Human Papillomavirus VaccinationSEARCHNCT05151367
SMS HPV Vaccine Reminders
A study testing Text message reminder in people with Human Papillomavirus Vaccination, run by Columbia University at 2 sites in 2 countries.
Trial summary
This study will take place at health centres and their affiliated schools and community immunization centers overseen by the Kampala Capital City Authority (KCCA) as well as at the Makerere/Mulago/Columbia Adolescent Health Clinic, also in Kampala. Read more about this study
- Who is it for?
- Ages 10 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Vaccination
- What is being tested?
- Text message reminder
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Feb 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Be a parenting adult of an adolescent girl aged 10-14 years
- Reside in Kampala and/or the surrounding districts
- Speak English or Luganda
- Have a cell phone with text messaging capability
- Must have ability to consent
Who cannot join
- Parenting adult speaks other language than English or Luganda only
- Parenting adult already enrolled in the study for another child
- Participation in pretesting activities
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: SEARCH: Short Message Service (SMS) Electronic Adolescent Reminders for Completion of HPV Vaccination - Uganda: Pilot
This study will take place at health centres and their affiliated schools and community immunization centers overseen by the Kampala Capital City Authority (KCCA) as well as at the Makerere/Mulago/Columbia Adolescent Health Clinic, also in Kampala. While text messages can be used in populations with low literacy, families can opt to receive automated phone call reminders instead. The investigators will pilot assess the impact of vaccine reminders on human papillomavirus (HPV) vaccination. Caregivers of preteens/adolescents will be randomized and stratified by site, language and HPV vaccine dose needed (initiation vs. completion). As this is a feasibility trial, the investigators expect to measure effect size but not necessarily achieve statistical significance.
Read the detailed description
Cervical cancer is the leading female cancer in Uganda. Many women are diagnosed with late-stage disease, and 80% of women die within 5 years of diagnosis, making primary prevention critical. HPV is the principal cause of cervical cancer, making vaccination the single most important primary preventive measure. The national HPV vaccination program in Uganda began in November 2015 and focuses solely on preteen/adolescent girls. Two strategies have been adopted for the multi-dose series: 1) school-based and 2) community-based. However, in Kampala, only 29% of girls receive both needed doses. Reasons for undervaccination include school absenteeism on special vaccination days for those receiving vaccination as part of a school program, failing to remember to come to a health facility for a needed dose for those being vaccinated in the community, and lack of knowledge regarding HPV and the vaccines including vaccine misperceptions. While research regarding the use of text message vaccine reminders is strong in the U.S., their use has not yet been demonstrated in a preteen/adolescent population in Sub-Saharan Africa and other low and middle income countries (LMICs). According to the World Bank, currently 89.9% of urban households in Uganda have a cell phone.
- Conditions
- Human Papillomavirus Vaccination
- Being tested
- Text message reminder
- Keywords
- Human papillomavirus, Vaccination, Text message, SMS, mHealth, Reminder, Uganda
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message reminderBehavioural
Receipt of text messages notifying when the next HPV vaccine dose is due (either first or second)
| Study group | Role | What they receive |
|---|---|---|
| Text message reminders | Experimental | Text message reminders Receives: Behavioral: Text message reminder |
| Usual Care | No intervention | No reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Received the Next HPV Vaccine Dose
Timeliness of vaccination will be measured by the number of participants who received the next HPV vaccine dose.
Measured: Up to 6 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start23 Feb 2022
- Primary completion30 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus VaccinationStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Melissa Stockwell, Columbia University
- Investigators
- Melissa S. Stockwell, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151367
- Sponsor's protocol ID
- AAAT1572
- Other IDs
- 1R21CA253604-01
- Acronym
- SEARCH
- Status last verified
- Jul 2024
- First submitted
- 26 Nov 2021
- Last updated
- 8 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kitaka SB, Rujumba J, Zalwango SK, Pfeffer B, Kizza L, Nattimba JP, Stephens AB, Nabukeera-Barungi N, Wynn CS, Babirye JN, Mukisa J, Mupere E, Stockwell MS. SEARCH Study: Text Messages and Automated Phone Reminders for HPV Vaccination in Uganda: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 May 5;13:e63527. doi: 10.2196/63527.
