Two-way Texting (2wT) to Improve Patient Retention While Reducing the Healthcare Workload in High-Burden Public HIV Clinics in Malawi
Phase: NA
Conditions: Retention in Care
Sponsor: University of Washington

0 
 
 
 
Two-way Texting (2wT) to Improve Patient Retention While 
Reducing the Healthcare Workload in Two High-Burden Public 
HIV Clinics in Urban Lilongwe: a pragmatic randomized control 
trial (RCT) 
 
Version 1.0 
September 3, 2022 
 
 
 
 
 
 
 
 
 
 
 
Collaborating Institutions:  
Lighthouse Trust 
Malawi Ministry of Health 
University of Washington, Seattle WA USA 
 
Funding Source:  
National Institutes of Health, USA 
 
Principal Investigator(s)/Primary Contact:  
Jaqueline Huwa,  Research manager, Lighthouse Trust 

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Hannock Tweya, PhD, MSc, Senior Evaluation Technical Advisor, I-TECH/Malawi 
Caryl Feldacker, PhD, MPH, Assistant Professor, Department of Global Health, University of 
Washington, Seattle, USA  
 
Table of Contents 
Acronyms ..........................................................................................................................................3 
Executive Summary ............................................................................................................................4 
Participating Institutions and Roles ......................................................................................................5 
Investigators and roles ........................................................................................................................5 
Funding Source and Mechanism: .........................................................................................................7 
Conflicts of Interest Statements: ..........................................................................................................7 
Background........................................................................................................................................8 
Justification ....................................................................................................................................9 
Study Objectives: .............................................................................................................................. 10 
Broad objective: ...........................................................................................................................10 
Specific objectives ........................................................................................................................10 
Methods: .......................................................................................................................................... 10 
Overall approach .........................................................................................................................10 
Study design ..................................................................................................................................10 
Study setting and Population ......................................................................................................11 
Technology overview ...................................................................................................................11 
Staff training.................................................................................................................................12 
Sample size calculation ................................................................................................................12 
Study outcomes.............................................................................................................................12 
Participant eligibility ...................................................................................................................12 
Recruitment of 2wT clients: ........................................................................................................13 
Randomization .............................................................................................................................13 
Routine ART initiation procedures (both arms) .......................................................................13 
Study procedures .........................................................................................................................14 
Control/comparison group (Routine Back to Care  (B2C)): ....................................................14 
Data sources ..................................................................................................................................16 

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Data analysis .................................................................................................................................16 
Retention:......................................................................................................................................16 
Limitations and uncertainties: ............................................................................................................ 17 
Protection of Human Subjects ....................................................................................................17 
Consent Procedures: ....................................................................................................................17 
Risks to participants:......................................................................................................................... 18 
Protection Against Risk:.................................................................................................................... 19 
Confidentiality ..............................................................................................................................21 
Ethics Training .............................................................................................................................22 
Potential Benefits of the Proposed Research to Research Participants and Others .................................. 22 
Importance of the Knowledge to be Gained ........................................................................................ 22 
Dissemination .................................................................................................................................. 23 
Ghant chart of RCT research activities ................................................................................................ 23 
Appendices: ..................................................................................................................................... 24 
Appendix 1: Client consent for routine 2wT, year 2.................................................................25 
Appendix 1a: Client consent for RCT ........................................................................................30 
References ....................................................................................................................................... 35 
 
 
 
 

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Acronyms 
2wT 
 
 
 
Two-way texting 
ART  
 
 
Antiretroviral Therapy 
ARV  
 
 
Antiretroviral 
B2C 
 
 
 
Back to Care  
DGH  
 
 
Department of Global Health  
DHA  
 
 
Department of HIV and AIDS 
EMRS  
 
 
Electronic medical records system 
HCW  
 
 
Healthcare worker 
HIV 
 
 
 
Human Immunodeficiency Virus 
HTS 
 
 
 
HIV Testing Services 
IEC 
 
 
 
Information, Education, and Communication 
I-TECH 
 
 
International Training and Education Center for Health  
IP 
 
 
 
Implementing partner 
LH 
 
 
 
Lighthouse  
LTFU  
 
 
Loss to follow up 
M&E  
 
 
Monitoring and evaluation 
MOH  
 
 
Ministry of Health 
MPC  
 
 
Martin Preuss Centre 
NHSRC 
 
 
National Health Sciences Research Committee 
PI 
 
 
 
Principal Investigator 
PLHIV 
 
 
People Living With HIV 
RTC  
 
 
Randomized control trial 
SSA 
 
 
 
Sub-Saharan Africa 
VL 
 
 
 
Viral Load 
VLS 
 
 
 
Viral Load suppression 
WHO  
 
 
World Health Organization 
UNAIDS 
 
 
United Nations   
UW 
 
 
 
University of Washington 
 

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Executive Summary  
In sub-Saharan Africa (SSA), retention of HIV-infection people in antiretroviral therapy (ART) 
care is an increasing challenge. With only 67% retained on ART in SSA, over 7.5 million people 
are out of care, threatening both individual health and HIV epidemic control. With significant 
healthcare system constraints and formidable healthcare worker (HCW) shortages, ART services 
in SSA struggle to meet ambitious global targets of 90% retained in care. In research settings, text-
based mHealth innovations show promise to increase ART retention and, therefore, reduce viral 
load (VL). However, few mHealth innovations have been tested or proven effective in real-world 
settings with severe human and financial resource constraints. mHealth innovations that 
successfully retain more patients on ART within large-volume public ART clinics in SSA are 
urgently needed. Lighthouse Trust (LT), the largest public provider of ART in Malawi, operates 
two large clinics in Lilongwe with the Malawi Ministry of Health (MoH), Lighthouse Clinic (LH) 
and Martin Preuss Center (MPC), with a combined 35,000 ART patients. 12-month retention at 
Lighthouse is 67%, below the 90% global target for epidemic control. Both clinics employ a real-
time electronic medical records system (EMRS) and implement a resource-intensive patient 
retention program, Back to Care (B2C). B2C aims to trace patients who miss ART visits by ≥14 
days. MPC has over 7800 monthly ART visits, and more than 10% of clients are B2C-eligible. 
B2C demand, coupled with HCW constraints, results in tracing of only 33% of target clients. Lack 
of, or delayed, tracing reduces ART retention. Moreover, over 50% of traced B2C clients are found 
on ART, 60% of whom had transferred, demonstrating significant unnecessary tracing. Poor data 
quality reduces B2C effectiveness. Therefore, LT and the University of Washington’s International 
Training and Education Center for Health (I-TECH), and Medic Mobile, implemented an 
innovative, proactive, patient retention system using two-way texting (2wT) between new ART 
patients and staff. A previous study (#20/06/2565 Two-way Texting (2wT) to Improve Patient 
Retention While Reducing the Healthcare Workload in High-Burden Public HIV Clinics in Urban 
Lilongwe) suggested that 2wT improved retention, resolved potential retention issues before they 
occured and improved data quality (e.g. identifying transfers), potentially reducing B2C workload. 
MoH requested a randomized control trial to create more rigorous evidence of 2wT impact. 
Therefore, with 2wT fully operational, we now implement a pragmatic randomized control at LT 
trial using routine 2wT teams. The pragmatic RCT will test the existing 2wT intervention to 
provide adherence support for, and visit-focused communication with, new ART initiates at both 
LH and MPC clinics, comparing 6-month retention (ART outcomes, visit adherence, VL) and B2C 
referrals among two groups of new ART clients: 2wT-supported (intervention) and routine B2C 
(control). With this rigorous evidence, we set the stage for national or regional 2wT scale-up.  
 
