CareConekta: A Pilot Study of a Smartphone App to Improve Engagement in Postpartum HIV Care in South Africa
Phase: NA
Conditions: HIV/AIDS, Pregnancy Related
Sponsor: Vanderbilt University

 
Study Protocol 
 
 
CareConekta: a pilot study of a smartphone app to improve engagement in postpartum HIV care in 
South Africa   
 
Version 7.0 
 
October 9, 2020 
 
CareConekta: Mobile health for a mobile population 
 
Project Period: 05/10/2019 – 03/31/2022 
 
Institutional Review Board (IRB) approval numbers: 
• 
Vanderbilt University: 181640 
• 
University of California, San Francisco: 18-26811 
• 
University of Cape Town: 659/2018 
 
IRB Federalwide Assurance numbers: 
• 
FWA00024139 (Vanderbilt University) 
• 
FWA00000068 (University of California, San Francisco) 
• 
FWA00001637 (University of Cape Town) 
 
ClinicalTrials.gov study number: NCT03836625 
 
Study sponsor: National Institute of Mental Health (R34 MH118028)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Protocol summary 
 
CareConekta: a pilot study of a smartphone app to improve engagement in postpartum HIV care in 
South Africa   
 
Study aims:  
Aim 1: Characterize mobility among South African women during the peripartum period and its 
impact on engagement in HIV care. 
Aim 1a. To use GPS location data from CareConekta and spatial analysis to characterize 
peripartum mobility within the complete observational cohort (n=200), including the 
frequency, distance, and timing. 
Aim 1b. To assess the association between mobility and engagement in HIV care for mother 
(retention in care and viral suppression six months after delivery) and infant (completion of 
routine early infant diagnosis). 
Aim 2: Evaluate enhanced CareConekta as an intervention to improve engagement in HIV care. 
Aim 2a. To assess the acceptability and feasibility of the standard and enhanced app, with a 
focus on identifying user preference and implementation outcomes. 
Aim 2b. To evaluate the initial efficacy of the enhanced CareConekta intervention, using 
notifications and staff contact to improve engagement in HIV care, by assessing the 
association between study arm and engagement in HIV care at six-months postpartum. 
 
Sample size: 200 participants  
 
Study population: Adult (≥18 years), HIV-positive, pregnant (≥28 weeks) women attending antenatal 
services at the study site  
 
Participating site: Gugulethu Midwife Obstetric Unit, Cape Town, South Africa 
 
Study design:  
Hybrid pilot trial assessing efficacy as well as feasibility and acceptability 
 
Study timeline: August 2019 – July 2022 (approximately) 
 
Principal investigator: 
Kate Clouse, PhD, MPH 
Assistant Professor  
Vanderbilt University School of Nursing 
461 21st Avenue South 
Nashville, TN 37240 
+1 (615) 343-5351 
kate.clouse@vanderbilt.edu 
 
Co-Investigators: 
Landon Myer, MBChB, PhD 
Professor, School of Public Health and Family Medicine 
Director, Centre for Infectious Disease Epidemiology and Research 
University of Cape Town 
Cape Town, South Africa 
+27 (0)21 406 6661 
Landon.Myer@uct.ac.za 
 

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Study protocol, version 7.0 
Tamsin Phillips, MPH 
Research Officer 
School of Public Health & Family Medicine, Division of Epidemiology & Biostatistics 
University of Cape Town 
+27 (0)21 650 1646 
tamsinkatephillips@gmail.com 
 
Carol Camlin, PhD, MPH 
Associate Professor in Residence 
Department of Obstetrics, Gynecology & Reproductive Sciences 
University of California, San Francisco 
ANSIRH Program, 1330 Broadway, Suite 1100 
Oakland, CA 94612 
+1 (510) 986-8981 
Carol.camlin@ucsf.edu 
 
Study sponsor: National Institute of Mental Health (R34 MH118028)  
 
ClinicalTrials.gov study number: NCT03836625 
 
 
 
 

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ABSTRACT 
South Africa is home to the world’s largest antiretroviral therapy (ART) program, but sustaining high 
engagement along the HIV care continuum has proven challenging in the country and throughout 
the wider region. Population mobility is common in South Africa, but important research gaps exist 
describing this mobility and its impact on engagement in HIV care. Postpartum women and their 
infants in South Africa are known to be at high risk of dropping out of HIV care after delivery and are 
frequently mobile. We recently developed a beta version of a smartphone application (app) – 
CareConekta – that detects a user’s smartphone location to allow for prospective characterization of 
mobility. Through this three-year award, we propose to adapt and test CareConekta to conduct 
essential formative work on mobility and evaluate an intervention – the CareConekta app plus text 
notifications and phone calls and/or WhatsApp messages – to facilitate engagement in HIV care 
during times of mobility. During the three-year project period, our primary objective is to evaluate 
the acceptability, feasibility, and initial efficacy of using CareConekta as an intervention to improve 
engagement in HIV care. Our secondary objective is to characterize mobility among South African 
women during the peripartum period and its impact on engagement in HIV care. We will enroll 200 
eligible women at the Gugulethu Midwife Obstetric Unit in Cape Town, South Africa. This work will 
provide critical information about mobility during the peripartum period and the impact on 
engagement in HIV care, and piloting an intervention to improve engagement. This study will lay the 
necessary groundwork for a larger efficacy trial of the intervention within different geographic 
settings. 
 
INTRODUCTION 
With more than seven million HIV-infected people,1 South Africa is home to more people living with 
HIV than any other country in the world,2 and their national ART program is the world’s largest.2 
South Africa adopted a “treat all” policy to provide ART to all HIV-positive people, regardless of CD4+ 
cell count, in September 2016.3 Expanded ART availability has dramatically altered the health and 
quality of life of people living with HIV/AIDS, with an estimated life expectancy gain of 11.3 years 
between 2003 and 2011 due to ART4 and a 77% decrease in HIV transmission in stable 
serodiscordant couples.5 However, the rapid scale-up of the national ART program has put 
tremendous pressure on the limited resources of a public health sector that is hurrying to meet this 
immense need, and despite widespread availability of ART, over 135,000 people died of AIDS-related 
causes in 2016 in South Africa.1 HIV and tuberculosis (usually exacerbated by HIV) are the top two 
causes of death among women ages 15-44 in South Africa.6 The potential for improved health 
through expanded ART availability will only be realized if individuals sustain engagement in HIV care.  
 
