Efficacy of an Intervention With Text Messaging to Improve Early Retention in HIV Care for People With HIV Who Receive Treatment at VIA LIBRE
Phase: NA
Conditions: HIV
Sponsor: NGO Via Libre

August 7, 2018 
Efficacy of an intervention with text messaging to improve early retention in HIV 
care for people with HIV who receive treatment at VIA LIBRE 
 
Brief title:  
Efficacy of SMS to improve retention in HIV care for PLWH in Lima 
 
 
1. 
Investigators 
 
Robinson Cabello, Principal Investigator, rcabello@vialibre.org.pe 
Luis Menacho, Principal Investigator, luchomenacho@gmail.com 
Gianina Cisneros, Co Investigator, gcisneros@vialibre.org.pe 
María Teresa Romero, Study Nurse, mromero.vialibre@gmail.com 
 
 
2. 
INTRODUCTION  
 
The HIV epidemic in Latin America is concentrated in men who have sex with other 
men (MSM) (1). In Peru, the prevalence in them is greater than 12% versus 0.5% in 
the general population (2). Less than 50% of people living with HIV in the country know 
their status, and 56% of those diagnosed receive treatment. The Ministry of Health 
reports 35% viral suppression (3), however, this figure could be underestimated due to: 
lack of a timely period of follow-up; inability to unify data between different health 
centers and; inadequate quality control of the data (4). 
 
In 2017, it was estimated that globally 75% of people living with HIV knew their 
diagnosis, 79% were in treatment, and 81% had reached viral suppression (UNAIDS). 
In Latin America, 75% knew their status, 55% were in treatment and 41% achieved 
viral suppression. One study evaluated trends in a large cohort of Hispanics in relation 
to the initiation of treatment and achievement of viral suppression (5). Wolff and 
colleagues found that both variables have been improving over time; however, there 
are still significant inequalities, for example, with the youngest (5). 
 
In VIA LIBRE during 2016, 192 people started antiretroviral treatment (ART). Viral 
suppression varies between 70 - 90%. This depends on whether or not we include 
those who do not have a viral load lab result. This is because 23% does not have a 
follow-up viral load result. There is still an important gap to retain in care those who 
receive ART and thus to have timely measures of viral suppression. Additional 
measures must be implemented both in Peru and in other countries of the region (6). 
 
 

The World Health Organization recommends sending text messages (SMS) as a good 
practice to reinforce adherence to ART (7). Recent studies with MSM have shown 
acceptability, feasibility and preliminary efficacy to increase adherence and viral 
suppression with the use of mobile health (8). However, it is necessary to develop new 
methodologies that allow a better scalability of the approach across all the HIV 
continuum of care, and to be evaluated in other regions of the world such as Latin 
America (8). 
 
Most interventions have used structured models, that is, with specific contents and 
schedules to send and / or receive SMS (9, 10). A more versatile and individualized 
strategy has the potential to improve the continuum of care, and to understand the 
perspectives, barriers and facilitators of patients; to continuously adapt the approach, 
and thus achieve a lasting retention (11). We propose to evaluate the acceptability and 
efficacy of an intervention with semi-structured SMS, to improve retention in the timely 
monitoring of viral load (VL) of people with HIV who receive treatment in the clinic VIA 
LIBRE. 
 
In VIA LIBRE we implemented, during 2015, a research using SMS to improve early 
linkage to care among newly diagnosed patients. The participants of the intervention 
interacted for 3 months with a trained counselor who helped them to become linked. 
The subjects of the intervention were linked 16% more than the control group 
(manuscript in finalization). The exchange of SMS between counselors and participants 
was important to reveal concerns, challenges and solutions that had more impact 
shortly after diagnosis. This individualized interaction identified opportunities to provide 
support in relation to: (a) mental health symptoms; (b) coping behaviors; (c) 
interpersonal support; (d) physical symptoms; (e) knowledge of HIV; and (f) care 
coordination (11). 
 
Thus, since May 2016 we implemented this strategy on a regular basis in the 
counseling service. During the first 4 months we found that 24% more users were 
linked to care (defined as having attended the 1st appointment), compared to the 4 
months prior to implementation. This semi-structured strategy consists of sending 
some predetermined SMS messages plus an individualized interaction between users 
and previously trained counselors. It seems to be versatile to improve early linkage 
and, we suggest that it can have similar impact to improve retention in the timely 
monitoring of VL, for which we aim to implement a controlled study to assess this. 
 
