Evaluation of Mhealth Strategies to Optimize Adherence and Efficacy of PMTCT/ART
Phase: NA
Conditions: mHealth, PMTCT, Adherence, Medication, SMS, Maternal Health, HIV/AIDS
Sponsor: University of Washington

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mHealth Strategies to optimize PMTCT/ART 
 
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1) TITLE: Evaluation of mHealth strategies to optimize adherence and efficacy of 
PMTCT/ART 
 
2) INVESTIGATORS (Roles and responsibilities): 
Grace John-Stewart, MD, PhD (PRINCIPAL INVESTIGATOR) 
(Responsible for the development and overall oversight and science of the project) 
Professor 
 
 
 
  
Departments of Global Health, Medicine, Epidemiology and Pediatrics, University of Washington 
Harborview Medical Center, 325 Ninth Ave., Box 359909, Seattle, WA 98104 
Tel:  +1-206-543-4278 
Fax: +1-206-543-4818 
Email:  gjohn@uw.edu 
 
 
John Kinuthia, MBChB, MMed, MPH (SITE PRINCIPAL INVESTIGATOR)  
(Responsible for the development and overall oversight and science of the project) 
Head, Department of Research & Programs, Kenyatta National Hospital 
PO Box 20723-00202, Nairobi, Kenya 
Tel: +254 0722 799-052 
Email: kinuthia@uw.edu 
 
Alison Drake, MPH, PhD (CO-INVESTIGATOR, Project epidemiologist) 
(Responsible for protocol, data and analysis plan, and evaluation of the project)  
Acting Assistant Professor  
Department of Global Health, University of Washington 
Harborview Medical Center, 325 Ninth Ave., Box 359909, Seattle, WA 98104 
Tel:  +1-206-685-8464 
Fax: +1-206-543-4818 
Email: adrake2@uw.edu 
 
Jennifer A. Unger, MD, MPH (CO-INVESTIGATOR, Project clinical and mHealth expert) 
(Responsible for the protocol, mHealth system and message development and evaluation of the 
project)   
Assistant Professor 
Department of Obstetrics and Gynecology, University of Washington 
Harborview Medical Center, 325 Ninth Ave., Box 359909, Seattle, WA 98104 
Tel:  +1-206-685-8464 
Fax: +1-206-543-4818 
Email: junger@uw.edu 
 
 
Richard Anderson, PhD (COMPUTER SCIENCE CONSULTANT) 
(Responsible for mHealth system development and evaluation of the project)   
Professor 
Department of Computer Science and Engineering, University of Washington 
185 NE Stevens Way (Paul G. Allen Center-582), Box 352350, Seattle, WA 98195 
Tel: +1-206-543-4305 
Fax: +1-206-543-1695 
Email: anderson@cs.washington.edu  
 
 
Rose Wafula (PMTCT PROGRAM CONSULTANT) 
(Responsible for advisement on message development and project evaluation) 

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PMTCT Program Manager 
National AIDS and STI Control Program 
Tel: +254-705-951-531 
Email: rosewafula@yahoo.com 
 
Gabrielle O’Malley, PhD (QUALITATIVE RESEARCH CONSULTANT) 
(Responsible for the qualitative develop and evaluation and message development)   
Assistant Professor 
Department of Global Health, University of Washington  
International Training and Education Center for Health (I-TECH), 902 Boren Ave, Suite 1100, Box 
359932, Seattle, WA 98104 
Tel: +1-206-685-0775 
Email: gomalley@u.washington.edu 
 
Barbara Richardson, PhD (STATISTICS CONSULTANT) 
(Responsible for protocol, data and analysis plan, and evaluation of the project) 
Research Professor 
Department of Biostatistics, University of Washington 
Harborview Medical Center, 325 Ninth Ave., Box 359909, Seattle, WA 98104 
Tel:  +1-206-744-2425 
Fax: +1-206-543-4818 
Email: barbrar@u.washington.edu 
 
Trevor Perrier (COMPUTER SCIENCE CONSULTANT) 
(Responsible for mHealth system development and evaluation of the project)   
PhD Student 
Department of Computer Science & Engineering, University of Washington 
185 NE Stevens Way., Box 352350, Seattle, WA 98195 
Tel: +1-206-685-9432 
Email: tperrier@cs.washington.edu  
 
Brian DeRenzi, PhD (MHEALTH CONSULTANT) 
(Responsible for mHealth system development and evaluation of the project)   
Senior Lecturer 
Department of Computer Science 
University of Cape Town 
Tel: +254 708 054 320 
Email: bderenzi@gmail.com 
 
Bhavna Chohan (VIROLOGIST) 
(Responsible for advisement on laboratory protocol and analysis)  
Senior Research Scientist 
Kenya Medical Research Institute 
Nairobi, Kenya 
Tel: +254-722-322-378 
Email: bchohan@u.washington.edu 
 
Dyphna Kerubo Mogaka (CLINICAL CONSULTANT) 
(Responsible for protocol development and collaborations with MOH staff)  
Mathare North City Council Clinic 
Nairobi, Kenya 

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Tel: +254-725-662-840 
Email: dyphna.k@gmail.com 
 
Lusi Osborn (DATA MANAGEMENT SPECIALIST) 
(Responsible for data collection, data analysis management and scientific plans)  
Ahero sub-district Hospital 
Ahero, Kenya 
Tel: +254 725 662 840 
lusiosborn@gmail.com 
 
Daniel Matemo (SITE STUDY COORDINATOR) 
Department of Obstetrics and Gynecology 
University of Nairobi 
Nairobi, Kenya 
(Responsible for lab and site protocol development, data analysis and staff oversight)  
Tel: +254-722-322-378 
Email: daniel.matemo@gmail.com 
 
Beryne Odeny, MBChB, MPH (STUDY COORDINATOR) 
(Responsible for study coordination, ERC/IRB communication and protocol development)  
Senior Fellow  
Department of Global Health, University of Washington 
Harborview Medical Center, 325 Ninth Ave., Box 359909, Seattle, WA 98104 
Tel:  +1-206-543-4278 
Fax: +1-206-543-4818 
bodeny@uw.edu  
 
Jillian Pintye, RN, MPH (STUDY COORDINATOR) 
(Responsible for study coordination, protocol development and analysis)  
PhD Student 
Department of Global Health and Nursing, University of Washington 
Harborview Medical Center, 325 Ninth Ave., Box 359909, Seattle, WA 98104 
Tel:  +1-206-543-4278 
Fax: +1-206-543-4818 
jillian.pintye@gmail.com 
 
Keshet Ronen, PhD (STUDY COORDINATOR) 
(Responsible for study coordination, ERC/IRB communication, protocol development and 
analysis)  
Senior Fellow  
Department of Global Health, University of Washington 
Harborview Medical Center, 325 Ninth Ave., Box 359909, Seattle, WA 98104 
Tel:  +1-206-543-4278 
Fax: +1-206-543-4818 
kronen@fhcrc.org 
 
3) COLLABORATING INSTITUTIONS 
Kenyatta National Hospital, University of Nairobi, University of Washington, Kenya Medical 
Research Institute (KEMRI) 
 
4) FUNDING AGENCY 

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Funding type: Grant 
Name of Funding agency: National Institutes of Child Health and Human Development (NICHD), 
National Institutes of Health (NIH) 
Principal Investigator on Proposal: Grace John-Stewart  
Proposal Identification Number: 1 R01 HD080460-01 
Title of Proposal: Evaluation of mHealth strategies to optimize adherence and efficacy of 
PMTCT/ART 
Dates: 01/04/2014 – 31/03/2019 
 
5) SUMMARY 
 
In 2013, WHO recommended that all HIV-infected pregnant women receive lifelong antiretroviral 
therapy (ART) for prevention of mother-to-child transmission (PMTCT-ART) (formerly Option B+). 
This approach provides treatment benefits for women, preventive benefits for their infants and 
sexual partners, and implementation advantages. However, there are valid concerns about risks 
of this approach if maternal retention in care or adherence falters. PMTCT programs have 
demonstrated remarkable flexibility to incorporate new HIV-specific counseling, testing and 
educational messages in maternal child health (MCH) clinics. PMTCT programs now need to add 
adherence and retention support for all women initiating lifelong ART in settings where health 
care workers are already overburdened.  
 
mHealth (Mobile Health) SMS (short message system) messaging is an evidence-based 
intervention that has been shown to significantly decrease treatment failure in adult ART treatment 
programs in Africa and may provide an inexpensive, feasible approach to enhance PMTCT-ART 
outcomes while supplementing rather than adding to provider workload. Our overarching 
hypothesis is that investment in mHealth for retention and adherence in PMTCT-ART will provide 
cost-effective benefit in sustaining antiretroviral regimen efficacy and durability. 
 
We have collaborated with the University of Washington (UW) Department of Computer Science 
and Engineering (CSE) along with Kenyan telecommunication providers to develop a hybrid 
messaging system that includes both 1.) unidirectional automated yet personalized SMS 
messaging and 2.) innovative bidirectional SMS messaging.  This system is currently under study 
in MCH clinics in Kenya. In qualitative research, women in Kenya have expressed a strong desire 
for mHealth support to provide additional education, counseling and reminders to supplement 
counseling by health workers. We hypothesize that mHealth strategies will improve PMTCT-ART 
maternal and infant outcomes. We also posit that both unidirectional and bidirectional SMS 
approaches will be cost-effective, and that bidirectional SMS may be superior to unidirectional 
SMS in improving both retention and adherence as well as maternal and infant outcomes.   
 