Black African women of reproductive age (ages 20-34) are the population most heavily affected by 
the South African HIV epidemic, with 31.6% prevalence.7 Access to ART for all HIV-positive pregnant 
women through Option B+ has helped to reduce mother-to-child transmission of HIV to the point 
where near-elimination is now thought possible.8 Despite this astounding achievement, there is 
mounting evidence that women who initiate ART during pregnancy may be at very high risk of loss to 
follow-up (LTFU),9–12 with re-engagement in routine HIV care after delivery a particular concern.13,14 
The problem of patient LTFU within the public sector in South Africa has been well documented.15,16 
Our earlier research conducted in South Africa found that 25.2% of women pregnant at ART 
initiation were LTFU after one year, compared to 15.8% of men and 11.1% of non-pregnant 
women.10 Our work also has helped to pinpoint the timing of LTFU to after delivery: among women 
diagnosed with HIV during antenatal care in Johannesburg, 47.9% were lost within six months of 
delivery;13 in Cape Town, disengagement was over twice as frequent in the postpartum period as 
during antenatal care.17   
 
A challenge to ensuring a continuity of HIV care is that the fragmented health care system is not 
adapted for a mobile population. Patients considered LTFU actually may have switched facilities on 

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their own as “silent transfers,” which typically are not recognized due to unlinked data across 
facilities.18–20 This misclassification makes it very difficult to accurately assess the effectiveness of 
national ART programs. Mobility as a potential barrier to engagement in HIV care has been noted in 
Kenya,21,22 Lesotho,23 Zambia,24 and the US25. South Africa’s population is highly mobile; the most 
typical pattern is of circular, within-border migration between rural and urban areas, with the 
mobile individual keeping strong ties to the rural areas by sending remittances to their family and 
returning to the rural area for holidays and family events, and upon retirement, illness, or during 
lapses in employment.26 Postpartum women in South Africa are likely to be a particularly mobile 
group, due to a tradition of returning to one’s rural home after delivery to receive care from family 
members.12,27,28 Our recent formative work at three sites in Johannesburg found that among 150 
peripartum, HIV-positive women interviewed, 44% planned to travel around delivery – typically after 
delivery – to stay with family, sometimes leaving the infant in the care of family while the mother 
returned to work in Johannesburg (manuscript under review). HIV-exposed infants – even if HIV-
uninfected – are at higher risk of mortality than HIV-unexposed infants29 and require attentive 
follow-up. With no way of tracking mobility, it is difficult to intervene appropriately to ensure 
continuity of HIV care for mother and infant.  
 
Cell phones are as common in South Africa as they are in the US,30 according to a recent Pew 
Research study that found that 89% of adults in South Africa owned a cell phone.30 Our own 
research among pregnant, HIV-positive women attending public antenatal care in Johannesburg 
found that phone ownership was ubiquitous, phone sharing was uncommon (94% did not share), 
and the median time with the current phone number was three years.31 Additionally, smartphone 
use is increasing rapidly; a 2015 survey found that half of South African respondents owned a 
smartphone.32 While this does not represent complete saturation, South Africa is rapidly adopting 
increasingly sophisticated mobile phones; thus, it is the most appropriate country in the African 
region to develop and test mHealth interventions, and lessons learned there will be relevant 
throughout the continent as other countries similarly adopt new technologies. mHealth 
interventions, particularly short message service (SMS) interventions, have been shown to improve 
adherence to ART33,34 and patient retention.35,36 Global positioning system (GPS) technology has 
been used successfully to track subject location in several studies, mostly in developed countries.37–
39  
 
In summary, a better understanding of mobility patterns and the impact of mobility on HIV 
engagement is urgently needed – particularly among postpartum women. Given high LTFU and 
unlinked data systems in many settings, mHealth technology offers an opportunity to intervene at 
the critical moment and to improve continuity of care among a highly mobile population. 
 
CareConekta smartphone app and preliminary studies 
In 2017, through a small grant from the Tennessee Center for AIDS Research (TN CFAR), we 
conducted formative research on smartphone use among our target population: peripartum, HIV-
positive women at the proposed study site. Through focus group discussions (Vanderbilt IRB 
approval: 161805; UCT HREC approval: 792/2016), respondents told us they had few issues with data 
connectivity and privacy while using smartphones, and they were highly enthusiastic about mHealth 
interventions.40 We also identified that over half of HIV-positive pregnant women we sampled 
owned a smartphone, the WhatsApp messaging app is very popular and widely-used, and about 90% 
of phones used the Android operating system.40 We specifically asked participants about tracking 
their mobility for research purposes, and acceptability was high, noting that clinics could use an 
individual’s location to help them find a new facility when traveling.  
 
Based on this formative information, and through the same TN CFAR pilot funding, we developed a 
beta version of the app that we will now adapt and pilot: CareConekta. This smartphone app uses 

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the phone’s GPS to prospectively characterize mobility and intervene in real-time. The beta version 
app was developed in collaboration between the current study team (Dr. Clouse, Dr. Myer, Ms. 
Phillips) and Dr. Martin Were of Vanderbilt University Medical Center’s Department of Biomedical 
Informatics.  
 
STUDY AIMS 
Aim 1: Characterize mobility among South African women during the peripartum period and its 
impact on engagement in HIV care. 
Aim 1a. To use GPS location data from CareConekta and spatial analysis to characterize 
peripartum mobility within the complete observational cohort (n=200), including the 
frequency, distance, and timing. 
Aim 1b. To assess the association between mobility and engagement in HIV care for mother 
(retention in care and viral suppression six months after delivery) and infant (completion of 
routine early infant diagnosis). 
 
Aim 2: Evaluate enhanced CareConekta as an intervention to improve engagement in HIV care. 
Aim 2a. To assess the acceptability and feasibility of the standard and enhanced app, with a 
focus on identifying user preference and implementation outcomes. 
Aim 2b. To evaluate the initial efficacy of the enhanced CareConekta intervention, using 
notifications and staff contact to improve engagement in HIV care, by assessing the 
association between study arm and engagement in HIV care at six-months postpartum. 
 
STUDY DESIGN  
Hybrid pilot trial assessing efficacy as well as feasibility and acceptability 
 
STUDY SITE  
The study site for participant enrollment is the Gugulethu Midwife Obstetric Unit (MOU), based at 
the Gugulethu Community Health Centre near Cape Town, South Africa. The MOU serves Gugulethu 
as well as the surrounding informal settlements, and is often attended by women who come from 
the Eastern Cape to have their babies in Cape Town, resulting in travel to and from the Eastern Cape 
during pregnancy and postpartum.41 The local antenatal HIV prevalence is high (~30%), and the 
mother-to-child HIV transmission rate is estimated at 2-4%.42 The MOU team has helped to deliver 
HIV care and treatment services in this setting since 2003 and has a history of successful ART service 
delivery and research in partnership with the provincial government. Dr. Myer and Ms. Phillips have 
conducted studies at the MOU since 2006.43  
 
ABOUT CARECONEKTA 
 
CareConekta, developed in parallel with a series of focus group discussions, is a novel smartphone 
app that uses GPS to identify the user’s location to record location coordinates meet two primary 
functions: (1) to allow the participant to locate ART facilities in South Africa that are near her current 
location, and (2) to trace mobility prospectively. We employ an algorithm on the mobile application 
to reliably determine when a participant has traveled outside the study area. If the participant 
travels more than 50 km outside the study area for more than 7 days, the app will automatically 
notify the participant of available care facilities near her new location, and will provide the facility 
address and phone number, if available. The notifications will be available to both English and 
isiXhosa-language speakers (the predominant languages of the region). 
 
Through the TN CFAR award, we conducted a proof-of-concept study by enrolling four participants 
at the proposed study site and following them for 90 days (Vanderbilt IRB approval: 170510; UCT 
HREC: 227/2017; ClinicalTrials.gov: 170510). We identified technological issues to address in order to 

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maximize the compatibility of CareConekta for the local context. Namely, we would like to transfer 
CareConekta’s development architecture from the Ionic platform to native Android, so that we can 
ensure that CareConekta is compatible with all Android phones, which represents most smartphones 
in use by the population at the proposed study clinic. We will then be ready to pilot CareConekta to 
explore mobility and its impact on HIV care, and to conduct a preliminary evaluation of the 
enhanced CareConekta intervention. 
 