 

5 
 
 
 
Participating Institutions and Roles 
Institution 
Roles 
Lighthouse 
• Lead the development of the study design 
• Implement study activities in collaboration with the Ministry 
of Health, relevant technical working groups and stakeholders 
• Conduct daily supervision of project staff and ongoing support 
at participating sites 
• Conduct necessary training to implement this project 
• Co-lead data management, analyses and publication 
• Provide oversight of communications, reporting, and staff 
University of 
Washington 
• Secure funding, serving as administrative and financial 
oversight 
• Lead study conceptualization 
• Co-lead project design and protocol development 
• Review and approve the protocol 
• Co-lead data analysis and publication 
• Lead all reporting to the NIH 
• Provide technical assistance with regards to study design, 
international IRB and local IRB approvals, implementation, 
evaluation, publication 
Ministry of Health 
• Provide inputs to implementation, analyses and publication 
• Support integration of the project system into routine EMRS 
• Provide insight to policy needs and implications  
Medic  
• Development, implementation, and supervision of the 
technology for two-way texting 
• Responsible for ensuring open-source software is integrated 
into EMRS according to research timeline 
• Training for technology for Lighthouse teams 
 
Investigators and roles 
Name 
Title/affiliation  
Role on project 
Contact details 
Hannock 
Tweya, 
PhD, MSc 
Monitoring, 
Evaluation and 
Research 
Director, 
Lighthouse Trust 
Co-Principle Investigator 
• Provides overall direction and 
oversight for project management and 
implementation at Lighthouse 
• Oversight for program 
implementation according to 
approved protocols  
htweya@lightho
use.org.mw  

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• Provides assistance to Project Team, 
as needed, in the development of 
study design and methods, 
implementation, evaluation, and 
publication. 
• Responsible for technology 
coordination and system 
implementation oversight 
Caryl 
Feldacker, 
PhD, MPH 
Assistant 
Professor, 
University of 
Washington, 
Seattle, WA, 
USA 
Co-Principle Investigator 
• Responsible for NIH reporting and 
overall research oversight 
• Provides technical assistance to 
Project Team, as needed, in the 
development of study design and 
methods, implementation, evaluation, 
and publication. 
• Provides supervision and mentoring 
to junior staff involved in the project 
• Coordinates and supervises the work 
of technology partner, Medic Mobile 
cfeld@uw.edu  
Jacqueline 
Huwa 
Research 
manager, 
Lighthouse Trust 
Co-Investigator 
• Provides supervision for project 
management and implementation at 
Lighthouse 
• Provides assistance to project team in 
the development of study protocols 
including SOPs 
Fosters and facilitates communications 
with collaborators and stakeholders 
jhuwa@lighthou
se.org.mw  
Beatrice 
Wasunna, 
PhD 
Medic Mobile, 
Nairobi Kenya 
Investigator 
• Leads and supervises all aspects of 
technology design, development, 
implementation and integration. 
• Provides quality assurance and 
supervision for the technal Medic 
Mobile team for project 
implementation.  
isaac@medicmo
bile.org  
Rose 
Nyirenda, 
MPH 
Director, HIV 
Department, 
Malawi Ministry 
of Health 
Investigator 
• Provides insight to policy needs and 
implications  
• Provides assistance to Project Team, 
as needed, in the development of 
rnirenda@hivm
w.org  

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study design and methods, 
implementation, evaluation, and 
publication. 
Thom 
Chaweza, 
DCM, 
MPH 
Medical Officer, 
Lighthouse Trust 
Investigator 
• Responsible for project coordination 
and monitoring 
• Provides assistance to Project Team, 
as needed, in the development of 
study design and methods, 
implementation, evaluation, and 
publication 
tchaweza@lighth
ouse.org.mw  
 
Funding Source and Mechanism: National Institute of Health 1 4R33TW011658-03 
entitled Two-way Texting (2wT) to Improve Patient Retention While Reducing the Healthcare 
Workload in High-Burden Public HIV Clinics in Malawi.   
 
Conflicts of Interest Statements: No conflicts of interest to declare. 
 
 

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Background  
 
In Malawi, with an estimated 1 million (9%) living with HIV [1], 5-year ART retention 
falls to 54% [2], stymying progress towards HIV epidemic control  [3, 4]. Reactive retention 
efforts are resource intensive, reducing likelihood of scale or sustainably [2]. Lighthouse Trust 
(LT), a national ART Centre of Excellence in Lilongwe, Malawi, operates with the Malawi 
Ministry of Health (MoH) to provide HIV care, treatment, and support across Malawi. In its two 
Lilongwe flagship clinics, 35,000 patients are on ART: 24,000 at Martin Preuse Centre (MPC) and 
11,000 at Lighthouse (LH). Patients at both are managed via a real-time, point-of-care, electronic 
medical records system (EMRS) [5-9]. Despite its prominence, retention at MPC and LH clinics 
falls short: an average of 67% of ART patients are retained at 12-months, well below the 90% 
threshold needed for epidemic control [10]. Since 2006, LH and MPC implemented a patient 
retention program, “Back-To-Care” (B2C), that traces ART patients by phone or home visit who 
miss a clinic visit by >14 days. B2C has been well-recognized for its success returning patients to 
care [11-18]. Although early patient tracing increases likelihood of patient reengagement [19], 
tracing-based retention efforts are reactive -- waiting for clients to miss visits before intervention. 
B2C and other tracing programs are highly resource intensive [20], limiting scale. At MPC, there 
are over 7800 scheduled ART visits each month: of these, over 800 clients are presumed LTFU 
and referred to the 8 full-time B2C tracers. Program resource constraints cause B2C delays and 
tracing gaps, greatly diminishing B2C effectiveness and retention success. In December, 2019 
only 30% of eligible clients were traced at MPC, a tracing gap found in other ART programs in 
SSA [21-23]. Additional proactive retention efforts, within the existing limited resources, are 
needed to reduce LTFU before it happens.  
Myriad mHealth interventions, including text-based, improve ART retention in research 
settings. However, evidence of successful transfer of these gains to routine ART services delivery 
in low-resource settings and at scale are missing [24, 25]. With expanding internet access [26], 
mobile phones are common tools for healthcare needs, even in rural areas [27]. As such, the World 
Health Organization (WHO) promotes mHealth interventions in low resource settings to support 
ART adherence [28]. These interventions appear highly acceptable to clients [23, 29-32]. Although 
mHealth retention efforts aimed at youth [33`] or implemented within already-high retention 
settings (over 80%) may not be effective [34, 35], numerous text-based research interventions 
significantly increased ART retention (adherence, visit attendance, and viral suppression) among 
adults [36-45]. Digital innovations also increased engagement among men [23, 38, 46, 47] who 
are often poor users of health services [48-51]. Interventions that “blast” one-way pre-defined, 
messages to many people, simultaneously, increase ART adherence [22, 42, 52]. Interactive, two-
way texting (2WT) improves upon blast messaging by encouraging direct client to HCW 
communication, increasing engagement in care [53] and improving care outcomes [43, 44, 
54, 55]. However, some 2WT intervention require intensive HCW effort, limiting scale-up [44, 
56]. mHealth innovations need to provide workload advantages for frontline HCWs who must 
manage these efforts [54, 57-59].  
 
We successfully led a 2WT-based randomized control trial (RCT) among male 
circumcision (MC) clients in a routine MC clinic in Zimbabwe. We improved the quality of 
care and reduced provider workload by 85% [59] while reducing costs by 33%. Our 2WT 
extended the reach of HCWs to effectively monitor more patients while improving the quality and 

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timeliness of routine data. Both clients and HCWs found the system highly usable and acceptable: 
93% of men responded to texts  [60]. The routine messages and real-time provider feedback 
engaged clients as care partners. Similarly, providers received real-time information from clients, 
allowing for timely reporting of routine data. This project will build on successful 2WT technology 
developed in Zimbabwe by this team, adapting it for retention efforts in high-burden, public ART 
programs in Malawi. Engaging patients in retention efforts could similarly improve client 
care, data quality and HCW workload at lower cost.  
 
Lighthouse and its B2C program appear primed for this new kind of task-shifting where 
mHealth tools enable clients and care givers to exchange information directly and quickly. The 
hybrid workflow designed for the Zimbabwe RCT integrated the efficiency benefits of automated 
messaging with the familiarity of SMS on basic phones common in Zimbabwe and Malawi. The 
intervention also implemented core characteristics of mHealth excellence, including optimizing 
client accessibility and acceptance; low technology costs, local adaptation, strong stakeholder 
collaboration, and government partnership for sustained impact [61]. With the same fundamental 
approach, our experience suggests ART retention efforts and B2C workload would benefit 
similarly because: 1) tracing is burdensome to providers; 2) the intervention enhances routine care 
quality, minimizing risk; 3) clients can remotely update outcomes in real-time (transfer, travel, 
other), improving data quality; and 4) frequent visits reduce issues like lost phones, new numbers, 
etc. [30]. 2wT was successfully tested in 2020-2022 with initial results suggestive of modest 
increases retention among 2wT participants with high uability and acceptability among LT staff.  
 
