 
6 
In what year do you think you were infected? 
 
All questions below are Likert­scale (1­5) based on the original WHOQOL­BREF HIV
 
 
 
 
 
 
 
 
 
 
 
 
tool 
7 
How would you rate your quality of life? 
8 
How satisfied are you with your health? 
9 
To what extent do you feel that physical pain prevents you from doing what you
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
need to do? 
10 
How much are you bothered by any physical problems related to your HIV infection? 
11 
How much do you need any medical treatment to function in your daily life? 
12 
How much do you enjoy life? 
13 
To what extent do you feel your life to be meaningful? 
14 
To what extent are you bothered by people blaming you for your HIV status? 
15 
How much do you fear the future? 
16 
How much do you worry about death? 
17 
How well are you able to concentrate? 
18 
How safe do you feel in your daily life? 
19 
How healthy is your physical environment? 
20 
Do you have enough energy for everyday life? 
21 
Are you able to accept your bodily appearance? 
22 
Do you have enough money to meet your needs? 
23 
To what extent do you feel accepted by the people you know? 
33 

24 
How available to you is the information that you need in your day­to­day life? 
25 
To what extent do you have the opportunity for leisure activities? 
26 
How well are you able to get around? 
27 
How satisfied are you with your sleep? 
28 
How satisfied are you with your ability to perform your daily living activities? 
29 
How satisfied are you with yourself? 
30 
How satisfied are you with your personal relationships? 
31 
How satisfied are you with your sex life? 
32 
How satisfied are you with the support you get from your friends? 
33 
How satisfied are you with the conditions of your living place? 
34 
How satisfied are you with your access to health services? 
35 
How satisfied are you with your transport? 
36 
How often do you have negative feelings such as sadness, despair, anxiety, 
depression? 
 
 
Satisfaction survey 
Likert Scale (1 Strongly disagree ­ 5 Strongly agree) 
(To be given at end of study. Note: Questions in bold will only be asked to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
intervention patients) 
1 
Overall I am very happy with the study 
2 
Overall I am very happy with the app 
3 
The app helped me learn about my condition 
4 
The app was easy to use 
5 
The language in the app was easy to understand 
6 
I felt like I could trust the information in the app 
7 
I learnt a great deal about HIV in the past 12 months 
8 
I learnt a great deal about CD4 count in the past 12 months 
9 
I learnt a great deal about viral load in the past 12 months 
10 
I would recommend the app to other patients 
34 

11 
The app made life easier for me 
12 
The clinic staff was always friendly when received HIV care 
13 
I feel I know a great deal about HIV 
14 
I feel I have the tools to keep myself healthy 
15 
I feel I could help a friend who was HIV­positive 
16 
I visited the frequently asked questions (FAQ”s) in the app 
17 
The frequently asked questions (FAQ”s) were helpful 
18 
The frequently asked questions (FAQ”s) were relevant 
19 
I read the “More Information” section of the app 
20 
The “More Information” section of the app was helpful 
21 
The “More Information” section of the app was relevant 
22 
The explanation of CD4 count was useful 
23 
I went to the links to additional sites to get more information 
24 
The reminder to go for an additional test at 6 months was helpful 
25 
The reminder to go for the additional tests was useful 
26 
I would recommend the app to other people 
27 
The app would have been more useful if it covered other health issues. 
 
 
Costs incurred tool 
(To be given at end of study for all participants) 
1 
How much do you usually pay per month to support the routine use of your mobile
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
phone (including air time, maintenance, and other costs)? 
2 
How much money do you usually spend on transportation to attend the HIV clinic? 
3 
Do you usually take time off from work to attend the HIV clinic? 
3a 
If yes, how much money or income did you lose because of this absence from work? 
4 
What is the amount of time (in minutes) you usually spend on your HIV clinic visits
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
from the time you depart (your home, work or elsewhere) to go to the health facility
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
until the time you returned? 
4a 
Travel time (round trip): _______ 
 Waiting time: _______ 
35 