STUDY POPULATION  
Adult (≥18 years), HIV-positive, pregnant (≥28 weeks) women who 1) own a smartphone that meets 
the technical requirements, 2) are willing to opt-in to installation of CareConekta on her personal 
phone and mobility tracking, 3) demonstrate basic smartphone-level literacy, and 4) are willing to be 
randomized.   
 
Technical requirements 
For the purposes of this study, a smartphone will be defined as a mobile phone device with a 
touchscreen interface and internet and GPS capabilities. CareConekta is only available for phones 
using the Android operating system, version 5.0 or later. In our preliminary work, nearly 90% of 
smartphones of women approached for study participation used the Android system. Cell phone 
service providers must be one of the following: Vodacom, Cell-C, Telkom, or MTN. The phone must 
be able to demonstrate that it can use GPS by opening a map app, such as Google Maps, and finding 
current location. The phone must be capable of holding a battery charge; phones will be ineligible if 
they need to be charged more than twice per day on average (by self report). 
 
INCLUSION AND EXCLUSION CRITERIA 
Inclusion criteria: 
• 
≥18 years old 
• 
HIV-positive 
• 
Pregnant (≥28 weeks gestation)  
• 
Able to speak and understand isiXhosa and/or English 
• 
Currently own a smartphone that meets the technical requirements of the app 
• 
Willing to opt-in to installation of the app on her personal phone and to mobility tracking 
• 
Able to demonstrate basic smartphone-level literacy 
• 
Willing to be randomized   
Exclusion criteria: 
• 
Currently enrolled in another research study which may impact on the study outcomes 
 
STUDY TIMELINE 
Study activities will occur from August 2019 – July 2022 (approximately) 
Human subjects’ participation will begin with recruitment and enrollment in approximately Q3 of Y1, 
following the adaptation and revision of the CareConekta smartphone app. 

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STUDY DESIGN 
Sample Size 
We will enroll 200 participants. 
For this pilot trial formal sample size estimation was not conducted. The sample size was reached 
based on the feasible enrolment from the study site within the study timeline. Approximately 4,000 
women seek antenatal care at the MOU annually; ~30% of these are HIV-positive, about 1 200 per 
year, or 100 per month. Our formative work (HREC REF 792/2016 and 227/2017) showed that over 
half of these women own smartphones. If we conservatively estimate that 30% of all pregnant, HIV-
positive women seeking antenatal care each month will be eligible and interested which equals 30 
participants enrolled per month. We anticipate that it will take approximately seven months to reach 
our enrolment target of 200 participants (see Timeline above).  
 
Based on our earlier work in South Africa and at the study site, we estimate that 25% of the 
participants will engage in long-distance travel during the study period. A sample size of 200 allows 
us to characterize the mobility experiences of 50 women who travel and explore differences with 
those who do not. While we do not anticipate having sufficient power to detect statistically 
significant differences between groups in Aims 2b, the information gained through this pilot study 
will inform sample sizes for larger future studies should this pilot show promise. 
 
Study arms 
• 
Control arm (n=100): Participants will receive standard CareConekta, which will track their 
mobility and allow the participant to look up new ART facilities upon request.  
• 
Intervention arm (n=100): Participants will receive standard CareConekta with the following 
additions: 
o text notifications of nearby ART facilities when they have traveled >50 km from the 
study site for >7 days 
o phone call(s) and/or WhatsApp message(s) from study staff when they have traveled 
>50 km from the study site for >7 days.  The study staff calls and messages will ask 
about medication supply and will provide assistance with nearby facilities, if 
requested. The study staff member who conducts interviews will not deliver the 
intervention calls and/or messages. 
 
STUDY PROCEDURES 
This study will consist of two face-to-face study visits as well as abstraction of routine medical 
records. The details of each visit are described below. 
 
Activity
Q1 Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Study preparation
IRB approval and renewal
ClinicalTrials.gov registration
Develop study instruments and REDCap database
Adapt CareConetka smartphone app
Confirm eligibility, recruit and consent participants
Enrollment questionniare
Participant follow-up
Follow-up questionnaire
File review
Data analysis
Manuscript preparation
R01 submisson and revision
Year 1
Year 2
Year 3

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Enrollment visit procedures 
Recruitment and assessment of eligibility criteria 
Each week during the study recruitment period, study staff will review the list of upcoming 
appointments at the study site to assess who may be eligible for study participation. Pregnant 
women attending routine antenatal care services at the Gugulethu Community Health Centre will be 
approached by trained study recruiters and given brief information about the pilot study. If they are 
interested, they will be screened to ensure they meet the eligibility criteria using an eligibility 
checklist. If eligible, they also will be shown a demonstration of CareConekta and its functionality 
prior to the informed consent process. Text message-level literacy will be demonstrated by reading 
aloud the text, “I can look up a new clinic on the phone,” in either English or isiXhosa. 
 
Selection of study participants in an equitable manner 
The selection of participants will be equitable in relation to the research purpose and setting 
because any interested woman attending antenatal services at the study clinic who meets the 
eligibility criteria will be invited to enroll. Pregnant women will be limited by gestational age to the 
third trimester to allow for a nine-month total follow-up time within the time constraints of this 
three-year grant. In South Africa, most women present for their first antenatal visit around 20 weeks 
gestation or later,13,44,45 and attendance for antenatal visits is generally high,13,17 so we do not believe 
there will be substantial bias introduced by enrolling women later in pregnancy. isiXhosa is the 
predominant language in the region of the study site, and English also is widely spoken, so we do not 
anticipate excluding potential participants due to language. Basic smartphone-level literacy will be 
required of participants in order to assess the impact of messages. However, we anticipate that most 
women who own a smartphone already have a basic smartphone-level literacy ability. We 
acknowledge that women who own a smartphone may be different than those who do not, in terms 
of employment, education, or other factors. Besides the additional financial resources needed to 
provide phones, we want to be able to assess CareConekta in existing phones for maximal impact. If 
women already have a smartphone (over half of the population), providing a second phone for study 
purposes is redundant and burdensome. For women who do not already own a smartphone, we are 
concerned with ethical implications of providing such a highly-desired item as a smartphone in terms 
of possible coercion for study participation, the impact it may have on relationships between 
participants and partners and/or friends, and the potential for disclosure for participating in an HIV-
related study. 
 
In order to assess differences between our cohort of smartphone users and the general population 
assessed for eligibility, we will collect four demographic indicators at the time of recruitment: age, 
education, employment and nationality. These will be collected anonymously prior to study 
enrollment or the collection of any identifying data.  
 
Informed consent   
All women who meet the eligibility criteria and are interested in participating in the study will 
undergo written informed consent, which will be available in English and isiXhosa. The consent form 
will confirm the eligible woman’s understanding of the study procedures and her informed 
willingness to participate. The key messages of the informed consent process will include: 1) a 
description of the study goals and procedures, 2) voluntary participation in the study, 3) 
confidentiality and privacy with use of the app and study data, 4) the right to withdraw at any time, 
and 5) the standard of care received at the MOU or any other healthcare facility will not differ 
according to participation in the study. Specifically, we will request written informed consent for 
installation of the app, location tracking, data collection, medical record review (participant and 
infant), one blood draw, and re-contacting by study staff. 
 

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Once the consent form has been explained to the participant, any questions she may have will be 
answered. If the participant agrees to provide consent for participation, she will indicate this with 
her signature on the consent form. If she does not wish to participate or does not provide her 
consent for all the activities, she will not sign the consent form and will not be enrolled. A second 
copy of the form will be provided for her to sign as well and keep. The study staff member who 
administered the form will provide his or her name, signature and date as a witness to the signing. 
Signed informed consent forms will be stored in binders within a locked office and only accessible by 
study staff. 
 