We propose a 3-arm randomized trial comparing the effects of unidirectional SMS (ie: “push” 
messaging to participant) vs. bidirectional SMS dialogue between participant and provider vs. 
control (no SMS) among HIV-infected Kenyan mothers in Kenyan PMTCT-ART programs. In AIM 
1 we will compare trial arms for impact on maternal retention, adherence, virologic failure and 
resistance and infant HIV or HIV-free survival. In AIM 2, we will determine correlates of maternal 
loss to follow-up and virologic failure and correlates of infant HIV in the overall study and stratified 
by trial arm. In the bidirectional SMS arm, we will determine the rate of SMS interactivity, impact 
of critical time-points on messaging, and characteristics of high and low ‘interactors’. In AIM 3, we 
will determine cost-effectiveness of unidirectional and bidirectional SMS interventions. These data 
will contribute a potential scale-able strategy to improve PMTCT-ART as programs aspire to 
‘virtual elimination’ of infant HIV. 

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6)  
a) INTRODUCTION/ BACKGROUND 
PMTCT-ART is being scaled up and requires long-term retention and adherence. Over the past 
decade, interventions for PMTCT have increased in complexity from single-dose nevirapine 
regimens to Option A/B/B+ to the most recent WHO 2013 guidelines advocating lifelong 
antiretroviral therapy (ART) for all pregnant women (formerly Option B+).  
 
b) LITERATURE REVIEW 
There has been some experience with implementing this PMTCT-ART approach, notably in 
Malawi and Mozambique. In Malawi, recent scale-up of PMTCT-ART was rapid (Figure 1a), with 
a 12-month postpartum retention of 77%; the majority of those not retained were lost to follow-up 
(Figure 1b) (1). With increasing momentum to attain ‘virtual elimination’ of MTCT (e-MTCT) by 
2015, more women will be initiated on PMTCT-ART which contributes to decreased infant 
transmission and sexual transmission (2). Over 1.5 million pregnant women globally were 
estimated to require PMTCT in 2011(3). 
 
 
  
 
 
Figure 1a. PMTCT-ART in Malawi(1) 
 

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               Figure 1b. Proportion lost to follow-up (Chimbwandira MMWR 2013)(1) 
 
Retention in PMTCT Programs Declines throughout the PMTCT Cascade 
In a systematic review of 33 studies from African ART programs in 2007, 2-year retention was 
estimated to be 61.6% ranging from 24% (worst scenario) to 77% (best scenario). Kenya average 
2 year retention in this review was estimated at 66% (4). A review of 18 PMTCT studies noted 
loss to follow-up rates ranging from 19% to 89.4% whereas Kenyan loss to follow-up rates were 
ranged from 27% to 80% (5, 6). Initial efforts to enhance PMTCT coverage focused on HIV 
diagnosis, the first step to enter the PMTCT cascade – which was addressed by rapid, point-of-
care, ‘opt-out’ testing (7). The next drop-off in the PMTCT cascade occurs in defining ART 
eligibility due to lags in obtaining CD4 results; this drop-off will be overcome by PMTCT-ART (8, 
9). Post-ART retention is being estimated in programs implementing PMTCT-ART, however long-
term data are lacking. 
 
ART Adherence Declines Postpartum and May Compromise PTMCT-ART Effectiveness  
Because of rapid viral replication in HIV, non-adherence in HIV leads to higher risk of disease 
progression and drug resistance (10). The contributors to non-adherence are multifactorial (5 
dimensions) (11). In qualitative studies, reasons for non-adherence to ART included 
dissatisfaction with clinic, HIV denial, use of alternative medications, and side-effects, while 
adherence was facilitated by social support, ability to fit taking ART into their schedule, a belief 
that the regimen was of value, transportation to clinic, partner disclosure/violence and food 
availability (12-15). The relatively healthy status of mothers starting on ART may also pre-dispose 
them to non-adherence (16, 17). In a meta-analysis, postpartum adherence was significantly 
lower than during pregnancy (75.7% adherence in pregnancy vs. 53% postpartum, p<0.005) (18-
20). Thus, in the context of PMTCT-ART a tailored approach that involves initial adherence 
counseling at ART initiation in pregnancy and ‘booster’ counseling messages when PMTCT ends 
may be necessary to sustain ART adherence and could be delivered via SMS messaging. 
Interventions to Improve ART Adherence  
There have been diverse approaches to improving ART adherence (21, 22). Intensive adherence 
counseling was associated with increased adherence and decreased viral failure (23). In a 
systematic review of ART adherence interventions, several interventions were found to be 
effective, including mobile phone SMS (24). However, for these interventions, effectiveness data 
was limited and long-term durability undefined. The US CDC guidelines combine pragmatic 
recommendations for improving ART adherence with educational/motivational approaches, some 
of which can be incorporated into an mHealth approach as shown in table 1 (25). 
Table  1. US CDC guidelines to enhance ART adherence and potential applicability to mHealth (25) 
 

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US CDC guidelines for clinicians 
Can be incorporated in PMTCT-ART 
mHealth 
Multidisciplinary long-term adherence support team 
Yes, include elements from pharmacy, 
clinic 
Patient readiness 
No-all women need ART promptly 
Benefits of adherence 
Yes 
Decrease pill burden 
Not applicable 
Patient involved in decision-making re: regimen 
Not applicable 
Acknowledge difficulties;  encourage disclosure of non-
adherence 
Yes bidirectional 
Viral load to motivate 
Possibly – currently no because VL not 
used 
in 
LMIC 
PMTCT; 
however, 
guidelines may shift to make this possible 
Referrals to address factors leading to non-adherence 
Yes 
Education and tools 
Yes  
Manage side-effects of ART 
Yes 
 
PMTCT Counseling Quality and Quantity is Often Inadequate 
PMTCT counselling already incorporates messages to help women cope with their new HIV 
diagnosis, disclosure to their partners, and PMTCT interventions. The high volume of patients 
and health care worker shortage makes it challenging to add a new message of lifelong ART 
adherence counseling. In an observed evaluation of PMTCT counseling, median post-test 
counseling was 38 minutes (26). Unlike prior short-course PMTCT models, PMTCT-ART 
programs will need to encourage ART adherence habits that persist lifelong and focus dually on 
child and maternal long-term outcomes. Thus, there is need to supplement PMTCT/MCH activities 
with ART-specific adherence interventions (Table 2). 
 
Table 2. PMTCT Programs have Less Long-Term HIV Care Focus than HIV Treatment Programs 
 
PMTCT 
HIV Treatment Programs 
Clients 
Young women, often no 
symptoms 
Men and women suspect HIV risk, 
symptomatic 
Health care workers 
serving clinic 
MCH nurses – routine MCH and 
PMTCT 
ART-dedicated health care workers 
Counseling approach 
Group pre-test, individual post-
test 
One-on-one, several adherence 
sessions 
Counseling messages in 
clinic 
Stop infant HIV 
ART adherence lifelong 
Health care worker focus 
MCH, PMTCT, and HIV 
HIV alone 
Evidence that mHealth SMS Messages Enhance ART Adherence  
In Kenya, the number of mobile subscribers was reported at 29 
million in 2012, in a national population of ~43 million (27, 28). In 
our preliminary studies in Kenya, pregnant and postpartum 
women report interest and perceive utility in receiving MCH SMS 
messages and are particularly interested in bidirectional dialogue 
options (29). A Cochrane review concluded that weekly SMS 
messages were beneficial for ART adherence and better than 
daily messages and that ‘there is high quality evidence that SMS 
messages enhance ART adherence and viral suppression’ (30-
32). In an updated review of mHealth interventions for ART 
adherence presented at IAS 2013, 6 Randomized Controlled 
Trials (RCTs) and 2 observational studies were identified that 
 

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used SMS approaches (Table 3). However, the total number of studies is small and there are no 
data from PMTCT-ART programs. 
 
Table 3: mHealth ART interventions published and ongoing 
Study author, 
location, year 
Number 
Intervention 
Study 
Design 
Outcomes 
Results or Status 
Lester, WelTel 
Kenya, 
2010 (30) 
538 patients 
initiating ART 
Bidirectional short SMS 
Weekly message required 
response in 48 hrs 
RCT 
Self-reported ART 
adherence (>95%), 6 & 
12 mo 
VL suppression (<400 
c/mL), 12 mo 
RR for non-adherence 
0.81 (95% CI O.69-0.94)  
RR for virologic failure 
0.84 (95% CI 0.71-0.99) 
Pop-Eleches, 
Kenya, 
2011 (33) 
431 patients 
initiating ART last 
3 mo 
4 unidirectional 
interventions (short wkly, 
short daily, long wkly, long 
daily) 
RCT 
Self-reported ART 
adherence >90% at 6 
mo 
Shortly weekly RR 0.78 
(95% CI 0.68-0.89) 
Mbuagbaw, 
Cameroon, 
CAMPS, 2012 
(34) 
200 patients in 
ART for at least 1 
mo 
Unidirectional “standard 
motivational” msg 
RCT 
Adherence by visual 
adherence score (VAS), 
self-report, pharmacy 
refill 
 
No difference in any 
measure 
Kimani, Kenya, 
registered 2010 
˜ 856 HIV+ 
pregnant women 
Unidirectional SMS 
RCT 
Compliance with ANC, 
NVP in labor, EID 
Ongoing  
Ong’ech, 
Kenya, 
registered 2012 
600  HIV+ 
pregnant women 
seeking ANC 
Bidirectional “mobile 
communication with 
providers 
Cohort 
Proportion of women 
who complete PMTCT 
milestones to 6 wk 
postpartum 
Ongoing 
Palha, 
Mozambique 
SMSaude, 
registered 2013 
HIV infected 
adults and HIV  
infected pregnant 
women 
Unidirectional PMTCT 
SMS reminders,  
ART reminders 
RCT with 
2 different 
cohorts 
Retention in ART 
Clinical procedures 
completed 
Need For Further mHealth Research Including Optimizing mHealth Strategy, Cost-Effectiveness 
and Cost-Savings To Inform Programmatic Scale-Up  
PEPFAR and Ministries of Health (MOH) are in need of relevant effectiveness and programmatic 
cost data to inform scaling of mHealth interventions. The Kenya MOH has included mHealth 
interventions as part of its eMTCT priorities. However, there are still limited published mHealth 
evaluations in HIV. While studies have evaluated the role of differing frequency of messages, they 
have either used unidirectional or bidirectional messages but not compared these to each other. 
To date no study has demonstrated the level of SMS interactivity required to demonstrate optimal 
effectiveness or evaluated the additional cost and provider burden of this SMS intervention. 
Unidirectional messaging is less expensive and complex than bidirectional messaging but may 
have lower effectiveness.  
 