 The current 2WT improves upon previous texting interventions for retention in several 
significant ways: 1) Hybrid 2WT with a mix of automated and human-to-human messaging is 
optimized for staff efficiency by proactively and directly engaging with clients,  preventing default 
(changing visit dates) or ascertaining true outcomes (transfer, stop, etc.); 2) Real-time data 
provided by clients will improve ART outcome data before 14 days, reducing unnecessary referrals 
to B2C for tracingand 3)  Medic Mobile’s open-source intervention software will aid efforts to 
adapt, maintain, and sustain the system, leveraging the global community of developers to 
contribute to design improvements in inbox management, message prioritization, or task 
management. 
 
Justification 
 
Two-way texting, itself, is not novel for retention. However, we developed and evaluated 
a low-cost 2WT intervention to increase ART retention within a high-volume, routine, public 
healthcare setting. 2wT is timely, innovative, and programmatically important, aiming to close the 
gap between what works in research and in routine practice. Lighthouse’s hybrid 2wT system 
among new ART clients at MPC clinic, the largest single clinic for ART patients in Malawi is 
designed, developed, and initially evaluated with preliminary results appearing positive. The 
previous study is nearing completion under approved protocol: #20/06/2565 Two-way Texting 
(2wT) to Improve Patient Retention While Reducing the Healthcare Workload in High-Burden 
Public HIV Clinics in Urban Lilongwe). This complementary, small-scale, pragmatic randomized 
control trial (RCT) will strengthen results to inform scale-up while subsequent expansion into 
routine B2C operatations allows for routine evaluation of 2wT in practice.  The RCT will provide 
rigorous evidence for future expansion by implementing 2wT within both LH’s and MPC’s  

10 
 
 
 
existing, public ART program. Comprehensively evaluating 2WT’s impact on patient retention 
and B2C referrals under routine pragmatic conditions will provide real-world evidence of its value, 
greatly improving the relevance of findings and likelihood of program expansion. Using the RCT 
results will further optimize 2wT for expansion in routine B2C efforts, supporting LT’s retention 
program. See key innovations: Appendix 6, Table 1. 
 
 
 
Study Objectives:  
Broad objective:  
To determine if the innovative two-way testing mHealth intervention can significantly increase 
retention on ART among PLHIV, reducing patient tracing workload. 
Specific objectives 
1. To determine how much 2-way, visit reminder texting between the Lighthouse clinic and 
Lighthouse patients can increase new ART client retention and reduce the tracing workload 
within the first 6 months on ART 
Methods:  
 
Overall approach 
 
Overview (See key activities and study timing in Appendix 7, Table 2): Building on the 
previous 2wT study, this study conducts an RCT for strengthened evidence generation. Over 12 
months, we will conduct an RCT in both MPC and LH to prove if 2WT increases 6-month retention 
(clinic visits, ART outcomes, VL) and reduces workload in both MPC and LH clinics. 6-month 
outcomes are used as the timeframe is short due to funding constraints. For the RCT, no changes 
are required in the 2wT software beyond a field for randomization arm. No changes to the 
educational materials nor to the implementation are needed. The RCT will enroll 410 participants, 
randomized 1:1 2wT and control. At 6 months, all participants will receive 2wT and continue with 
2wT in routine retention activities. The RCT will provide rigorous evidence and generate lessons 
in direct response to the request of the MoH DHA for more evidence of 2wT impact.  
 
Study design 
 
In this current pragmatic RCT study, we randomize eligible 2wT patients who wish to opt-into 
2wT, allocating them 1:1 to 2wT and routine Back to Care (B2C) retention efforts. For 6 months, 
each participant will receive the assisged intervention (2wT or control). At 6 months post 
enrollment, all RCT participants will receive 2wT and continue with 2wT support as part of 
routine LT retention activities. We will enroll at both LH and MPC, using results to provide the 
MoH with data needed to consider 2wT for scale-up.  

11 
 
 
 
 
Study setting and Population 
MPC and LH clinics are in urban Lilongwe, largest public clinic that currently serve over 25,000 
patients alive on ART. About 60% of patients are female. On average, MPC and LH clinic initiates 
over 800 clients on ART per quarter, ensuring sufficient pace of enrollment. 
 
Technology overview 
Since 2008, Medic Mobile has been a leader in the global mHealth community [62-68], 
equipping more than 26,000 health workers serving over 12 million people across 25 countries. 
Medic Mobile is the steward of the Community Health Toolkit (CHT), an open source project 
(https://communityhealthtoolkit.org/) supporting dozens of mHealth implementations, including 
2WT in Zimbabwe. Interventions and apps built using the CHT work with or without internet 
connectivity, in any language, on basic phones, smartphones, tablets, and computers [69] and are 
tailored to meet key digital health characteristics recommended by the World Health Organization 
(WHO) [70]. The core areas of functionality used by the current 2WT system include peer-to-peer 
and automated interactive messaging, task management features (unread message; message not 
delivered), longitudinal patient records, data collection forms, routine syncing, and dashboard 
reports for routine monitoring (e.g. client response rates, referrals, etc.) [58]. Together, these 
features will enable an integrated 2WT workflow tailored to ART retention, generating the data 
needed to monitor program delivery and facilitate research. The CHT also supports interoperability 
with other eHealth tools (via the NIH-supported FHIR standard [71] or custom data formats). The 
existing 2wT flow diagram is illustrated below.  
 
 

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Staff training 
All staff at LH and MPC will be informed of the study and briefed on study protocols. A 2WT 
study coordinator, selected from current staff, will be trained in confidentiality, protection of 
human subjects, enrollment, randomization, and data collection methods. This person will 
manage enrollments, randomization, and the 2WT database, including text and voice follow-up 
communication with intervention clients. Malawi-based co-investigators, including MoH 
collaborators, will also be invited for Medic Mobile training. 
Sample size calculation   
Supposing a two-arm prospective study with 3-4 months recruitment period and 6 months 
follow-up. Assume the hazard for the control group is a constant risk over time at 0.2 (20%). To 
achieve 80% power to detect a hazard ratio of 0.41 in the exposed group by using a two-sided 
0.05-level log-rank test, the required sample size per arm is 197. With an estimated dropout of 
10%, 410 (205 per arm) will be needed, and up to 500 will be enrolled, total, to allow for buffer 
and withdrawal of those with lack of SMS confirmation receipt (documented).).  
 
Study outcomes 
 
Primary retention outcomes: 1) Proportion of patients retained in care at 6-months; (2) visit 
attendance; and 3) VL (suppressed = HIV RNA < 400 copies). Primary workload outcome is 
cumulative B2C referrals at 6 months. Secondary outcomes include: Text response rates, #visit 
date change requests, #ART outcomes updated, % of failed messages, client contact number 
updates, % referral of true LTFU for tracing, and B2C tracing outcomes (transfer, stop, alive, etc.).  
 
 
 
Participant eligibility  
The intervention will be offered to all new ART registrants and new ART initiates (clients who 
initiated ART in the last 6 months) at MPC and LH aged 18 years and above with mobile phones. 
This allows for collection of all outcome data by 12 months. 2WT-specific eligibility criteria for 
all clients are: 1) New ART registrants (Initial screening visit for ART initiation) OR new ART 
initiate (within 6 months of initiating ART); 2) ≥18 years; 3) possession of own phone at 
enrollment; 4) willing to receive/send SMS; 5) informed consent; 6) receives confirmed 2WT 
enrollment text to verify enrollment number; and 7) initiates ART. Those without cell phones will 

13 
 
 
 
be excluded. As phone sharing is common, informed 2WT-specific consent will ascertain whether 
eligible clients have consistent access to send and receive messages. Patients will see example text 
context that will not contain HIV- or clinic-based information to reduce risk of disclosure; these 
steps have been used in similar SMS-based studies [72, 73]. 2WT cannot control message content 
sent by clients. Study-eligible clients will be automatically enrolled into 2wT messages with 
confirmed ART dispensing. Consenting 2wT enrollees who do not initiate ART will not be sent 
messages.  
 
