A Mobile Phone Short Message Service Intervention to Increase Retention in HIV Care Among HIV-Positive Men Who Have Sex With Men in Peru (WELTEL PERU)
Phase: NA
Conditions: Retention in Care, Hiv
Sponsor: Universidad Peruana Cayetano Heredia

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A MOBILE PHONE SHORT MESSAGE SERVICE INTERVENTION TO INCREASE 
RETENTION IN HIV CARE AMONG HIV-POSITIVE MEN WHO HAVE SEX WITH MEN (MSM) 
IN PERU  
 
WELTEL PERU 
 
SUMMARY 
 
Retention in care (or in care) for HIV is associated with increased survival and viral suppression, 
and with less transmission of the virus. HIV disproportionately affects men who have sex with 
men (MSM). In Peru, the HIV epidemic is concentrated in them (prevalence of 12.2%), while only 
0.4% of the general population is HIV+. What is concerning is that MSM tend to have lower rates 
of retention in HIV care. Studies with text messages (SMS) have been reported to be effective in 
promoting testing for HIV and other sexually transmitted infections in MSM. Two-way text 
messaging (2-way, ie when the patient can reply) can provide a higher level of real-time support 
to patients. WelTel was the first randomized controlled trial to use this interactive approach and 
reported a significant increase in adherence and viral suppression. WelTel has been used 
successfully for HIV, asthma and tuberculosis. However, further studies are needed to evaluate 
the use of this strategy to increase retention in HIV care in resource-limited settings, such as in 
Latin America. The hypothesis is that an adapted version of WelTel can be used to implement a 
2-way text message-based intervention, and to increase retention in care among HIV+ MSM in 
Peru. 
 
To address the low retention in HIV care among MSM in Lima, we will use the WelTel system and 
its strategy managed by health providers consisting of sending reminder and informative SMS 
and differentiated follow-up. We will assess the efficacy of the intervention with a randomized 
controlled trial comparing the proportion of HIV+ MSM retained in HIV care among those who 
received the intervention versus the standard care arm, up to one year after enrollment. We will 
recruit 208 participants who will be randomly assigned (1:1) to an intervention group (receives the 
intervention with WelTel) and a control group (standard of care). Delivery of the intervention will 
take place over 6 months, and the main outcome to be measured will be retention in HIV care up 
to 1 year after enrollment. 
 
ACRONYM 
PLWHA: people living with HIV/AIDS. 
MSM: men who have sex with men. 
ART: antiretroviral therapy. 
SMS: short message service (short text message). 
CD4: CD4 T lymphocyte cell. 
CV: viral load. 
RR: relative risk. 
MINSA: Ministry of Health. 
PS: health provider. 
STIs: sexually transmitted infections. 

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RESEARCHERS 
 
Dr. Luis Menacho 
Dr. Giovani Díaz 
Dra. Magaly Blas 
Dra. Elsa Gonzáles 
 
INTRODUCTION 
 
23.3 million people living with HIV/AIDS (PLWHA) are now receiving antiretroviral therapy (ART) 
and it is estimated that there will be 2.8 million more per year in the next 3 years (19). For 
continued access to ART and monitoring of clinical and virological progress, PLWHA must be 
maintained in high-quality care. Retention in HIV care is associated with increased survival, 
viral suppression; and reduced HIV transmission and viral resistance (20,21). Missing more 
than two HIV care visits increased mortality risk in a multicenter cohort study (HR = 3.61; 95% CI, 
2.35-5.55) (21). Low retention in HIV care is a critical barrier to achieving optimal individual and 
community outcomes. Continuum of HIV care includes testing for exclusion, linkage to care, 
initiation of ART, retention, and adherence to therapy to achieve and maintain viral suppression. 
Since 2010, the number of new HIV infections in Latin America has remained stable, without 
significant decreases as observed in all other regions of the world (19). Viral suppression remains 
low in some regions: 22% in the Middle East and North Africa; 40% in the Caribbean; and 52% in 
Latin America (19). With the expansion of ART, urgent efforts are needed to retain PLWHA 
in care and thus reduce morbidity, mortality, and the incidence of new HIV-related 
infections (22-24). 
 