7) RATIONALE 
SMS Messaging has potential not only to educate but also engage women to adhere to PMTCT-
ART without placing an additional burden on health care workers. This project leverages the 
innovation of mobile communications to sustainably increase ART adherence within PMTCT-
ART. Personalized and dynamic messaging may be more effective in producing behavioral 
change (35). SMS interventions may be cost saving in avoiding treatment failure and cost-
effective. Furthermore, evaluation of unidirectional informative SMS versus bidirectional 
interactive SMS in a health care setting is novel. Determining the optimal level of messaging 
interaction required for successful behavioral change is essential for development of large-scale 
mHealth strategies. While unidirectional SMS provides low-cost dissemination without additional 
interactions with health care workers, it may not engage women enough. In contrast, bidirectional 
SMS requires action from the message receiver and allows for exchange of questions and 

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concerns, which may enhance engagement and ultimately uptake of services; however, it is 
requires more interaction with health care workers than unidirectional SMS. This project will 
evaluate potential added benefit as well as expense and health care worker time for bidirectional 
messaging. 
 
8) HYPOTHESIS & STUDY QUESTIONS: 
Our overarching hypothesis is that investment in mHealth technologies for PMTCT-ART will yield 
cost-effective, long-term benefits by maximizing impact and durability of ART. This hypothesis is 
motivated both by emerging adherence literature, and specific ART adherence RCTs in Kenya, 
in which SMS interventions significantly decreased treatment failure in adult HIV Treatment 
programs and increased return for early infant HIV detection in PMTCT programs. Building on our 
qualitative research among pregnant women in Kenya that revealed a desire for mHealth SMS 
messages and dialogue, we developed an interactive mHealth system (Mobile WACh) in 
collaboration with the UW Department of Computer Science and Engineering (29). This system, 
now in use in Kenya, can be readily adapted to deliver and receive messages regarding PMTCT-
ART. We propose to conduct a 3-armed RCT to determine the impact of mHealth SMS strategies 
on adherence, retention, and outcomes in PMTCT-ART programs with the following specific 
AIMS: 
 
9) OBJECTIVES 
a) BROAD OBJECTIVES 
The broad objective of this study is to determine the impact of mHealth SMS strategies on 
adherence, retention, and outcomes in PMTCT-ART programs. 
 
b) SPECIFIC OBJECTIVES 
AIM 1: To compare mother-infant pairs receiving systematic, tailored unidirectional SMS 
messaging vs. bidirectional SMS dialogue vs. control (no SMS) for outcomes measured during 2-
year postpartum follow-up, including:  
a) Maternal retention in care, ART refills, virologic treatment failure, and ART drug 
resistance  
b) Infant HIV infection and HIV-free survival at 6 weeks, 6 months and 24 months  
c) Maternal perceptions of acceptability, utility and strengths/weaknesses of unidirectional 
and bidirectional SMS  
 
Hypothesis 1: Long-term retention, ART adherence, and maternal/infant outcomes will be 
enhanced by SMS. Mothers will endorse SMS approaches, preferring bidirectional messaging 
dialogue.  
 
AIM 2: To determine correlates of maternal treatment failure (loss to follow-up, virologic failure, 
or ART resistance) and correlates of infant HIV infection in the cohort overall and stratified by 
arm, and characterize SMS interactions among women in the bidirectional SMS arm, including 
frequency of and changes in interactivity over time, relationship to pivotal time-points (delivery, 
cessation of breastfeeding, transfer of care to ART clinic), characteristics of high and low 
‘interactors’, and topics motivating interactions. 
 
Hypothesis 2: Lack of disclosure to partner, distance to clinic, and poor understanding of need for 
lifelong ART, will be associated with maternal treatment failure. Interaction frequency with 
bidirectional SMS will decline over time, and ‘higher-interactors’ will be younger, primigravida, and 
more educated.  
 

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AIM 3: To assess the cost-effectiveness of unidirectional SMS and bidirectional SMS interactions: 
a) Estimate net cost savings realized through the reduction of treatment failure and drug 
resistance. b) Estimate incremental cost-effectiveness in improving infant and maternal health 
outcomes. 
 
Hypothesis 3: Both interventions will be cost saving and cost-effective; bidirectional SMS will be 
more cost-effective. 
 
10) STUDY DESIGN AND METHODOLOGY 
This is mixed methods study that includes qualitative components and a triple-arm, non-blinded 
RCT. The study has 3 phases:  
• 
Phase 1: Formative phase with 2 rounds of female focus group discussions (FGDs), male 
in-depth interviews (IDIs) and health provider IDIs.  
• 
Phase 2: RCT phase, a triple-arm RCT to evaluate two mHealth interventions designed to 
enhance long-term ART adherence in PMTCT-ART programs.  
• 
Phase 3: Post-RCT phase, IDIs with RCT participants, clinic health providers, study 
nurses, and surveys with male partners of RCT participants. 
 
a) STUDY AREA DESCRIPTION:  
The proposed study will be conducted at six sites in Kenya: the Ahero sub-District Hospital, Bondo 
District Hospital, Siaya County Referral Hospital and Rachuonyo sub-County Hospital in Nyanza 
region and Mathare North City Council Clinic and Riruta Health Centre in Nairobi. These are all 
high volume government-run public health facilities which serve low- to middle-income rural 
(Bondo, Ahero, Siaya and Rachuonyo) and peri-urban (Mathare and Riruta) populations. From 
our previous studies at these sites, HIV seroprevalence among pregnant women is 15% at 
Mathare and 19% Ahero and Bondo. These four sites provide a wide range of ANC, postnatal 
care, and HIV services in their catchment areas.  
 
An overview of all study procedures is shown in Figure 3. 
 
 
 

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Figure 3: Overview of study procedures 
 
 
 
Formative phase 
 
Round 1: Operations and 
Thematic evaluations of SMS 
 
 
 
 
 
 
 
Formative phase 
 
Round 2: Presentation of 
messages & SMS Refinement 
for validation 
 
 
 
 
 
 
 
 
 
RCT phase 
 
 
 
 
Post-RCT phase 
 
 
 
 PHASE 1: FORMATIVE PHASE 
 
a) STUDY DESIGN 
 
FGDs and IDIs 
FGDs are an effective technique to compare experiences and views between participants, 
and gather the “group effect”, rather than relying on individual data (36).They also provide a 
breadth and depth of information regarding social norms such as acceptability, which is 
imperative for successful interventions. IDIs are useful because they provide much more 
detailed information than what is available through other data collection methods, such as 
surveys. They may also provide a more relaxed atmosphere in which to collect information 
and people may feel more comfortable having a conversation (37). IDIs and FGDs will be 
conducted by a Kenyan team trained in qualitative research methods and will probe for further 
elaboration on relevant content from the semi-structured FGD guide. Study investigators 
experienced in qualitative methods, Dr. John Kinuthia (site-PI) and Dr. Gabrielle O’Malley (co-
investigator), have reviewed topic guides for content validity and cultural relevance.  
 
b) STUDY POPULATIONS 
The formative phase of the study will include three different populations and study designs: 
female FGDs, male IDIs, and health care provider IDIs. The study participants will be drawn 
from peri-urban (Mathare, Nairobi) and rural (Ahero and Bondo, Nyanza) regions of Kenya. 
Female FGDs 
(Round 1) 
Health Providers IDIs 
 
 
 
Male IDIS 
 
Adapt and refine SMS 
Female FGDs 
(Round 2) 
3-arm RCT 
Female  
IDIs 
  
Male  
Surveys 
 
Clinic 
Provider IDIs 
 
Finalize message 
development 
RCT Provider 
IDIs 
 

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Female FGDs:  
The study population will comprise HIV-infected pregnant women seeking antenatal care 
services at three public facilities in Nairobi and Nyanza regions.  Women are primarily 
attended to by health providers: nurses, clinical officers, pharmacists, peer counselors, and 
mothers-to-mothers (M2M) counselors. The source population is drawn from both rural (Ahero 
and Bondo) and peri-urban (Mathare) areas, diverse in ethnicity, and of generally low 
socioeconomic status. Women who are HIV-infected will be offered participation in the study.   
 
The overall objective of the female FGDs is to narrow/refine themes and wording of SMS 
messages for the RCT.  We will conduct 2 rounds of FGDs with women prior to initiating the 
RCT.   
The goals of Round 1 FGDs are to: 
1.) Determine the acceptability of potential pre-developed SMS content themes 
2.) Elicit ideas for additional messaging themes  
3.) Present and evaluate pre-developed messages to determine comprehension, 
acceptability, and ideas for refinement.   
The pre-developed SMS topics will include: pregnancy, antenatal and postpartum care, 
medication and clinic visit reminders, infant care including feeding practices and general 
encouragement messaging.  Utilizing data from Round 1, the second round of FGDs will 
be used to refine and finalize SMS messages for the RCT.   
 