Recruitment of 2wT clients:  
Information about the study will be disseminated through MPC teams. As the backbone of the 
intervention, the Back to Care program is already part of the core patient counseling for ART 
registrants, taking place before ART initiation.  Adding the study-specific information will occur 
during this routine part of ART initiation counseling, while clients are considered ART registrants. 
Over 92% of ART registrants initiate ART the same day.  Recruitment will be managed by a 
specifically-trained research coordinator who will be a part of the Back to Care program. This 
research coordinator will meet with incoming ART initiation patients to sensitize them about the 
opportunity to participate in a study of text-based follow-up; those meeting eligibility criteria will 
be informed as a group about the opportunity to participate in the study. Flyers will also be 
available in clinic waiting areas and counseling rooms. Interested patients at ART initiation visit 
or within 6 months of ART initiation will be referred to the study staff for study enrollment and 
informed consent. Participant enrollment may be made by teams/clinicians using the Medic Mobile 
phone/tablet app or the laptop-based system.   
Randomization 
After routine recruitment consistent with 2wT procedures, eligibility, and informed consent, 410 
2wT-eligible participants will be randomized 1:1 intervention and control using a randomized 
block design in groups of 10.  Assignments will be held in opaque envelopes distributed to LH and 
MPC to meet enrollment pace. This block design reduces variability within treatment conditions 
and potential confounding, allowing near equal-size groups for interim analysis. Site coordinator 
will be unaware of the envelope’s contents until the participant opened and revealed the group 
assignment to the coordinator. Coordinator then enters participant group assignment as part of 2wT 
enrolment, confirming phone number as is routine. Those who do not receive the confirmation text 
while in clinic will be immediately withdrawn and replaced. The study design requires that 
participants and clinic staff are aware of allocation after assignment as routine early retention and 
B2C processes differ from 2wT. 
Routine ART initiation procedures (both arms) 
All ART care is provided free to clients as mandated by MoH. All diagnosed HIV-positive 
individuals who report to clinic reception are registered in the EMRS (ART registrants) and initiate 
ART same day (ART initiates). All new registrants receive augmented adherence counseling as part 
of the ART initiation visit. New ART patient visits are scheduled monthly during the first six 
months on ART and every two or three months thereafter if the patient is stable and adherent to 
therapy. Routine VL testing occurs at initiation and annually, thereafter. Clinic visits, side effects 

14 
 
 
 
and dispensed drugs are captured in EMRS in real-time by clinic staff. LH and MPC follow all 
MoH protocols based on WHO guidelines [74] including standard indicator reporting: ART 
outcomes (dead; transferred; alive on ART; stopped ART; never started ART; and LTFU), VL, 
and adherence [75].  
 
Study procedures 
Processes between 2wT and routine Back to Care (B2C)  
 
Control/comparison group (Routine Back to Care  (B2C)):  
All patients are eligible for B2C. Patients with any ART drug dispensing record (including 
initiation) who missed a scheduled appointment by 14 days or more are identified using the 
EMRS and considered LTFU. A team of B2C tracers manually verifies the LTFU list to rule out 
EMRS data errors and creates a paper-based B2C tracing list. Then, patients with completed 
locator forms are first traced by phone (SMS or call) up to five phone attempts and/or then up to 
three home visit attempts. The EMRS at ART patient registration is used daily to determine if/when 
a client returns to care and to stop B2C client follow-up for that specific event/month. For all 
patients reached, B2C interviews clients to ascertain ART outcomes and records data on paper B2C 
forms; data clerks enter it into the EMRS. 
 
2WT (intervention):   
All new ART registrants who fill locator forms will be asked to consent to 2WT; those who enroll 
will receive an enrollment confirmation text, additional texting information, and response 
instruction at initiation. ART initiates who fail to bring their phone at their first visit or otherwise 
decide to participate after the initiation visit will be eligible to join the study at any visit within the 
first 6 months on ART. They will also be asked to consent to 2WT; those who enroll will receive 
an enrollment confirmation text, additional texting information, and response instruction at 
enrollment. 2wT paper clients files will be marked to alert reception of participation. Then, 2WT 
data clerk will manually enter client unique ID, client phone number and scheduled visit dates into 
2WT system. Successful SMS receipt is verified by 2WT’s system; failed SMS creates a system 
report. Based on these inputs, the 2WT system will automatically send varying, weekly adherence 

15 
 
 
 
support texts and visit reminders (3 and 1 day before) for 12 months, with opt-out at any time. 
Clients will be asked to respond to visit reminder messages with a “1=will attend” or “0=no.” A 
“yes” will trigger, “See you soon!” A “no” will trigger hybrid automated and interactive SMS 
follow-up where clients can request an appointment date change, report transfers, note other 
outcome, or request a call. These modifiable, scripted texts between 2wT staff and the client will 
complete ART outcome data (transfer, stop, etc.) or determine the next steps (Figure 2 for mock- 
up).  
To support visit verification, the 2wT system will produce a set of daily “tasks” (IDs of client with 
expected visits) for 2WT clerks to monitor visit attendance. Using these daily lists of presumed 
visits, a clerk will confirm visits using the EMRS, recording attended visits in the 2WT system, 
updating subsequent visit dates if needed. Confirmed attendance stops visit reminders for that 
specific instance; completion of other ART outcomes ascertained via 2WT (stop, transfer, dead) 
also stops all messaging. If an expected client visit was not confirmed, and outcome otherwise not 
updated, the 2wT system will create another alert after 5 days, triggering 2wT staff to launch an 
automated a series of “missed visit” SMS with similar 2WT response options every 3 days until 
day 14. If no visit, no text, or otherwise updated ART outcome by day 14, the 2wT system will 
create another alert for referral to routine B2C. B2C referrals will be compiled weekly. The 2WT-
based generation of the B2C list with reported transfers removed and visits verified, will reduce 
delays in identification and tracing of those presumed LTFU. The system is free for clients. See 
text message flow: Appendix 11, Figure 2 and Appendix 12: 2wT interface mock-up. 
Specifically, procedures for 2WT RCT participants will include the following:  
1. Patients will have routine Lighthouse adherence counseling as per new ART initiates 
2. For those eligible, desirous to opt-into 2wT, and who consent, they will be randomized 1:1 
into the 2wT retention or routine retention groups  
3. In addition to routine care instructions, 2WT clients will receive additional counseling on 
the texting system and expected responses, and instruction in how to use the texting system 
before enrollment at either ART registration or within 6 monts of initiating ART. 
4. For follow-up, 2WT clients will receive automated weekly texts from initiation through 12 
months. They will also receive message 1- and 3-days before scheduled visits. Flow chart 
of texting is included in Figure 2. Automated texts, as illustrated in Science, will be in 
either both English or Chichewa, as per client selection at enrollment. It is free to use the 
system for clients.  
5. If they respond that they will attend a visit, no immediate follow-up action will be taken.  
6. If a 2WT ART client responds they will not attend a visit, a 2WT staff will exchange 
modifiable, scripted texts with the client to determine to change visit date, record transfer 
or other. Multiple responses and free text are acceptable. Regardless of response, the 2wT 
will enter into interactive texting with the client. 
7. No client has to respond to messages 
8. Any 2wT client, as per routine care who does not respond and does not attend any visit by 
>14 days will be referred to routine B2C 

16 
 
 
 
9. Data from the 2wT toolkit, participating clients, and ART forms will be reconciled by the 
Lighthouse study team as per routine monthly reporting requirements. Data on all visits 
will be entered into the online 2wT toolkit database.  
10. Brief, self-administered, mixed-method surveys on 2WT usability (Appendix 3: usability 
survey with clients) will be implemented at ART visits at 3- and 6-months with a subset of 
100 2WT clients (50 at 3 months/50 at 6 months) to gauge client acceptability, self-
efficacy, perceived benefits, and barriers to 2WT for intervention improvement. Clients 
may refuse to participate in these surveys and will be replaced to reach 100.  
11. At 6 months, RCT participants who were randomized to routine retention will be enrolled 
into 2wT 
 
Data sources 
During the course of the study, in both year 1 and 2, study team members will review existing 
paper-based records at the site with identified patient data, including paper ART visit forms for 
purposes of data quality assurance. Data will be collected across two objectives: data abstractions 
from participants’routine ART data in the electronic medical records system (EMRS) as well as 
supplemental information from the 2WT database. EMRS data is routine data. 2WT system data 
entry and forms will be checked for completeness and correctness on a weekly basis. Data for 
analysis will be abstracted only from the study database. 
 
Data abstracted from EMRS: 
• Basic demographic data such as name and age, WHO stage 
• Routine ART visit dates, viral load, adherence, ART outcomes 
 
Supplemental, study-specific data includes: 
• Enrollment form: confirmation of study consent, enrollment date, phone company, cell 
number 
• 
Non-routine data in 2WT database: client messages exchanged with 2WT staff, message 
failures, visit date changes, ART outcomes completed.  
 
Data for program retention (clinic visits, ART outcomes, VL), will be extracted from routine 
EMRS for both 2WT and comparison clients. B2C referrals and outcomes will come 2WT database 
(intervention) and from the routine B2C database (comparison). Process data from the 2wT 
database includes all other data for secondary outcomes.  
 
Data collection timing: prospective for new initiates in 2WT and retrospective comparison without 
2WT.  
 