Consultation time: _______ 
Pharmacy time (obtaining medicines): _______ 
Total time: _______ 
5 
Did you have to pay someone to take care of any other children while you attended
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the HIV clinic? 
5a 
If yes, how much did you spend?  
6 
How many times have you been to the clinic to receive HIV care since your HIV
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
diagnosis? 
7 
Did you ever attend the clinic for care and were not seen? 
7a 
Why were you not seen? 
­ Attended wrong time/day 
­ Clinic too busy 
­ Other: _______ 
 
 
ACTG Adherence Tool ​­ Standardised HIV treatment adherence tool 
(To be given at end of study to study participants on ARV medicine) 
1 
What HIV medicines are you currently taking? 
2 
How many pills of each do you take each time? 
3 
How many times a day do you take each of your pills? 
4 
How many doses of each of your pills did you miss yesterday? 
5 
How many doses of each of your pills did you miss the day before yesterday? 
6 
How many doses of each of your pills did you miss three days ago? 
7 
How many doses of each of your pills did you miss four days ago? 
8 
During the past 4 days, on how many days have you missed taking all your doses? 
9 
Most anti­HIV medications need to be taken on a schedule, such as '2 times a day'
 
 
 
 
 
 
 
   
 
 
   
   
 
or '3 times a day' or 'every 8 hours.' How closely did you follow your specific
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
schedule over the last four days? 
10 
Do any of your anti­HIV medications have special instructions, such as 'take with
 
 
 
 
 
 
 
 
 
 
 
 
 
food' or 'on an empty stomach' or 'with plenty of fluids?' 
10a 
If Yes, how often did you follow those special instructions over the last four days? 
11 
Some people find that they forget to take their pills on the weekend days. Did you
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
miss any of your anti­HIV medications last weekend­­ last Saturday or Sunday? 
12 
When was the last time you missed any of your medications? 
36 

13 
People may miss taking their medications for various reasons. Here is a list of
 
 
 
 
 
 
 
 
 
 
   
 
 
possible reasons why you may miss taking your medications. How often have you
 
 
 
 
 
 
 
 
 
 
 
 
 
missed taking your medications because you: 
Were away from home? 
Were busy with other things? 
Simply forgot? 
Had too many pills to take? 
Wanted to avoid side effects? 
Did not want others to notice you taking medication? 
Had a change in daily routine? 
Felt like the drug was toxic/harmful? 
Fell asleep/slept through dose time? 
Felt sick or ill? 
Felt depressed/overwhelmed? 
Had problems taking pills at specified times (with meals, on empty stomach, etc.) 
Ran out of pills? 
Felt good? 
14 
The following questions ask about symptoms you might have had during the past
 
 
 
 
 
 
 
 
 
 
 
 
 
four weeks. Please select, from 1 (I do not have this symptom) to 5 (I have this
 
 
 
 
     
 
 
 
 
 
     
 
 
symptom and it bothers me greatly) the answer which describes how much you
 
   
 
 
 
 
 
 
 
 
 
 
have been bothered by each symptom: 
Fatigue or loss of energy? 
Fevers, chills or sweats? 
Feeling dizzy or lightheaded? 
Pain, numbness or tingling in the hands or feet? 
Trouble remembering? 
Nausea or vomiting? 
Diarrhoea or loose bowel movements? 
Felt sad, down or depressed? 
Felt nervous or anxious? 
Difficulty falling or staying asleep? 
Skin problems, such as rash, dryness or itching? 
Cough or trouble catching your breath? 
Headache? 
Loss of appetite or a change in the taste of food? 
Bloating, pain or gas in your stomach? 
Muscle aches or joint pain? 
Problems with having sex, such as loss of interest or lack of satisfaction? 
Changes in the way your body looks, such as fat deposits or weight gain? 
Problems with weight loss or wasting? 
Hair loss or changes in the way your hair looks? 
 
