Retention Through mHealth for Adolescents and Young Adults With HIV in Care
Phase: NA
Conditions: Adolescent Behavior
Sponsor: Mbarara University of Science and Technology

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Protocol 
 
 
 
 
“Retention through mHealth for adolescents and young adults with HIV in care (REMAIN study) ” 
 
 
Version 1.0  
 
26 August 2023 
 
Funding: 
National Institutes of Health (Fogarty International Center/ National Institutes of Mental Health). Grant 
number: K43TW012640 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study team 
 
Mbarara University of Science and Technology 
Julian Adong, MBChB, MMed 
Elias Kumbakumba, MBChB, MMed 
 
Massachusetts General Hospital/Harvard Medical School 
Jessica Haberer, MD, MS 
Christina Psaros 
Lisa Bebell, MD 
 
Harvard Medical School 
Bethany Hedt-Gauthier 
 
Makerere University 
Sabrina Bakeera-Kitaka 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Background/ rationale: 
 
AYWH aged 15-24 are the fastest growing population living with HIV globally. In 2019, AYWH 
accounted for 25–30% of new infections in sub-Saharan Africa1. This large group is comprised of children 
born with HIV surviving to older ages and a high number of incident infections1–3, especially among girls 
and young women. Despite successful rollout of antiretroviral therapy (ART) and coordinated care, AYWH 
experience worse outcomes along the HIV care continuum, and AIDS-related mortality is the leading cause 
of death in AYWH4. In 2020, AYWH registered a 50% increase in mortality while mortality in other age 
groups decreased1. AYWH experience large gaps in HIV testing, delays in treatment initiation, and poor 
retention in care5. Improving these metrics for AYWH is critical to achieving the UNAIDS 95-95-95 goal of 
ending HIV by 20306. 
 
AYWH experience poor retention in care. For every 10 AYWH enrolled in HIV care only 5 – 6 will be 
engaged in care 12 months later7–9. Neurodevelopmental factors play an important role in the poor retention 
in care of AYWH10,11. The developmental transition from childhood to adulthood is a period of intense 
physical, emotional, and social change. This neurodevelopmental process is associated with increased risk 
taking including sexual exploration and experimentation, and prioritization of short-term rewards over long-
term health priorities, leading to establishment of negative lifelong health behaviour. Thus, 
neurobiological differences in AYWH drive poor retention in care and require solutions targeted to 
their developmental stage. Also, perinatally- and non-perinatally infected AYWH have differences in HIV 
knowledge, attitudes and treatment expectations12. For example, non-perinatally infected AYWH are more 
likely to be newly engaging in care and therefore may lack HIV knowledge, whereas perinatally-infected 
AYWH may come in and out of care and may be fatigued with health care engagement12. Differentiating 
the needs of perinatally and non-perinatally infected AYWH is necessary for the optimized design of 
interventions that are effective for AYWH12. 
 
AYWH who are not retained in care continue to drive HIV transmission. Poor retention in care is 
associated with suboptimal ART adherence and virologic non-suppression, a major driver of the HIV 
epidemic13. In 2020, female AYWH contributed to 49% of all new HIV infections1. Adolescents explore 
sexuality, gender, and sexual relationships, and AYWH may engage in both risky generational and cross-
generational sexual relationships, leading to new HIV infections and further fuelling the HIV epidemic. 
AYWH also experience stigma, disclosure issues, and are less likely to negotiate safe sex14. AYWH face 
social and environmental disadvantages, including poverty and gender identity questions, and are often 
engaged in health lacking safe spaces to discuss AYWH-specific issues15,16. These complexities, coupled 
with poor retention in care and virologic non-suppression, drive behavioural and vertical HIV transmission 
through AYWH pregnancy13. Thus, keeping AYWH engaged in care will decrease HIV transmission 
and achieve milestones towards ending the HIV epidemic.  
 