Table 4: Composition of female FGD participants with varied PMTCT/ART experience in each 
FGD 
 
PMTCT 
experience1 
ART 
experience1 
No-PMTCT /ART 
experience1 
Total1 
Pregnant HIV+ women 
2 
2 
2 
 
 
 
15 
Postpartum HIV+ women 
3 
3 
3 
Total per category 
5 
5 
5 
1Maximum number of women 
 
We will purposively sample women based on pregnancy/postpartum status and 
PMTCT/ART experience as indicated in Table 4 above until we have up to 15 women 
enrolled in each FGD and the desired population.   
 
For each round of FGDs, we will conduct 6 FGDs (2 FGDs per clinic) for a total of 12 FGDs 
combined in Rounds 1 and 2 (Figure 4). Thus, we will recruit a total of 180 women for the 
FGDs.  
 
Figure 4: Focus groups by study site  
 
 
 
+ 
= 
 
 
 
Male IDIs: IDIs will be conducted with a total of 30 men who have HIV-infected partners 
to: 
§ 
Obtain additional information to guide SMS intervention development and 
distribution 
Round 1 (n=6) 
Mathare – 2 FGD 
Ahero – 2 FGD 
Bondo – 2 FGD 
Round 2 (n=6) 
Mathare – 2 FGD 
Ahero – 2 FGD 
Bondo – 2 FGD 
n = 12 FGDs 

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13 
 
§ 
Obtain feedback on sample SMS messages 
§ 
Explore desirability and feasibility of involving male partners 
§ 
Understand potential concerns of male partners that could be addressed by 
modifying SMS messages   
 
We will include two groups of men for IDIs: HIV infected men with a current infected partner 
recruited from HIV clinics where the men attend care and HIV uninfected men who are 
referred to the study from their self disclosed partners who attend MCH clinics. HIV-
infected men will be purposively sampled from CCCs.  HIV-uninfected men will be referred 
to the study by women who have disclosed their HIV status to their partner and have 
known HIV-uninfected partners for potential participation in an IDI and survey 
administration.   
 
Provider IDIs: We will conduct 30 Key Informant IDIs (10 per site). We will interview 
Nursing officer in charge, MCH nurses, clinical officers and pharmacists to determine how 
SMS messaging can be used to augment the current care being delivered in clinics.  We 
will specifically explore challenges providers face in the care of HIV infected women and 
their views on how enhanced communications via SMS could address these challenges 
and improve retention and adherence.   We will also engage peer counselors and mother-
to-mother (M2M) counselors through IDIs to elicit their views of how SMS can work to 
improve adherence and retention.  M2M are mothers living with HIV who are trained to 
provide health education and psychosocial support to other HIV-positive mothers on 
PMTCT. We will specifically explore how this technology could be useful for their 
responsibilities (psychosocial support, counseling, assisting client on enrolment in care, 
patient tracing) and elicit advice regarding sensitive issues around confidentiality and other 
concerns when communicating with HIV infected women, and suggestions for enhancing 
the intervention.    
  
Table 5:  Layout of Phase I (formative) procedures, study populations, and eligibility 
 
 
FORMATIVE PHASE 
 
 
 
Females 
 
Males  
Providers 
Population 
& maximum 
sample size 
Women  
N=180 (15 per FGD) 
Men 
N=30 
Health providers 
N=30  
Study 
procedures 
FGDs, N=12 
• 6 FGD x 2 rounds (2 FGD per clinics 
per round) 
IDIs 
10 in Mathare 
10 in Ahero 
10 in Bondo 
Key Informant IDIs 
• 
10 per site 
Topic 
Additional strategies and themes for 
message content, share SMS content 
for feedback and refinement 
Additional adherence 
strategies, personal 
experiences, assess 
desired degree of 
involvement 
Current counseling 
messages, duration of 
HIV counseling, 
messages they lack 
time to deliver, SMS 
content to consider 
adding, concerns 
about SMS 
 
Recruitment From ANC, MCH, and CCC 
From ANC, MCH and 
CCC 
ANC, MCH 

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Eligibility 
• HIV-infected women > 14 years  
• PMTCT or ART naïve or experienced  
• Women should be either: 
§ <36 weeks gestation or 
§ Have HIV-uninfected child <2 years 
(and HIV infected when pregnant 
with the child), 
• Daily access to mobile phone  
• Willing to receive SMS   
• Literacy not required if women have 
access to a partner/family member 
whom she would be comfortable to 
have read her the messages 
• Willing to provide informed consent  
 
• Have HIV-infected 
female partner with a 
child (≤2years old) OR 
who is accessing 
antenatal care or 
postnatal care services 
• Referred by female 
partner or attending 
CCC alone.  
• Willing to provide  
informed consent  
• Directly involved with 
care of HIV-infected 
pregnant women 
and HIV-exposed 
infants 
• Willing to provide 
informed consent 
 
 
 
 
c) RECRUITMENT PROCEDURES 
 
Female FGD: A study staff member will approach HIV infected women in ANC, MCH clinics 
and CCC to briefly describe the purpose of the FGDs and invite interested women to be 
assessed for eligibility and participation. It will be emphasized that participation is completely 
voluntary. Women will be notified that by participating in FGDs with other HIV infected women, 
they are self-disclosing their HIV status and confidentiality cannot be maintained within the 
FGD due to the nature of FGDs. It is common practice for these women to meet in a group 
during ANC and MCH care.  Women who are uncomfortable having group discussions with 
other HIV-infected women in the FGD will be told that the FGD is not a good fit for them. 
However, we will emphasize the need for confidentiality outside of the FGD for all study 
participants. Eligible participants will be given a date to return for FGD. Participants will 
undergo the informed consent process prior to FGD.   
 
Male IDIs: HIV-infected women from ANC, MCH and CCC will be approached by study staff 
about potential participation of their male partners and informed about the Male IDIs. They will 
be asked whether they have disclosed their HIV status to assess study eligibility. Women who 
have disclosed their HIV status to their partners, will be requested to refer their male partners 
for IDIs. For those women interested in asking their partners to participate, we will provide 
them a “study clinic referral form” (Male Partner IDI Pre RCT Referral Form) to give their 
partner. A study staff will also approach partnered male patients, in CCC, previously identified 
by clinic staff, and describe the purpose of the IDIs and invite interested men for eligibility 
assessment and participation. Study staff will work with clinic staff to identify men who have 
visited CCC alone. Once male participants present for enrollment, they will be given more 
information on the study. It will be emphasized that participation is completely voluntary. If 
interested in participation, they will get an appointment for an IDI. Eligible participants will 
undergo the informed consent process.  IDIs will occur immediately after the consent process.   
 
Provider IDIs: Pre-RCT, key informant health providers will be approached by study staff who 
will describe the purpose of IDIs and invite health providers to participate. Health providers 
consist of clinical staff serving HIV-infected pregnant women (Nursing officer in-charge, 
nurses, clinical officers, pharmacist) and non-clinical staff (peer counselors and Mothers to 
Mothers (M2M) counselors). We will emphasize that IDIs are completely voluntary. Those who 

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are willing and able to participate will get an appointment for IDIs. Eligible participants will 
undergo the informed consent process. IDIs will occur immediately after the consent process.   
 
 
d) DATA COLLECTION PROCEDURES (clinical and non-clinical, field, data collection 
instruments) 
 
Both FGDs and IDIs will be performed in a private area. Participants will meet a trained 
interviewer or moderator who will ask questions and take notes. Consent will be obtained from 
participants to take notes and audio record the discussion. Socio-demographic information 
from participants will be documented in separate forms. Socio-demographic information that 
will be captured include: age, marital status, education level, employment, number of children, 
and partner HIV status as shown in the participant survey (included in with the IDI and FGD 
guides). 
 
The interviewer/moderator will describe procedures and norms for discussion and 
participation. Participants will be given a chance to ask questions regarding procedures prior 
to the discussion.  
 
Discussions will be guided by the interviewer or moderator using a discussion guide 
(attached). Prior to FGD, the moderator will stress the importance of maintaining 
confidentiality within the group. Participants will receive unique identification numbers and will 
not be addressed by their real names so as to maintain confidentiality. Topics that generate 
the most discussion, participant attitudes, non-verbal gestures, and interaction dynamics 
among group members will be documented by the moderators. Discussions will be conducted 
in English, Kiswahili, or Luo depending on participant preferences. Thereafter, notes will be 
compared to audio-recordings to fill in missing information and transcribed to English (if 
necessary). Transcribed data will be de-identified. Tape-recorded discussions will be 
destroyed no later than 3 years after conducting the FGD or IDI. 
 
Participants will be provided refreshments and Ksh. 300 to compensate for their time and 
transportation expenses to participate in the study. We will provide this monetary 
compensation to each participant at the conclusion of each discussion. 
 
e) DATA COLLECTION INSTRUMENTS 
Paper copies of data collection tools for surveys accompanying IDIs and FGDs are submitted 
with this application for human subjects review. 
 
 
 PHASE 2: RANDOMIZED CONTROLLED TRIAL 
 
a) STUDY DESIGN 
 
We will enroll and randomize 825 HIV-infected pregnant women (275 per arm) in a triple-arm, 
non-blinded RCT. We will enroll and randomize women to unidirectional SMS, bidirectional SMS, 
or control during pregnancy and measure maternal retention in care, ART refills, virologic 
treatment failure, and drug resistance during a 2-year postpartum follow-up period (Aim 1a). We 
will also assess the effect of the interventions on infant HIV infection and HIV-free survival (Aim 
1b). 
 
SMS MESSAGE DEVELOPMENT AND DELIVERY 

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SMS messages will be designed using an iterative process that integrates findings from a 
preliminary SMS intervention (Mobile WACh) and formative FGDs and IDIs. This process will 
incorporate the constructs of Theory of Planned Behavior and Social Cognitive Theory in 
understanding drivers of behavior change and direct appropriate message development (38, 39) 
 
SMS messages will provide tailored and actionable education, counseling, and reminders specific 
to pregnancy/postpartum status.  Messages will be based on Focused Antenatal Care WHO 
guidelines and the recently adopted Kenyan maternal child health handbook as well as the 
Kenyan HIV guidelines (40-42). 
 