Linkage information and study ID assignment 
After the informed consent is signed, the participant will be assigned a study ID number. The master 
list of study ID numbers linked with participants’ names and MOU clinic file numbers will be kept in a 
password-protected file, accessible only by designated study staff. In order to re-contact the 
participant and access her medical records, we will collect identifying information on a separate 
paper-based linkage form, including contact information, name, study number, clinic record number, 
phone number, national identification number, address, date of birth, and we will also update this 
form with infant information, when available. As is standard practice for research studies at the 
study site, the participant may also provide details for an alternative contact person in the event 
that we are unable to reach the participant after multiple attempts. No details about the participant 
will be shared with the alternative contact; study staff simply will ask that the participant return to 
the clinic when she can. Identifiers and study details will only be linked on the linkage form which 
will be stored in a locked cabinet in the study office. 
 
Randomization 
Randomization will occur after study ID assignment and will follow a dynamic permuted block 
design. All participants will be randomized 1:1 to the control or intervention arms. Randomization 
numbers will be generated prior to the start of the study, and placed in sequentially numbered 
opaque envelopes. Randomization envelopes will be stored in a locked cabinet in the study office at 
the study site that will be accessed by the study coordinator when a participant is fully consented, 
with independent documentation of the participant ID number, randomization date, and 
randomization assignment. 
 
Enrollment questionnaire 
Following randomization, study staff will complete a face-to-face questionnaire with each 
participant. Responses will be recorded directly into a password-protected REDCap database by an 
interviewer using a tablet computer or laptop. The questionnaire will collect information on 
demographic characteristics, smartphone type and usage preferences, barriers and facilitators to 
engagement in HIV care, and travel intentions. Response options primarily will be categorical, with 
open-ended questions to allow for deeper elaboration. Questionnaire data collected will identify 
participant responses by study ID, not by names or identifiable data. 
 
App installation 
After the enrollment questionnaire, the participant will be invited to install the app on her own 
phone, with assistance available from study staff. The app will be provided free of charge. The 
participant will enter her phone number into the app during installation, which will be automatically 
confirmed through a one-time PIN. 
 
Reimbursement 
After all the above steps are complete, the enrollment visit will conclude with providing the 
participant R150 reimbursement for transport and missed opportunity costs. Payment will be made 
in cash and/or grocery vouchers and will be recorded in a reimbursement log. Data charges to 

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compensate for data used by the app will be reverse-billed to the study and will not be the 
responsibility of participants. 
 
Interim procedures 
Interim procedures for participants in the intervention arm 
Participants in the intervention arm will receive text notifications of nearby ART facilities when they 
have traveled >50 km from the study site for >7 days. They also will receive phone call(s) and/or 
WhatsApp messages from study staff to when they have met this travel threshold. The study staff 
calls and messages will provide adherence support and assistance with connecting to nearby 
facilities, if requested. Messages will be written at an 8th-grade reading level or lower. All contact 
attempts (successful or not) will be recorded on a contact log. 
 
Other notifications 
Participants in both arms may receive notifications via the CareConekta app that are unrelated to 
linkage to ART care and nearby health facilities. Such notifications may include reminders to keep 
the app installed on the phone or messages about the raffle incentive (see below). There is no 
charge to the participant for receiving notifications. 
 
Follow-up phone call 
We will contact all participants by phone approximately one week after the expected delivery date 
to determine current location, and infant name and date of birth. This contact may take place in 
person at the study site if the participant is attending a regularly scheduled visit. We are including 
this step due the difficulty of tracing infant outcomes and linking mother-child dyads without infant 
date of birth and name. This information will be recorded on a CRF and captured in REDCap. A 
minimum of three contact attempts will be made for each participant. All contact attempts 
(successful or not) will be recorded on a contact log. 
 
Mobility data 
Mobility data will be collected throughout the follow-up period. Geospatial coordinates will be 
recorded with a timestamp. Upon bulk extraction of these data, we will import location information 
as decimal degree coordinates into ArcMap spatial analysis software. Data charges related to the 
app are reverse-billed through our app development consultants to ensure timely transmission of 
data with no cost to participants. 
 
Weekly raffle incentive 
To encourage participants to keep the CareConekta app installed on their phone and the GPS 
function enabled throughout the entire study period, we will offer an incentive: a weekly raffle of 
one 200MB data bundle (worth approximately $4). Participants will be eligible to enter the raffle if 
their phone sent GPS coordinates at least once per day for the prior week. Winners will be randomly 
selected among all eligible participants using a randomization code automated in STATA. The weekly 
raffle incentive will only apply to participants enrolled from October 2020 onwards and who have 
signed version 5.0 or later of the Informed Consent document. There is no limit to the number of 
times a participant may win the raffle. 
 
Six-month postpartum follow-up visit procedures 
Recontacting participant 
All participants will be recontacted six months postpartum to return to the study site for a one-time 
visit. A minimum of three contact attempts by phone and/or home visit will be made for each 
participant. All contact attempts (successful or not) will be recorded on a contact log. 
 
Follow-up questionnaire 

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Study staff will complete a face-to-face questionnaire with each participant. This follow-up 
questionnaire will include reasons for overall acceptability of CareConekta (standard or enhanced), 
reasons for travel and clinic switching, and barriers and facilitators to care since the start of the 
study. Response options primarily will be categorical, with open-ended questions to allow for deeper 
elaboration. Additional questions will be asked of participants in the intervention arm regarding 
acceptability and feasibility of the intervention. Responses will be recorded directly into a REDCap 
database by an interviewer using a tablet computer or laptop. This questionnaire may be conducted 
telephonically.  
 
Viral load testing and potential blood draw 
In routine care in this setting, viral load tests are to be repeated every three months in pregnancy 
and every six months during breastfeeding, so we expect that most women will have a routine viral 
load completed before six months postpartum. To avoid additional blood draws for the participant, 
at the follow-up visit, the study staff will check NHLS to determine the most recent viral load test. If 
the participant has had no viral load test within 3 months prior to the six-month study follow-up 
visit, a blood draw for viral load will be conducted by the clinical staff at the Gugulethu CHC. A clinic 
nurse will collect 5 ml of venous blood, which will be transported daily to the National Health 
Laboratory Services (NHLS) for HIV viral load testing (Abbott Molecular RealTime HIV-1 assay (Abbott 
Molecular, Illinois, USA). We will not recontact participants about viral load results unless 
participants are on ART and the viral load result indicates lack of viral suppression. In that case, 
results will be made available to participants over the phone (or in person, at participant’s wish) with 
appropriate referrals. For all participants, viral load results will be captured using the participants 
provincial folder number into the NHLS database, as is standard practice for routine laboratory 
results in South Africa. 
 
Uninstall app 
During the follow-up visit, the CareConekta app will be uninstalled from each participant’s phone. 
 
Reimbursement 
After all the above steps are complete, the enrollment visit will conclude with providing the 
participant R150 reimbursement for transport and missed opportunity costs. Payment will be made 
in cash and/or grocery vouchers and will be recorded in a reimbursement log. 
 