 
37 

Appendix III: App specifications 
General use case description: 
I.
A newly diagnosed HIV­positive patient with Android smartphone will be
 
 
 
 
 
 
 
 
 
 
enrolled to the SmartLtC study by study staff and randomised to receive the
 
 
 
 
 
 
 
 
 
 
 
 
 
smartphone app or not. Upon being randomised to smartphone app arm, the
 
 
 
 
 
 
 
 
 
 
 
 
study staff member will install the app on the phone through a USB cable
 
 
 
 
 
 
 
 
 
 
   
 
 
connection, (or through a Library Box ­ http://librarybox.us/whatis.php). The
 
 
   
 
   
 
 
app icon and name will not refer to health or medicine in any way to ensure
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
privacy for the user. 
II.
Once app has been installed patient will create username and password, and
 
 
 
 
 
 
 
 
 
 
 
 
select PIN code. The app can then be accessed immediately which will
 
 
 
 
 
 
 
 
 
 
 
 
provide
access
to
“More
information”
and “FAQ’s” (Frequently Asked
 
 
 
 
 
 
 
 
 
Questions) sections, but will not include lab results. The study staff member
 
 
 
 
 
 
 
 
 
 
 
 
5
will provide the patient with a brief training session on use of the app. Patients
 
 
 
 
   
 
 
 
 
   
 
 
 
will be informed that they can read “More information” and “FAQ” sections at
 
 
 
 
 
 
 
 
 
 
 
 
 
any time, but laboratory results will only be displayed after they have been
 
 
 
 
 
 
 
 
 
 
 
 
 
received. All past results will be accessible to the patients and displayed along
 
 
 
 
 
 
   
 
 
 
 
 
with any new results. 
III.
When a CD4 count/Viral Load (VL) result is received by the NHLS database
   
 
 
 
 
   
 
 
 
 
 
an App­based notification will show on the patient's screen informing them
 
 
 
 
 
 
 
 
 
 
 
new information is available and to open the app. (Suggested text for the
 
 
 
 
 
 
 
 
 
 
 
 
 
app­based notification “You have new information waiting. Please open the
 
 
 
 
 
 
 
 
 
 
app”.) Once the patient opens the app and enter their PIN code (which is
 
 
 
 
 
 
 
 
 
 
 
 
 
 
verified by the server) their CD4/VL result is shown under “Lab results” in the
 
 
 
 
 
 
   
 
 
 
   
 
app. The CD4 count/VL results will be written in red, yellow or green to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
highlight the relative immediacy of action needed by the patient. 
IV.
If the patient selects a CD4 count number (to be a suggested action on
 
 
 
   
 
 
 
 
   
 
 
 
screen), a pop­up screen will provide a basic explanation of what that CD4
   
 
 
 
   
 
 
 
 
 
 
count means and what action they need to take. (Note: The numerical text will
 
 
 
 
 
 
 
 
 
 
 
 
 
 
be coloured and the pop­up screen will also display a visual­analogue scale
 
 
 
 
 
 
 
 
   
 
 
going from red to yellow to green, with a marker showing where the patient's
 
 
 
 
 
 
 
   
 
 
 
 
 
CD4 count sits along the scale.) At the bottom of the pop­up will be a link to
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
more detailed information about HIV and laboratory results. On every screen
 
 
 
 
 
 
 
 
 
 
 
will be a link to a help page which displays the contact number for the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
National AIDS Helpline and the study coordinator. 
V.
HIV­positive patients require life­long care and treatment. For follow­up care,
 
 
 
 
 
 
 
 
 
 
the app will notify the patient that it is almost time to attend a follow­up blood
 
 
 
 
 
 
     
 
 
 
   
 
 
test (at both 5.5 months and 6 months after the first CD4 count result has
 
 
 
 
 
   
 
 
 
 
 
 
 
 
been received). Patients will attend the clinic for a second blood test (the
 
 
 
 
 
 
 
   
 
 
 
 
follow­up CD4 counts or VL) at the 6 month mark. The app will connect to the
 
 
 
 
 
 
   
 
 
 
 
 
   
 
results server daily at this point until there is a new laboratory result in the
 
 
 
 
 
 
 
 
   
 
 
 
 
 
database. When the app received the new lab result the app will create
 
 
 
 
 
 
 
 
 
 
 
 
 
another notification for the patient to check their results through the app. 
VI.
Regular 6 month or 1 year (depending on patient's most recent CD4 count)
   