HIV disproportionately affects men who have sex with men (MSM). MSM represent 41% of 
new infections in the region (19). In fact, MSM have a 27-fold higher risk of HIV infection than 
the general population (25). In Peru, the epidemic is concentrated among them (prevalence 
12.2%), while only 0.4% of the general population is HIV+ (19,26). The incidence among MSM 
aged 18 to 29 years has increased substantially and 60% of new infections occur in this group 
(27,28). Of concern, HIV-positive MSM are less likely to remain in care than other 
population groups (29-33). In the United States, 54.3% retention in HIV care and 50.8% viral 
suppression were reported among MSM aged 20-24 years (32). In Peru, less than 50% of MSM 
have been tested for HIV and it is estimated that only 24% of those infected know their status 
(28). The Ministry of Health reported that retention in HIV care after the first year is 55%, which 
drops significantly during the second year (26). National viral suppression is only 36% (26). 
 
Based on multiple studies that have shown efficacy, the World Health Organization (WHO) 
strongly recommends the use of text messages (mobile health) to improve adherence to ART (34-
38). However, evidence on the impact of mobile health for retention in HIV care is scarce 
(39,40). Some studies in Africa concluded that short message service reminders (SMS or text 
messages) are effective in improving retention in HIV care in the general population (39). Until 
now, no controlled study has done the same with MSM, one of the populations most affected by 
HIV. Studies with MSM have reported good efficacy of SMS reminders to promote testing for HIV 

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and other sexually transmitted infections (STIs) (41-43). More trials with this key population are 
needed to evaluate the use of SMS to increase retention in HIV care in resource-limited settings, 
such as in Latin America (39). 
 
Two-way communication (between patient and healthcare provider) with text messages 
(SMS) has the potential to provide comprehensive care through improved communication. 
A meta-analysis comparing one-way versus two-way SMS found that two-way SMS is the main 
driver for improving treatment adherence, while one-way messages have little or no benefit (44). 
Two-way messaging can provide a higher level of real-time support to patients. An evaluation of 
this strategy using the “behavior change wheel” suggested that the flow of support after an initial 
SMS is a key contributor to improving ART adherence (45). Health providers need appropriate 
tools to optimize the delivery of two-way text-based interventions and make them feasible and 
easy to deliver (38). An existing tool supported by evidence from previous studies can be adapted 
for use with MSM in Peru, with the aim of optimizing the delivery of a two-way text message 
intervention to increase retention in HIV care (38). 
 
WelTel was the first randomized controlled trial using an interactive two-way text messaging 
approach that reported a significant increase in adherence and viral suppression in Kenya (RR 
for non-adherence: 0.81, 95% CI: 0.69 -0.94; RR for virologic failure 0.84, 95% CI: 0.71-0.99), as 
well as among HIV+ women in Vancouver, BC (38,46). WelTel is based on a well-structured 
platform that connects healthcare providers with patients through regular text messages. It uses 
a web-based program (software) (accessed through the Internet) with intuitive functionalities that 
allow providers to monitor, track and support large numbers of people (47). The platform allows 
addressing multiple morbidities, as well as different health services. The system has been tested 
in Kenya, Rwanda, South Africa, the United States, and Canada and has been used for other 
diseases such as tuberculosis and asthma (46,48,49). A recent study with WelTel in Kenya 
significantly improved Quality of Life scores ("the 4th 90") (40). HIV+ MSM in Peru may benefit 
from receiving an SMS-based intervention delivered through the WelTel platform to increase low 
retention in HIV care (retention = 50% at study site). 
 
JUSTIFICATION 
 
Peru is a relevant place to test an SMS intervention to increase retention in HIV care based 
on existing WelTel technology. The country has a high number of cell phone subscriptions (121 
per 100 people), and smartphone use is also very common and constantly growing (50-52). Our 
preliminary data shows that Peruvian MSM are interested in receiving HIV prevention information 
via SMS (2,3,50,53). Other studies report that HIV+ MSM are interested in interacting with health 
providers to discuss HIV-related issues that may positively affect their retention in care (55). The 
proposed study will develop, implement, and evaluate an adapted version of WelTel to deliver a 
two-way interactive SMS intervention to increase retention among HIV+ MSM. WelTel has been 
used extensively in other resource-limited settings, and there is preliminary information in Peru to 
help tailor the content of such an intervention (3,4,12,40,43,49,55). 
 