File review activities 
Electronic and paper files will be reviewed after the participant’s final visit to assess engagement in 
HIV care. If the participant fails to return for a final visit, files will be reviewed a minimum of seven 
months after estimated delivery. Electronic data on health facility visits and pharmacy dispensing, 
including facility recorded deaths, will be requested the Provincial Health Data Centre of the 
Western Cape Department of Health by providing a list of folder numbers of women who have 
consented and enrolled in the study. These data include all public health facilities in the Western 
Cape Province, which is the location of the study site. Laboratory records, including viral loads, from 
any South African facility will be abstracted from the NHLS database. Participants in both arms who 
are lost from the study at the time of study close will be traced through staff outreach and 
electronic/paper medical records. Informed consent will include permission to link with electronic 
medical records. 
 

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Table of schedule of measures 
Item for completion 
Enrolment 
Early postpartum 
phone call 
6 months postpartum  
Eligibility Checklist 
x 
 
 
Informed Consent  
x 
 
 
Linkage form 
x 
x child details 
 
Randomisation log 
x 
 
 
Demographics and 
medical history 
x 
 
x 
Maternal mobility (past 
and planned) 
x 
 
x 
Maternal clinic switching 
x 
 
x 
Perceived barriers and 
facilitators of 
engagement in care 
x 
 
x 
Depression (PHQ-4) 
x 
 
x 
Alcohol and drug use 
(AUDIT-C and DUDIT Q1) 
x 
 
x 
Patient provider 
relationship scale 
x 
 
x 
ART adherence 
x 
 
x 
WHO VAW (intimate 
partner violence) 
x 
 
 
Social impact scale 
(stigma) 
x 
 
 
Availability of social 
support 
x 
 
 
Life events (trauma) 
 
 
x 
Infant health 
 
 
x 
Child mobility 
 
 
x 
Acceptability of 
CareConekta 
 
 
x 
Impact of COVID-19 & 
lockdown of HIV care and 
mobility 
 
 
x 
Laboratory tests 
 
 
 
HIV viral load* 
 
 
x 
Record review 
 
 
 
Antenatal and obstetric 
information 
x 
x 
x 
ART pharmacy records 
x 
x 
x 
Maternal laboratory 
results 
x 
x 
x 
Child HIV testing 
 
x 
x 
* If no routine viral load result found in the three months before the study visit 
 
DATA COLLECTION AND STORAGE 
Data collection methods 
Data will be collected in three ways: 
• 
Face-to-face enrollment and follow-up questionnaires 

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• 
Medical record review (electronic and paper file records) to determine participant engagement 
in HIV care 
• 
Electronic app usage and mobility data 
 
Questionnaire data 
Questionnaire responses will be recorded directly into a REDCap database by an interviewer using a 
tablet computer. The study team has extensive experience building and using REDCap databases. 
The database will be password-protected with access limited to the members of the study team. All 
questionnaire data will be converted to SAS, STATA or SPSS for data analysis. All databases will be 
password-protected with access restricted to the members of the study team. All questionnaire data 
will be stored on the University of Cape Town secure network drive and any files sent for 
transcription or review will be sent as password-protected encrypted files or through a secure file 
share program, such as the REDCap’s Send-It secure data transfer application. The encrypted 
REDCap data servers will be housed at Vanderbilt University Medical Center. 
 
Study document storage 
All hard copies of study documents, including signed consent forms, linkage forms, and logs will be 
stored in locked cabinets in the study office with only the study team having access to the data. For 
increased protection, the linkage form and signed consent forms will stored separately from other 
study documents.  
 
Smartphone data 
The transmission and storage of sensitive participant information will follow best practices regarding 
smartphone app confidentiality. All information collected by CareConekta, including location, device 
ID and timestamp, will be encrypted and transmitted to secure study servers using the secure https 
protocol. Time-stamped GPS coordinates will be stored in a longitudinal history.  Electronic mobility 
data will be stored on a back-end storage system at the South African Medical Research Council 
(MRC) that meets Health Normative Standards Framework guidelines, which call for restricted 
access, and the separation of patient demographics and health data. The user reference (unique ID 
or demographic information of the patient) is separated from the user’s cell number and phone ID, 
as well as separated from the location information for security and purposes.  
 
Destruction of data 
All identifiable data, including linkage forms and signed informed consent forms, will be destroyed 
five years after the study is completed and closed with the IRB. 
 
ANALYSIS PLAN AND STUDY OUTCOMES 
Aim 1a. To use GPS location data from CareConekta and spatial analysis to characterize peripartum 
mobility within the complete observational cohort (n=200), including the frequency, distance, and 
timing. 
 
Outcome: Mobility within the study period 
We will use data from all 200 participants to describe mobility within a complete observational 
cohort. In order to assess mobility comprehensively, we will use multiple data sources: time- and 
date-stamp data as well as geographic location data from CareConekta, participant self-report during 
questionnaires, and electronic medical records during the file review. Participant questionnaire data 
and medical record data will be exported from REDCap, and mobility data from CareConekta will be 
imported from .csv files to SAS for data analysis. To assess the primary outcome of interest, we will 
report the number of participants who travel during the study period (defined as >50 km for >7 
days), over the denominator of all participants. Among those who travel, we will report the median 
and interquartile range number of trips during the study period and will determine timing and 

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frequency of travel as it relates to delivery date, which will be obtained from participant 
questionnaire and/or medical records. Median and interquartile range duration of travel will be 
reported in days, and we will also assess temporicity (frequency of trips x duration of trips). Reasons 
for travel will be obtained from the enrollment and follow-up questionnaire and will be grouped by 
theme, such as family, work, housing, and education. 
 
For a more detailed assessment of mobility, we will use ArcMap to geographically place all locations 
in which participants were recorded during the study period. We will plot origin and destination 
locations on a map of South Africa, and neighboring countries (if necessary). We will connect origin 
and destination locations using ArcMap’s XY-to-line tool, and will use a spherical calculator to 
estimate the distance between origin and destination. The geographic data will be used in 
conjunction with the novel metrics of mobility developed by Dr. Camlin, which are reflective of the 
complex forms of mobility in sub-Saharan Africa. For example, we will apply geopolitical boundaries 
to location codes so that measures of internal migration and localized mobility within and across 
those boundaries can be estimated, such as inter- and intra-provincial mobility. We also will map 
mobility flow according to origin and destination pairs, classified by geopolitical categories. We will 
thereby demonstrate how geographic data can be used to characterize the mobility of populations – 
providing a vital alternative to survey measures – in order to measure the impacts of that mobility 
on care cascade outcomes, with broad applicability to the measurement of its impact on other 
health outcomes. We also will conduct a secondary analysis to validate whether self-reported 
anticipated travel matches data collected from the CareConekta app. 
 
Aim 1b. To assess the association between mobility and engagement in HIV care for mother 
(retention in care and viral suppression six months after delivery) and infant (completion of routine 
early infant diagnosis). 
 
Outcome: Impact of mobility on engagement in HIV care in the absence of the intervention 
We will limit the analysis to the control arm only to explore the impact of mobility on engagement in 
HIV care in the absence of intervention. We will report baseline participant characteristics as 
collected on the questionnaire. We will report proportions and 95% confidence intervals for 
categorical variables and medians and interquartile ranges for continuous variables. Open-ended 
questions will be reviewed for key themes. Themes will be abstracted and quantified. 
 
To assess engagement in HIV care, we will report retention in care, which will be assessed at the six-
month postpartum point and defined as no documented HIV-specific contact with any healthcare 
facility (including medication pick-ups) for >3 months. We also will report viral suppression six 
months after delivery, using thresholds of ≤50 and ≤1000 copies/ml. Additionally, we will report 
vertical HIV transmission and completion of the routine 10-week infant PCR test.  
 