Messages will be tailored to antenatal/postpartum timing, new vs. prior ART, maternal age group 
(adolescent or adult), and HIV disclosure to partner. SMS messages will be translated into local 
dialects. Messages will be tested in English, Kiswahili and Luo.  
 
 
Informative Unidirectional SMS Messaging: SMS will be delivered once weekly to participants. 
The message will act both as a reminder and cue to action. Pre-programmed messages will be 
delivered at times and in languages based on patient preferences. The service will be provided 
free of charge.  
 
Interactive Bidirectional SMS Messaging: SMS will be delivered once weekly to participants. The 
diagram (Figure 5) on the left shows a screen shot of Mobile WACh SMS interface with dummy 
messages and data. Pre-programmed messages will be delivered at times and in languages 
based on patient preferences. They will include a question soliciting a response from the 
participant. If no response is received, the participant will receive a “check-in” SMS after failing to 
respond for 2 weeks. The “check-in SMS” will ask if participant is receiving SMS and if she is well. 
If no response is received from the participant, no further “check-in SMS” will be sent. However, 
she will continue to receive standard weekly SMS. Participants in the bidirectional messaging 
group will also have the capability of texting spontaneously to the system. Interactive SMS 
communication will be responded to and managed by the study nurse at each site. 
 
We have partnered with a local premium rate service provider (PRSP), Shujaa Solutions, to 
provide SMS dialogue free of charge to participants. 
 
In this RCT, bidirectional SMS dialogue will be managed by study nurses and standard operating 
procedures (SOPs) will be developed for standardizing responses to the questions received. 
Thus, study nurses will follow national guidelines and local practice standards to respond.  The 
process will be adaptive as new scenarios unfold with dialogue –a new question not addressed 
by the SOPs will be discussed by study team and SOP developed if it is a question likely to be 
encountered repeatedly. Weekly review of the log of SMS narrative will enable standardization, 
quality assurance, and understanding women’s use of the system and their level of interaction it. 
Issues to be examined within the bidirectional intervention arm include ability to standardize 
messaging, time demands, and time-cost.  
 
Figure 5: Screen-shot of mobile WACH SMS interface with drafted data 
 

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Controls: The control arm will receive standard education and counseling provided in ANC. 
 
Phone Calls:  All participants will receive a phone call at 1 month and 1 year after the estimated 
delivery date (EDD).  The purpose of this phone call is to obtain delivery information and health 
status information for those women who have been lost to follow up.  We will also conduct a final 
phone call at 2 years postpartum along with the home visit.  The purpose of the final phone call 
is to set up the home visit.  If the patient prefers not to have a home visit, we will attempt to collect 
final data follow-up during this phone call.  
 
Figure 6: Map of timeline of message themes that will be sent out to women 
 
 

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18 
 
 
Figure 7: Display of sample SMS messages by themes 
 
Examples of one-way messaging  
 
 
 
 
 
 
 
 
Medication Adherence
<Name>, this is 
<nurse> from <x> 
clinic.  Take time 
each day for your 
health.  If you are 
having challenges, let 
us know.    
General Encouragement 
<Name>, this is 
<nurse> from <x> 
clinic.  If you are 
having any health 
concerns we are 
available to help.  
Visit Reminder
<Name>, it is 
<nurse> from <x> 
clinic. You are to 
come in XX day XX 
date.  We will give 
vaccines to your 
baby.  You may also 
get free family 
planning.  Please 
come in.
Missed Visit 
<Name>, it is 
<nurse> from <x> 
clinic.  We missed 
you in clinic today.  
You are due for your 
visit.  Please come in 
so we can check you 
and your baby.
Infant Feeding
<Name>, this is 
<nurse> from <x> 
clinic.  Breastfeeding 
a baby right after 
birth helps the milk 
come.  The first 
yellow sticky milk 
has many vitamins & 
cleans out the 
stomach.  Milk has all 
the nutrients the 
baby needs.  
Infant Immunization 
Reminder
<Name>, this is 
<nurse> from <x> 
clinic.  It's time for 
your baby's clinic 
visit in 2 days. Your 
baby will receive a 
vaccine and check 
growth.  If you have 
questions about your 
baby's health, ask the 
nurse.   
Family Planning 
<Name>, this is 
<nurse> from <x> 
clinic.  The IUCD or 
coil is a small device 
for family planning. 
Easy to put in, safe 
and very effective for 
years but can be 
removed at any time! 
Ask your nurse.  
Birth Preparedness 
Counseling 
<Name>, this is 
<nurse> from <x> 
clinic.  Regular, 
strong contractions 
are a sign of labour. 
If you feel strong 
tightening of your 
belly,  leaking of fluid 
or any bleeding go to 
the clinic.  Don't 
wait.

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Examples of two-way messaging with questions 
 
 
 
 
 
b) STUDY POPULATION 
The study population will comprise HIV-infected pregnant women seeking antenatal care services 
at three public facilities in Nairobi and Nyanza regions. The source population is drawn from both 
rural (Ahero, Bondo, Siaya and Rachuonyo) and peri-urban (Mathare and Riruta) areas, diverse 
in ethnicity, and of generally low socioeconomic status. Women who are HIV-infected will be 
offered participation in the study. HIV care and treatment in these sites is supported by the MOH 
and two non-governmental organizations, International Center for AIDS Care and Treatment 
Medication Adherence
<Name>, this is 
<nurse> from <x> 
clinic.  Take time 
each day for your 
health.  If you are 
having challenges, 
let us know. Have 
you had any 
challenges this 
week?   
General Encouragement 
<Name>, this is 
<nurse> from <x> 
clinic.  If you are 
having any health 
concerns we are 
available to help.  
Are you feeling well 
this week?
Visit Reminder
<Name>, it is 
<nurse> from <x> 
clinic. You are to 
come in XX day XX 
date.  We will give 
vaccines to your 
baby.  You may also 
get free family 
planning.  Please 
come in.  Are you 
coming for your 
visit?
Missed Visit 
<Name>, it is 
<nurse> from <x> 
clinic.  We missed 
you in clinic today.  
You are due for your 
visit.  Please come in 
so we can check you 
and your baby.  Are 
you having difficulty 
coming to clinic? 
ANC
<Name>, this is 
<nurse>from <x> 
clinic. Iron helps 
carry nutrition to 
your baby. If it is low, 
you feel tired.  Are 
you taking iron or do 
you need tablets? 
Infant Health 
<Name>, this is 
<nurse> from 
<x>clinic.  If your 
new baby is having 
trouble breathing or 
feeding, is too warm, 
or very sleepy, go to 
the clinic. Does the 
baby have trouble 
feeding?   How many 
times a day does the 
baby feed? 
Family Planning 
<Name>, this is 
<nurse>from <x> 
clinic.  The Implant is 
a small rod with 
medicine for family 
planning. It is placed 
in your arm and is 
very effective for 3 
years. The Implant 
can be removed at 
any time! Would you 
like to try the 
Implant?  Do you 
have any questions 
about it? 
Birth Preparedness 
Counseling 
<Name>, this is 
<nurse>from <x> 
clinic.   Delivery at 
the clinic or hospital 
could save your 
baby’s life. Do you 
have any questions 
about where to go in 
labor and how to get 
there? 

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Programs (ICAP) and AIDS, Population and Health Integrated Assistance (APHIA-plus). Based 
on ANC attendance and HIV prevalence data, we anticipate 20 women per month will be eligible 
for participation at Ahero, Bondo, Rachuonyo and Riruta and 35 women per month at Mathare 
and Siaya. 
 
c) SAMPLE SIZE DETERMINATION AND FORMULAS USED 
 
RCT sample size 
Sample Size Estimates Assuming 
alpha=5%, 
power=80%, 
2-sided 
test, 1:1:1 allocation ratio, with a 
sample size of 275 per arm, we 
would have sufficient power to 
detect an increase in retention or 
increase in virologic suppression 
(inverse of virologic failure) from 
75% (control) to ≥85%, allowing for 
10% attrition; we will also be able to 
detect an increase in ARV adherence from 85% to ≥95% (Table 6). Thus, the total cohort sample 
is 825 women. We could see a difference from 75% to 85% between control and unidirectional 
SMS and additionally detect a difference between uni- and bidirectional SMS (85% to 95%). 
Similarly, we will have sufficient power to detect an increase in infant HIV-free survival from 85% 
to ≥95%. 
 
d) RECRUITMENT PROCEDURES 
 
MCH nurses or other clinic staff will introduce the study and refer interested women to the study 
clinic after the ANC visit.  (please see attached recruitment scripts) Study nurses will inform 
women about the study, answer any questions they have and invite women to participate in 
eligibility screening for the RCT.  It will be emphasized that their participation would be completely 
voluntary and would not in any way affect their access to ANC, HIV, postnatal, or infant care 
services.  In order to capture the proportion of women referred who meet our eligibility criteria and 
are interested in participating, a screening questionnaire will be used to collect data on eligibility. 
The screening questionnaire (attached) records no personally identifiable information. Oral 
consent will be obtained for participation of interested women in the screening phase.  Eligible 
women will be invited to participate in the RCT.  Those eligible women who decide not to 
participate will be asked for their reasons for non-participation, and these will be recorded in the 
screening questionnaire. 
 
Eligibility:  HIV- infected pregnant women will be recruited for the study.  Women will be eligible if 
they are ARV naive, previously received ART or are currently on ART, have access to cell phone, 
≥ 14 years and ˂ 36 week gestation (Table 7).   
 