PubMed 40324213
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEARCH: Short Message Service (SMS) Electronic Adolescent Reminders for Completion of HPV Vaccination - Uganda: Pilot
- ClinicalTrials.gov ID
- NCT05151367
- Acronym / sponsor ID
- SEARCH / AAAT1572
- Conditions
- Human Papillomavirus Vaccination
- Keywords
- Human papillomavirus, Vaccination, Text message, SMS, mHealth, Reminder, Uganda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Makerere University, National Cancer Institute (NCI)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Posted 8 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will take place at health centres and their affiliated schools and community immunization centers overseen by the Kampala Capital City Authority (KCCA) as well as at the Makerere/Mulago/Columbia Adolescent Health Clinic, also in Kampala. While text messages can be used in populations with low literacy, families can opt to receive automated phone call reminders instead. The investigators will pilot assess the impact of vaccine reminders on human papillomavirus (HPV) vaccination. Caregivers of preteens/adolescents will be randomized and stratified by site, language and HPV vaccine dose needed (initiation vs. completion). As this is a feasibility trial, the investigators expect to measure effect size but not necessarily achieve statistical significance.
Detailed description
Cervical cancer is the leading female cancer in Uganda. Many women are diagnosed with late-stage disease, and 80% of women die within 5 years of diagnosis, making primary prevention critical. HPV is the principal cause of cervical cancer, making vaccination the single most important primary preventive measure. The national HPV vaccination program in Uganda began in November 2015 and focuses solely on preteen/adolescent girls. Two strategies have been adopted for the multi-dose series: 1) school-based and 2) community-based. However, in Kampala, only 29% of girls receive both needed doses. Reasons for undervaccination include school absenteeism on special vaccination days for those receiving vaccination as part of a school program, failing to remember to come to a health facility for a needed dose for those being vaccinated in the community, and lack of knowledge regarding HPV and the vaccines including vaccine misperceptions. While research regarding the use of text message vaccine reminders is strong in the U.S., their use has not yet been demonstrated in a preteen/adolescent population in Sub-Saharan Africa and other low and middle income countries (LMICs). According to the World Bank, currently 89.9% of urban households in Uganda have a cell phone.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text message reminders | Experimental | Behavioral: Text message reminderText message reminders |
| Usual Care | No intervention | –No reminders |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Be a parenting adult of an adolescent girl aged 10-14 years
- Reside in Kampala and/or the surrounding districts
- Speak English or Luganda
- Have a cell phone with text messaging capability
- Must have ability to consent
Key exclusion criteria (3 listed)
- Parenting adult speaks other language than English or Luganda only
- Parenting adult already enrolled in the study for another child
- Participation in pretesting activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text message reminderReceipt of text messages notifying when the next HPV vaccine dose is due (either first or second) | Behavioural | Text message reminders |
Primary outcome
Number of Participants Who Received the Next HPV Vaccine Dose
Time frame: Up to 6 months from randomization
Timeliness of vaccination will be measured by the number of participants who received the next HPV vaccine dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40324213Kitaka SB, Rujumba J, Zalwango SK, Pfeffer B, Kizza L, Nattimba JP, Stephens AB, Nabukeera-Barungi N, Wynn CS, Babirye JN, Mukisa J, Mupere E, Stockwell MS. SEARCH Study: Text Messages and Automated Phone Reminders for HPV Vaccination in Uganda: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 May 5;13:e63527. doi: 10.2196/63527.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa S. Stockwell, MD, MPH principal investigator
Columbia University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message reminder in people with Human Papillomavirus Vaccination, run by Columbia University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Received the Next HPV Vaccine Dose (time frame: Up to 6 months from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05151367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.