We will fit a series of models of mobility metrics on outcomes. For one, we will use  a dichotomous 
exposure of mobility (any travel >50 km: yes/no), we will use Cox proportional hazard regression 
models to estimate the association of mobility on these outcomes, and will produce adjusted hazard 
ratios and 95% confidence intervals for retention in care and achieving viral suppression. We also 
will identify other predictors of engagement in HIV care. We will produce crude Kaplan-Meier curves 
to time to loss to follow-up and time to viral suppression by mobility group. Additionally, we will 
perform sensitivity analyses to explore how the estimated effect size changes when using varying 
cut-off points to define mobility. 
 
Aim 2a. To assess the acceptability and feasibility of the standard and enhanced app, with a focus on 
identifying user preference and implementation outcomes. 
 

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Outcome: Acceptability and feasibility of CareConekta 
Acceptability and feasibility data will be collected among all 200 participants. Those in the 
intervention arm will receive additional questions related to the enhanced app features. The 
outcomes selected for analysis in Aim 3a correspond with the Technology Acceptance Model for 
Resource-Limited Settings (TAM-RLS) framework, which was designed to draw attention to end-user 
acceptability as a predictor of mHealth technology adoption in low-resource settings.46 We will 
report proportions and 95% confidence intervals for categorical variables and medians and 
interquartile ranges for continuous variables. For open-ended questions, we will create a list of 
categorical themes that emerge over multiple readings and calculate the proportions for the 
response categories. We will select key illustrative quotes for each theme. 
 
Aim 2b. To evaluate the initial efficacy of the enhanced CareConekta intervention, using 
notifications and staff contact to improve engagement in HIV care, by assessing the association 
between study arm and engagement in HIV care at six-months postpartum. 
 
Outcome: Efficacy of the intervention 
The overall efficacy analysis will include participants in both arms (n=200). To assess overall cohort 
engagement in HIV care, we will report retention in care, which will be assessed at the six-month 
postpartum point and defined as no documented HIV-specific contact with any healthcare facility 
(including medication pick-ups) for >3 months. We also will report viral suppression six months after 
delivery based on the viral load test closest to the six-month period, using thresholds of ≤50 and 
≤1000 copies/ml. Additionally, we will report vertical HIV transmission and completion of the routine 
10-week infant PCR test.  
 
Study arm assignment is the primary exposure of interest. We will use Cox proportional hazard 
regression models to estimate the association of study arm assignment on these outcomes, and will 
produce adjusted hazard ratios and 95% confidence intervals for retention in care and achieving viral 
suppression by study arm. We also will identify other predictors of engagement in HIV care. We will 
produce crude Kaplan-Meier curves to time to loss to follow-up and time to viral suppression by 
study arm. In a secondary analysis, we will perform an as-treated analysis using self-reported data 
regarding actually reading the notifications and/or WhatsApp messages or staff phone calls to 
analyze the effect of receiving the intervention. 
 
HUMAN SUBJECTS’ PROTECTION 
Ethical review process 
The research protocol will be reviewed by the Institutional Review Boards at Vanderbilt University; 
the University of California, San Francisco; and the University of Cape Town in South Africa.  All 
research activities will occur in South Africa. All procedures will conform to U.S. and South African 
ethical standards for human subjects’ research. 
 
Informed consent 
Informed consent will be obtained for all participants as described in the “Informed Consent” section 
above. 
 
Privacy and confidentiality  
Certainly the concept of tracing an individual’s personal location is one that must address substantial 
protections of human subjects. First, our formative research with potential users in focus group 
discussions specifically addressed issues of privacy regarding a mobility-tracing app and notifications. 
For both issues, we found high acceptability.  
 

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While we feel that our formative research clearly indicates initial acceptability of mobility tracing 
and notifications, we have designed this work with a strong commitment to offering the highest 
level of protection of our participants’ privacy and confidentiality. First, the location data of interest 
is at the macro-level, showing movement between towns, cities or regions, not at the micro-level, 
showing specific whereabouts. Thus, to protect participants’ privacy, the transmitted location 
information will be made “fuzzy” by transmitting a random location within 1 km of each participant’s 
exact location. Any participant’s exact location within that radius will be unknown. All information 
collected by the app, including location, device ID and timestamp, will be transmitted to secure 
study servers using the secure https protocol. The participant’s numerical study ID number will be 
used during installation; and no identifiable participant information will be recorded in the app. 
 
Potential risks of the proposed research to participants and others 
There is always the possibility of a breach of confidentiality of study materials when conducting 
research. While this is acknowledged, there is very low likelihood because of the precautions that 
will be taken to protect confidentiality. Study staff will be trained on the expectations that they are 
not to disclose any information collected in the study to anyone outside the study team. All 
identifying information associated with the study participants will be maintained in locked storage 
cabinets and complex password-protected computers that themselves are kept in locked rooms or 
cabinets. All participants will be encouraged to contact the clinic staff, principal investigators, or 
other staff to report any undesirable conduct associated with the study. These reports will be 
brought to the attention of the PI. 
 
In the unlikely event that a study participant experiences or is involved in criminal activity that may 
relate to CareConekta mobility or user data, we will comply with all local laws regarding data 
handover. 
 
Another risk to participants is that an HIV-positive status may be discerned through disclosure of 
participation in the study. However, we will do everything possible to minimize the risk of disclosure. 
We only will communicate with participants outside of the study if they do not return for their 
follow-up visit. No communication, whether on the phone or by text message, will identify the 
participant as HIV-positive. Importantly, among participants in the intervention arm who receive 
notifications of new facilities and phone calls and/or WhatsApp messages, the study staff will not 
use HIV-specific language. To avoid the possibility of inadvertent disclosure, ART facilities will only be 
referred to generically as “clinics” and any reference to ART will be to “tablets,” a common term for 
any medication that we demonstrated was acceptable in an earlier mHealth study in South Africa.44 
We considered providing smartphones to all study participants, but felt that this might lead to 
inadvertent disclosure of HIV status through one’s participation in the study, as well as potential 
issues related to coercion. 
 
Additionally, discomfort or distress may arise from answering interview questions about behaviors 
or feelings.  We will explain the nature of the questions to be asked during the consent process and 
all participants will be able to refuse to answer questions or terminate the interview at any time. 
Women who indicate psychological distress during study visits or interviews will be referred for 
support and counseling at the MOU.  The interviews are designed to be supportive and non-
confrontational and attempts will be made during administration of the study to minimize the 
discomfort of participants. Interviews will be conducted in private rooms with closed doors within 
the clinic that provide privacy for the participants. If an individual is uncomfortable during an 
interview, she will be reminded that she can terminate the interview and/or withdraw from the 
study at any time.  
 

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Risk to subjects will be minimized by: 1) training research staff in the ethical conduct of research; 2) 
strict protection of confidentiality by detailed standard operating procedures and on-site 
monitoring; 3) careful handling of sensitive data, procedures and processes in place to ensure data is 
securely stored and transferred; and 4) referral of participants to appropriate social and health 
services when necessary. The study site is well connected with the social worker and psychology 
services at the site as well as local non-governmental organizations providing counselling and 
support. While the potential risks to subjects are low, any social harm will be reported to the PI and 
a serious event will be reported to the Vanderbilt University and University of Cape Town IRBs within 
48 hours of becoming aware of the event. Should any respondent experience discomfort or distress 
from participation in the study, we will provide the participant with the appropriate referral needed 
for follow-up and care.  
 