Our hypothesis is that participants receiving the semi-structured SMS intervention will   
increase their retention from 70% to 90%, compared with the control group. 
 
 
 
 
 
 
 

3. 
OBJECTIVES 
 
3.1. 
Primary 
a) Evaluate the efficacy of an intervention through text messages to 
increase the retention of patients in the HIV Care Center. 
 
Measurement of the main outcome: retention in VL monitoring (rate of 
participants with a second lab result of VL available 6 months after 
initiation of ART). 
 
Measurement of the secondary outcome: retention in HIV care (rate of 
participants attended the 2nd and 3rd appointments for HIV care at the 
study clinic). 
 
 
 
4. 
METHODS 
 
4.1. 
Design 
 
Interventional, randomized controlled trial with two parallel arms. 
Participants linked to HIV care at the study clinic will be randomized to 
interact with a nurse through text messages (intervention group); or only 
receive standard care information (control group). Participants of both 
groups will have access to HIV care services. 
 
 
4.2. 
Variables 
 
Variable 
Definition 
Categories 
Source 
Age 
Date of birth 
18 or more 
Medical 
record, 
self-
report 
Civil status 
Civil status of the 
patient when starting 
the study registered 
by self report 
Single, 
married, 
widower, 
divorced, 
cohabiting 
Medical 
record, 
self-
report 
Education 
Degree of education 
of the patient when 
starting the study 
Less 
than 
high school, 
high school, 
technical, 
superior 
Medical 
record, 
self-
report 
Sexual 
identification 
Self-reported sexual 
identification 
Heterosexual  
Homosexual  
Self-report 

Variable 
Definition 
Categories 
Source 
Trans 
Bisexual 
Retention in 
viral load 
monitoring 
Result available of 
VL 6 months after 
initiation of ART 
Yes 
No 
Medical 
record, 
lab 
appointment 
book 
Retention in 
care 
Attendance of the 
third 
medical 
appointment at the 
HIV care center. 
 
Yes 
No 
Medical 
record, 
appointment 
book 
Arm 
Assigned arm 
Intervention 
Control 
Randomization 
Diagnosis 
Date of diagnosis 
Date 
Medical record 
Visit 1 
First 
medical 
appointment 
after 
diagnosis (linkage) 
 
Date 
Medical record 
Visit 2 
Second 
medical 
appointment 
after 
diagnosis (usually to 
start ART) 
Date 
Medical record 
ART start 
Date of initial of ART 
Date 
Medical record 
 
 
 
 
4.3. 
Population 
 
Study population: 
Men diagnosed with HIV at VIA LIBRE (the study clinic) and people 
referred from other centers to start treatment. 
 
Unit of analysis: men linked to HIV care at VIA LIBRE. 
 
 
Sample size: 
 
With a power of 0.80, and an alpha level of 0.05, we will need 72 
participants in each arm (i.e. 144 in total) to evaluate a retention increase 
from 70 to 90%. 
 
 
 
 
 

 
 
 
4.4. 
Eligibility criteria. 
4.4.1. Inclusion criteria 
a) Male 18 years old or older. 
b) Linked to HIV care at the study clinic. 
c) Have a cell phone. 
d) Diagnosed at the study clinic of referred from other center to start ART. 
e) Give consent to participate. 
 
4.4.2. Exclusion criteria 
a) Enrolled in other HIV study using text messages. 
b) Have started ART. 
c) Enrolled in a clinical trial. 
 
4.5. 
Overview of the intervention.  
This is a randomized controlled pilot study with a parallel 2-arm design. It 
will evaluate the effect of a text message-based strategy to improve 
retention in HIV care at the study clinic, compared to the standard of care. 
Trained counselors will deliver the text messages. After a block 
randomization, the trained counselor (a nurse) will send the first welcoming 
message to participants in the intervention arm. The nurse will send 2 
tailored text messages per week. In addition 2 to 4 days before an 
appointment, the nurse will send a message reminder. In addition, the 
nurse will have bilateral communication with participants using text 
messages according to their needs. The participants of the intervention arm 
will interact with the nurse during 3 months with a semi-structured strategy, 
that is, with template text messages (predesigned) and open messages (for 
which the nurse will be trained). Three and six months after started the 
intervention the variables of interest will be assessed (Figure 1). 
 