To enhance generalizability, literacy will not be required if women have access to a partner or 
family member whom she would be comfortable to have read her the messages. This approach 
was developed in consultation with mothers in Kenya, who felt that involving their partner was 
acceptable and may engage more support. Eligible women will undergo screening, the informed 
consent process, and be randomized. Participants will be asked their preferences for message 
delivery including language, days of the week and time of the day. 
 
 
Table 6. Sample size for unidirectional or bidirectional 
SMS vs. control or unidirectional vs. bidirectional; gray 
shaded shows cells with sufficient power and n is number 
per arm 
Intervention 
Prevalence 
of 
outcome 
Control 
70% 
75% 
80% 
85% 
85% 
120 
250 
302 
- 
90% 
62 
100 
199 
686 
95% 
35 
49 
75 
140 

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21 
 
 
 
Table 7: Layout of Phase 2 (RCT) procedures, study populations, and eligibility 
 
 
RCT PHASE 
 
Females 
 
Population & maximum 
sample size 
Women  
N=825 
 
Study procedures 
3-arm RCT 
 
Topic 
Compare unidirectional, bidirectional and no SMS 
 
Recruitment 
ANC 
 
Eligibility 
• HIV-infected women > 14 years  
• Daily access to mobile phone and willing to receive SMS   
• Literacy not required if women have access to a partner/family 
member whom she would be comfortable to have read her the 
messages. 
• Expected continued residence in study area for the study 
duration 
• Willing to provide informed consent  
• Not enrolled in other studies 
 
 
e) RANDOMIZATION PROCEDURES 
 
Participants will be randomized to: 1) Simple unidirectional SMS messaging, 2) Interactive 
bidirectional SMS dialogue, and 3) Control, using 1:1:1 allocation. A computer-generated 
randomization list will be generated using random block sizes in STATA. The allocation codes will 
then be put in sequentially numbered sealed envelopes. Participants and study will be un-blinded 
to randomization arms.  
 
f) DATA COLLECTION PROCEDURES 
 
Women will be followed during pregnancy and for two years postpartum; all clinical care will be 
managed through the existing MCH and CCC infrastructure. Because the study aims to determine 
mHealth benefits in a routine clinic setting, specific ANC/PMTCT/HIV services will be delivered 
by the MOH programs with minimal clinic interactions with study personnel. The study team will 
abstract data regarding clinic attendance, pill refills, infant health and infant HIV status from the 
PMTCT program registry, labor and delivery ward, pharmacy and peer counselors registers. Viral 
load and infant HIV testing results will be abstracted from the national electronic viral load 
dashboard. We will make check-in calls to all participants regardless of study arm at 1 month and 
1 year post-EDD. This will be done to ascertain mother’s delivery status, infant status, and that 
phone number is up to date. Check-in calls will be done by data management teams and will call 
the participants contacts if they fail to reach study participant. 
 
The study visit schedule will be: enrollment (any time in pregnancy), 6 weeks postpartum, then 
every 6 months up to 24 months. At each visit a standardized questionnaire will be administered 
using a tablet-based system (Open Data Kit, ODK) developed by the UW Department of 

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Computer Science and Engineering collaborators. Between study visits, data will be obtained 
from patient records in order to inform personalized, dynamic messaging. For example, if a 
participant in one of the intervention arms misses an appointment an appropriate SMS will be sent 
to address this absence and encourage the participant to reschedule. If a participant in the 
bidirectional arm does not respond after receiving two weekly messages, she will receive a check-
in message asking if she is receiving messages. The study nurse will review clinical records daily 
to check for missed appointments, deliveries, clinic visits, infant immunizations, or any clinic 
contact from study participants. Delivery information from women will be obtained at 6 weeks 
postpartum and data abstracted from records at MCH-linked maternity centers. Follow-up will 
continue until 24 months postpartum.  
In order to ensure completeness of clinic record abstraction for the study period, photographs 
will be taken at study exit of participants’ CCC cards. All identifiable information, including name, 
date of birth, CCC number, ANC number and address will be covered with paper, and the 
record will be labeled with the participant’s study ID only. Photographs will be transferred to a 
password-protected computer and secure server within 1 day of the photograph being taken 
and permanently deleted from the device used to capture the image. At the final study visit, in 
order to verify the data collected during abstraction, we will measure the height, weight, and 
mid-upper arm circumference of participants and their infants. 
 
We will collect 14 ml maternal plasma samples for CD4 count, HIV viral load, and suspected drug 
resistance testing for mothers and 0.5 ml for HIV DNA DBS and HIV antibody testing for infants 
at all study visits. SOPs will be used to guide venipuncture procedure. The study will obtain viral 
loads for all participants. However, if the Kenyan MOH incorporates routine HIV viral load testing 
on a national scale and the testing intervals are similar to those proposed by the study, we will 
utilize viral load results from the standard of care rather than repeat viral loads. 
 
While retention procedures will be minimized in order to avoid contamination of the intervention 
on retention outcomes, we will obtain phone numbers of contacts and conduct home visits after 
enrollment to ascertain locator information.  This information will be used at the end of the RCT 
to conduct home visits to re-establish contact for participants who failed to return for appointments 
and are lost to follow up in order to ascertain 24-month postpartum outcomes. Participants who 
are not able to attend the 24-month visit at the clinic will have their 24-month visit procedures 
conducted at the home visit. Figure 6 illustrates study flow from enrollment to follow up.  
 
In addition to collecting data from study participants during the trial, a facility survey will be 
conducted with a facility manager at each study site to collect information regarding facility 
characteristics, Option B+ implementation, human resources, service disruption and service 
management. The purpose is to identify whether facility-level factors associated with participant 
clinical outcomes. No human-subject data will be collected. 

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23 
 
 
 
 
We will collect patient information at baseline and follow-up visits using: 
• 
Participant surveys: demographics, clinical and sexual history, family planning, disclosure, 
medication adherence, experience with SMS and technology, intimate partner violence, 
and depression 
• 
Medical and pharmacy record extraction forms will be completed by data teams: delivery 
information, infant immunizations, maternal health, infant health, medication adherence, 
lab forms, pharmacy data, maternal mortality, and infant mortality. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Enrolment 
Randomization 
Assess eligibility for mHealth intervention 
• 
HIV infected 
• 
 ≥14 years 
• 
 pregnant 
• 
Access to mobile phone 
Exclusion 
• 
Does not meet eligibility criteria 
• 
Refuses to participate 
Unidirectional SMS  
Usual counseling, weekly 
SMS 
Bidirectional SMS  
Usual counseling, weekly 
SMS and dialogue potential 
Baseline data collection 
• 
Socio-demographic 
• 
CD4, Viral load, infant HIV 
• 
Adherence  
Follow-up (6wk, 6,12,18, 24 months)  
• 
WHO stage, CD4, Viral load,  
• 
Adherence 
• 
Delivery info  
• 
Infant DBS for PCR 
• 
Infant HIV antibody test  
• 
Infant immunization  
Control  
Usual counseling, no SMS 
Loss to follow-up 
Target enrollment = 825 
Figure 6: Consolidated Standards of Reporting Trials-CONSORT diagram of RCT design 

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24 
 
• 
Viral load and infant HIV test results will be abstracted from the national electronic VL 
dashboard. 
 
 
g) VARIABLES: Outcomes, indicators, and source documents 
 
Table 8: RCT Outcomes  
Primary Outcomes 
Indicator 
Source  
Retention 
Seen at scheduled visits 
PMTCT register for scheduled visits 
Drug Adherence 
Number/ expected 
Self-report , pharmacy 6 wk, 6, 12, 18, 24 mos 
Maternal viral suppression 
HIV RNA 
Maternal blood at 6 wk, 6, 12, 18, 24 mos 
Maternal drug resistance 
OLA 
Resistance assay in mothers with viral failure 
Infant HIV 
HIV testing: DNA on DBS 
and antibody 
HEI register week 6, infant specimens  
Infant HIV-free survival 
HIV DNA, antibody and 
mortality 
HEI register week 6, Infant specimens 6, 12, 
18, 24 mos; verbal autopsy 
Maternal 
perceptions 
of 
intervention 
Standardized questions 
At study visits, subset FGD 
Cost-effectiveness, cost-savings 
Cost/time questions 
Interview, clinic 
Selected Secondary Outcomes 
Postpartum contraception 
Use of effective 
contraception 
MCH card, CRF 
Exclusive breastfeeding 
Ever, duration 
CRF 
Infant mortality 
Death during follow-up 
CRF, verbal autopsy 
Notes: MCH: Maternal-Child Health; CRF: case report form 
Outcomes 
A summary of proposed outcomes is provided above in Table 8 (above). Retention is a primary 
outcome in this RCT, thus we seek to observe the effect of the intervention on retention rather 
than using comprehensive strategies to optimize it. To ascertain other outcomes, a relatively low 
intensity of study visits (6-monthly) has been designed; however, we are aware that this will 
compromise retention compared to our prior studies with >90% retention in which more frequent 
study visits facilitated retention. For all arms, we will not trace participants who do not attend clinic 
with home visits until study end, when we will conduct home visits for final ascertainment of 
outcomes.  
 
ART adherence is difficult to accurately assess – patient self-report, pill counts, and MEMS-caps 
(Medication Event Monitoring System caps are able to record the number of bottle openings and 
the date and time of each opening) have been used with varying success due to subjectivity and 
need for participant cooperation (43). Drug levels, treatment or virologic failure, and resistance 
are more objective measures of adherence long-term. We will use simple, standard measures of 
adherence (pharmacy refills, and self-reported missed doses at study visits) but rely on the viral 
suppression measurements as the superior outcome marker of adherence. 
 
h) LABORATORY METHODS  
 
We will conduct maternal HIV viral load testing and infant HIV DNA DBS testing at the branches 
of the KEMRI/Centers for Disease Control (CDC) located in Kisumu and Nairobi, and CD4 testing 
at the KEMRI/Centers for Disease Control (CDC) located in Kisumu and Kenyatta National 
Hospital. Test results will be shared with the clinics and providers to help guide clinical care. 
Among women with detectable virus, drug resistance will be measured using oligonucleotide 
ligation assays (OLA) in collaboration with Dr. Lisa Frenkel. OLA assays will be conducted in Dr. 
Frenkel’s laboratory in Seattle Children’s Hospital. 