Data analysis 
Retention:  

17 
 
 
 
Descriptive statistics will be performed to explore the patients’ characteristics at ART initiation 
using means or medians for continuous variables and proportions for categorical variables.  Chi-
square test and Kruskal-Wallis tests will be used to compare baseline characteristics. The 
proportion of patients retained in ART care (or known transferred in care) at 6 and 12 months post-
ART initiation between groups using chi-square test will be compared, reporting relative risks and 
95% confidence intervals (CIs). Time to event analysis will explore retention curves between 
groups in the first year of ART. T-test will compare the mean proportion of attended ART visits 
between groups. VL suppression (HIV RNA < 400 copies) at 12 months post-ART initiation will 
be compared between groups using chi-square test, reporting relative risks and 95% CIs.  
Multivariate logistic regression models (12-month retention v not) will quantify the magnitude of 
retention difference between groups, adjusting for any potential confounders (age, sex, WHO stage 
at ART initiation, etc.). Statistical analysis: B2C referrals (workload) outcomes: T-test will 
compare the cumulative number of B2C referrals between groups. A multivariate linear regression 
model will further quantify the effect of intervention on referrals, adjusting for potential 
confounders. For the RCT, the above outcomes will be measured and compated between arms at 
6 months.  
Limitations and uncertainties:  
While the study retention target of 82% still falls short of the global goal of 90% retained, it is 
well above the global average of 67% and acknowledges that improving retention is a multipronged 
approach. Also, a 15% increase in retention is ambitious for a routine, public, urban setting and 
would translate to a 55% reduction in B2C tracing workload. As costing analysis takes a 
conservative approach, looking at direct costs and not accounting for potential benefits accruing 
from avoidance of morbidity and mortality [76], sensitivity analysis may reveal that the break-even 
point for 2WT cost advantage over routine care is even lower than15%, requiring a smaller increase 
in retention to be cost-effective.  Phone ownership in urban Malawi is high, but if the clinic 
population ownership is lower, the effect of 2WT will decrease. It is possible that clients will not 
respond to SMS, increasing the need for routine B2C, thus reducing the efficiency and cost gains 
afforded by 2WT.  
 
Protection of Human Subjects:  
Consent Procedures: 
In obtaining informed consent, the study member enrolling patients will follow a strict script that  
emphasizes: 1) participation in the study is completely voluntary; 2) whether or not they  
participate will in no way adversely affect they care they receive. Consent procedures will occur  
before enrollment in the intervention study.  
 
The consent documentation was written by the Malawian staff and reflects the average literacy 
level of their clients. Study staff will be available to answer any questions.  The informed consent 
process is initiated prior to an individual agreeing to enroll in the cohort and continues throughout 

18 
 
 
 
the individual’s participation in the cohort. Patients who choose to enroll in the study will be 
provided with the enrollment informed consent, which describes in detail the study procedures and 
risks. Upon reviewing the document, the site staff member explains the study to the subject and 
answers any questions that may arise. Discussion of risks and possible benefits of study 
participation will be provided. The participant signs the informed consent document prior to the 
conduct of any study procedures. A copy of the enrollment consent form is given to the subjects 
for their records. Participants, both clients and providers,  will also be informed that they can 
withdraw from the study at any time with no repercussions.  
 
This RCT is registered with ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT05531448) and 
will receive UW approval as an amendment to current 2wT IRB approvals before implementation. 
Current consent documentation is updated with RCT-specific requirements, attached.  
 
Patients (Appendix 1: Client consent): Interested patients will be referred to the site 2WT study 
coordinator for study enrollment and informed consent. This person will meet with patients in the 
ART initiation counseling room (where clients are considered ART registrants), further explain 
the study, confirm study eligibility, and seek informed consent. For clients within the first 6 months 
of initiation who are interested in 2wT, they will also meet with the 2wT coordinator in the 
counseling room to further explain the study, confirm study eligibility, and seek informed consent. 
Participant enrollment may be made by teams/clinicians using the Medic Mobile phone/tablet app 
or the laptop-based system. Subject recruitment and consent will be in English and Chichewa. All 
staff are fluent in both English  and local languages for translation and transcription of activity 
materials. Consent forms, advertisements,  and study information materials will be translated by 
the local study team.  
 
Risks to participants: 
Injury/side effects/adverse events: All routine ART care procedures will be followed for this study. 
Any additional risk that may be incurred by participants by virtue of their text-based follow-up 
will be monitored closely and managed as described above. Participants will also be informed that 
they can withdraw from the study at any time with no repercussions.  
 
Discomfort/stress: Individuals who consent to participate may experience mild discomfort or stress 
as they will be asked to discuss topics that may be sensitive, including their opinions on the 
intervention. We will prevent undue influence by stressing the voluntary nature of this study and 
each person’s ability to decline without any risk to their ART service quality. 
 
Specific for participants, this study carries some small risk of social harms for clients. ART 
clients face a risk of stigma from HIV as their HIV status may be inadvertently revealed to 
others outside the study as a result of their participation or as a result of the texting intervention. 
ART clients who participate in surveys may feel uncomfortable answering questions about service 
quality and their opinions about the intervention. 
 

19 
 
 
 
Protection Against Risk: 
1.  Procedures for minimizing risk to participants include the careful selection, training, and  
supervision of study personnel and site-level study liaisons, together with the systematic  
preparation of other HCW involved in study operations. Study personnel are selected for past  
training and ability to work with participants in this target population. All site-based study  
personnel (project site coordinator, data clerk) will be working specifically for this study from  
partner organization, Lighthouse, and trained in procedures to ensure confidentiality in  
research settings. They will also be trained in research ethics and human subjects’ issues via the  
Collaborative Institutional Training Initiative (CITI) training. At each site, there will be a  site-
level study liaison who is a regular staff member at the health facility who  will be informed on 
study recruitment procedures, confidentiality protection, and documenting study operations. Dr. 
Feldacker will also take the Clinical Research Training On-Line Course for Principal Investigators 
and any additional courses suggested by University of Washington Or NIH to further her 
understanding of ethical conduct of clinical research. 
 
2.  The study database with study-specific data will include only coded information and no names 
or identifying numbers which could be used for individual identification of participants. 
Safeguarding confidentiality of personal data reported on study surveys and questionnaires will be 
achieved through identifier codes instead of full names on all research materials. The list 
referencing code number to name will be kept in a locked file cabinet in the research manager’s 
private office and coded data will be stored in computers in locked offices to which only project 
staff have access. The list relating names to number codes will be destroyed at the end of the study. 
Secondary data containing identifying information will be used to match records for patients who 
specifically consent to use of their health records, between the routine ART data and the study-
specific database. Following the matching of data sing names and codes, the identifying 
information within the dataset abstracted from the secondary data sources will be destroyed and 
only the study-specific coded identifiers will be preserved. No individually identifiable 
information from ART clients will be published. 
3. Safety and Progress reviews: 
1. 
ART outcome among all Lighthouse/MPC clients, including those 2WT,  will be 
reviewed quarterly as part of routine care. LTFU will be reviewed quarterly as per 
routine care.   
2. 
Annual report will include: 
• Progress report: summary of recruitment and retention and reason for dropouts;  
• whether LTFU are consistent with pre-study assumptions;  
• whether the study is on track to be completed and accomplish the stated objectives.  
• Technology challenges 
• Study challenges 
• Success and preliminary data 
4. Linkages to subjects and access to subject identities: LH and MPC use unique IDS that will be 
used in this study to ease processes and data linkages. Routine EMRS data practices that safeguard 

20 
 
 
 
this data as part of rouinte EMRS use will be employed in addition to restricting the 2WT database 
access to only the study team. Confidentiality will be maintained by assigning a unique study-
specific ID for all non EMRS data collected as part of the study. 
 