Risk to subjects from participation in the study is minimal. All possible precautions will be taken to 
ensure complete confidentiality and protection of study participants. Given the minimal risk, the 
overall benefit of the study outweighs the risks. 
 
Potential benefits of the proposed research to participants and others   
The participants in the intervention arm who receive notifications while traveling may benefit from 
improved linkage to care while traveling and may have improved HIV-related outcomes. Moreover, 
the information obtained in this study will provide valuable information for future design and 
implementation of interventions aiming to improve retention in care among HIV-positive 
postpartum women. In addition, information obtained from participants will help inform our 
understanding of mobility among postpartum women and how it may contribute to HIV-positive 
women dropping out of care after pregnancy. 
 
Data and safety monitoring plan 
The study team will undergo extensive training prior to beginning the study, including training on 
issues of confidentiality. The PI has extensive experience with conducting research studies in South 
Africa and in training staff in the ethical application of research. In addition, the study team will be 
trained in ethical conduct of research.  
 
The PI will monitor the study safety data on an ongoing basis. They will report to their IRBs and the 
South Africa HREC any breaches in confidentiality identified. In the event that a breach in 
confidentiality does occur, staff will be retrained on human subjects’ protection and confidentiality if 
possible or removed from subject contact if the either the breach is too serious or if the PIs feel the 
staff member cannot be sufficiently retrained. Staff will be made aware of this condition on 
employment. 
 
The PI will be responsible for reporting to the grant program director any action resulting in a 
temporary or permanent suspension of the research.  
 
We will not convene a Data Safety Monitoring Board (DSMB) for this study.  
 
Data accuracy and completeness 
In addition to the co-investigators, the local South African study team will consist of a study 
coordinator, a site coordinator, and an interviewer/fieldworker. These team members will be trained 
in human subjects’ research through the NIH's website or through a presentation developed by UCT 
faculty based on the NIH course, but adapted to the local context. Prior to contact with any subjects, 
all staff with participant interaction duties will be trained on the background and objectives of the 
study, procedures for obtaining informed consent, and correct administration of the questionnaire. 
Training will include procedures for minimizing risk to subjects, assuring data accuracy and protocol 

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compliance. The study team will also be asked to complete several practice interviews. To avoid bias 
and/or contamination, the study staff member who conducts interviews will not deliver the 
intervention calls and/or messages. 
 
Participant remuneration 
Following standards set by the University of Cape Town Research Ethics Committee, all participants 
will be reimbursed R150 (approximately US $10.50) per study visit (enrollment and follow-up) for 
transport and missed opportunity costs. There will be no participant reimbursement for routine care 
visits made between study visits.  
 
 

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REFERENCES 
 
1.  
Statistics South Africa. Mid-Year Population Estimates 2018. Pretoria; 2018. 
https://www.statssa.gov.za/publications/P0302/P03022018.pdf. 
2.  
UNAIDS. Global Report: UNAIDS Report on the Global AIDS Epidemic 2013. Geneva; 2013. 
http://www.unaids.org/en/media/unaids/contentassets/documents/epidemiology/2013/gr2
013/UNAIDS_Global_Report_2013_en.pdf. 
3.  
UNAIDS. South Africa takes bold step to provide HIV treatment for 
all.http://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2016
/may/20160513_UTT. Published May 13, 2016. 
4.  
Bor J, Herbst AJ, Newell M-L, Bärnighausen T. Increases in adult life expectancy in rural South 
Africa: valuing the scale-up of HIV treatment. Science (80- ). 2013;339(6122):961-965. 
5.  
Oldenburg CE, Bärnighausen T, Tanser F, et al. Antiretroviral therapy to prevent HIV 
acquisition in serodiscordant couples in a hyperendemic community in rural South Africa. Clin 
Infect Dis. 2016;63(4):548-554. 
6.  
Statistics South Africa. Mortality and Causes of Death in South Africa, 2016: Findings from 
Death Notification. Pretoria; 2018. 
http://www.statssa.gov.za/publications/P03093/P030932016.pdf. 
7.  
Shisana O, Rehle T, Simbayi LC, et al. South African National HIV Prevalence, Incidence and 
Behaviour Survey, 2012. Cape Town; 2014. 
http://www.hsrc.ac.za/uploads/pageContent/4565/SABSSM IV LEO final.pdf. 
8.  
World Health Organization. Antiretroviral Drugs for Treating Pregnant Women and 
Preventing HIV Infection in Infants: Recommendations for a Public Health Approach. Geneva; 
2010. http://whqlibdoc.who.int/publications/2010/9789241599818_eng.pdf. 
9.  
Kaplan R, Orrell C, Zwane E, Bekker L-G, Wood R. Loss to follow-up and mortality among 
pregnant women referred to a community clinic for antiretroviral treatment. AIDS. 
2008;22(13):1679-1681. 
10.  
Clouse K, Pettifor A, Maskew M, et al. Initiating antiretroviral therapy when presenting with 
higher CD4 cell counts results in reduced loss to follow-up in a resource-limited setting. AIDS. 
2013;27(4):645-650. 
11.  
Myer L, Cornell M, Fox MP, et al. Loss to follow-up and mortality among pregnant and non-
pregnant women initiating ART: South Africa. In: 19th Conference on Retroviruses and 
Opportunistic Infections. Seattle, WA; 2012. 
12.  
Wang B, Losina E, Stark R, et al. Loss to follow-up in a community clinic in South Africa--roles 
of gender, pregnancy and CD4 count. S Afr Med J. 2011;101(4):253-257. 
13.  
Clouse K, Pettifor A, Shearer K, et al. Loss to follow-up before and after delivery among 
women testing HIV positive during pregnancy in Johannesburg, South Africa. Trop Med Int 
Heal. 2013;18(4):451-460. 
14.  
Rotheram-Borus MJ, Tomlinson M, Scheffler A, Le Roux IM. Re-engagement in HIV care 
among mothers living with HIV in South Africa over 36 months postbirth. AIDS. 
2015;29(17):2361-2362. 
15.  
Cornell M, Grimsrud A, Fairall L, et al. Temporal changes in programme outcomes among 
adult patients initiating antiretroviral therapy across South Africa, 2002-2007. AIDS. 
2010;24(14):2263-2270. 
16.  
Fox MP, Rosen S. Patient retention in antiretroviral therapy programs up to three years on 
treatment in sub-Saharan Africa, 2007-2009: systematic review. Trop Med Int Heal. 
2010;15(Suppl 1):1-15. 
17.  
Phillips TK, Thebus E, Bekker L-G, Mcintyre J, Abrams EJ, Myer L. Disengagement of HIV-
positive pregnant and postpartum women from antiretroviral therapy services: a cohort 
study. J Int AIDS Soc. 2014;17:19242. 
18.  
Geng EH, Glidden D V, Bwana MB, et al. Retention in care and connection to care among HIV-