 
   
 
 
 
 
 
 
 
 
blood tests must be done. The app will create reminder notifications, ping the
 
 
 
 
 
 
 
 
 
 
 
 
 
5 ​Note: Wits RHI to supply medical content for the “More information” and “FAQ’s”. 
38 

server for results soon afterwards, and notify the patient when the results are
 
 
 
 
 
 
 
 
 
 
 
 
 
received. 
VII.
App analytics on use is to be collected within the app. This will include patient
 
 
 
   
 
 
 
 
 
 
 
 
 
 
use of the app such as length of time app is open, number of times app
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
opened, which screens were seen, number of unsuccessful and successful
 
 
 
 
 
 
 
 
 
 
lab result collections, number of incorrect username/password or PIN errors
 
 
 
 
 
 
 
 
 
 
etc. 
 
A tabular overview of app requirements is available below: 
Platform 
Android smartphone running Gingerbread or higher 
Deployment 
On­site USB/Wi­Fi (LibraryBox) install by research staff 
Use of 
Smartphone 
App 
­ Patient registration will occur at clinic site with study staff 
member; Demographic information, photo ID and lab ID required. 
­ Patient will receive an Android notification through their app on 
their phone when new CD4/VL result is in NHLS database 
­ Patient can view CD4 results (new and historical) on app 
  ­ NB: CD4 and VL results are colour­coded (red, yellow, green) 
based on  
          ­ CD4 level: yellow >500, red < 501 
          ­ VL: green below 1001, red above 1000 
­ Patient can select individual results which will open up an 
information box explaining what that result means along with a 
visual­analogue scale showing green to yellow to red and where 
the patient's CD4 count or viral load sits on the scale 
­ Patient offered FAQ and information sections to learn more 
about HIV (‘basics’. ‘signs and symptoms of co­infection, ‘sex and 
hiv’),  laboratory results, online resources, and contact 
information (National AIDS helpline) 
­ Contact numbers (study coordinator, SA AIDS helpline) and 3rd 
party HIV­related websites provided in app help 
­ Patient to receive further Android notification at 5.5 months and 
6 months after app installation to remind about upcoming visit to 
clinic for additional blood test. 
Authorization 
& 
Authentication 
At first use: 
­ Patient to create username (e­mail address?)  and password 
connected to SA ID/Passport number/Refugee number & Lab 
Requisition ID 
Notes​: 
­
Must create or connect to NHLS database for results! 
­
Server­side user creation  
At subsequent use: 
­ PIN required at every use of app (similar to Standard Bank 
android app) 
   ­ Server­side PIN authentication 
­ PIN and/or password change possible (how?) 
39 

App & data 
security 
Network 
­ All passwords and patient data encrypted  
App 
­ All app data to be encrypted 
­ PIN not stored locally 
Main screens 
­ Login: UN/PW 
­ PIN code 
­ Lab results 
­ More information 
­ FAQ 
­ Help me (available from any screen) 
Notifications 
or Alerts (to 
patient) 
App­based notification when: 
­ Patient joins study: Welcome message 
­ New patient laboratory result arrives to phone from lab 
database: Notification of new information 
­ It is time for patient to return to clinic for blood test (reminders; 
early notification at 5.5 months, regular notification at 6 months): 
Reminder to attend clinic 
Note: 
­
Notifications created by app based on time passed and 
results available 
Patient 
enrolment 
details (to link 
to NHLS 
database) 
­ First name 
­ Last name 
­ SA ID, passport or refugee number 
­ DOB (if no SA ID number) 
­ Gender 
­ Lab requisition ID of blood specimen 
Important 
contact 
information 
Help icon displayed at bottom of every screen (even login) to 
allow for easy access to support. Selecting icon will provide a list 
of support numbers (study coordinator, SA AIDS helpline) and 
3rd party HIV­related websites 
Analytics 
All screens of the app should report to an analytics aggregator 
(Android Analytics?) to allow the study team to monitor app 
usage by user. 
 
40 

Appendix IV: App Mockup Screens 
 
41 

 
42 

 
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