DATA QUALITY AND MANAGEMENT  
Quality Control will be ensured through the timely review of all study data to verify accuracy and 
validity. QC will take place on a weekly basis, allowing for swift review and correction if needed. 
Validation review will also happen weekly. The 2wT study database with study-specific data will 
include only coded information and no names. Safeguarding confidentiality of personal data 
reported on study surveys and questionnaires will be achieved through identifier codes instead of 
full names on all research materials. The list referencing code number to name will be kept in a 
locked file cabinet in the research manager’s private office and coded data will be stored in 
computers in locked offices to which only project staff have access. The list relating names to 
number codes will be destroyed at the end of the study.  Secondary data containing identifying 
information will be used to match records for patients who specifically consent to use of their 
health records, between the routine VMMC data and the study-specific database. Following the 
matching of data, the identifying information within the dataset abstracted from the secondary data 
sources will be destroyed and only the study-specific numeric identifiers will be preserved.  No 
individually identifiable information from ART clients will be published. Databases will be 
password protected and shared through encrypted file sharing services.  
Medic Mobile Data Security 
All data in the Medic Mobile database is stored on users’ local computers, and then synced to a 
cloud server hosted by Amazon Web Services. We make use of Amazon’s developer tooling to 
automate the process of creating routine back ups of all data that reaches the server. This means 
that data can only be lost if a health worker is using the software on a computer that is fully offline, 
and then the computer is damaged/stolen before connecting to the internet. In this scenario, the 
project would only lose data generated since the computer’s last sync to the server. The Excel 
study database will be backed up on a Google cloud server via the Google Apps service. Both of 
these cloud services are widely used in health services in the United States and around the world, 
in part because they provide very high levels of data security, and back-up and other data 
management tools. 
Medic Mobile is committed to data security and follows the data protection standards set by the 
Ministry of Health or our in-country implementing partner, as appropriate. We recognize the 
security benefits and drawbacks of different technology tools, and work with our partners to make 
the best choices and mitigate risk. 
• 
Web app: Medic Mobile uses secure transfers over HTTPS for all communication between 
the browser and our web application, with perfect forward secrecy (PFS) and 4096-bit SHA-2 
certificates by default. We use a non-standard port for SSH access to reduce our exposure to 
automated brute-force attacks, and can configure the web app to accept only public key 

21 
 
 
 
authentication for SSH connections. Access to the web application requires a password, and user 
access can be established to varying degrees using a role-based access control facility (e.g. full 
access, restricted access, data entry only, and data export only). 
• 
Data storage: Medic Mobile uses Amazon  Web Services (AWS) with enforced two-factor 
authentication, HTTPS, and Identity and Access Management (IAM) for all hosted instances. We 
use IAM policies on AWS to restrict what any one individual Medic Mobile 
developer/administrator can do. The data storage system is backed up daily.  
• SMS: We train users to input data using simple SMS codes or freeform SMS. We use 
"plain text encoding" which means viewers can see the value but not know the context of the data. 
SMS is inherently insecure but we work with every partner on safety practices to reduce and 
minimize mishandling of data and transmission of protected health information. 
• 
Android phones: Full disk encryption  with an auto-lock screen will be deployed.  
Security training for our  partners: Staff will trained and equipped to create secure passwords and 
PINs, secure hardware, and how to safely transport data. 
Confidentiality 
Patients’ routine ART data from EMRS, including patient demographics, clinical characteristics 
at baseline and during follow-up period. This data will be entered into the study-specific database. 
For the study specific database for analysis, IDs and no names will be used, as is routine with 
Lighthouse research. Confidentiality will be maintained by assigning a unique study-specific 
identifying alphanumeric code to each participant’s data in the 2WT database. 
Encryption will also be used wherever data are transferred. Implementation strategies for data 
management will take full consideration of regulations on confidentiality and security of electronic 
data transmission and storage. Upon completion of this study and exhaustion of the data retention 
period, all study identifiers will be deleted. In addition to the study staff’s maintenance of 
confidentiality, healthcare workers involved in the study will be oriented to the importance of 
confidentiality and their own roles in maintaining confidentiality. 
Data containing identifying information will be used to match records for patients using the EMRS 
and the study-specific database. Following the matching of data sing names and codes, the 
identifying information within the dataset abstracted from the secondary data sources will be 
destroyed and only the study-specific coded identifiers will be preserved. No individually 
identifiable information from ART clients will be published. All members of the study team 
(including Medic Mobile) that interact with data sign a confidentiality agreement. Sensitive data 
is de-identified and/or made inaccessible to certain employees. Medic Mobile's protected  health 
information  (PHI) policy requires that developers, employees, and contractors use full-disk 
encryption  on any computers receiving or manipulating PHI. 

22 
 
 
 
Ethics Training 
All staff who have contact with participants will receive training on the protection of human 
research participants and Good Clinical Practice (GCP) prior to conducting any study activities 
and every three years thereafter. Lighthouse Trust will facilitate ethics training for staff during the 
award. We will seek appropriate approvals from Institutional Review Board (IRB) at the 
University of Washington (UW) as well as the National Health Sciences Research Committee 
before contacting any human subjects to ensure that the study complies with both UW and local 
laws and requirements. Because this project involves local health authorities and we have 
successfully received UW and Malawi-based ethical review for other health-related research 
projects in Malawi, we do not expect any problems or delays with this approval. Below we discuss 
our plan to minimize risks to human subjects involved in this research and to maintain adequate 
protection against risks. We also outline the potential benefit of this research and describe the 
importance of the knowledge to be gained. All investigators involved in this application have 
completed or will complete training on the protection of human subjects before the project begins. 
 
Potential Benefits of the Proposed Research to Research Participants and 
Others 
Patients may benefit from improved adherence or increased communication with clinic staff, 
easing their visit adherence or transfer reporting. Information obtained in this study will be used 
by the MOHand its partners to inform retention efforts, which may lead to improving ART 
retention and thus HIV prevention. 
 
Importance of the Knowledge to be Gained 
The risks are offset by the potential value of the information to be gained in this study. This project 
will evaluate the effectiveness, feasibility, and acceptability of a promising intervention to improve 
ART retention at reduced cost and workload. If successful, both providers and patients would 
encounter distinct advantages. We will integrate 2wT into EMRS to improve and ease reporting. 
These advantages could be scaled up if the approach is adopted by the MoH, providing population-
levels gains to thousands of LH/MPC patients and, ultimately, millions of patients in regional ART 
programs. If texting with ART clients to increase retention is found to be better than routine to 
prevent default and improve data, scale up could dramatically reduce time spent on unnecessary 
tracing and decrease the burden on B2C staff. Future funding could enable scale-up of the 
intervention in other high volume ART sites with an EMRS, conducting additional rigorous 
evaluation in diverse field and clinical contexts. We would seek funding to test 2wT among rural 
populations or smaller urban areas – perhaps testing the advantages of only 2WT without the 
EMRS linkage for sites without EMRS options.  

23 
 
 
 
Dissemination  
This project will estimate the effectiveness, feasibility, and acceptability of a two-way texting 
(2WT) follow-up to improve ART retention. We will conduct an RCT and then expand in routine 
care in two large public ART clinics in Lilongwe Malawi.  
If successful, patients would be retained in care at lower cost and reduced healthcare worker 
workload, providing distinct advantages to both groups. These advantages could be scaled up if 
the approach is routinized with help of 2WT to electronic medical records system (EMRS) 
integration, providing population-levels gains to millions of providers and patients. Publications 
resulting from this study will adhere to human subjects rules and regulations for this low-risk, non-
research determination are adhered to.  
 
Ghant chart of RCT research activities 
 
Completed 
RCT 
Q1 
Q2 
Q3 
Q4 
Previous 2wT study  
UW & Malawi: Review and approve protocol and 
materials 
X 
 
  
  
  
Formative research, user-feedback, message testing X 
 
  
  
  
Revise SOPs, data collection instruments, database X 
 
Train local teams in 2wT X 
 
  
  
  
Implement 2wT among new MPC ART clients X 
 
  
  
  
Pragmatic RCT at Lighthouse and MPC with routine care teams 
Review and approve protocol and materials  
X 
 
 
 
Train study team in RCT protcols 
X 
 
 
 
Randomize 2wT enrollment among those eligible 
X 
X 
X 
 
Those randomized to routine start 2wT at 6 months 
X 
X 
Stakeholder engagement and process eval updates  
  
  
  
X 
Analysis of main RCT outcomes  
 
 
 
X 
Publication and dissemination 
  
  
x 
 

24 
 
 
 
Appendices: 
 
 

25 
 
 
 
Appendix 1: Client consent for routine 2wT, year 2 
INFORMED CONSENT FOR PARTICIPANTS  
Two-way texting for Loss to Follow-up Prevention Study 
Version 1.0, Dated 04-15-2020  
PRINCIPAL INVESTIGATOR 
Phone and Address 
Dr. Hannock Tweya 
0999 386 715, Lighthouse Trust, Box 
106, Lilongwe 
 
INTRODUCTION: 
You are being asked to take part in the research study named above. This study is being 
conducted at Lighthouse Trust clinics in Lilongwe. The persons in charge of the study is Dr. 
Hannock Tweya. 
 