21 
CareConekta: a pilot study of a smartphone app to improve engagement in postpartum HIV care in South Africa   
Study protocol, version 7.0 
infected patients on antiretroviral therapy in Africa: estimation via a sampling-based 
approach. PLoS One. 2011;6(7):e21797. 
19.  
Clouse K, Vermund SH, Maskew M, et al. Mobility and Clinic Switching Among Postpartum 
Women Considered Lost to HIV Care in South Africa. J Acquir Immune Defic Syndr. 
2017;74(4):383-389. 
20.  
Hickey MD, Omollo D, Salmen CR, et al. Movement between facilities for HIV care among a 
mobile population in Kenya: transfer, loss to follow-up, and reengagement. AIDS Care. 
2016;28(11):1386-1393. 
21.  
Kwena ZA, Camlin CS, Shisanya CA, Mwanzo I, Bukusi EA. Short-term mobility and the risk of 
HIV infection among married couples in the fishing communities along Lake Victoria, Kenya. 
PLoS One. 2013;8(1):e54523. doi:10.1371/journal.pone.0054523 
22.  
Marson KG, Tapia K, Kohler P, et al. Male, mobile, and moneyed: loss to follow-up vs. transfer 
of care in an urban African antiretroviral treatment clinic. PLoS One. 2013;8(10):e78900. 
23.  
Bygrave H, Kranzer K, Hilderbrand K, et al. Trends in loss to follow-up among migrant workers 
on antiretroviral therapy in a community cohort in Lesotho. PLoS One. 2010;5(10):e13198. 
24.  
Sikombe K, Kadota JL, Simbeza S, et al. Understanding patient mobility in HIV-positive adults 
across multiple clinics in Zambia. In: Conference on Retroviruses and Opportunistic Infections. 
Boston, MA; 2018. http://www.croiconference.org/sites/default/files/posters-
2018/1430_Sikombe_1091.pdf. 
25.  
Taylor BS, Reyes E, Levine EA, et al. Patterns of geographic mobility predict barriers to 
engagement in HIV care and antiretroviral treatment adherence. AIDS Patient Care STDs. 
2014;28(6):284-295. 
26.  
Statistics South Africa. Migration and Urbanisation in South Africa. Pretoria; 2006. 
http://www.statssa.gov.za/publications/Report-03-04-02/Report-03-04-02.pdf. 
27.  
Hoffman RM, Black V, Technau K, et al. Effects of highly active antiretroviral therapy duration 
and regimen on risk for mother-to-child transmission of HIV in Johannesburg, South Africa. J 
Acquir Immune Defic Syndr. 2010;54(1):35-41. 
28.  
Ferguson L, Lewis J, Grant AD, et al. Patient attrition between diagnosis with HIV in 
pregnancy-related services and long-term HIV care and treatment services in Kenya: A 
retrospective study. J Acquir Immune Defic Syndr. 2012;60(3):e90-97. 
29.  
Brennan AT, Bonawitz R, Gill CJ, et al. A meta-analysis assessing all-cause mortality in HIV-
exposed uninfected compared with HIV-unexposed uninfected infants and children. AIDS. 
2016;30(15):2351-2360. 
30.  
Pew Research Center. Cell Phones in Africa: Communication Lifeline.; 2015. 
http://www.pewglobal.org/files/2015/04/Pew-Research-Center-Africa-Cell-Phone-Report-
FINAL-April-15-2015.pdf. 
31.  
Clouse K, Hanrahan CF, Van Rie A, Bassett J, Vermund S, Pettifor AE. High cell phone 
ownership but low internet and email usage among pregnant, HIV-infected women attending 
antenatal care in Johannesburg, South Africa. J Telemed Telecare. 2015;21(2):104-107. 
32.  
Mobile Marketing Association South Africa. MMA SA 2016 Report.; 2016. 
http://www.bizcommunity.com/f/1604/MMA_SA_Mobile_Report_-_AMPS_2015A_LR.pdf. 
33.  
Pop-Eleches C, Thirumurthy H, Habyarimana JP, et al. Mobile phone technologies improve 
adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled 
trial of text message reminders. AIDS. 2011;25(6):825-834. 
34.  
Lester RT, Ritvo P, Mills EJ, et al. Effects of a mobile phone short message service on 
antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 
2010;376(9755):1838-1845. 
35.  
Odeny TA, Bailey RC, Bukusi EA, et al. Text messaging to improve attendance at post-
operative clinic visits after adult male circumcision for HIV prevention: a randomized 
controlled trial. PLoS One. 2012;7(9):e43832. 
36.  
Joseph-Davey D, Ponce W, Augusto O, Traca D, Jetha E, de Palha de Sousa C. Improved 

22 
CareConekta: a pilot study of a smartphone app to improve engagement in postpartum HIV care in South Africa   
Study protocol, version 7.0 
retention in HIV care following SMS reminders in Mozambique: a randomized controlled trial. 
In: 7th IAS Conference on HIV Pathogensis, Treatment and Prevention. Kuala Lumpur; 2013. 
http://pag.ias2013.org/abstracts.aspx?aid=3054. 
37.  
Phillips M, Hall T, Esmen N, Lynch R, Johnson D. Use of global positioning system technology 
to track subject’s location during environmental exposure sampling. J Expo Anal Env 
Epidemiol. 2001;11(3):207-215. 
38.  
Elgethun K, Fenske RA, Yost MG, Palcisko GJ. Time-location analysis for exposure assessment 
studies of children using a novel global positioning system instrument. Env Heal Perspect. 
2003;111(1):115-122. 
39.  
Byrnes HF, Miller BA, Morrison CN, Wiebe DJ, Remer LG, Wiehe SE. Brief report: Using global 
positioning system (GPS) enabled cell phones to examine adolescent travel patterns and time 
in proximity to alcohol outlets. J Adolesc. 2016;50:65-68. 
doi:10.1016/j.adolescence.2016.05.001 
40.  
Mogoba P, Phillips TK, Myer L, Ndlovu L, Were MC, Clouse K. Smartphone usage and 
preferences among postpartum HIV-positive women in South Africa. In: AIDSImpact 13th 
International Conference. Cape Town; 2017. 
41.  
Phillips TK, McNairy ML, Zerbe A, Myer L, Abrams EJ. Postpartum Transfer of Care Among 
HIV-Infected Women Initiating Antiretroviral Therapy During Pregnancy. J Acquir Immune 
Defic Syndr. 2015;70(3):e102-9. 
42.  
Myer L, Phillips T, McIntyre JA, et al. HIV viraemia and mother-to-child transmission risk after 
antiretroviral therapy initiation in pregnancy in Cape Town, South Africa. HIV Med. 
2016;18(2):80-88. doi:10.1111/hiv.12397 
43.  
Myer L, Phillips TK, Manuelli V, McIntyre J, Bekker L-G, Abrams EJ. Evolution of antiretroviral 
therapy services for HIV-infected pregnant women in Cape Town, South Africa. J Acquir 
Immune Defic Syndr. 2015;69(2):e57-e65. 
44.  
Schwartz SR, Clouse K, Yende N, et al. Acceptability and Feasibility of a Mobile Phone-Based 
Case Management Intervention to Retain Mothers and Infants from an Option B+ Program in 
Postpartum HIV Care. Matern Child Heal J. 2015;19(9):2029-2037. 
45.  
Myer L, Harrison A. Why do women seek antenatal care late? Perspectives from rural South 
Africa. J Midwifery Womens Heal. 2003;48(4):268-272. 
46.  
Campbell JI, Aturinda I, Mwesigwa E, et al. The Technology Acceptance Model for Resource-
Limited Settings (TAM-RLS): A Novel Framework for Mobile Health Interventions Targeted to 
Low-Literacy End-Users in Resource-Limited Settings. AIDS Behav. 2017;21(11):3129-3140.