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The use of a two-way SMS intervention to improve retention in HIV care among MSM is 
innovative. Globally, there are no published controlled studies on improving retention among HIV+ 
MSM that have used this approach and this study will be the first to evaluate this type of mHealth 
intervention in Peru. This study will provide evidence on the use of mobile health to improve 
retention in HIV care, where retention is currently very low. Retention has been the focus of fewer 
interventions compared to other steps of the HIV care continuum, and it is a crucial step because 
it involves multiple visits over time (35,57-59). This is the first study that will test the WelTel system 
in Latin America, specifically in Peru, where there are promising characteristics to carry out the 
intervention. We will adapt and validate the system for use in Spanish. We will test an already 
developed system that has the flexibility to add new features to improve patient follow-up. 
 
 
OBJECTIVES 
General Objective: 
To assess the efficacy of a text message (SMS)-based strategy delivered with the support of a 
web tool (WelTel) to increase retention in HIV care in Peru. 
 
Specific Objective:  
To determine the efficacy of SMS-based intervention delivered through the WelTel system in 
increasing retention in HIV care compared to standard care. 
 
Hypothesis: 
An SMS-based intervention delivered through the WelTel system will increase retention in HIV 
care among MSM. We hope to increase retention in HIV care from 50% to 70%. 
 
 
METHODS 
 
Study Overview: 
To address the low retention in HIV care among MSM in Lima, we will use the WelTel system and 
its strategy managed by health providers that consists of sending reminder and informative SMS 
and with differentiated follow-up. We will assess the efficacy of the intervention with a randomized 
controlled trial comparing the proportion of HIV+ MSM retained in HIV care versus the standard 
care arm up to one year after enrollment. Table 1 summarizes the exposures, results, and design. 
 
Behavior Theory: 
The behavior change wheel framework has been used to explain how WelTel can promote 
adherence to ART. The Capability, Opportunity, Motivation, and Behavior model is at the core of 
the theory (45). According to this model, the achievement of a behavior requires the presence of 
capacity, opportunity and motivation. To perform in a behavior, a person needs psychological 
(knowledge and skills) and physical capacity. Opportunity (physical and social) refers to factors 
that promote behavior. Physical opportunities are those that occur in the external environment, 
such as a physical reminder (SMS) to take medication. Social opportunities refer to non-physical 
factors, such as social norms and interpersonal influences. Motivation includes automatic and 

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reflexive processes that elicit behaviors such as emotions, habits, beliefs, and plans. Automatic 
processes are those that involve emotional responses, impulses, desires, and reflex responses, 
while reflective processes involve conscious planning and evaluation. This framework advocates 
identifying behavior change techniques as components of the intervention. 
 
Only 1 behavior change technique has been identified for the automated text messaging 
component of the intervention: requesting/indicating the behavior. The behavior change 
techniques identified in WelTel were mainly related to its personalized communication component 
delivered to patients who reported a problem or query. These techniques were: a) 
eliciting/indicating the behavior, b) unspecified social support, c) reducing negative emotions, d) 
communication from a credible source, e) information about health consequences, f) social 
emotional support, g) practical social support, eh) instructions on how to perform a behavior. At 
WelTel, such behavior change techniques were linked to 5 intervention functions: environmental 
restructuring, empowerment, education, persuasion, and training. 
 
Finally, to specify possible mechanisms of action to promote a behavior, such techniques and 
functions must be connected to influences on behavior following this model. The proposed 
mechanisms of action to facilitate adherence behavior in WelTel were: a) the delivery of an 
external trigger (SMS reminder to complete a behavior) and social support, to influence 
opportunities and automatic motivation through restructuring and environmental clearance; b) 
delivery of health-related information and social support to influence ability, opportunity, and 
motivation through education, persuasion, and training. We believe that retention in HIV care will 
be similarly influenced in our intervention. 
 