You should only participate if you want to; choosing not to take part will not disadvantage you in 
any way. Before you decide whether you want to take part, it is important for you to understand, 
why the research is being done and what your participation will involve. Please feel free to ask us 
if there is anything unclear or if you would like more information. Once you understand the study, 
and if you agree to take part, you will be asked to sign this consent form or make you mark in 
front of someone. You will be offered a copy to keep.   
Please note that: 
• 
Your participation in this research is entirely voluntary; 
• 
You may decide not to participate or to withdraw from the study at any time without 
losing the benefits of being treated at this clinic. 
• 
If you decide not to participate in this study, you can still join another research study 
later, if one is available and you qualify. 
 
PURPOSE OF THE STUDY: 
Loss to follow up from HIV care is a problem in this clinic and in Malawi. The purpose of this study 
is to find out if two-way texting – where we can text you and you can text us back – could help us 
better keep our patients in care. Moreover, we want to find out if sending patient reminders of 
their visits could encourage patients to return to the clinic, and, if patients transfer, they could tell 
us by text. We also want to see if we could change appointment date by text, making it easier for 
patients who cannot make their appointments. Approximately 500 participants will take part in this 
study. 
STUDY PROCEDURES: 

26 
 
 
 
You will be given all information you need to decide if you want to participate in this study. If you 
decide to participate in this study, we will register your phone number into the texting system. We 
will test your phone to make sure you get the message. Then, if you start HIV medication, you will 
receive a weekly message on your phone with an encouraging message, like: “This is your 
reminder.” “Thank you for staying healthy!” or “You’re making great choices every day!”. You will 
also receive a reminder of your visit 3 and 1 day before the visit, and you will tell us if you can 
come for your visit or not. The message will say, “You have a visit in 3 days. See you soon! If you 
will return, enter 1=Yes  or  0=No and press send.” If you tell us you will not return,  we will ask 
you if you need to change your appointment or if you started receiving ARVs from another clinic. 
You will be texting with a member of the Lighthouse team or we can call you back if you prefer. 
The messages will not contain information about your HIV status or ARVs.  Sending us messages 
to this number is free. We will not send messages if you do not start HIV medication.  
We will send these weekly messages and visit reminders by text for 12 months. You may decide 
not to take part in the study at any time.  
We will ask about 100 participants to tell us how they feel about the texting system at ART visits 
at 3 months or  6-months. We would like to know your opinions on the texts and using the texting 
for visit confirmation. This may help us improve the system.  
The research team will use the routine clinic data and your responses to these messages as part 
of the study. The information in the texting system uses your Lighthouse patient ID. Data will be 
saved on central computers and in an online database that will be analysed by authorized 
individuals (e.g. researchers) other than the usual healthcare provider. Your privacy will be 
protected and other people cannot identify you.  
POTENTIAL RISKS /BENEFITS:  
There is a risk that others who see your phone may find out your HIV status and/or ART use as 
a result of these texts. That could cause problems between you and your sexual partners, 
including the potential for physical, verbal, sexual, or economic harm. Aside from the reminders, 
there are no other direct benefits to you by participating in this study. We believe that the 
healthcare providers can profit from the knowledge we gain from this study. People who see your 
phone may see that you have an appointment, but no texts will contain any HIV information that 
could disclose your status.  
CONFIDENTIALITY: 
Your identity will be kept confidential by using your Lighthouse ID number, which will be used to 
identify you, and we will only be using that number through the record keeping. You have the right 
to have insight in your data if you wish so. The information leaving the health clinic for research 
purposes will be contained within an online database that can be viewed by study researchers in 
the United States. This database is encrypted and password protected. Only coded study data 

27 
 
 
 
will be used for analyses in the United States. If you withdraw from the study, the data that is 
collected before the withdraw your consent will be used in the study. 
We have a Certificate of Confidentiality from the United States from the National Institutes of 
Health. These protections only apply to data held in the United States. This helps us protect your 
privacy. The certificate means that we do not have to give out information, documents, or samples 
that could identify you even if we are asked to by a court of law in the United States. We will use 
the Certificate to resist any demands for identifying information. 
We can’t use the Certificate to withhold your research information if you give your written consent 
to give it to an insurer, employer, or other person. Also, you or a member of your family can share 
information about yourself or your part in this research if you wish. 
There are some limits to this protection. We will voluntarily provide the information to: 
• 
a member of the United States government who needs it in order to audit or evaluate the 
research; 
• 
individuals at the institution(s) conducting the research, the funding agency, and other 
groups involved in the research, if they need the information to make sure the research is 
being done correctly; 
• 
individuals who want to conduct secondary research if allowed by federal regulations and 
according to your consent for future research use as described in this form; 
• 
to relevant authorities as required by other Federal, State, or local laws. 
 
The Certificate expires when the NIH funding for this study ends.  Currently this is June 30, 2022.  
Any data collected after expiration is not protected as described above.  Data collected prior to 
expiration will continue to be protected 
ALTERNATIVES TO PARTICIPATION:  
It is up to you to decide whether or not to take part in this study. If you do decide to take part you 
will be given this form to keep and be asked to sign a consent form once you are enrolled. If you 
do not wish to participate, you may have routine care, including routine Back to Care tracing 
services.  
FUTURE USE 
The information that we obtain from you for this study might be used for future studies. We may 
remove anything that might identify you from the information and specimens. If we do so, that 
information may then be used for future research studies or given to another investigator without 
getting additional permission from you. It is also possible that in the future we may want to use or 
share study information that might identify you. If we do, a review board will decide whether or 
not we need to get additional permission from you. 
PERSONS TO CONTACT FOR PROBLEMS OR QUESTIONS: 

28 
 
 
 
All research on human volunteers is reviewed by the Malawi Health Sciences Research 
Committee, a committee that works to protect your rights and welfare. If you have questions about 
the research or your rights as a research participant, you can contact: 
The Chairman  
 
 
 
 
 
 
Dr Hannock Tweya 
National Health Science and Research Committee  
 
Lighthouse Trust 
P.O Box 30377 
 
 
 
 
 
 
Kamuzu Central Hospital 
Lilongwe  
 
 
 
 
 
 
 
P. O Box 106 
Tel +265789400 
 
 
 
 
 
 
Tel +2651758940 
Cell+265994063425  
 
 
 
 
 
htweya@lighthouse.org.mw 
 
SIGNATURE PAGE 
INFORMED CONSENT FOR PARTICIPANTS  
Two-way texting for Loss to Follow-up Prevention Study 
Version 1.0, Dated 04-15-2020  
STATEMENT OF CONSENT 
Thank you for considering taking part in this research. The person organizing the research must 
explain the project to you before you agree to take part. If you have any questions arising from 
the informed consent sheet or explanation already given to you, please ask the researcher 
before you decide whether to join in. You will be given a copy of this consent form to keep and 
refer to at any time. 
 
1. I have read the informed consent or had it read and explained to me. I 
understand the information and l voluntarily agree to join this study. 
2. I consent that medical data that has been collected by my antiretroviral therapy 
providers can be further used in this study.  
3. I consent that my medical records may be examined and statistically analysed 
by authorized individuals other than my usual healthcare provider. 
4. I consent that data collected during the study will be stored on central 
computers and online to be used for review, while kept strictly confidential.  
5. I understand that if I decide at any time during the research that I no longer 
wish to participate in this project, I can notify the researchers involved and 
withdraw from it immediately without giving any reason.  
Participant’s Statement: 
 
_____________________________________________________                 
Name 
 
_________________________                ____________________ 
Signature                                                  Date 
 
 
 
       Thumbprint 
Please tick or initial 

29 
 
 
 
Investigator’s Statement: I ____________confirm that I carefully explained the nature, demands 
and any foreseeable risks (where applicable) of the proposed research to the participant. 
 
_________________________               ____________________ 
Signature                                                 Date 
 
 
 
 
 
Witness to consent if Subject Unable to Read or Write (Must be different from the person 
obtaining consent): 
 
____________________________________________________                
Name 
 
_________________________               ____________________ 
Signature                                                 Date 
 
 
 
 
 
 

30 
 
 
 
Appendix 1a: Client consent for RCT 
 
INFORMED CONSENT FOR PARTICIPANTS  
Two-way texting for Loss to Follow-up Prevention Study 
Version 1.0, Dated 09-03-2022  
PRINCIPAL INVESTIGATOR 
Phone and Address 
Dr. Hannock Tweya 
0999 386 715, Lighthouse Trust, Box 
106, Lilongwe 
 
INTRODUCTION: 
You are being asked to take part in the research study named above. This study is being 
conducted at Lighthouse Trust clinics in Lilongwe. The persons in charge of the study is Dr. 
Hannock Tweya. 
 