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i) DATA COLLECTION INSTRUMENTS 
Data collection instruments for the RCT will be submitted in a subsequent modification of this 
protocol.  The RCT will not commence until these instruments are reviewed and approved by the 
UW Human Subjects Department (HSD) and KNH-UoN ethical review committee (ERC).  RCT 
data collection instruments will include forms to record data from: 
• 
Participant surveys: demographics, clinical and sexual history, family planning, disclosure, 
medication adherence, experience with SMS and technology, intimate partner violence, 
and depression 
• 
Medical and pharmacy records: delivery information, infant immunizations, maternal 
health, infant health, medication adherence, lab forms, pharmacy data, maternal mortality, 
and infant mortality. 
 
j) QUALITY ASSURANCE PROCEDURES 
Clinical care:  The study will adhere to Government of Kenya guidelines for the care of 
pregnant/postpartum women and their infants; however, no clinical care will be provided by study 
staff.  Data collected as part of the study will be abstracted from the mother’s “Mother & Child 
Health Booklet” and patient file as well as the MCH clinic’s medical records.  Counseling and 
testing for HIV will be performed in accordance with government-approved MCH guidelines.  
Study participants will receive their HIV medicines in the MCH where PMTCT services are 
integrated or CCC if PMTCT services are not integrated, enabling reporting of antiretroviral 
therapy and follow-up in accordance with the national AIDS strategy. 
Adherence to protocol:  Weekly reporting of enrolment, follow-up, medical complications, 
laboratory results, and specimen collection will enable us to monitor that the study is running 
according to approved protocols.  Frequent reporting will also enable us to quickly respond to any 
problems that arise during the study. 
Laboratory quality control: The site-specific labs and the KEMRI/CDC laboratory that will process 
the specimens and conduct most of the laboratory tests are ISO certified, and participates in 
external quality control verification.  For rapid HIV testing, we will use the test kits that have been 
approved by the Kenya Ministry of Health. 
k) TRAINING PROCEDURES 
Dr. John Kinuthia will supervise training of clinical personnel in study procedures.  This will include 
research ethics, HIV counseling and testing, infant PCR testing and rapid HIV testing, specimen 
collection, and completion of surveys. 
 
 
PHASE 3: POST RCT 
 
a) STUDY DESIGN 
 
IDIs will be conducted by a Kenyan team trained in qualitative research methods and will probe 
for further elaboration on relevant content from the semi-structured IDI guide. Study investigators 
experienced in qualitative methods, Dr. John Kinuthia (site-PI) and Dr. Gabrielle O’Malley (co-
investigator), have reviewed topic guides for content validity and cultural relevance. We will also 
conduct surveys among male partners. 
 
b) STUDY POPULATIONS 
 
Female IDIs 

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26 
 
After completion of the RCT, we will invite 20 women from 1-way arm and 40 women from 2-way 
arm to participate in IDIs to understand reasons for success or failure of the intervention in 
supporting virologic suppression. Within each arm, sampling will be stratified based on VL and 
SMS engagement (see definitions below and Table 9). Participants will be samples from two study 
sites (1 in Kisumu and 1 in Nairobi).  
 
Women who exit the RCT will be stratified based on two outcome variables: 
a. VL suppression 
i. 
Participants with suppressed VL will be defined as: 
• 
Has ³4 VL results available ³6mo post-ART initiation 
• 
³2 latest VL results <1000c/ml and ³6mo post-ART initiation 
• 
³1 earliest VL result ³1000c/ml and ³6mo post-ART initiation 
 
ii. Participants with unsuppressed VL will be defined as: 
• 
Has ³2 VL results available ³ 6mo post-ART initiation (fewer VL results needed so 
this group may have lower retention also) 
• 
³2 sequential VL results ³1000c/ml and ³6mo post-ART initiation and span ³1 year 
• 
No ART resistance detected 
 
b. System engagement (among 2-way participants with more than 100 system messages 
and ³ 90% of these system messages successfully delivered) 
i. 
Highly engaged participants will be defined as: 
• 
Participant’s percent weeks active is ³75th percentile of all participants’ percent of 
weeks active. 
 
ii. Poorly engaged participants will be defined as: 
• 
Participant’s percent weeks active is £25th percentile of all participants’ percent 
weeks active. 
Table 9. Female IDIs sampling 
 
Viral load 
SMS interaction 
site 
n 
  
suppressed 
High 
Site 1 (Kisumu) 
5 
10 
Site 2 (Nairobi) 
5 
low 
Site 1 (Kisumu) 
5 
10 
Site 2 (Nairobi) 
5 
unsuppressed 
high 
Site 1 (Kisumu) 
5 
10 
Site 2 (Nairobi) 
5 
low 
Site 1 (Kisumu) 
5 
10 
Site 2 (Nairobi) 
5 
suppressed 
NA (one-way) 
Site 1 (Kisumu) 
5 
10 
Site 2 (Nairobi) 
5 
unsuppressed 
NA (one-way) 
Site 1 (Kisumu) 
5 
10 
Site 2 (Nairobi) 
5 
TOTAL 
 
 
 
60 
 
These IDIs will be instrumental in understanding whether the intervention did or did not work, why 
it did or did not work, and possible recommendations for enhancement of the intervention. 

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mHealth Strategies to optimize PMTCT/ART 
 
27 
 
Male surveys 
We will conduct exit surveys with partners who are referred by intervention arm study participants. 
Partners will be assessed for eligibility prior to conducting surveys. A total of 80 male partners will 
be involved (40 from urban, 40 from peri-urban). This approach will be helpful in understanding 
perceptions of the intervention in terms of benefits to care for mother and child, experiences with 
SMS, factors that influence the success of the intervention, and enhancement strategies. 
 
Clinic providers IDIs 
After the RCT, we will conduct IDIs with 12 MOH healthcare providers (2 per site) to understand 
their experiences, perceived impacts of SMS intervention on workload, possibilities for scaling up, 
and share final SMS content with them. 
 
RCT providers IDIs 
We will also conduct IDIs with 6 study nurses from the Mobile WAChX study team (1 per site) to 
understand their experiences of with SMS messaging, barriers and facilitators of use, perceptions 
of SMS intervention in terms of benefits to care, ability to integrate in long-term care, and 
recommendations for enhancement of SMS intervention. 
 
c) RECRUITMENT PROCEDURES 
 
Female IDIs: After women complete the RCT, study staff will approach women randomized to 
either 1-way or 2-way intervention arm with suppressed or unsuppressed VL and low or high 
engagement with the SMS intervention to describe the purpose of the IDIs and invite interested 
women to participate. It will be emphasized that participation is completely voluntary. If interested 
in participation, they will undergo the informed consent process and IDI. 
 
Male surveys: After women complete the RCT, we will sample women randomized to either 
intervention arm of the RCT and ask them if they would be interested in referring their male partner 
to participate in a survey about the SMS intervention. Only women who have disclosed their HIV 
status to their partner and whose partners know about their participation in the RCT will be eligible 
for study participation. Interested women will be provided a “study clinic referral form” to give their 
partners (Male Partner survey Post RCT Referral Form).  Once partners come for enrollment, 
they will be given more information on the study. It will be emphasized that participation is 
completely voluntary. If interested in participation, they will undergo the informed consent process 
and complete the survey. 
 
Clinic provider IDIs: Health providers working in MCH and CCC will be given information on the 
RCT and requested to participate in IDIs. Eligible providers are those who are directly involved 
with care of HIV-infected pregnant women and HIV exposed infants. Those who are willing and 
able will undergo the informed consent process prior to IDIs.  
 
RCT provider IDIs: Nurses who are recruited by the Mobile WAChX study at all study sites will be 
given information on the IDIs. Those who are willing to participate and able to provide informed 
consent will be enrolled. 
 
d) DATA COLLECTION PROCEDURES (clinical and non-clinical, field, data collection 
instruments) 
 
Both FGDs and IDIs will be performed in a private area. Participants will meet a trained interviewer 
or moderator who will ask questions and take notes. Consent will be obtained from participants 
to take notes and audio record the discussion. The interviewer/moderator will describe procedures 

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28 
 
and norms for discussion and participation. Participants will be given a chance to ask questions 
regarding procedures prior to the discussion. Their socio-demographic information will be 
documented in separate forms. Socio-demographic information that will be captured include: age, 
marital status, education level, employment, number of children, and partner HIV status as shown 
in the participant survey portion of each FGD and IDI guide (attached). 
 
Discussions will be guided by the interviewer or moderator using a discussion guide (attached). 
Prior to FGD, the interviewer will stress the importance of maintaining confidentiality within the 
group. Participants will receive unique identification numbers and will not be addressed by their 
real names so as to maintain confidentiality. Topics that generate the most discussion, participant 
attitudes, non-verbal gestures, and interaction dynamics among group members will be 
documented by the moderators. Discussions will be conducted in English, Kiswahili, or Luo 
depending on participant preferences. Thereafter, notes will be compared to audio-recordings to 
fill in missing information and transcribed to English (if necessary). Transcribed data will be de-
identified. Tape-recorded discussions will be destroyed no later than 3 years after conducting the 
FGD or IDI. 
 
Participants will be provided refreshments and Ksh. 300 to compensate for time and 
transportation expenses to participate in the study. We will provide this monetary compensation 
to each participant at the conclusion of each discussion. 
 
e) DATA COLLECTION INSTRUMENTS 
 
Paper copies of data collection tools for IDIs and quantitative ODK questionnaires are submitted 
with this application for human subjects review.   
 