General description: 
 
This intervention will be designed for MSM who are HIV positive. We will recruit subjects 18 years 
of age or older. The intervention will begin one day after enrollment. The two-way SMS 
intervention will have four components: 1) an automated weekly SMS sent to ask how they are 
doing (basic follow-up); 2) phone calls from a health provider to participants who respond that 
they have a problem, or that they need support or some information that cannot be resolved by 
text message; 3) SMS reminder 1 week before an appointment for HIV care. 
 
Design:  
 
Randomized controlled trial. 
 
Main result: 
The primary outcome will be retention in HIV care for up to 1 year after enrollment. 
Participants will be classified as retained in care if they attend three HIV care appointments 
that are separated by 90 days or more within a one-year period (at the study HIV center) 
(64). Otherwise, they will be classified as not retained. The delivery of the intervention will 
last 6 months and the follow-up period to verify retention will last up to 12 months. 
 

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Main exposure: 
Text message (SMS) based intervention delivered through the WelTel system by trained 
health providers. 
 
Procedures: 
 
1. Recruitment and eligibility criteria. We will identify and recruit 208 HIV+ MSM in the 
Cayetano Heredia Hospital HIV service for a period of up to 12 months. Eligible 
participants will be 1) men who have sex with men; 2) 18 years or older; 3) has been 
diagnosed HIV positive; 4) own a cell phone that can send and receive SMS; 5) resides in 
Lima; and 6) not be enrolled in another study that uses text messaging. 
 
2. Enrollment and randomization: During enrollment, the recruiter will be blinded to 
assignment to the intervention group. The recruiter will obtain informed consent and 
instruct the participant on how he should interact if he starts receiving text messages (see 
appendix 1). Participants will be randomly assigned after providing their cell phone number 
and brief general information (first name, date of diagnosis, email). They will be assigned 
a study ID and randomly divided into intervention or control arm (1:1 ratio) using computer 
generated random numbers. Arm assignments will be in sequentially numbered sealed 
envelopes. Healthcare providers trained to administer the intervention will be informed by 
the research team when a new participant is enrolled in the intervention arm. Due to the 
nature of the study, healthcare providers and participants will not be blinded to group 
assignment. The participants assigned to the intervention arm will have their telephone 
numbers registered on the platform. 
 
3. Intervention. We will use the WelTel platform. For 6 months, every Monday the system 
will send automatic SMS with the question "How are you?" or similar questions (How are 
you?; How are you doing?). Participants will be instructed to respond if they are okay ("All 
OK") or if they have a problem ("I want support"; "I'm not okay"). The provider will send a 
return SMS to participants who have a problem or query; or they will call those who need 
it. The WelTel program has a customizable dictionary that identifies the words (or phrases) 
that the administrator indicates; thus, the answers of the participants are automatically 
ordered to indicate who needs follow-up through a reply SMS or call. One week before 
each appointment for HIV care, health providers will send an SMS reminder (Table 1). 
 
4. Standard care arm. In 2018, the government published new national guidelines for HIV 
care (65). After pre-test counseling, the diagnosis of HIV is made with two rapid tests. 
Those who test positive for both tests receive post-test counselling, including emotional 
support, and are linked to an ART initiation center, ideally within the same week. During 
the first medical appointment after diagnosis, laboratory tests including CD4 and viral load 
(VL) are requested. In most cases, initiation of antiretroviral treatment (ART) occurs at the 
second medical appointment when basic laboratory results are available. Currently, it is 
not mandatory to have CD4/CV results available to start ART. ART, viral load and CD4 

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lab tests are provided free of charge. It is recommended that patients have CD4 counts 
and viral load testing twice during the first year. A one-month supply of ART is initially 
provided. If patients are adherent, nurses dispense ART every 3 months and also assess 
adherence. 
 
Table 1. Summary of the study: exposures, results and design. 
 
Component 
Sub-
component 
Description 
 
 
Intervention 
arm 
(exposure) 
Basic follow-up 
SMS (check-in) 
Weekly automatic SMS with the question "How are you?" or similar 
messages. This will be shipped for 6 months. 
Calls 
The provider can call participants who have a problem. 
Appointment 
reminders 
SMS reminder one week before each appointment for HIV care. 
 