You should only participate if you want to; choosing not to take part will not disadvantage you in 
any way. Before you decide whether you want to take part, it is important for you to understand, 
why the research is being done and what your participation will involve. Please feel free to ask us 
if there is anything unclear or if you would like more information. Once you understand the study, 
and if you agree to take part, you will be asked to sign this consent form or make you mark in 
front of someone. You will be offered a copy to keep.   
Please note that: 
• 
Your participation in this research is entirely voluntary; 
• 
You may decide not to participate or to withdraw from the study at any time without 
losing the benefits of being treated at this clinic. 
• 
If you decide not to participate in this study, you can still join another research study 
later, if one is available and you qualify. 
 
PURPOSE OF THE STUDY: 
Loss to follow up from HIV care is a problem in this clinic and in Malawi. The purpose of this study 
is to find out if two-way texting – where we can text you and you can text us back – could help us 
better keep our patients in care. Moreover, we want to find out if sending patient reminders of 
their visits could encourage patients to return to the clinic, and, if patients transfer, they could tell 
us by text. We also want to see if we could change appointment date by text, making it easier for 
patients who cannot make their appointments. Approximately 410 participants will take part in this 

31 
 
 
 
study. About half will be in texting now. The other half will start with texting reminders in 6 months. 
. 
STUDY PROCEDURES: 
You will be given all information you need to decide if you want to participate in this study. 
Participants will be enrolled in either a texting group or to routine care for 6 months. You will not 
get to choose which group you are in. It will be assigned to you. At 6 months, everyone will receive 
reminder texts. If you decide to participate in this study, we will register your phone number into 
the texting system. In both groups, we will test your phone now to make sure you get the message.  
Then, if you start HIV medication, and you are in the routine group, you will start receiving these 
messages in 6 months. If you start HIV medication, and you are in the texting group, you will 
receive a weekly message on your phone with an encouraging message, like: “This is your 
reminder.” “Thank you for staying healthy!” or “You’re making great choices every day!”. You will 
also receive a reminder of your visit 3 and 1 day before the visit, and you will tell us if you can 
come for your visit or not. The message will say, “You have a visit in 3 days. See you soon! If you 
will return, enter 1=Yes  or  0=No and press send.” If you tell us you will not return,  we will ask 
you if you need to change your appointment or if you started receiving ARVs from another clinic. 
You will be texting with a member of the Lighthouse team or we can call you back if you prefer. 
The messages will not contain information about your HIV status or ARVs.  Sending us messages 
to this number is free. We will not send messages if you do not start HIV medication.  
We will send these weekly messages and visit reminders by text for 12 months. You may decide 
not to take part in the study at any time.  
The research team will use the routine clinic data and your responses to these messages as part 
of the study. The information in the texting system uses your Lighthouse patient ID. Data will be 
saved on central computers and in an online database that will be analysed by authorized 
individuals (e.g. researchers) other than the usual healthcare provider. Your privacy will be 
protected and other people cannot identify you.  
POTENTIAL RISKS /BENEFITS:  
There is a risk that others who see your phone may find out your HIV status and/or ART use as 
a result of these texts. That could cause problems between you and your sexual partners, 
including the potential for physical, verbal, sexual, or economic harm. Aside from the reminders, 
there are no other direct benefits to you by participating in this study. We believe that the 
healthcare providers can profit from the knowledge we gain from this study. People who see your 
phone may see that you have an appointment, but no texts will contain any HIV information that 
could disclose your status.  
CONFIDENTIALITY: 

32 
 
 
 
Your identity will be kept confidential by using your Lighthouse ID number, which will be used to 
identify you, and we will only be using that number through the record keeping. You have the right 
to have insight in your data if you wish so. The information leaving the health clinic for research 
purposes will be contained within an online database that can be viewed by study researchers in 
the United States. This database is encrypted and password protected. Only coded study data 
will be used for analyses in the United States. If you withdraw from the study, the data that is 
collected before the withdraw your consent will be used in the study. 
We have a Certificate of Confidentiality from the United States from the National Institutes of 
Health. These protections only apply to data held in the United States. This helps us protect your 
privacy. The certificate means that we do not have to give out information, documents, or samples 
that could identify you even if we are asked to by a court of law in the United States. We will use 
the Certificate to resist any demands for identifying information. 
We can’t use the Certificate to withhold your research information if you give your written consent 
to give it to an insurer, employer, or other person. Also, you or a member of your family can share 
information about yourself or your part in this research if you wish. 
There are some limits to this protection. We will voluntarily provide the information to: 
• 
a member of the United States government who needs it in order to audit or evaluate the 
research; 
• 
individuals at the institution(s) conducting the research, the funding agency, and other 
groups involved in the research, if they need the information to make sure the research is 
being done correctly; 
• 
individuals who want to conduct secondary research if allowed by federal regulations and 
according to your consent for future research use as described in this form; 
• 
to relevant authorities as required by other Federal, State, or local laws. 
 
The Certificate expires when the NIH funding for this study ends.  Currently this is June 30, 2023.  
Any data collected after expiration is not protected as described above.  Data collected prior to 
expiration will continue to be protected 
ALTERNATIVES TO PARTICIPATION:  
It is up to you to decide whether or not to take part in this study. If you do decide to take part you 
will be given this form to keep and be asked to sign a consent form once you are enrolled. If you 
do not wish to participate, you may have routine care, including routine Back to Care tracing 
services.  
FUTURE USE 
The information that we obtain from you for this study might be used for future studies. We may 
remove anything that might identify you from the information and specimens. If we do so, that 
information may then be used for future research studies or given to another investigator without 

33 
 
 
 
getting additional permission from you. It is also possible that in the future we may want to use or 
share study information that might identify you. If we do, a review board will decide whether or 
not we need to get additional permission from you. 
PERSONS TO CONTACT FOR PROBLEMS OR QUESTIONS: 
All research on human volunteers is reviewed by the Malawi Health Sciences Research 
Committee, a committee that works to protect your rights and welfare. If you have questions about 
the research or your rights as a research participant, you can contact: 
The Chairman  
 
 
 
 
 
 
Dr Jacqueline Huwa 
National Health Science and Research Committee  
 
Lighthouse Trust 
P.O Box 30377 
 
 
 
 
 
 
Kamuzu Central Hospital 
Lilongwe  
 
 
 
 
 
 
 
P. O Box 106 
Tel +265789400 
 
 
 
 
 
 
Tel +2651758940 
Cell+265994063425  
 
 
 
 
 
jhuwa@lighthouse.org.mw 
 
SIGNATURE PAGE 
INFORMED CONSENT FOR PARTICIPANTS  
Two-way texting for Loss to Follow-up Prevention Study 
Version 1.0, Dated 04-15-2020  
STATEMENT OF CONSENT 
Thank you for considering taking part in this research. The person organizing the research must 
explain the project to you before you agree to take part. If you have any questions arising from 
the informed consent sheet or explanation already given to you, please ask the researcher 
before you decide whether to join in. You will be given a copy of this consent form to keep and 
refer to at any time. 
 
6. I have read the informed consent or had it read and explained to me. I 
understand the information and l voluntarily agree to join this study. 
7. I consent that medical data that has been collected by my antiretroviral therapy 
providers can be further used in this study.  
8. I consent that my medical records may be examined and statistically analysed 
by authorized individuals other than my usual healthcare provider. 
9. I consent that data collected during the study will be stored on central 
computers and online to be used for review, while kept strictly confidential.  
10. I understand that if I decide at any time during the research that I no longer 
wish to participate in this project, I can notify the researchers involved and 
withdraw from it immediately without giving any reason.  
Participant’s Statement: 
Please tick or initial 

34 
 
 
 
 
_____________________________________________________                 
Name 
 
_________________________                ____________________ 
Signature                                                  Date 
 
 
 
       Thumbprint 
Investigator’s Statement: I ____________confirm that I carefully explained the nature, demands 
and any foreseeable risks (where applicable) of the proposed research to the participant. 
 
_________________________               ____________________ 
Signature                                                 Date 
 
 
 
 
 
Witness to consent if Subject Unable to Read or Write (Must be different from the person 
obtaining consent): 
 
____________________________________________________                
Name 
 
_________________________               ____________________ 
Signature                                                 Date 
 
 
 
 
 
 

35 
 
 
 
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