Table 10: Layout of Phase 3 (Post RCT) procedures, study populations, and eligibility 
 
 
 
POST RCT PHASE 
 
 
 
RCT participants 
Males  
Clinic providers 
RCT providers 
Population 
& maximum 
sample size 
Women 
N=60 (see Table 9)  
Stratify by: 
- RCT arm [1-way/2-
way] 
- Viral suppression 
[success/failure] 
- System interaction 
[high/low] 
- Clinic [1 Nairobi, 1 
Kisumu]) 
Male partners  
 
N=80 
(40 urban, 40 peri-
urban) 
By referral through 
participant in 1-way 
or 2-way arm 
Health providers 
N=12 
(2 per site) 
Study nurses 
N=6  
(1 per site) 
Study 
procedures 
IDIs 
Surveys 
IDIs 
IDIs 
Topic 
Experiences and 
barriers to SMS use, 
perceived utility and 
impact, 
recommendations for 
improvement. 
 
Reasons for high, low 
or moderate adherence 
Evaluate 
perceptions of 
women’s 
experiences, 
perceived impact, 
concerns/challenge, 
recommendations 
for improvement. 
Workload,  
experiences,  
perceived impact, 
share final SMS 
content, possibilities 
for scale 
Workload, 
improvements, 
possibilities for scale 

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29 
 
and low or medium 
responsiveness 
 
Impact of SMS on 
resulting adherence  
Recruitment 
RCT participant 
Through female 
RCT participant 
MCH, CCC 
Study staff 
Eligibility 
• Randomized to one of 
the intervention arms 
(one way or two way 
SMS) 
 
• Has partner  
randomized to one 
of the intervention 
arms in RCT 
• Partner disclosed 
her HIV status to 
male partner 
• Partner aware of 
RCT participation 
• Willing to provide 
an informed 
consent 
• Age ³18 
 
• Nurses, Clinical 
officers, Mother to 
mother, Peer 
counselors  
• Directly involved 
with care of HIV-
infected pregnant 
women and HIV 
exposed infants 
• Willing to provide 
informed consent 
 
 
• Mobile WAChX 
study nurse at any 
point in the study 
• Willing to provide 
informed consent 
 
 
 
11) STUDY MATERIALS: 
Equipment: The grant award includes support to purchase one -80C freezer to store study 
specimens, SMS platform messaging delivery and receipt, 4 tablets, field office supplies 
(stationary, paper, toner), 4 desktop computers, clinic supplies to collect and store biological 
samples. 
 
Personnel: The grant award includes support for UW investigators, clinic personnel, the data 
team, and a study coordinator.  Study personnel working in Kenya will be hired through KNH 
according to standard procedures. 
 
Costs data 
We will assess the cost of all services and equipment necessary to implement each of the three 
arms (direct medical costs). Using WHO guidelines and its ingredients approach (45, 46) direct 
medical costs will quantify the resources and associated unit costs to deliver each intervention, 
organized in standard expenditure categories: personnel (salaries), supplies including drugs and 
medications, equipment (e.g. computer programming), services (e.g. airtime, media, costs related 
to the mHealth such as cellular phones, wireless network), space and overhead, community 
awareness and mobilization. A particular emphasis will be put on the measurement of the costs 
incurred by treatment failure and drug resistance, as well as on the costs for the different types of 
personnel employed (e.g. nurses) and the time demanded from them in each intervention 
(unidirectional SMS vs. bidirectional SMS messaging). In addition, direct non-medical costs 
quantifying transportation costs, food and housing expenses, and user fees; and indirect costs 
quantifying the time loss for patients to seek care and associated lost wages, due to long waiting 
times will be assessed in participant surveys. 
 
12) ETHICAL CONSIDERATIONS 
 
Data Ownership 

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30 
 
The proposed project is a collaborative effort between investigators at the UW and KNH.  The 
aforementioned institutions will jointly share ownership of the data.  Study investigators at the UW 
and KNH will have full access to the data.  Authorship on publications, conference presentations, 
abstracts and other materials generated from this study will reflect contribution to design, 
execution and analysis of the study.  
 
Data Release/Sharing Policy 
All data collected as part of this proposed research project will be made available without cost 
after registration to access or download files on a study related website (URL to be determined) 
and agreement to the data sharing agreement.  The data sharing agreement will ensure 
commitments to: 
1. Using the data only for research purposes and without attempting to identify study participants 
(if applicable);  
2. Securing the data using appropriate computer technology;  
3. Destroying or returning the data after analyses are completed; 
4. Restrictions on redistribution of the data to third parties; and 
5. Proper acknowledgement of the data resource. 
 
13)  STUDY LIMITATIONS AND HOW TO MINIMIZE THEM: 
The study evaluates several concepts, first whether SMS decreases maternal virologic failure, 
enhances infant HIV prevention, decreases resistance and preserves regimens. The study is 
powered for maternal outcomes but may have power to detect effects on infant HIV-free survival 
and a variety of secondary outcomes. Data from maternal viral load effects could inform future 
models of down-stream impacts of the intervention on infant and sexual HIV transmission. We 
intentionally designed the study to have long follow-up time (rather than larger cohort with short 
follow-up) because long-term PMTCT-ART outcomes are the most relevant for policy/programs. 
Second, the study will evaluate whether dialogue has a discernable advantage over simple 
unidirectional messaging. This is a novel comparison, not previously addressed in mHealth 
studies with important implications both for HIV and other chronic medical conditions. Fidelity and 
generalizability of dialogue interventions are challenging. We have proposed SOP-driven 
dialogue and implementation and evaluation in two sites to address these issues, but it will not be 
possible to completely standardize bidirectional interventions. Finally, defining programmatic 
cost-savings or effectiveness is based on specific time/costs of the sites. We believe that these 
sites reflect other national and regional settings. 
 
14) TIMELINE/ TIME FRAME: 
 
2014 
2015 
2015 
2016 
2017 
2018 
2019 
2020 
Checklist Item 
Oct- Dec 
Jan- Jun 
Jul-Dec 
Jan-Dec 
Jan-Dec 
Jan-Dec 
Jan- Dec 
Jan-Dec 
Study protocol developed 
X 
 
 
 
 
 
 
 
Develop FGD guides 
X 
 
 
 
 
 
 
 
Consent forms developed 
X 
 
 
 
 
 
 
 
Kiswahili translated consent 
X 
 
 
 
 
 
 
 
IRB/ERC applications 
X 
 
 
 
 
 
 
 
Study specific SOP/CRF 
training 
 
X 
 
 
 
 
 
 
Trainings-HSR,mHealth, data 
mx 
 
X 
 
 
 
 
 
 
Database development 
 
X 
 
 
 
 
 
 
mHealth system 
 
X 
 
 
 
 
 
 
CRFs 
X 
X 
 
 
 
 
 
 
SOPs 
X 
X 
 
 
 
 
 
 
FGD 
 
X 
 
 
 
 
X 
 
RCT 
 
X 
X 
X 
X 
X 
X 
 

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31 
 
 
 
 
15) HUMAN SUBJECTS 
 
Ethical Approval 
We will obtain ethical approval from the University of Washington (UW) Human Subjects Division 
and the Kenyatta National Hospital-University of Nairobi Ethics and Research committee .   
 
Collaborating sites 
The study will be conducted in collaboration with the UW, KNH, KEMRI, and CDC.  The study will 
be reviewed by the KNH ERC and UW IRB and will not be started before approvals are obtained 
from all two organizational review boards. For this specific study, University of Washington 
investigators will not be directly involved in fieldwork, data collection, or study recruitment or 
consenting processes. Data analysis performed by investigators, co-investigators and personnel 
will be performed using only de-identified data. 
 
 
 
Data collection 
 
X 
X 
X 
X 
X 
X 
 
Data analysis 
 
 
 
 
 
 
X 
 
Manuscript writing 
 
 
 
 
 
 
X 
X 
Fiscal close-out 
 
 
 
 
 
 
 
X 
Dissemination of results 
 
 
 
 
 
 
 
X 

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mHealth Strategies to optimize PMTCT/ART 
 
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 LIST OF ABBREVIATIONS 
 
ANC 
 
Antenatal Care 
APHIA-plus 
AIDS, Population and Health Integrated Assistance 
ART 
 
Antiretroviral Therapy 
ARVs  
Antiretroviral drugs 
CCC 
 
Comprehensive Care Clinic 
CDC   
Centers for Disease Control and Prevention 
CTX 
 
Cotrimoxazole  
DNA 
 
Deoxyribonucleic Acid 
ERC 
 
Ethics Review Committee 
GoK 
 
Government of Kenya 
HAART 
Highly active antiretroviral therapy 
HEI 
 
HIV-exposed infant 
HIV 
 
Human Immunodeficiency Virus 
HAZ 
 
Height-for-age Z-score 
ICAP  
International Center for AIDS Care and Treatment Programs  
IRB 
 
Institutional Review Board 
KEMRI  
Kenya Medical Research Institute 
KNH 
 
Kenyatta National Hospital 
M2M  
Mothers-to-Mothers 
MCH  
Maternal and Child Health 
MOH  
Ministry of Health 
MTCT  
Mother-to-Child Transmission 
NASCOP 
National AIDS and STI Control Program 
ODK 
 
Open Data Kit 
OI 
 
Opportunistic Infections 
OLA 
 
Oligonucleotide Ligation Assays 
PCR 
 
Polymerase Chain Reaction 
PMTCT 
Prevention of Mother-to-Child Transmission of HIV 
PNC 
 
Postnatal Clinic 
RCT 
 
Randomized Controlled Trial 
SMS 
 
Short Messaging System 
UON  
University of Nairobi 
UW 
 
University of Washington 
WHO  
World Health Organization 
 
 
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