 
 
 
 
 
 
 
 
 
 
Assess eligibility 
ü  MSM; >17y 
ü  Cell phone 
ü  Linked to HIV care at Via Libre 
Objetive: 72 per 
arm  
Exclusion 
 
Enrollment 
 
Randomization 
Intervention 
ü  Standard of care 
ü  Counsellor + SMS 
Follow-up (3 & 6 months)* 
ü  Primary: timely viral load monitoring 
ü  Secondary: retention in care (2nd and 3rd appointments 
attended) 
Control 
ü  Standard of care 
 
ü  Other studies 
ü  Receiving ART 
* Participants will interact 3 months with counsellors; variables of interest will be assessed at 3 and 
6 months with follow-up surveys and medical records 

Figure 1. Intervention. 
 
4.6. 
Standard of care.  
After pre-test counseling, diagnosis is performed with two positive rapid 
tests. Those who test positive receive post-test counseling including 
emotional support and are link to a facility for ART initiation, ideally, within 
one week. ART, CD4 and viral load lab tests are provided for free. During 
the first year they recommend to have 2 measurements of CD4 and viral 
load. At the beginning, ART is provided for 1 month. If clients are adherent 
the next visits for pick-ups are every 3 months. Nurses are in charge of 
delivering the medication and assessing adherence. At VIA LIBRE, the 
study clinic, during the first medical appointment (linkage) after being 
diagnosed, the clinician performs a clinical assessment and requests lab 
tests. During the second (retention) appointment, most patients receive for 
the first time ART for 30 days. During the third (retention) appointment, 
patients receive for the first time ART for 90 days, and the clinician 
requests monitoring of viral load and CD4. 
 
4.7. 
Procedures. 
 
a) Semi structured interviews. 
In order to explore and understand the reasons why previously linked 
users and those who are under treatment do not have a timely 
monitoring of their viral load, we will perform up to 30 in-depth semi-
structured interviews of 1 hour each. Participants will go through verbal 
informed consent. 
 
b) Design of the content of the intervention. 
Based on the results of the in-depth interviews, and previous studies 
(14, 15), we will design 24 template messages that will be the core of 
the intervention. Following the guidelines of previous studies, such 
messages will be short and neutral (that is, without words that can 
reveal that it is an HIV study). The messages will be informative and 
motivating to improve retention in HIV care and the timely attendance to 
the laboratory for viral load monitoring. Also, providers will send 
reminder messages before the appointments. 
 
 
 
 
 
 
 
 
 

c) Training of counselors and pilot of the intervention.  
In addition to the template messages, a nurse will interact with the 
participants to provide support; information about treatment benefits, 
and importance of monitoring viral load; and to send appointment 
reminders (15, 16). Likewise, other general health topics may be 
addressed in these messages to arouse interest and create rapport 
with the participants (17). The intervention will be carried out for 12 
weeks. The interaction with all the participants will not be simultaneous 
but according to the continuous enrollment that will be carried out in the 
period of 6 to 7 months until reaching the sample size. 
 
Before beginning the intervention, a nurse will be trained in the 
following topics: HIV continuum of care; studies with text messages to 
improve the continuum of care; strategies for communication with 
mobile health; delivery of the intervention; reasons for not being 
retained in care; and logistical aspects of the intervention. Based on the 
experience of Young and collaborators, we estimated that each 
counselor could spend half an hour a week to interact with each 
participant (with the cell phone). If one nurse were in charge of 18 to 20 
participants simultaneously, he/she would spend 10 hours a week for 
the interactions. Therefore, one nurse would use 25% of his/her time for 
delivering the intervention to 18 to 20 participants. 
 