Results 
Primary 
Retention in HIV care up to 1 year after enrollment, defined as attending 3 
appointments that are 90 days apart within a 1-year period. 
 
 
 
Design 
Desing 
Randomized controlled trial with a parallel group. 
 
Sample size 
We aim to increase retention in HIV care from 50% to 70%. With 104 
participants in each arm, we will have 80% power to detect this difference. 
Follow-up 
6 months (intervention); 12 months (retention measure). 
Theory 
The behavior change wheel framework and its model of Capability, 
Opportunity, Motivation and Behavior. 
 
Control arm 
Standard of care 
Post-test counselling, including emotional support and linkage to ART 
initiation, ideally within a week. ART, CD4, and viral load laboratory tests are 
provided free of charge in Peru. 
 
Analysis plan: 
 
1. Data sources for the main result. The main outcome to be measured will be retention in 
HIV care during the first year after enrollment. Retention in care will be considered if they 
attend 3 HIV care appointments that are at least 90 days apart within a one-year period 
(64). We will verify retention in HIV care with: study registration (enrollment) sheets, 
physical medical records from the HIV service, reception appointment notebooks, and with 
a final follow-up survey. 
 
Health providers will enter the data from the enrollment registration sheets into a database 
that will be stored in a password-protected computer file. The data from the final follow-up 
online survey completed by the participants will be exported to the physical database and 
will be periodically deleted from the online survey system server. All data resulting from 
the interaction between providers and participants will be stored on the WelTel platform 
that has high security standards: encrypted, password protected and HIPAA compliant 
(The Health Insurance Portability and Accountability Act). 
 
2. Statistic analysis. for the main outcome, we will compare the proportion of MSM who 
were retained in care in both groups, as a cumulative incidence rate. If any variable of 
interest is not balanced between intervention and control arms, we will calculate Mantel 

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Haenszel-adjusted relative risks (RR). For secondary outcomes, we will also assess 
differences in the proportion of participants. 
  
3. Calculation of the sample size. We hope to increase retention in HIV care from 50% to 
70% one year after enrollment in the study clinic among HIV+ MSM. With 104 participants 
in each arm, we will have 80% power to detect this difference. 
 
Our main outcome is the degree of loss to follow-up. Retention in care at the study HIV 
service (as opposed to being lost to follow-up) is the primary outcome, and retention in 
any HIV clinic will be a secondary measure. Participants lost to follow-up will be considered 
as not retained. We will measure the retention in an establishment of the Ministry of Health 
(MINSA). MINSA provides care to more than 60% of Peruvians (73). Since retaining 
subjects in our public health system is an important goal, we have not adjusted the sample 
size calculation based on the potential loss of subjects to follow-up. 
 
 
OPERATIONALIZATION OF VARIABLES 
 
Table 2. Operationalization of variables. 
 
Variable 
Type 
Options 
Source 
Age 
Continuous 
> 18 
Online follow-up survey 
Education 
Categorical 
Secondary, Technical, 
Superior, 
Online follow-up survey 
Civil status 
Categorical 
Single, Married, 
Outgoing, Coupled 
Online follow-up survey 
Employment situation 
Categorical 
Unemployed, Employed 
Online follow-up survey 
Nationality 
Categorical 
Peruvian, Foreign 
Online follow-up survey 
sexual orientation 
Categorical 
Gay, Bisexual, Straight 
Online follow-up survey 
Diagnosis date 
Date 
Day month Year 
Clinic history; dating 
record 
Treatment start date 
Date 
Day month Year 
Clinic history; dating 
record 
Attended appointment 
dates 
Date 
Day month Year 
Clinic history; dating 
record 
Viral load 
Continuous 
 
Clinic history 
CD4 
Continuous 
 
Clinic history 
alcohol use 
numeric 
 
Online follow-up survey 
Condom use, last 
encounter 
Categorical 
Yes, No 
Online follow-up survey 
Email 
Text 
 
enrollment sheet 
Cell phone number 
Numeric 
NA 
enrollment sheet 
Arm 
Categorical 
Control, Intervention 
Study Database 
Retention in HIV care 
Categorical 
If 
not; 
Attend 
three 
appointments 
for 
HIV 
care that are 90 days or 
more apart within a one-
year period (at the study 
HIV center) 
Clinic history; dating 
record; online follow-up 
survey; WelTel system 
 
 

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9 
TIMELINE 
 
Actividades 
Year 1 
Year 2 
Year 3 
Year 4 
 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment/Enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
Delivery of intervention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Monitoring and analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Manuscript development 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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APPENDIX 1 
INFORMED CONSENT FORM 
 
Study Title:  
A mobile phone short message service intervention to increase retention in HIV care among HIV-
positive men who have sex with men in Peru. 
 