Traditional interventions to improve AYWH retention in care are inadequately tailored to AYWH17,18 
and to their route of infection. Current interventions targeting the AYWH population specifically include 
facility-based and community-based interventions, including differentiated HIV care, task shifting and down 
referral, patient tracking, and peer interventions17–19. Facility- and community-based interventions may not 
to be effective in improving retention in care for AYWH20, especially those living in low-resourced settings. 
These interventions are limited by structural barriers like physical space and transportation costs, 
and often not effective due to lack of time flexibility and little privacy18 – all important factors for effective 
retention of AYWH in care. Moreover, they may be affected by the ever evolving global challenges like the 
COVID-19 lockdown17 restrictions, and currently in Uganda, the Ebola Virus disease outbreak21. 
Importantly, they are largely extrapolated from adult HIV care18 with minimal regard for route of infection. In 
2016, the Ministry of Health Uganda rolled out nation-wide clinic-based adolescent friendly services to 
improve retention in care and adherence which included adolescent safe spaces, holding specific clinic 
days for AYWH and flexible clinic hours; however, in a post hoc mixed evaluation, the impact of these 
interventions on retention in care were disappointing. Only 53% of AYWH were active in care at 24 months, 
while only 56% received a viral load test and of these only 77% were suppressed at 12 months22 All these 
interventions require physical presence of AYWH and the health care team, as well as physical 
infrastructure. These ventures are costly for many health facilities where human resources are an ever-
present challenge. Notably, only 30% of health facilities evaluated were able to establish adolescent safe 
spaces23. Although community-based interventions may offer some advantages over those in facilities, they 
are still more restrictive. Thus, more flexible approaches tailored to adolescent needs should be developed.  
 

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Figure 1: Intervention conceptual framework 
mHealth interventions for AYWH could supplement and augment in-person HIV care visits and 
improve retention in care. In sub-Saharan Africa, >70% of AYWH aged 15-24 have access to mobile 
phones and about 60% have daily access to the internet24,25. Many AYWH use the internet to access social 
media sites for entertainment and health information26,27 Therefore, social media-based interventions are 
promising, and they enable additional interactive features attractive to AYWH, including memes, visual 
images, and videos, and allow flexible timing of use. The two published studies evaluating social-media 
based interventions used Facebook- and Mxit-based peer groups. They reported that AYWH found the 
interventions acceptable, increased their knowledge about HIV, and improved HIV self-efficacy25,28. 
However, these interventions used less popular (Facebook) or no longer used (Mxit) social media 
applications, and they did not offer individual-level interaction with AYWH. Given AYWH demonstrated high 
acceptability of social-media based mHealth interventions in these studies, further research is needed to 
examine the effect of social-media based interventions to improve retention in care. Studies are needed on 
how interventions can be tailored to the neurodevelopmental needs of AYWH and consider unique needs of 
perinatally and non-perinatally infected AYWH. The key knowledge gaps include: 1) the impact of 
adolescent-tailored social media-based mHealth interventions on retention in care of AYWH who are new 
to or newly re-engaging in care; and 2) optimization of the design of social-media based mHealth 
interventions to improve retention in care of AYWH for both perinatally- and non-perinatally infected AYWH 
while also catering for the neurodevelopmental needs of AYWH.  
 
Theory-driven psychosocial-based interventions for AYWH, including mHealth interventions to 
improve retention in care, are promising but need further development. Existing psychosocial 
interventions have a small-to-moderate effect on AYWH behaviour and modestly improve outcomes like 
adherence17,19,29. However, their effect on retention in care for new, and newly re-engaging, AYWH is not 
yet fully explored17,19. In a meta-analysis of 36 interventions to keep AYWH engaged in care, 60% were 
conducted in high income countries17,19 and 80% of the studies were grounded in theory; however, only one 
utilised social media for intervention delivery. Thus, there is a lack of research on social media-based 
interventions to improve AYWH retention in care, especially in low-resourced settings. We propose to begin 
addressing these gaps by leveraging Social Cognitive Theory (SCT)30,31 and Theory of Planned Behaviour 
(TPB)32. SCT accounts for the interrelation among relevant cognitive and environmental factors with 
behaviour, while the TBP integrates the attitudes, subjective norms, and perceptions of behavioural control 
over intention and behaviour. Using qualitative and mixed methods. We propose to develop and pilot test 
an adolescent-tailored social media-based mHealth intervention accounting for these domains to improve 
retention in care for AYWH. The ultimate aim of the intervention is to improve viral suppression and other 
HIV treatment outcomes, thus reducing AYWH morbidity, mortality, and onward transmission. 
Intervention development will be informed by a conceptual framework (Figure 1) derived from two theories 
relevant to health behaviour change: the SCT30,31 and the TPB32 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In this study, we propose to adapt a novel WhatsApp-based intervention called U-SMART (Uganda-
SMART). Compared to other social media instant messaging applications, WhatsApp has superior privacy, 

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Figure 2: IDEAS framework for developing digital health interventions 
accessibility, and interactivity and is used widely in SSA; up to 60% of AYWH have access to a smartphone 
with access continually growing33. We also propose to examine the preliminary impact of the intervention 
on six-month clinic retention with the aims below: 
 
SPECIFIC AIMS 
 
Aim 1: Define the cognitive, environmental, and behavioural challenges and their impact on behavioural 
intention for AYWH who are new or newly re-engaging in HIV care. We will use in-depth interview (IDIs) 
with 30 AYWH to achieve this aim.   
 
Aim 2: Iteratively develop a social media-based adolescent-tailored mHealth intervention to improve 
retention in care for AYWH who are new or newly re-engaging in care. We will use data from Aim 1 above 
to develop the intervention. We will conduct two separate series of IDIs to gather feedback from AYWH (n = 
15) and ISS clinic counselors (n = 10)  to achieve this aim. 
 
Aim 3: Test the acceptability, feasibility, and preliminary impact of the developed adolescent-tailored 
mHealth intervention for retention in care of AYWH who are new to or newly re-engaging in care. Here we 
will randomize 50 AYWH to either receive the intervention immediately or to the deferred intervention arm. 
 
 
Study Approach  
Study overview: We will engage AYWH aged 15-24 who are new to or newly re-engaging in care at the 
Mbarara University of Science and Technology (MUST)/Mbarara Regional Referral Hospital’s Immune 
Suppression Syndrome (ISS) clinic. In Aim 1, using IDIs, We will identify their HIV knowledge gaps 
(cognitive factors in Figure 1), environmental and social challenges (environmental factors in Figure 1) and 
behavioural factors. We will then apply Aim 1 findings to develop a social media based mHealth 
adolescent-tailored intervention using the WhatsApp platform to improve retention in care (Aim 2). The 
intervention development approach will follow the Integrate DEsign Assess and Share (IDEAS) framework 
for developing digital health behaviour change interventions (Figure 2). Based on this framework, we will 
initiate intervention design using theory and participant insight (Aim 1), which allows for rapid and iterative 
designs with feedback from AYWH (Aim 2). We will conclude with rigorous assessment of the intervention 
through a pilot randomized clinical trial (Aim 3). We will assess the primary outcomes of intervention 
acceptability and feasibility and an exploratory outcome of preliminary impact on 6-month retention in care. 
 
Study population and research setting: The study setting for Aims 1, 2 and 3 will be the MUST/MRRH 
ISS clinic. The ISS clinic offers comprehensive HIV care services, including an adolescent-specific clinic. 
The clinical care is managed by two separate clinical teams offering specialized paediatric and adult HIV 
care according to the Uganda Ministry of Health guidelines34, adapted from World Health Organization 
(WHO) guidelines. To date, the ISS clinic has cared for over 3,000 children and adolescents with HIV, with 
1,500 active in care. The ISS clinic is an outpatient HIV testing facility and the initial interface for all patients 
who are new to care. The clinic enrolls about 18 new patients per month, half of them aged 15-24. 
 
 
 
 
 
 
Eligibility/enrolment:  
AYWH 

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• 
Inclusion criteria for all study aims 
o AYWH (age 15-24 years) who are new to care or re-engaging in care; we will enroll 
emancipated minors per Ugandan laws (e.g.; children who head households) or 15-17 year-olds 
with parental consent. 
o Ability to understand (verbal and /or written) English and/or Runyankole. 
o Additionally in study aim 3, access to a smart phone 
• 
Exclusion criteria- inability to provide informed consent (e.g., intoxication, mental disability). 
 
Adherence counselors (Aim 2) 
• 
Inclusion criteria 
o Have provided ART adherence counseling at the ISS clinic for a period of ≥ 1 one year 
o Able to understand  (verbal and/or written) English and/or Runyankole 
• 
Exclusion criteria 
o Inability to provide informed consent i.e due to critical illness or current mind-altering 
substance use 
 
For all study aims, we will enrol AYWH aged 15-24 who are either new to HIV care or newly re-engaging in 
care (defined as previously lost to follow-up [LTFU] based on missing appointments for 6 months or more) 
and are fluent in English or the local language, Runyankole. As part of routine care, AYWH who are LTFU 
are tracked down by clinic-based trackers in order to re-engage them in care. A study screener will 
generate a list of all eligible participants from the HIV testing register and ISS clinic database, this will be 
done bi-weekly, any participant who meets study criteria will be approached for screening and recruitment. 
AYWH who would have been newly enrolled or re-engaging into care in the preceding two weeks to the 
generation of the list will be considered for screening and enrolment. All participants aged ≥18 years and 
those who are <18 years but are considered emancipated minors as per Ugandan lwas will provide 
informed consent; AYWH who are minors will provide assent and parental permission and consent will be 
obtained. Emancipated minors by Ugandan laws (e.g., children who head families) will also provide 
informed consent.  
The consenting/assenting process will take place in a private room and will comprehensively include the 
following information: (a) introduction to the consent/assent process, explaining the consent/assent form 
and compliance with institution policy and country laws; (b) emphasis that participation is voluntary; (c) 
nature and purpose of the study; (d) explanation of study procedures; (e) potential discomforts and risks, as 
well as plans to protect participants from these risks; (f) potential benefits; (g) alternatives to participation in 
the study; (h) confidentiality, including how data will be used and how it will be kept private; (i) 
refusal/withdrawal, including right to withdraw consent/assent and leave the study at any time; and (j) rights 
and complaints. After each major section, research staff obtaining consent/assent will pause and check for 
understanding- for example, by asking the potential participant to repeat, in their own words, what "the right 
to refuse" means. 
 
Aim 1: Define the cognitive, environmental, and behavioural challenges and their impact on behavioural 
intention for AYWH who are new or newly re-engaging in HIV care.  In Aim 1, We will complete the 
intervention conceptual framework (steps 1-3 of the IDEAS framework, Figure 2). 
 
Design: We will purposively enrol 30 AYWH to conduct IDIs. Purposive sampling will ensure that the 
sample reflects a diversity of age (15-18 vs 19-24), and HIV care status (new to care vs newly re-engaging 
in care).  
Interview guide: We will design the interview guide to elicit discussions that will explore and define 
participants’ HIV knowledge gaps, social, environmental, and behavioural barriers to HIV care. Other 
concepts from the SCT and TPB will be included in the interview guide will include attitudes, subjective 
norms, and perceived behavioural control. We will iteratively refine the interview guide through thorough 
literature review utilizing the SCT and TPB theoretical frameworks. After translation to Runyankole and 
back-translation to English, the interview guide will be piloted with five AYWH participants and revised prior 
to formal study enrollment. Any new domains will prompt regulatory review. 
IDIs will be conducted face-to-face and one-on-one by trained research assistants and will be guided by 
open-ended questions in the interview guide, we will begin each interview with basic demographic data 
collection. We will digitally record participant interviews in their preferred language (English or Runyankole). 
Interviews will be conducted in a private space and last up to 90 minutes. All audio recordings will be 
transcribed and translated into English, the study PI will verify all transcripts and any discrepancies will be 

7	  
	  
addressed within 24 hours of the interview. ,Qualitative research methods will be guided by Consolidated 
criteria for REporting Qualitative research (COREQ) guidelines35.  
 
Analysis: We will analyze IDIs using content analysis36, in an iterative, multi-step process. Here we will 
review transcripts for key concepts to develop a codebook and use the codebook to code the data using 
software (Dedoose). We will use these codes to develop thematic categories that are both deductive 
(guided by the SCT and TPB) and inductive (guided by new concepts discovered from data). We will 
double-code at least 25% of the interviews to ensure reliability and provide ongoing feedback as we 
iteratively refine and review major and minor themes and resolve data interpretation discrepancies to inform 
the mHealth adolescent-tailored intervention development. 
 
Sample size consideration: Sample size for IDIs is based on thematic saturation. We will enroll up to 30 
AYWH for IDIs, as  prior studies have demonstrated that this number is sufficient to reach saturation37,38. 
 
 
Aim 2: Iteratively develop a social media-based adolescent-tailored mHealth intervention to improve 
retention in care for AYWH who are new or newly re-engaging in care. In Aim 2, we will design the 
intervention iteratively with user feedback (steps 4-7 of the IDEAS framework, Figure 2). 
 
Intervention development: We will develop and iteratively refine an mHealth-based adolescent-tailored 
intervention as per the IDEAS model in the design phase (Figure 1, Figure 2)39. The intervention will 
emphasize dealing with antecedent factors that affect retention in care and we will utilize themes from Aim 
1 interviews relevant to a potential intervention to improve retention in care to design and refine the 
intervention. We will develop the intervention using constructs from the SCT and TPB. Constructs utilised 
from the SCT will include cognitive factors (e.g., HIV & ART knowledge, treatment expectations, and 
understanding of mental health) and environmental factors (e.g., social support, Figure 1). Constructs 
utilised from the TPB include behavioural factors (e.g., disclosure, adherence). changing attitudes towards 
retention in care, subjective norms and behaviour control (Figure 1). These are all important antecedent 
and ongoing factors for retention in care. Structural barriers (transportation costs, physical clinic space 
availability) will be overcome by the mHealth nature of the intervention. We anticipate the intervention will 
encompass 12 modules, with each module delivered bi-weekly over 6 months. The intervention aims to 
modify participants’ antecedent factors and barriers to retention in care by providing skills and knowledge 
that can modify these antecedent factors. After developing an initial intervention manual, we will conduct 
two separate series of IDIs to gather feedback from AYWH (n = 15) and ISS clinic counselors (n = 10) who 
meet eligibility criteria (as described above). We will use these IDIs to refine the intervention iteratively, 
consult the study mentorship team and hold discussions before reaching a consensus; after which we will 
build a minimum intervention package for use in Aim 3.  
 
Analysis: The IDIs will be analysed using content analysis as in Aim 1 above. 
 
Aim 3: Test the acceptability, feasibility, and preliminary impact of the developed adolescent-tailored 
mHealth intervention for retention in care of AYWH who are new to or newly re-engaging in care. In Aim 3, I 
will “Assess rigorously and Share” (steps 8-10 of the IDEAS framework, Figure 2). 
 
                                        
 
 
 Table 1. Confidence interval estimates for a sample size of n = 50  
Power considerations: For the Aim 3 
primary outcomes of intervention 1) 
acceptability, 2) feasibility, and we 
hypothesize that 35/50 participants 
(70%) will rate the intervention positively 
on the Acceptability of intervention 
measure (AIM) and Feasibility of 
intervention measure (FIM) outcome domains. With the sample size of 50, our 95% confidence interval 
around the estimate of 70% positive response will range from 0.55 – 0.82. The confidence interval range 
will remain acceptable even if the intervention is rated lower (60% positive rating) or higher (80% or 90% 
positive rating, Table 1). This level of precision around for determining the primary outcomes is sufficient to 
determine the success of the pilot trial and rationale to progress to a larger trial. 
 
Rated intervention 
positively 
90% CI 
95% CI 
0.6 
0.47 – 0.72 
0.45 – 0.74 
0.7 
0.58 – 0.81 
0.55 – 0.82 
0.8 
0.68 – 0.89 
0.66 – 0.90 
0.9 
0.80 – 0.96 
0.78 – 0.97 

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Randomization and intervention implementation: We will allocate 25 AYWH per arm (total N = 50), 
either to receive the immediate intervention (at first HIV care visit) or to a wait list control group (to receive 
the intervention six months later). Participants will be randomized in a 1:1 ratio using permuted block 
randomization, using pre-filled sealed envelopes, randomization will be tracked in REDCap and reviewed 
after every 10 participants to ensure fidelity. Procedures in the intervention arm will be determined in Aim 2, 
but we anticipate up to 12 modules to cover all relevant theory-driven components; these modules will be 
delivered via WhatsApp every 2 weeks over 6 months (Table 2). The module content will be adjustable for 
level of adolescent developmental stage, prior HIV care exposure (new to care vs re-engaging in care) and 
by route of infection (perinatal vs non-perinatal infected).  
Table 2: Aim 3 intervention procedures and relevant conceptual theory. 
Visit / time point 
Conceptual theory 
constructs 
Session activity 
Enrolment 
 
Overview and phone set up, questionnaire administration 
Sessions 1 – 12  
Every 2 week for 
the immediate 
intervention group 
and wait list control 
groups (to start 6 
months later) 
Cognitive factors 
01. Understanding HIV 
02. ART regimens and common side effects 
03. Treatment expectations 
04. Dealing with stress and anxiety 
Environmental factors 
05. Stigma and rights 
06. Social support 
07. Exploring your feelings 
Behavioural factors 
08. Treatment adherence 
09. Self-efficacy and ART adherence 
10. Health and nutrition 
11. Positive prevention 
12. Reproductive health  
At 6 months	  
	  
Outcome assessment: IDIs and questionnaires for acceptability, 
feasibility, and usability. 
HIV viral load results extracted from clinical chart, questionnaire.	  
At 12 months 
 
Repeat outcome assessment (immediate intervention arm only).	  
 
Study procedures: All prospective participants will be screened for eligibility  and enrolment as described 
in the eligibility/enrolment sections above. If found eligible, they will undergo informed consent/assent to 
join the study. Participants will then be allocated to either receive the intervention immediately (at the time 
of enrolment) or the waitlist control group (six months after enrolment).  
Participants in the immediate intervention group will then start to receive the intervention while those in the 
waitlist control group will receive the usual standard of care at the ISS clinic which includes baseline 
counseling and initial one-monthly review and subsequent three-monthly reviews. 
Research assistant-administered questionnaires: Participant socio-demographics, clinical information such 
as mode of HIV acquisition, staging, ART regimen, socioeconomic status, mental health, social support, 
and self-efficacy will be collected as shown in the table 3 below.  
Table 3. Summary of data collection by study aim. 
Data collection 
Source 
Aim 1 
Aim 2 
Aim 3 
Demographics 
Structured questionnaire 
X 
 
X 
Health care information 
 ART regimen, mode of HIV 
acquisition, HIV staging,  
X 
 
X 
 
X 
 
X 
Alcohol use 
Alcohol Use Disorders Identification 
Test-Consumption (AUDIT-10) 40 
X 
 
 
Depression 
Centers for Epidemiological Studies-
Depression (CESD)^41,42 
X 
 
 
Anxiety/psychosocial distress 
25-Item Psychological Distress Scale43  
X 
 
 
Perceived social support 
(family and friends) 
A standardized social support scale44 
 
 
 
Mobile phone utilization  
Structured questionnaire 
X 
 
 
Anticipated acceptability for 
mHealth service delivery 
Acceptability of intervention measure, 
Feasibility of intervention measure, 
systems usability scale, IDIs interview 
guide 
 
X 
 
X 
 
X 
 

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At the end of follow-up we will conduct IDIs with 10 AYWH, five from each arm to assess feedback about 
the intervention. IDI interview guide will include domains like intervention appeal, likes/dislikes, 
barriers/facilitators to participation and concerns. 
 
Study counselor training: Two qualified counselors based at the ISS clinic will receive training on the 
intervention protocol and will be dedicated to delivery of the intervention, one counselor per trial arm to 
avoid trial arm contamination. We will have a back up counselor in case any one of them is absent or off. 
We will create a training manual for the intervention content, including mechanisms to adjust for 
neurodevelopmental stage and route of infection. It will also include guidance on maintenance of participant 
privacy throughout the follow-up period and procedures for any necessary mental health referrals. We will 
also create a protocol adherence and fidelity checklist45,46 to ensure all sessions are delivered as per 
protocol.  
 
Primary outcomes of acceptability, feasibility, and usability of the adolescent-centered intervention: 
 
Definitions and quantitative analysis:  
1) Acceptability: The intervention will be considered acceptable if ≥70% (35/50) of intervention participants 
rate all 4 items on the Acceptability of Intervention Measure (a 5-point Likert scale) as “agree” or higher. 
 2) Feasibility will be defined by the Feasibility of Intervention Measure47,48, and achieved if ≥70% (35/50) 
rated all 4 items on the Feasibility of Intervention Measure (a 5-point Likert scale) as “agree” or higher.  
3) Usability will be defined by the Systems Usability Scale, and achieved if ≥70% (35/50) rated all 10 items 
on the Systems Usability Scale49 (a 5-point Likert scale) as “agree” or higher. At the end of follow-up, we 
will conduct IDIs with 10 AYWH (five from each arm) to assess feedback about the intervention.  
Hypothesis: >70% of AYWH will find the intervention acceptable and >70% will rate the intervention as 
good or higher on the systems usability scale. 
 
Qualitative analysis: We will assess acceptability and feasibility through the content analysis approach 
outlined in Aim 1 to analyze the IDIs in Aim 3.  
 
Secondary outcomes: preliminary impact on 6 and 12-month retention in care: We will compare the 
proportion of participants who are still actively engaged in care at the end of 6 months in the immediate 
intervention and wait list control arm. Being active in care will be defined as not missing more than one 
consecutive scheduled visit. The main exposure will be the group to which participants were randomized 
(immediate intervention vs wait list control group). All analyses will be adjusted for gender and age and 
route of infection, socioeconomic status, mental health and whether they are new or re-engaging in care, 
which may affect retention in care. We will also compare 6 and 12-month retention in the immediate 
intervention group only for sustainability of effect. Although the sample size will be small, we will perform 
regression analyses to explore mechanisms for retention in care through change in key variables (self-
efficacy, mental health and route of infection).  
Hypothesis: 6-month retention in care will be 20% higher in the intervention group compared to the wait list 
control arm.  
 
Participant retention and withdrawal 
The study is designed to improve retention in care (and study follow-up); however, to ensure uniform 
retention in follow-up, we will employ the clinic standard of care methods for retention, including a locator 
map for the participants’ primary residence which will be collected at enrolment, secondary phone numbers 
with pre-written participant-approved messages that should be used if we need to contact the participant 
through a secondary contact. This information will be stored separately from other participant information 
and will be keep securely in a locked cabinet. Participants will be able to withdraw from the study at any 
time and this will not in any way affect their care and treatment at the ISS clinic.  
Potential problems and alternative strategies  
 
Risk of contamination between study arms: To prevent this, the study will employ separate counsellors per 
trial arm and these counsellors will instructed to only exchange WhatsApp messages with participants 
when they are receiving the intervention. Bias related to counsellor skill will be mitigated through structured 
training and the use of a manual prior to recruitment, we will assess intervention delivery for fidelity every 
three months..  
 
Participant recruitment: We will recruit participants from the ISS clinic; however, if I experience challenges 
with adequate enrollment, then I will expand to the Mbarara Municipal clinic, which is less than 1 km away 
and services a similar population of AYWH. 

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Source of materials, recruitment of subjects and informed consent 
We will obtain Institutional Review Committee approval for this study through the Mbarara University of 
Science and Technology and the Mass General Brigham Institutional Review Board, as well as the Uganda 
National Council of Science and Technology. Approval will cover recruitment, written and informed consent, 
enrollment, data collection, retention, study procedures, protection from risk, data safety, monitoring, and 
analysis. 
Potential risks and protection against risk 
Study participants will face the following risks from the study procedures: 
 
1. Risk: Risk of inadvertent exposure of protected health and personal information, including HIV 
status address and location information.  
This risk also includes a third party gaining access to a participant’s phone and gains access to their 
WhatsApp communications. 
 
Protection: Inadvertent exposure of confidential information, including HIV status and medical and 
social history will be minimized by conducting interviews in private spaces,. Data will not be linked to 
participant name or date of birth except through a separately stored participant ID number. Data will 
only be accessed by the research assistants, and PI. The database containing abstracted chart 
data, interviews, and questionnaire results will be locked behind the MGH firewall and stored in a 
secure database. Tablets and computers containing patients’ information will be password locked 
and kept in a lockable cabinet accessible only to the research assistants and study PI. 
 
2. Risk: Emotional discomfort when being asked sensitive questions.  
AYWH will be interviewed using instruments to assess for symptoms of depression, anxiety, these 
are sensitive questions and may cause mild discomfort. Participants will be told they can refuse to 
respond to any questions that they do not feel comfortable responding to with no negative 
consequences. 
Protection: To ensure this discomfort is further minimized, the interviews will be conducted in private 
space by trained study research assistants. Participants will be able to skip any questions per their 
preference. 
 
Risk: As part of the interview, some of the AYWH may be screened for possible depression, anxiety, 
and having experienced SRH and abuse. The recommended instrument screening cutoff values will 
be used.  
Protection/action: AYWH will be referred to the MRRH’s mental health unit for further evaluation and 
treatment. The details of the clinical care will not be prescribed or controlled by study staff.   
 
Potential benefits and relation to risks 
In the formative data collection, participants may benefit from sharing their experiences and their desired 
features of a social media counseling intervention. Participants in the pilot may benefit from additional 
support offered by the counselor and improved knowledge of HIV/AIDS.  There may be indirect benefit in 
terms of improved care for AYWH and their peers as a result of dissemination of our research findings both 
within MUST and through scholarly publication of findings. 
 
We feel the risks associated with the study are small. The benefits are consistent with cultural expectations 
and they follow the established standard with institutional review board approval in our other studies. We 
therefore believe the balance of benefit and risk is appropriate. 
 
Importance of the knowledge to be gained 
Innovative and acceptable interventions to improve retention of care for AYWH are still urgently needed. 
The knowledge generated will be a critical initial step in this direction and will help generate preliminary 
data to which interventions to improve retention in care of AYWH can be based, with the overarching goal 
of improving outcomes in this population.  
Data and safety monitoring plan 
We will work to ensure that high quality data is collected and the safety of study participants is upheld. Dr. 
Adong (study PI) will be responsible for oversight of the day-to-day activities at the ISS clinic of MRRH. Dr. 
Adong will conduct staff trainings, study monitoring, and result dissemination. Reports on study progress 

11	  
	  
will be generated at least monthly and shared among the investigators for discussion.  The study PI will 
report any serious adverse events to the IRB within 7 days of the study being notified. 
Study records 
We will maintain, and store in a secure manner, complete, accurate and current study records throughout 
the study. Data will be entered as electronic records in REDCap installed on password locked study tablets, 
this will be done using encrypted devices protected by institutional firewalls, and will not contain any 
personal identifiers. Links between participant identifiers and study identification numbers will only be 
maintained in a separate, locked document. The investigator will retain all study records for at least five 
years after completion of the study. Study records include administrative documentation and regulatory 
documentation, as well as documentation related to each participant screened and/ or enrolled in the study, 
including consent forms, notations of all contacts with the participant, logs linking participant name to study 
identification number and other identifying information in study files, and all other source documents. After 
five years, these documents will be destroyed. 
Participants’ study information will not be released without their written permission, except as necessary for 
oversight by: 
• 
Study investigators 
• 
Study funders	  
Dissemination of results 
Study results will be made available to the ISS clinic staff at the end of the study during one of their weekly 
meetings and AYWH will be given feedback of important study findings such as acceptability of the 
intevervention, effect of the intervention on retention in care and other treatment outcomes. This will be 
done during the AYWH  scheduled bi-annual psychosocial meetings. The main study findings will be 
shared at academic conferences and published in peer-reviewed journals for international dissemination. 
 
Investigator roles 
Dr. Adong will be the overall PI for the study; she will be responsible for development of the study protocol, 
training and data collection materials, domestic regulatory approval, data management systems and quality 
control, data analysis, manuscript preparation, and result dissemination. 
 
Dr. Kumbakumba will contribute to study protocol development and mentor Dr. Adong throughout the 
period of study implementation and result dissemination.  
 
Dr. Haberer will be responsible for supporting protocol development, design of data collection tool, 
submission of international regulatory approval, quality control, data analysis and manuscript preparation. 
She will also provide overall mentorship for Dr. Adong throughout the period of the study. 
 
Dr. Bebell will be responsible for supporting protocol development, design of data collection tool, quality 
control, data analysis and manuscript preparation. Dr. Bebell will also provide mentorship to Dr. Adong 
throughout the study period.  
 
Drs. Psaros, Hedt-Gauthier and Bakeera-Kitaka will provide Dr. Adong with mentorship in mixed methods, 
advanced statistical methods and adolescent psychology respectively. 
 
 
 
 
 
 
 
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