If requested by the participant, the counselor could make a voice call 
to clarify some of the issues addressed through text messages. The 
counselor can see the participants in person only at the study clinic, 
and to discuss topics related to the project. The counselor will keep a 
weekly record of the number of text messages / chats, calls made to 
each participant, and appointments (missed and attended) at the study 
clinic. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

d) Recruitment, enrollment and randomization. 
Potential participants will be contacted the day they go for their first 
medical appointment after having been diagnosed (that is, the day they 
are linked). They will be explained about the study through an informed 
consent process. After consenting, participants will be randomly 
assigned to the intervention or control with a 1:1 ratio and random block 
sizes of 2 and 4 using computer generated random numbers. Block 
sizes will not be disclosed. Allocations will be sealed in individual, 
sequentially numbered opaque envelopes. The recruiter, who will be 
masked to the group assignment, will give instructions to all participants 
on how they should interact if they start receiving SMS. We will 
emphasize that, by chance, a counselor through text messages will 
contact only half of them during 3 months. After completing the baseline 
survey, one of the principal investigators will assign the participant to a 
group by opening the corresponding envelope. The PI will report to one 
of trained providers in charge of delivering the intervention (different 
from recruiters) when a new participant of the intervention arm is 
enrolled. Because of the nature of the participation, providers and 
participants will not be masked to group assignment. At the time of 
enrollment the recruiter will send a text message to the cell phone of 
the participant who consents to participate to confirm that it is a valid 
number. On the same day of enrollment, the responsible counselor will 
send the first welcome text message. 
 
e) Baseline and follow-up surveys. 
At the time of enrollment (after providing written consent), at the end of 
the intervention and 3 months after the intervention is completed, 
participants will complete a survey with three sections: socio 
demographic, history of utilization of HIV care services at the study 
clinic and adherence to ART. The surveys will be completed through a 
survey platform (such as surveymonkey.com) by sending the link of the 
survey by email. Participants will also be able to complete surveys at 
the study clinic, using one of the computers or tablets designated for 
the project. After completing each survey, they will receive an incentive 
of 17 soles (5.3 US) for transportation. 
f) Follow-up. 
The follow-up and retention of participants of the intervention arm will 
be in charge of the nurse who will interact weekly with them. For 
participants in the control arm, the verification of the outcomes (to know 
if they attended their appointments) will be done through medical 
records, and laboratory and nursing records. In addition, the follow-up 
surveys will collect additional information about retention. 
 
 
 

4.8. 
Ethical aspects. 
 
In order to protect the confidentiality of the participants, the following 
procedures will be carried out: 
 
- 
One of the potential risks is the loss of confidentiality due to receiving 
text messages related to HIV. To avoid this, they will be explained that 
the text messages will be neutral in case they lose the cell phone or 
someone else reads the messages. For example, these words will not 
be used: HIV, AIDS, treatment, infection, VIA LIBRE, virus, 
homosexual, among others. Also, the messages will not be massive or 
sent at inappropriate times. They will be able to stop receiving 
messages when they want. 
 
- 
In addition, there is a potential risk of discomfort due to receiving 
some messages related to HIV (intervention arm, or by answering 
some questions from the surveys. To address this, counselors will be 
trained to provide emotional support and more information about 
related topics. For the surveys, most of the questions will be optional. 
 
- 
The personal information as name, telephone number, email, as well 
as the information of the surveys, will be kept confidential. It will be 
kept in a database with a password that will only be accessed by the 
research team. Likewise, the computers containing the databases will 
be protected with a password. 
 
- 
“Survey monkey” stores the data of the survey encrypted. In addition, 
the cell phone used by the counselors will be a smart mid-range or 
high-end cell phone that will need a key and fingerprint in order to open 
it and view the content. 
 
 
- 
The benefits of participating in the study are receiving additional 
support to improve their HIV care (intervention arm). In addition, the 
satisfaction of contributing to the evaluation of an innovative strategy to 
improve the health of people with HIV. Finally, participants will receive a 
modest incentive after completing each survey for transportation. 
 
- 
The publication of the results of the study will be done without names or 
any information that can identify the participants. 
 
 
 
 

5. 
ANALYSIS PLAN 
 
We will use Fisher's exact test for the univariate analysis of binary variables. T 
Student and Mann-Whitney tests will be used for the analysis of continuous 
variables. The analysis of the randomized controlled trial will be conducted using 
the intention-to-treat analysis. For the primary analysis, the adjusted relative risk 
between both arms will be calculated with the Mantel Hanzel test. The analysis will 
be carried out with the statistical program Stata v13. Audios of in-depth interviews 
will be transcribed and along with the interactions with text messages will be 
reviewed and codified. We will use theoretical framework analysis. After identifying 
concepts, we will create categories and themes. The analysis will be carried out 
with the Atlas.ti program. 
 
 
 
6. 
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