Investigators: 
Luis Menacho, Giovani Díaz, Magaly Blas, Elsa Gonzáles 
 
Institution: 
Universidad Peruana Cayetano Heredia 
 
Purpose of the study: 
We are inviting you to participate in a study to see the usefulness of a new text message follow-
up strategy to help you keep appointments at this care service, and to provide you with ongoing 
support. This is a study developed by researchers from the Universidad Peruana Cayetano 
Heredia and the Alexander Von Humboldt Institute of Tropical Medicine. 
We have seen that as time goes by, many patients receiving antiretroviral treatment stop coming 
for some controls. As a consequence, their health status cannot be assessed, they do not collect 
their medications, and they run the risk that the therapy will no longer work as well. The objective 
of this study is to evaluate a new strategy to motivate them and remind them not to stop coming 
to their controls. 
 
Procedures: 
If you decide to participate in this study, the following will be done: 
1. You will need to provide your cell phone number and email address. 
 
2. You will need to complete an online survey at the beginning, middle (at 6 months) and at 
the end of the study (at 12 months). We will send this survey to you by mail or cell phone. 
It will last 30 minutes (32 short items) and you will be asked for brief demographic 
information, sexual behavior, attendance at check-ups, and about some of your physical 
and mental health habits. 
 
 
3. Some participants will receive text messages from a health provider approximately once 
a week for 6 months. They will be informative messages, reminders and also motivating. 
For confidentiality, a neutral language will be used and some messages will be private: 
you will be able to see them only if you enter the password that you will be given at the 
beginning. You can reply to messages if you have any questions, or a member of the team 
will call you back if you need them. 
 
 
Risks: 
There is a possibility of a breach in confidentiality if someone else reads your cell phone. We will 
minimize this risk by sending text messages with neutral language that does not contain words 
directly related to HIV to anticipate if someone else reads the text messages on your cell phone. 
In addition, text messages with additional information will be protected by a password that only 

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you will know. We recommend having the cell phone with a password, which is very common 
now. There is a possibility that some of the questions in the follow-up online surveys may cause 
you some discomfort, you are free to answer them or not. 
 
Benefits: 
You may benefit from receiving informative, reminder and also motivational text messages to help 
you keep appointments, stay in care which will help maintain good health. Likewise, you could 
receive logistical and emotional support from health providers. 
 
 
 
Costs and compensation 
You will not have to pay anything to participate in the study. Likewise, you will not receive any 
economic or other incentive. 
 
Confidentiality: 
We will store your information with codes and not with names. Only researchers will have access 
to the databases. If the results of this study are published, no information will be shown that allows 
the identification of the people who participated in this study. 
 
Participant rights: 
If you decide to participate in the study, you may withdraw from the study at any time, or not 
participate in part of the study without harm. If you have any further questions, please ask the 
study staff or call Dr. Luis Menacho at 991671979. 
 
If you have questions about the ethical aspects of the study, or believe that you have been treated 
unfairly, you can contact Dr. Frine Samalvides Cuba, president of the Institutional Research Ethics 
Committee of the Universidad Peruana Cayetano Heredia at telephone 01-3190000 annex 
201355, the which will be enabled soon so, in the meantime, you can send an email to: 
duict.cieh@oficinas-upch.pe  
 
A copy of this informed consent will be provided to you. 
 
DECLARATION AND/OR CONSENT 
I voluntarily agree to participate in this study, I understand the activities I will participate in if I 
decide to enter the study, I also understand that I can decide not to participate and that I can 
withdraw from the study at any time. 
 
 
 
Name (participant): 
Date and time: 
 
Name (investigator): 
Date and time: