SEARCH: Short Message Service (SMS) Electronic Adolescent Reminders for Completion of HPV Vaccination - Uganda: Pilot
Phase: NA
Conditions: Human Papillomavirus Vaccination
Sponsor: Columbia University

SEARCH: Short Message Service 
(SMS) Electronic Adolescent 
Reminders for Completion of HPV 
Vaccination - Uganda: Pilot
ClinicalTrials.gov ID: NCT05151367
Document date:  August 9, 2021

COLLEGE OF HEALTH SCIENCES 
DEPARTMENT OF PAEDIATRICS AND CHILD HEALTH 
SEARCH: SMS Electronic Adolescent Reminders for Completion of 
HPV vaccination in Uganda 
PRINCIPAL INVESTIGATOR: 
DR. SABRINA BAKEERA-KITAKA (MBChB, MMed Paed, PhD) 
CO-INVESTIGATORS: 
1. DR. MELISSA STOCKWELL (MD MPH)
2. DR. BETSY PFEFFER (MD)
3. DR. JOSEPH RUJUMBA (SWSA, MA, PhD)
4. DR. SARAH ZALWANGO (MBChB, MPH)
5. DR. NICOLETTE NABUKEERA-BARUNGI (MBChB, MMed, PhD)
6. DR. JULIET BABIRYE (MD, MPH, PhD)
7. DR. EZEKIEL MUPERE (MBChB, MMed, MSc, PhD)
8. DR. ASHLEY STEPHENS (MD)
2021 

3.4.2 Objective 2b Study Population……… 
17 
OPERATIONAL DEFINITION……… 
LIST OF ABBREVIATIONS……… 
ABSTRACT……… 
Background………  
Objectives……… 
Methods………  
Utility……… 
Anticipated Study Outcomes……… 
CHAPTER ONE……… 
1.0 INTRODUCTION……… 
1 
1.1 Background……… 
1 
1.2 Problem Statement……… 
2 
1.3 Justification……… 
2 
1.4 Research Question……… 
2 
1.5 General Objective……… 
3 
1.5.1 Specific Objectives……… 
3 
1.6  Conceptual Framework……… 
3 
CHAPTER TWO……… 
2.0 LITERATURE REVIEW……… 
4 
CHAPTER THREE 
3.0 METHODOLOGY……… 
10 
Study Schema……… 
10 
Pilot Consort Diagram……… 
11 
3.1 Study design……… 
12 
3.2 Study Site……… 
12 
3.3 Objective 1 
13 
3.3.1 Study Population……… 
13 
3.3.2 Selection Criteria……… 
13 
3.3.3 Study Procedure……… 
14 
3.3.4 Data Management and Analysis……… 
16 
3.4 Objective 2 
16 
3.4.1 Objective 2a Study Procedure 
17 

Scale……..  
3.4.3 Objective 2b Selection Criteria……… 
18 
3.4.4 Objective 2b Study Procedure……… 
18 
3.4.5 Data Management and Analysis……… 
19 
3.5 Objective 3 
3.5.1 Study Population……… 
19 
3.5.2 Selection Criteria……… 
19 
3.5.3 Study procedure……… 
19 
3.5.4 Data management and analysis……… 
23 
3.6 Training of Research Assistants……… 
25 
3.7 Ethical Consideration……… 
25 
3.8 Dissemination of Results……… 
26 
REFERENCES……… 
29 
Appendices……… 
Study Instruments 
   Objective 1 
Appendix 1: English Caregiver Interview……… 
33 
Appendix 2: Luganda Caregiver Interview……… 
37 
Appendix 3: English Adolescent Interview……… 
41 
Appendix 4: Luganda Adolescent Interview……… 
44 
Appendix 5: English Staff/Clinic Interview……… 
47 
Appendix 6: Luganda Staff/Clinic Interview……… 
49 
Appendix 7: Governmental Interview……… 
52 
   Objective 2 
Appendix 8: Message Pre-Test Questions- English……… 
54 
Appendix 9: Message Pre-Test Questions- Luganda……… 58 
   Objective 3  
Appendix 10: English Demographic/HPV Knowledge 
     Survey…….. 
62 
Appendix 11: Luganda Demographic/HPV Knowledge 
     Survey…….. 
67 
Appendix 12: English Health IT Usability Evaluation 
Scale…….. 
72 
Appendix 13: Luganda Health IT Usability Evaluation 
73 

Appendix 14: Acceptability of Intervention Measure (AIM) 
and Intervention Appropriateness Measure (IAM)…….. 74 
Appendix 15: Luganda Acceptability of Intervention Measure  
    (AIM) and Intervention Appropriateness Measure (IAM) 75 
Appendix 16: English Post-Intervention Family  
Interview…….. 
76 
Appendix 17: Luganda Post-Intervention Family 
Interview…….. 
77 
Appendix 18: English Post-Intervention Staff/Clinic 
Interview…….. 
78 
Appendix 19: Luganda Post-Intervention Staff/Clinic 
Interview…….. 
79 
Appendix 20: Post-Intervention Government Interview…….80 
Consents 
    Objective 1 
Appendix 21: English Caregiver Information Sheet and 
Informed Consent Form……… 
81 
Appendix 22: Luganda Caregiver Information Sheet and 
Informed Consent Form……… 
84 
Appendix 23: English Adolescent Information Sheet and 
Informed Assent Form……… 
89 
Appendix 24: Luganda Adolescent Information Sheet and 
Informed Assent Form……… 
91 
Appendix 25: English Clinic Staff Information Sheet and 
Informed Consent Form………  
94 
Appendix 26: Luganda Clinic Staff Information Sheet and 
Informed Consent Form………  
97 
Appendix 27: Government Information Sheet and 
Informed Consent Form……… 
101 
Objective 2 
Appendix 28:  English Caregiver Pre-Test Information  
Sheet and Consent Form……… 
104 
Appendix 29: Luganda Caregiver Pre-Test Information 
Sheet and Consent Form ……… 
107 

Biosketch ………  
Appendix 30: English Adolescent Pre-Test Information  
Sheet and Assent Form……… 
112 
Appendix 31: Luganda Adolescent Pre-Test  Information 
Sheet and Assent Form……... 
114 
Objective 3 
Appendix 32:  English Caregiver Intervention Information  
Sheet and Consent Form……… 
117 
Appendix 33: Luganda Caregiver Intervention Information 
Sheet and Consent Form ……… 
121 
Appendix 34: English Staff Post-Intervention Information  
Sheet and Consent Form……… 
125 
Appendix 35: Luganda Staff Post-Intervention Information 
Sheet and Consent Form……... 
128 
Appendix 36: Government Post-Intervention Information  
Sheet and Consent Form……... 
131 
Letters of Support 
Appendix 37: KCCA Directorate of Public Health Support  
Letter……… 
Appendix 38: KCCA Directorate of Education and Social  
Services Support Letter……… 
Appendix 39: Ministry of Health Support Letter……… 
Other Study Documents 
Appendix 40: COVID-19 Risk Management Plan……… 
Appendix 41: Proposed Budget……… 
Appendix 42: KCCA Affiliated Schools……… 
Curriculum Vitaes  
Appendix 43: Dr. Sabrina Bakeera-Kitaka  
Biosketch ……… 
Appendix 44: Dr. Melissa Stockwell Biosketch……… 
Appendix 45: Dr. Betsy Pfeffer Biosketch………  
Appendix 46: Dr. Joseph Rujumba Biosketch………  
Appendix 47: Dr. Sarah Zalwango Biosketch……… 
Appendix 48: Dr. Nicolette Nabukeera-Barungi  

Appendix 49: Dr. Juliet Babirye Biosketch……… 
Appendix 50: Dr. Ezekiel Mupere Biosketch………  
Appendix 51: Dr. Ashley Stephens Biosketch……… 
OPERATIONAL DEFINITIONS 
Adolescence: The period of physical and psychological development from the onset of puberty 
to adulthood. 
Adolescent: A person of age 10 – 19 years. 
Vaccine: is a suspension of live (attenuated/weakened) or inactivated microorganisms (e.g. 
bacteria, viruses) or fractions of microorganism administered to induce immunity and prevent an 
infectious disease or its complications. 
Vaccine completion: defined as having received two doses of the HPV vaccine series with an 
interval of 6 months between the first and second doses. 
LIST OF ABBREVIATIONS 
HPV- Human papillomavirus 
KCCA - Kampala Capital City Authority 
UNEPI – Uganda National Expanded Programme on Immunization 
USA – United States of America 

ABSTRACT 
Background- Cervical cancer is the leading female cancer in Uganda. HPV is the principal cause 
of cervical cancer, making vaccination the single most important primary preventive measure. 
However, in Kampala, Uganda only 29% of girls receive both needed doses. Reasons for under-
vaccination include school absenteeism on special vaccination days, failing to remember to come 
to a health facility for a needed dose, and lack of knowledge regarding HPV and the vaccines. 
While research regarding the use of text message has not yet been demonstrated in a 
preteen/adolescent population in sub-Saharan African or other low- and middle-income countries 
(LMICs), phone reminders may improve adherence to vaccination completion rates. According to 
the World Bank, 89.9% of urban households in Uganda have a cell phone. While text messages 
can be used in populations with low literacy, families can opt to receive automated phone call 
reminders instead.  
Objectives- This protocol is for text and voice phone message intervention development for a 
subsequent pilot randomized control trial to improve adherence to HPV vaccination schedules in 
Kampala City. The specific objectives are as follows: 
1)
To identify HPV vaccine text message reminder content (and parallel automated voice
phone reminders) desired by the caregivers and their adolescent girls in Kampala.
2)
To develop and pre-test HPV vaccine reminders with caregivers and their adolescent girls
in Kampala.
3) To pilot assess the impact and feasibility of vaccine reminders on HPV vaccination
Methods- This study will utilize a qualitative approach as part of an exploratory sequential design 
with the primary intent of the exploratory design is to develop a digital tool which will then be 
tested. We will conduct formative research using key informant interviews with families of 
preteen/adolescent girls (throughout will be called adolescent) (n=30 dyads/triads), clinicians and 
immunization nurses of involved study sites (n=10), administrative staff and school leadership of 
involved study sites (n=12), and leadership within the KCCA and Ministry of Health (n=4) to 
assess attitudes towards HPV vaccination and text message reminders. Using the results from the 
interviews we will create prototypes of messages that will be shared with families (n=30 dyads) to 
identify issues with clarity, tone, and persuasiveness. Next, we will conduct a pilot trial to 

randomize caregivers of adolescents at one KCCA site and the adolescent clinic, stratified by site, 
language and HPV vaccine dose needed (initiation vs. completion). Feasibility milestones will 
include reach, effect size determination and implementation measures. If the pilot is succesful, we 
will conduct a future full-scale RCT assessing the impact of the HPV vaccine text message 
reminders. The main outcome will be timeliness of vaccination. We will also collect 
process/feasibility measures. 
Utility of the Study - The messages will be used for a pilot randomized control trial to examine 
their impact on HPV vaccination initiation and completion. 
Anticipated Study Outcomes- This study will allow us to understand the types of educational 
information parents and providers believe is needed in HPV vaccination reminders in an LMIC. 
We will be able to use this information in a future large-scale intervention that will utilize text 
message reminders to prompt caregivers to return their adolescents for their next HPV dose. 

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Page 2 of 142 
cervical abnormalities.13  HPV also plays an important role in anal, vulvar, penile and 
oropharyngeal cancer.1 
1.2 Problem statement: 
An important public health goal is enhancing HPV disease prevention through HPV vaccination. 
Despite high efficacy and an excellent safety profile HPV vaccine completion remains low 
compared to other routinely recommended vaccines worldwide. Uganda rolled out the HPV 
vaccination into the national extended programme on immunization (UNEPI) in November 2015. 
However, of the adolescents who receive the first dose of HPV vaccine many do not receive the 
second dose they need to complete the series for adequate protection. Furthermore, of those who 
do receive the second dose, many do not receive it in a timely fashion within the recommended 12 
months, resulting in more days at risk. In two previous national surveys, 72% and 83% of girls 
assessed initiated vaccination, but only 39% and 27% of them, respectively, completed the series. 
1.3 Justification: 
Text messages could be used to address many of the problems identified with poor HPV vaccine 
uptake. The study assessing HPV demonstration projects in LMICs found main vaccination 
barriers to include: 1) school absences on vaccination days and 2) lack of knowledge or awareness 
about cervical cancer, HPV vaccine and HPV vaccination programs. All these, and more, are 
targetable with HPV vaccine text message reminders. 
Although there is evidence from developed countries that text messaging is an effective 
intervention to promote vaccine completion rates, there is a knowledge gap about its use in 
resource-limited settings. Since the rates of mobile phone possession is high in this population, it 
is important to test the effectiveness of vaccine reminder text messages. 
1.4 
Research Questions 
What message content would key stakeholders prefer for HPV vaccination reminders? 
Are text message vaccine reminders for HPV vaccination feasible? 
Do text message vaccine reminders demonstrate potential impact on timely HPV vaccination 
initiation and completion? 

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Page 4 of 142 
CHAPTER TWO 
2.0 Literature Review 
Completion rates of HPV vaccination in Uganda are low. The national HPV vaccination program 
in Uganda began in November 2015,14 and targets girls who are 10 years old.15 In Kampala, the 
school-based program is to be delivered during every health facility and outreach immunization 
session, but intensified during Child Days Plus- month-long outreach sessions held two times a 
year in April and October, or whichever months they will be held during the course of the study. 
The community-based program occurs throughout the year at health facilities- overseen by city 
authorities or health institutions. 
Not all adolescents who receive the first dose of HPV vaccine receive the second dose they need 
to complete the series. Furthermore, of those who do receive the second dose, many do not 
receive it within the recommended 12 months, resulting in more days at risk. In two previous 
national surveys, 72% and 83% of girls assessed initiated vaccination, but only 39% and 27% of 
them, respectively, completed the series.16 While coverage rates have gone up in some areas of 
Uganda, in Kampala City currently only 29% of girls in the target age range have received two 
doses of the vaccine.17 Similarly, at an adolescent clinic (study site) in Kampala, of the girls aged 
less than 14 years old who initiated vaccination between November 2015 and July 2017, only 
30.2% completed the series within 6 months and 36.5% within 12 months—and only 69.8% 
completed the series at all.18 At three local health centres and affiliated schools (study sites), 
average completion rates are even lower, ranging from 10.5% to 40.5% of those who initiated.17 
The current rate of completion HPV2 is 12%.19 
A number of barriers to HPV vaccination in Uganda exist. The recent full country evaluation 
of HPV vaccination in Uganda highlighted the need for caregiver engagement to improve HPV 
vaccination rates, as well as the need to increase awareness of the importance of HPV 
vaccination.20,21 A number of caregiver factors can impact timely HPV vaccine completion. 
Investigators found that the most common reason the vaccine was missed was school 
absenteeism- making reminders to attend school that day of paramount importance.22 For health 
facility-based vaccination, families may not know when it is time to bring their adolescent back 
for the second dose. This is likely worsened by some girls being away at boarding school when 
the next dose is due; when they return from school break, the family may not remember to return 

Page 5 of 142 
for vaccination. A recent Gavi full country evaluation noted inadequate follow-up system for 
second dose of HPV to be a key factor as to why coverage rates for HPV2 are low.21 
In addition to these logistical barriers, parents may have knowledge gaps regarding the link 
between HPV and cervical cancer as well as misperceptions regarding the vaccine. In one study 
that included stakeholder interviews, investigators found that a key driver of vaccination was 
fears about vaccine safety.2 Another showed that the perceived benefits of vaccination- 
particularly cancer protection as well as perceived safety of HPV vaccination- increased girls' 
and caregivers' acceptability of HPV vaccination.23 Similarly, in a study that took place at an 
adolescent clinic (a site for this study), knowledge about cervical cancer, HPV, and HPV 
vaccination were associated with increased vaccine coverage. Other investigators have also 
found that families chose vaccination because it protects against cervical cancer, prevents 
infection, and because vaccines overall are good for health.22 In one evaluation, caregivers who 
received information about the vaccine in advance of the vaccination day at school were more 
likely to have their child vaccinated.20 
Failure to come in for vaccination is common. Reminders are an evidence-based approach to 
overcome this barrier to vaccine receipt.  One of the important factors affecting vaccination is 
failure to remember to come in for doses.24,25 The U.S. Task Force on Community Preventive 
Services found strong evidence that general vaccination reminders that notified families when 
vaccines were due improved vaccination rates.25 In Uganda, the only current reminder available 
is a paper appointment card, which can easily be misplaced or destroyed. Moreover, there is no 
electronic database for the immunization program. 
Text messaging offers low-cost, scalable opportunities to foster vaccination. Traditional 
reminder strategies (mail and phone call) have historically had more limited effects in adolescent 
and low-income populations.26-30 Moreover, a Cochrane review found that text messaging, as a 
single-method reminder, had the largest effect size with high certainty of evidence (RR: 1.29, 
95% CI: 1.15 – 1.44; six studies; 7,772 participants).31 
Text message vaccine reminders have several characteristics making them an attractive 
technology for vaccine reminders in all populations. 
a) Text messages are a good way to reach people. The number of mobile phone user is high,
with an estimated 6.8 billion users world-wide.32 According to the World Bank, 89.9% of
urban households in Uganda have a cell phone.33 

Page 6 of 142 
b) Text messages act as cues to action. They may draw attention more than written information
and may be perceived as less intrusive than a phone call.24 In addition, they remain on a
person’s phone as a persistent reminder. This makes them particularly useful for
interventions with a clear, desired behavioral outcome.
c) Text messages are useful across populations with various levels of literacy since space
limitations force a minimal number of short, simple words.
d) Text messages are delivered outside the office setting. This is important for reaching patients
not accessing care regularly, a key group for targeting HPV vaccine reminders as well as for
school-based programs. Text messages also allow more frequent contact with a health care
team than can be achieved with in-person visits alone.
e) Text messaging is scalable and can be personalized. It allows interaction with thousands of
patients simultaneously thereby enabling an impact not only on an individual patients’ health,
but also on the health of the public by increasing population-level vaccination coverage. Yet,
text messaging can also allow personalization based on individual characteristics such as age
and language.
f)
Text message reminders are a flexible platform. They can be used either for simple prompts
or for reminders that inform a patient or family when a vaccine is needed, and even for more
complex interactions that include embedded educational information and interactive
responses that can close knowledge gaps and dispel vaccine misperceptions.
Text messages could be used to address many of the problems identified with poor HPV vaccine 
uptake. The study assessing HPV demonstration projects in LMICs found main vaccination 
barriers to include: 1) school absences on vaccination days and 2) lack of knowledge or 
awareness about cervical cancer, HPV vaccine and HPV vaccination programs. All these, and 
more, are targetable with HPV vaccine text message reminders.22 
 They can notify families that their child is in need of vaccination either for their first dose 
or that it is time to return for the second dose 
 Timing of reminders can be tailored to the individual child based on when their dose is 
due as well as where and when they should go to receive that dose, including special days 
at school. 

Page 7 of 142 
 Educational information can be embedded into text messages to provide answers to 
common questions or concerns families have about vaccination or include information 
that has been shown to impact the likelihood of caregivers to accept vaccination, like 
cancer protection. 
We have established strong evidence supporting HPV vaccine text message reminders. Dr. 
Stockwell (MPI of the grant) published the first studies using text message vaccine reminders for 
adolescent and pediatric populations.34-40 In addition, she has previously identified the 
effectiveness of HPV vaccine text message reminders in two studies. In the first, caregivers 
whose child received a first or second dose of the HPV vaccine received a series of text message 
reminders when the next dose was due. Adolescents whose caregivers were texted were more 
likely to receive their next dose on-time vs. non-enrollees (51.6% of enrollees vs. 35.0% of non- 
enrollees [p = 0.001] or 38.1% of historical controls [p=0.003]).40 In a secondary analysis 
(unpublished), those receiving text messages also had higher series completion rates (45% vs. 
29% p<0.01). These conventional reminders solely notified caregivers via text that the next dose 
was due; they did not include any other information such as vaccination-related educational 
health information. While these results strongly supported the potential effectiveness of text 
message reminders, still fewer than half of adolescents (45%) completed the series. 
In her most recent study, Stockwell demonstrated 74.1% completion rates of HPV vaccine series 
within 12 months for adolescents of caregivers receiving text message reminders.41 This rate was 
much higher than both historical controls (34.8%) and the comparison group of non-enrollees 
(45.2%, p<0.0001). 
This proposed project is innovative in four important ways. 
1) This will be the first use of text message vaccine reminders for adolescent vaccinations
in not only Africa but for any LMIC. Text message vaccine reminders have been used for
pediatric vaccination studies in Africa in Kenya and Nigeria33,42-45 and three other non-
African LMICs,46-48 but not for adolescent vaccines including HPV. While on the surface
it may seem that the use of mHealth interventions for adolescent vaccination does not
differ from that of pediatric vaccination, that is not true. Adolescent vaccination patterns,
knowledge and perceptions do differ from that of pediatric vaccination, and interventions
in high and low-middle income countries also differ.49 Therefore, text message

Page 8 of 142 
performance cannot be extrapolated from those targeted to caregivers of young children 
or to caregivers in high-income settings. 
a.
In Uganda, similar to the rest of sub-Saharan Africa, vaccinations for young
children are delivered as part of EPI (Expanded Programme on Immunization) in
which primarily families bring their child in to a central location for vaccination.
This differs from vaccination for adolescents, who are being vaccinated in a
variety of places, including the school, health centres and immunization posts in
the community. This means that a more tailored mHealth approach is needed to be
able to provide reminders for these various groups.
b. Caregiver views of pediatric vaccination are generally positive, while in contrast
many concerns about HPV vaccination still exist making the embedded
educational information in HPV reminders particularly important.
c.
Caregivers are very accustomed to thinking about vaccinations for their infants
but vaccinations for adolescents are much newer to them and knowledge gaps
remain.50 In addition, care seeking patterns for infants may differ markedly than
for adolescents, making this type of outreach potentially even more important.
2) We will also be able to assess for the first time what types of educational information
caregivers and providers believe is needed in HPV vaccination reminders in a LMIC. An
August 2018 article highlighted that while nearly a quarter of the world’s population are
adolescents, on average only 1.6% of all global health development assistance funding
goes to adolescent health.51 Given the very high burden of cervical cancer coupled with
late diagnosis, the opportunity for primary prevention offered by vaccination is profound.
Uganda has a young population, 59.7% are <19 years old, making it a particularly
important country to understand the potential impact of HPV vaccine reminders.33 
Lessons drawn from this project may also be useful to other LMICs.
3) This project is at the intersection of two important governmental ministries- the Ministry
of Health and the Ministry of Education- these mHealth reminders would be a novel
intervention spanning the two arenas of health and education.

Page 10 of 142 
Qualitative Interviews 
30-40 minute audio-recorded interviews. Interviews to be transcribed, translated, and coded. 
Message Design 
Messages to be designed in English and then forward and reverse translated into Luganda. 
Message Pre-Testing (N=20 dyads) 
Parenting adult with girl aged 10-14 years, residents of Kampala or surrounding districts,
affiliated with one of the study sites (care or school), speak English or Luganda will pre-test
messages. 
Pilot Message Intervention  
(N=154) 
Intervention Arm: Targeted reminder messages to initiate 1st or 2nd dose 
receipt 
Usual Care Arm: No reminder messages  
CHAPTER THREE 
3.0 METHODOLOGY 
Study Schema 
(N=30 dyads/triads) 
Caregiver with girl aged 10-14 years, residents 
of Kampala or surrounding districts, affiliated 
with one of the study sites (care or school), 
speak English or Luganda, and have a cell 
phone with text message capability 
(N=10) 
Immunization 
nurses, 
administrative 
staff, and medical 
leadership at 
health 
centers/clinics. 
(N= 12) 
and staff at
Child Days
Plus
programs. 
(N=4) 
Kampala
Capital City
Authority
and Ministry
of Health
leadership 
Pilot Message Intervention Analysis  
Assess impact and feasibility of implementation of the intervention using a RE-AIM 
implementation framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). 
OBJECTIVE 1 
OBJECTIVE 2 
OBJECTIVE 3 

Page 11 of 142 
Pilot Message Intervention Consort Diagram
INTERVENTION (N=77 families) 
Targeted reminder messages to initiate 1st or 2nd
dose receipt 
USUAL CARE (N=77 families) 
No reminder messages 
ELIGIBLE (N=913 families) 
Parenting adult must: have a girl aged 10-14 years, be a 
resident of Kampala or surrounding districts, be affiliated 
with one of the study sites (care or school), speaks 
English or Luganda, and have cell phone with text 
message capability 
ENROLL (N=154 families) 
Consent and enroll in SEARCH Study 
RANDOMIZE 
by enrollment site, parental language (English or 
Luganda), and dose due (1st or 2nd) 

Page 12 of 142 
3.1 Study Design 
This is an exploratory sequential design study with the primary intent of the exploratory design to 
develop a digital tool which will then be tested in a pilot randomised control trial to assess the 
feasibility of text message reminders on vaccination. This study will be conducted in Kampala City 
involving adolescent girls, their caregivers,  health workers, school authorities  and government 
officials . Results from this phase (Objective 1: interviews) will be used to design the text and 
voice message reminders. We will use these results, along with the study teams’ expertise in in text 
messaging, HPV vaccination, adolescent medicine, health literacy and community engagement 
(Objective 2: message design and pretest), for a pilot randomized control trial to assess the 
effectiveness of intervention messages on timely receipt of the second HPV dose (Objecive 3: pilot 
assess text message feasibility through RCT). 
3.2 Study Site 
This study will take place at three health centres Kisenyi, Kawaala and Kiswa in Kampala, 
Uganda overseen by the Kampala Capital City Authority (KCCA) located in the suburbs of 
Kampala City. It will also take place in a sample of six KCCA schools selected from the schools 
in those areas (Appendix 26). It will also take place at the Makerere/Mulago/Columbia 
Adolescent Health Clinic (commonly referred to as the Friday Adolescent Clinic), at Mulago 
National Referral Hospital the teaching hospital for Makerere University College of Health 
Sciences. The study health facilities were selected purposively in consultation with KCCA to 
ensure inclusion of different city divisions as shown in Table 1. 
Table 1: Distribution of study health facilities by Division 
Health Facility 
Division 
Catchment 
population1
Kisenyi HC IV 
Central 
99,378 
Kiswa HC   III 
Nakawa 
64,509 
Kawaala HC III 
Lubaga 
52,035 
Mulago National Referral Hospital -Adolescent Clinic 
Kawempe 
1 KCCA (2019) Statistical Abstract https://www.kcca.go.ug/media/docs/Statistical-Abstract-2019.pdf
Each of the study health facilities provides HPV vaccination services to adolescent girls. 

Page 13 of 142 
3.3 Objective 1: To identify HPV vaccine text message reminder content (and parallel- 
automated phone reminders) desired by caregivers and their adolescent girls in Kampala. 
3.3.1 Population for Objective 1 Interviews 
Target population: Families of adolescent girls, clinicians, immunization nurses, 
administrative staff, and school leadership (at the governmental level, key informants will 
include leadership within the KCCA and Ministry of Health). 
Study population: Families of adolescent girls, clinicians, immunization nurses, 
administrative staff, and school leadership (at the governmental level, key informants will 
include leadership within the KCCA and Ministry of Health). 
Accessible population: Families of adolescent girls, clinicians, immunization nurses, 
administrative staff, and school leadership (at the governmental level, key informants will 
include leadership within the KCCA and Ministry of Health). 
3.3.2 Selection Criteria for Objective 1 Interviews 
Inclusion criteria for interviews: 

School-affiliated participants must:
o
Be affiliated one of the identified KCCA schools (Appendix 26)
o
Be in leadership role at school (i.e. Senior Woman or Head Teacher title)
o
Be involved in HPV-vaccination efforts at school

Government-Affiliated Participants must:
o
Be local or national government official involved in an immunization programs

Caregiver participants:
o
Is the primary caregiver of adolescent girl aged 10-14 years who has not completed
the HPV vaccination series
o
Resides in Kampala
o
Speaks English or Luganda
o
Have a phone in the household
o
Adolescent is willing to take part in interview

Page 14 of 142 

Adolescent participants:
o
Is an adolescent girl aged 10-14 years
o
Have not completed the HPV vaccination series
o
Have a phone in the household
o
Caregiver is willing to take part in interview
Exclusion criteria: 

Those who are unable to consent/assent to the study

Those unable to be interviewed at the affiliated study health centres
3.3.3 Study procedure for Objective  1 Interviews 
Interviews will be conducted by trained research staff overseen by an experienced social scientist 
on our study staff. At the Kisenyi, Kawaala and Kiswa study sites, families of adolescent girls aged 
10-14 who have not completed the HPV vaccine series will be given a consent form/information 
sheet by a member of our study team. Then, they will be asked if they have any questions and if 
they are willing to participate. After being read the consent/assent form, one willing adult 
participant who is the primary caregiver of the adolescent will be asked to sign the consent and the 
10-14 year old adolescent girl will also be asked to give written assent. In the case of there being 
more than one eligible female adolescent between the ages of 10-14, we will give the opportunity 
to both adolescents to be interviewed.  If two caregivers are present and willing to take part, we 
will select the primary caregiver who is usually responsible for the adolescent being vaccinated. 
To increase reach, study staff will also call families of 10-14 year old adolescent girls who have 
not completed the HPV vaccine series and receive care at the study-affiliated healthcare centres 
about possible participation. If these families are interested, they will be asked to travel to their 
study-associated healthcare centre to be consented and participate in the study interview and 
their transport to and from the health centre will be reimbursed. 
The interviews will be grounded in the general domains of the critical interpretive synthesis 
framework put forth by Phillips et al in their comprehensive systematic review of vaccination 
studies in LMICs. After obtaining informed consent, interviews will be conducted using a semi- 
structured interview guide by trained research assistants with experience in conducting 

Page 15 of 142 
interviews with adolescent and their caregivers. The guide was developed based on the 
investigators’ experience with HPV vaccination. Audio-recorded interviews will last 30-40 
minutes. We will use open-ended questions with neutral probes to facilitate discussion and 
\encourage unbiased responses. In addition, rather than leading the interview based on a 
predetermined hypothesis, we will allow the concepts to emerge inductively. 
We will seek to interview 30 caregiver and adolescent dyads/triads, but will use an iterative data 
collection and analysis approach and continue data collection until data saturation is reached 
(e.g. no new themes arise from the data). Eligible criteria are outlined as above. Adults and 
adolescents will be interviewed concurrently, but separately to facilitate comfort and encourage 
honest answers. Family interviews will concentrate on text message reminder content, focusing 
on the attitudes, perceived norms and perceived control that may affect intent to vaccinate in the 
Phillips et al model. We will also assess desired message timing and phrasing. Additionally, we 
will assess if families want for only the caregiver or the caregiver plus adolescent to receive the 
messages. 
At the health centres/clinics, we will interview clinicians caring for 10-14 year olds, 
immunization nurses, administrative staff, and medical leadership (n=12). We will purposefully 
sample schools from the list of KCCA health centre-affiliated schools included in Appendix 26, 
focusing on two per division each of which represent a different student demographic 
composition. At the study-affiliated schools, we will interview up to two people per school 
including the headmasters and staff involved in Child Days Plus/HPV vaccination. Interviews 
will include content discussions regarding experiences with families’ vaccine knowledge and 
attitudes as well as community access and facility readiness factors from the Phillips et al model 
in order to align reminder content and timing with current processes. Interviews will take place 
in person at the facilities in which the participant works, or another decided upon location. 
In addition, local and national government officials, including KCCA and MOH leadership 
involved in immunization programs, will also be interviewed with focus on access and readiness 
from the Phillips et al model and an eye towards sustainability (n=4). Interviews will take place in 
the leadership offices after written informed consent is obtained. We will interview the KCCA 
Directors of Education and Social Services, and of Public Health and Environment as well as the 

Page 16 of 142 
City Manager of Epidemiology and Surveillance. These individuals together oversee vaccination 
at the KCCA- affiliated schools, health centres, and immunization posts and in Kampala overall. 
At the MOH, we will interview the Program Manager of UNEPI. 
During the process of data collection, COVID-19 risk management procedure (Appendix 24) 
will be followed to protect the health and safety of study participants and researchers. 
3.3.4 Data management and analysis 
Individual interviews will be transcribed verbatim from audiotapes and translated, as appropriate. 
Our qualitative lead and their team will review all transcriptions and conduct coding 
independently. Transcripts will be analyzed using immersion and crystallization process and 
thematic analysis, which are standard methods of qualitative analysis. Analyses will follow a 
systematic, iterative process in which transcripts will be independently read for familiarity with 
content. General thematic domains and codes will be identified, and then transcripts will be 
systematically and independently coded line-by-line by two team members. The coding scheme 
will remain flexible and open to accommodate expansion as the teams agree on new codes. Double 
coding of all data will occur to facilitate reliability. Coding inconsistencies will be reviewed and 
resolved during meetings with the research team. Thematic analyses will then be conducted on the 
data to identify emerging themes. Qualitative data coding and analysis will be facilitated by the 
use of NVivo software. Summaries of coded texts and comparative analyses will be discussed with 
the investigatory team who were not involved with the coding, as well as outside experts, to obtain 
validation. The themes identified through the qualitative analysis will be used to guide the 
construction of the text (and parallel phone) messages that will be pre-tested in Objective 2. 
3.4 Objective 

Objective 2a: To develop HPV vaccine reminders with caregivers and their adolescent girls
in Kampala.

Objective 2b: To pretest HPV vaccine reminders with caregivers and their adolescent girls
in Kampala.

Page 17 of 142 
3.4.1 Study procedure for Objective 2a message development 
We will design the reminders using the information gathered under Objective 1 to identify the 
themes, content, timing and framing of the SMS reminders. We will also use content gathered 
during our previous studies described above, the relevant literature, and the team’s expertise in 
text messaging, HPV vaccination, adolescent medicine, health literacy and community 
engagement. The same message content and timing will be used for those opting for voice 
reminders. The messaging will be behaviorally-informed with the framing based on findings from 
participants from Objective 1. Possible examples include “loss-frame” messages that focus on the 
negative consequences of an adolescent not being vaccinated, and/or “gain-frame” messages that 
focus on what can be achieved through vaccination. Messages may also include social comparisons 
that capitalize on social desirability bias in completing the HPV vaccine series, contigent on if this 
is found to be motivating to families based on the Objective 1 responses. Other messages may 
highlight doctor recommendations if Objective 1 respondents relay that this may motivate others. 
The study team will design the messages. First, they will identify the key content, timing and 
framing for each message in the series as above. The project coordinator will then design the 
messages. The team will then iteratively revise the messages, keeping the text within the 160- 
character count and paying attention to reading level, as assessed by the Flesch–Kincaid readability 
test. The final draft messages will first be designed in English then will be forward translated from 
English into Luganda by an independent professional translator and then reverse translated by a 
second independent professional translator from Luganda into English. All the while, translators 
will ensure proper linguistic and cultural equivalence, following procedures adapted from 
guidelines for translating health services research measure. The two versions, the original English 
and the reverse-translated English, will then be compared by the study team. 
3.4.2 Population for Objective 2b message pretest 
Target population: Families at the adolescent clinics, KCCA health centres, immunization 
posts, and families of children registered at the affiliated schools. 
Study population: Families at the adolescent clinics, KCCA health centres, immunization 
posts, and families of children registered at the affiliated schools. 

Page 18 of 142 
Accessible population: Families at the adolescent clinics, KCCA health centres, 
immunization posts, and families of children registered at the affiliated schools. 
3.4.3 Selection Criteria for Objective 2b message pretest 
Inclusion Criteria 
To receive take part in this pre-testing, one must: 

Caregiver participants:
o
Is the primary caregiver of adolescent girl aged 10-14 years who has not completed
the HPV vaccination series
o
Resides in Kampala
o
Speaks English or Luganda
o
Have a phone in the household

Adolescent participants:
o
Is an adolescent girl aged 10-14 years
o
Have not completed the HPV vaccination series
o
Have a phone in the household
o
Caregiver is willing to take part in the pretest
Exclusion criteria 

Those who are unable to consent to the study

Those unable to be interviewed at the affiliated study health centres

Participation in Objective 1 study activities
3.4.4 Study procedure for Objective 2b message pretesting 
We will show/read the designed messages with caregivers and adolescent to identify issues with 
clarity and persuasiveness. Using methods previously utilized by members of the study team, the 
project coordinator will purposefully sample families meeting criteria a above from the waiting 
rooms at the adolescent clinic and KCCA health centres. Families will be consented/assented as 
outlined in objective 1. After obtaining informed consent, the project coordinator will share the 
proposed messages and ask the caregiver to relay back, in their own words, what the message 
means to them in order to assess clarity. S/he will then ask families about the level of 
persuasiveness as well as any problems or suggested changes. Messages will be updated in an 

Page 19 of 142 
iterative process until no new message changes are made. Based on our previous work, we 
anticipate needing 20 dyads (with representation by language and site). 
3.4.5 Data management and analysis 
Final messages will be reverse translated from Luganda and team members will review to make 
sure that the content is the same between the messages in the two languages. We will also map 
the final messages back to the factors of the critical interpretive synthesis framework related to 
attitudes, perceived norms and perceived control, as well as access. 
3.5 AIM 3:  To pilot assess the impact and feasibility of vaccine reminders on HPV vaccination 
3.5.1 Population 
Target population: Families of adolescent girls who visited any of the following health 
centers: Kisenyi HC IV, Kiswa HC III, or Kawaala HC III. 
Study population: Families of adolescent girls who visited any of the following health centers: 
Kisenyi HC IV, Kiswa HC III, or Kawaala HC III. 
Accessible population: Families of adolescent girls who visited any of the following health 
centers: Kisenyi HC IV, Kiswa HC III, or Kawaala HC III. 
3.5.2 Selection Criteria 
To receive messages one must: 

Be an adult parent of an adolescent girl aged 10-14 years

Reside in Kampala and/or the surrounding districts

Be affiliated with the study sites (care or school)

Speak English or Luganda

Have a cell phone with text messaging capability

Must have ability to consent.
Exclusion Criteria: 

Parenting adult speaks other language than English or Luganda only

Parenting adult already enrolled in the study for another child

Participation in Objective 1, 2a/2b study activities
3.5.3 Study procedure 
We will recruit eligible participants from the sites outlined in Aim 1 and 2. This includes health 
centres  overseen by the Kampala Capital City Authority (KCCA), as well as the associated schools 
and immunization posts in the community. In addition, we will also recruit at the 

Page 20 of 142 
Makerere/Mulago/Columbia Adolescent Health Clinic at Mulago National Referral Hospital, the 
teaching hospital for Makerere University College of Health Sciences. 
For those vaccinated through clinic sites: Families will be recruited multiple ways. First, families 
who are interested can enroll directly at the health centre at the times research staff are on-site, 
possibly at the time they are being evaluated for another health condition and are not receiving the 
vaccine that day. Second, if research staff are not on-site, providers and nursing staff at the study 
sites will ask families permission to provide the research staff with their contact information to 
reach out to them to explain the study and if interested to meet with them to enroll them into the 
study.  
For those vaccinated through community immunization posts: Village health workers who already 
work in each village will be mobilized to approach households with 10-14 year olds who are in 
need of vaccination (have not yet been vaccinated or who have initiated but have not completed the 
series) to identify those who would be interested in the study. Research staff will contact those who 
are interested, as above. The use of village health workers has been previously successful for both 
immunization campaigns and other research studies. 
For those vaccinated through the Child Days Plus: Girls will be given an information sheet and the 
study contact number to bring home to their parents. We would get permission from the schools to 
call families back as above.  
We will enroll only one child per family; if more than one is eligible, one will be randomly 
selected.  For the pilot feasibility trial, we will enroll families of girls who are in need of either the 
first or second dose, with an outcome of receipt of next needed dose. Due to the need to complete 
the pilot feasibility trial quickly, we will only enroll those in need of the second dose if their next 
dose is due strictly between 8-20 weeks from enrollment. We will seek written consent from 
caregivers. We will seek written assent from adolescents of consented caregivers given instead. At 
enrollment, parents will be verbally administered a demographic and HPV vaccination knowledge 
and attitude survey. 

Page 21 of 142 
After enrollment, the Ugandan project coordinator will randomize families into intervention vs. 
usual care arms (1:1 ratio) stratified by enrollment site, parental language (English or Luganda), 
and dose due (1st or 2nd) using a randomization module. Research staff will not know the study 
assignment during enrollment. The outcome assessor and analyst will remain blinded to arm 
assignments. 
Families who report on the demographic survey their highest degree of schooling as P7 or below 
will be asked at enrollment if, in the case they are randomized to the intervention, they would 
prefer a voice reminder in lieu of texts; such reminders would include the same content, timing and 
interactivity as the texts. While in Kampala only 2.1% of women and 0.5% of men have no formal 
education, 17.6% of women and 17.1% of men completed only some primary school.31  
Similarly, families whose daughter is returning to a boarding school and are enrolled at the 
Adolescent Clinic, health centres, or immunization post will be asked if, in the case they are 
randomized to the intervention, they want messages sent timed for the next school break. 
Alternatively, they can select the timing used for those not at boarding school. If the special timing 
is selected, we will account for the minimal interval between doses (for those in need of a second 
dose). Intervention-arm families enrolled through Child Days Plus will be sent their series prior to 
the next Child Days Plus event at their child’s school or before any other special immunization day 
events, if the school holds one. 
Intervention, Text Message Target, Content and Frequency: 
For those families randomized to the intervention arm: Based on our previous studies as well as 
the full country HPV vaccine evaluation highlighting the parents involvement as vaccine decision 
makers, we plan for the messages to be targeted to the parent, unless in Aim 1 families suggest that 
girls should also receive the message. All text messages are automated and will be sent in English 
or Luganda based on parental preference.  
The message sequence consists of 5 weekly, main message reminders beginning 5 weeks before the 

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SEARCH Protocol June 2021 
Page 23 of 142 
messages will be sent bi-weekly for one month and then monthly until the end of the 6 month 
observation period for each individual during the pilot trial. Sites will be visited every 2-4 weeks to 
abstract data; we will stop messages for those already vaccinated. HPV registers for schools are 
generally kept with the affiliated KCCA health centre immunization nurses. For families of those 
unvaccinated who were first vaccinated at Child Days Plus will receive booster messages directing 
them to bring their daughter to the KCCA health centre affiliated with their school (who conducts 
their Child Days Plus outreach) as they will have missed the school vaccination day. 
Usual Care arm: Families randomized to the usual care arm will not receive text message vaccine 
reminders. 
3.5.4 Data management and analysis 
Sample Size for Pilot For the feasibility pilot, we will plan to enroll 154 adolescents who are due 
for an HPV vaccine dose. With a minimal sample size of 77 in each arm, we will be powered to 
detect a hazards ratio of 1.67 with 80% power, allowing for a 5% type I error comparing time to 
next dose. 
At the study sites, we expect there to be, on average, 1074 girls aged 10-14 in need of vaccination 
over a 4-month period. We expect 913 families to meet age, language and cell phone/texting 
inclusion criteria. To meet our minimal sample size of 154 (77/arm) for this pilot/feasibility study, 
we need to recruit 16.9% of eligible families, which is feasible. If recruitment is slower than 
expected, we will be able to use more KCCA sites. 
Data Management 
Vaccination data will be abstracted from the HPV vaccination registers in use clinically at the sites. 
Girls generally seek care from one site. All data will be entered into a REDCap database hosted at 
Columbia with secure access provided only to Columbia and Ugandan study staff. The Ugandan-
based project coordinator will monitor text messages sent, replies, and “undeliverable” messages 
under the supervision of Drs. Bakeera-Kitaka and Stockwell. Linkages between parents’ and girls’ 
information, survey data and vaccine records will be maintained in separate password protected 
files. All final datasets will be coded. 
D10. Analytic Plan  
The primary analytic plan for the pilot will focus on feasibility of implementation of the 

SEARCH Protocol June 2021 
Page 24 of 142 
intervention using a RE-AIM implementation framework (Reach, Effectiveness, Adoption, 
Implementation, Maintenance). We will focus only on reach, effectiveness, and implementation 
(not adoption or maintenance which is not applicable for this pilot). 
Reach: We will collect data on number of families 

approached

eligible and ineligible (including reasons for ineligibility)

eligible who enrolled

number enrolled in text message vs. phone reminders
Effectiveness: While the focus of the pilot is on feasibility, we will also assess the effect size of the 
intervention. The outcome will be timeliness of vaccination (time to event). Time will be from start 
of main message series to receipt of the next needed dose. Data analysis will be performed using 
Stata. The primary analysis will be intention-to-treat (ITT), whether or not further messages were 
declined or undeliverable. A secondary per protocol analysis will only include those who received 
the entire set of reminders. Timeliness of vaccine receipt will be compared using Kaplan-Meier 
curves using a stratified log rank test. In addition, in order to gain effect sizes needed for a future 
large-scale intervention, comparisons will also be stratified assessing those due for the first dose 
(initiation) and second dose (completion). 
Implementation: We will assess various process measures, including: 

Messages sent/delivered (if a text message is electronically returned as undeliverable, we
will contact the family using alternative numbers that will be collected at enrollment)

Number who opted out of further messages

Number who responded to messages

Topics families request more information about in reminders

Factors associated with response and drop out
o
child characteristics (age, site, school status (in or out of school), grade, relationship
with caregiver)
o
family characteristics (age, education, employment, income, marital status, distance to
health facility, language)
We will also randomly select 30 intervention parents from whom we have received permission in 
the consent to re-contact. We will conduct a semi-structured interview that will focus on 

SEARCH Protocol June 2021 
Page 25 of 142 
intervention experiences and suggested changes, and follow the methods and analytic plan outlined 
under Aim 1. We will also have them complete two implementation measures: Acceptability of 
Intervention Measure (AIM), Intervention Appropriateness Measure (IAM). These were developed 
and psychometrically assessed by implementation scientists as consensus measures for 
acceptability and appropriateness. In addition, they will also complete an adapted Health 
Information Technology (IT) Usability Evaluation Scale (Health-ITUES).  
We will then present findings to key non-parental stakeholders (as identified under Aim 1) and 
conduct semi-structured interviews to gather feedback. Conduction of the interviews and the 
analytic plan will follow the methods outlined in Aim 1. 
3.6 Training of research assistants 
Multiple research assistants with experience in collecting qualitative data in a health care setting will 
be recruited to work in pairs and trained for 2 days. The training will cover, study objectives and 
approach as well as an in-depth review of the consent and assent process and data collection tools. 
Research assistants will also take part in the pre-test of data collection tools at one of the health 
centres in Kampala City.  Data from this phase will not be included in the final analysis. Research 
assistants will also be trained on the COVID-19 standard operating procedures and study risk 
management procedures. 
3.7 Ethical considerations 
Permission to carry out the study was already obtained Columbia University IRB in New York City 
under expedited review for meeting the following two criteria 
a) Research involving materials (data, documents, records, or specimens) that have been
collected, or will be collected solely for non-research purposes (such as medical treatment or 
diagnoses). 
b) Research on individual or group characteristics or behavior or research employing survey,
interview, oral history, focus group, program evaluation, human factors evaluation, or quality 
assurance methodology. 
We sought approval for the study through the IRB at Columbia University as part of our research 
team is located within that institution. We are seeking approval through SOMREC as the other 
researchers and research participants are located in Kampala, Uganda.    

Page 26 of 142 
3.8 Dissemination 
The findings of this study shall be availed to the Kampala Capital City Authority, the Columbia 
Department of Pediatrics and Child Health, and all other stakeholders. 
Risks / Benefits to Subjects 
This is a minimal risk study. Some caregivers might find there are interview questions they do 
not want to answer; they can skip any questions they like and can stop the interview at any time. 
Interviews can be converted to be conducted online to decrease risk of COVID-19 transmission 
if necessary. Patients do not receive any care as part of the study they or their 
parent/caergiver only receive a text message. They can choose to act or not act on the message. 
The vaccination is not directly part of the intervention. Some parents might find the alerts to be 
intrusive, but we will design them based on parental input. In addition, they can opt out at any 
time. There is also a minimal risk of loss of confidentiality. However, we will assure 
confidentiality as below. 
Compensation 
Staff, caregivers, and adolescents taking part in interviews will receive Ugandan Shillings (UgX) 
30,000 which is equivalent to ~USD$8, officials taking part in interviews will receive UgX 
75,000 which is equivalent to ~USD$18. Families who were contacted over the phone about the 
study and traveled to the study-affiliated health centre to be consented and participate in 
interviews will be given travel compensation of UgX 10,000 which is the equivalent of ~USD$3. 
Those enrolling in the pilot trial will receive Ugandan Shillings (UgX) 15,000 which is 
equivalent to ~USD$4.  These compensation amounts were determined by our Ugandan 
investigators based on what is customary. 
Informed Consent 

Page 27 of 142 
We have outlined above procedures to obtain written informed consent and assent. 
Confidentiality Assurances 
Data will be audio recorded using a device such as an audio recorder or smartphone. All data 
collection will occur in Uganda. Only participant first or last names will be recorded (last names 
will be used when it would be culturally or otherwise inappropriate for an interviewer to address 
an interviewee by their first name). Data will be stored on an encrypted computers and/or servers 
and in locked research offices at Makerere University and/or Global Health Uganda (the 
subcontractor). Only Columbia and Ugandan research staff will have access to the recordings. 
The researchers will be responsible for ensuring that the confidentiality of the data is maintained 
at all times. Paper documents will be stored in a locked cabinet at Makerere University and/or 
Global Health Uganda. The study database will reside at Columbia on the RedCap server. The 
recordings will be used solely for research purposes to inform the content of the intervention and 
possible future publications. The recordings will be destroyed upon conclusion of the study. 
Conflict of Interest 
There are no conflicts of interests amongst any of the researchers 
Collaborative Agreements 
None 
Intended Use of Results 
The intended use of the results is to design a trial of text message vaccine reminders, which if 
successful could lead to a larger-scale text message reminder program on timely human 
papillomavirus (HPV) vaccination in Ugandan adolescents. In addition, we will potentially 
publish a manuscript related to this data. The data will be used for future grant applications. 
Storage of and access to research data by other users 
All the data including informed consent forms should be kept at by the PI for at least 5 years before 
destruction. 
Data Sharing 

Page 28 of 142 
We will register the clinical trial component of this project with U.S. Clinicaltrials.gov in accordance of 
all reporting requirements, with an expectation that the Clinicaltrials.gov registration will occur prior to 
enrollment of the first subject in the clinical trial. All results and findings will be disseminated through 
professional scientific conferences, peer-reviewed publications including the final text messages, and 
reporting on Clinicaltrials.gov.  
Both institutions will have a de-identified copy of the final analytic trial dataset.  In addition, we will 
permit access to the data on the basis of the experience and scientific qualifications of the investigator(s) 
and their agreement to not reproduce or share the data with others and to not attempt to determine the 
identities of patients or locations. Requests must be submitted in writing on the letterhead of the 
sponsoring institution at which the research will be conducted and include identifying information about 
the Principal Investigator and Co-investigators, including their curricula vitae or NIH biosketch. This data 
set will be free of identifiers that would permit linkages to individual research participants or specific 
practice sites. Research data will be made available only if appropriate IRB permission are obtained. Data 
Use Agreements will be executed as necessary. Data will be able to be exported to common statistical 
packages (SPSS, SAS, Stata, R) for analysis.  
Data Safety 
This is a minimal risk study. Some caregivers might find there are interview questions they do not 
want to answer; they can skip any questions they like and can stop the interview at any time. There is 
also a minimal risk of loss of confidentiality. However, we will assure confidentiality. The researchers 
will be responsible for ensuring that the confidentiality of the data is maintained at all times. Paper 
documents will be stored in a locked cabinet at Makerere University and/or Global Health Uganda. 
The study database will reside at Columbia on a RedCap server. The recordings will be used solely for 
research purposes to inform the content of the intervention and possible future publications. The 
recordings will be destroyed upon conclusion of the study. 
Data will be stored on an encrypted computers and/or servers and in locked research offices at Makerere 
University and/or Global Health Uganda (the subcontractor).  
Study timeline 
Study Activity 
Time in Months 
1-4 
5 
6 
7-10 
8-16 
17-19 
20-24 
Proposal preparation 
X 

Page 29 of 142 
Hire and train study staff 
X 
Data collection 
X 
Transcription 
X 
Develop messages reminders 
 X 
Pre-test reminder messages 
X 
AIM 3: Pilot RCT Enrollment and 
Randomization 
X 
Outcome observation 
 X 
Process evaluation, analysis, stakeholder 
presentations, R33 transition package 
preparation, manuscript preparation 
X 
Data analysis and report writing 
X 
X 
X 
Dissemination of results to stakeholders 
X 
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