Human Papillomavirus VaccinationNCT06161831
HPV Vaccine Reminders - SEARCH II Study
A study testing Text Message/automated phone reminder in people with Human Papillomavirus Vaccination, run by Columbia University at 2 sites in 2 countries.
Trial summary
This RCT 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 in Kampala. Read more about this study
- Who is it for?
- Ages 10 to 14 years, women only
- Conditions the study is for
- Human Papillomavirus Vaccination
- What is being tested?
- Text Message/automated phone reminder
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Apr 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- 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 previous HPV vaccine reminder study
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 II: Short Message Service (SMS) Electronic Adolescent Reminders for Completion of HPV Vaccination - Uganda: Randomized Controlled Trial
This RCT 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 in Kampala. The investigators will assess the impact of vaccine text message and automated phone reminders on human papillomavirus (HPV) vaccination initiation and completion.
Read the detailed description
Cervical cancer is the leading female cancer in Uganda. HPV is the principal cause of cervical cancer. The national HPV vaccination program in Uganda includes preteen/ adolescent girls. Vaccinations are provided within schools or through community health centers. However, in Kampala, HPV vaccination especially series completion is low. While research regarding the use of text message vaccine reminders is strong in the U.S., their use has not been demonstrated in a preteen/adolescent population in Sub-Saharan Africa and other low and middle income countries (LMICs) in a full RCT. In this study, RCT caregivers of preteens/adolescents will be randomized and stratified by site, language and HPV vaccine dose needed (initiation vs. completion). Intervention families will receive text message or automated phone reminders based on family preference.
- Conditions
- Human Papillomavirus Vaccination
- Being tested
- Text Message/automated phone reminder
- Keywords
- Human papillomavirus, Vaccination, Text message, SMS, mHealth, Uganda
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message/automated phone reminderBehavioural
Receipt of text message or automated phone reminders notifying when the next HPV vaccine dose is due (either first or second)
| Study group | Role | What they receive |
|---|---|---|
| Text message/automated phone reminders | Experimental | Text message or automated phone reminders Receives: Behavioral: Text Message/automated phone reminder |
| Usual Care | No intervention | No reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Receipt of First HPV Vaccine Dose
Timeliness of vaccination (time to event) will be measured
Measured: 12 months
Time to Receipt of Second HPV Vaccine Dose
Timeliness of vaccination (time to event) will be measured
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start22 Apr 2024
- Primary completion31 May 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 396 participants (estimated)
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
- NCT06161831
- Sponsor's protocol ID
- AAAT1572_2
- Other IDs
- R33CA253604
- Status last verified
- Sep 2026
- First submitted
- 30 Nov 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEARCH II: Short Message Service (SMS) Electronic Adolescent Reminders for Completion of HPV Vaccination - Uganda: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06161831
- Acronym / sponsor ID
- AAAT1572_2
- Conditions
- Human Papillomavirus Vaccination
- Keywords
- Human papillomavirus, Vaccination, Text message, SMS, mHealth, Uganda
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Makerere University, National Cancer Institute (NCI)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This RCT 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 in Kampala. The investigators will assess the impact of vaccine text message and automated phone reminders on human papillomavirus (HPV) vaccination initiation and completion.
Detailed description
Cervical cancer is the leading female cancer in Uganda. HPV is the principal cause of cervical cancer. The national HPV vaccination program in Uganda includes preteen/ adolescent girls. Vaccinations are provided within schools or through community health centers. However, in Kampala, HPV vaccination especially series completion is low. While research regarding the use of text message vaccine reminders is strong in the U.S., their use has not been demonstrated in a preteen/adolescent population in Sub-Saharan Africa and other low and middle income countries (LMICs) in a full RCT. In this study, RCT caregivers of preteens/adolescents will be randomized and stratified by site, language and HPV vaccine dose needed (initiation vs. completion). Intervention families will receive text message or automated phone reminders based on family preference.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text message/automated phone reminders | Experimental | Behavioral: Text Message/automated phone reminderText message or automated phone reminders |
| Usual Care | No intervention | –No reminders |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not 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 previous HPV vaccine reminder study
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/automated phone reminderReceipt of text message or automated phone reminders notifying when the next HPV vaccine dose is due (either first or second) | Behavioural | Text message/automated phone reminders |
Primary outcome
Time to Receipt of First HPV Vaccine Dose
Time frame: 12 months
Timeliness of vaccination (time to event) will be measured
Time to Receipt of Second HPV Vaccine Dose
Time frame: 12 months
Timeliness of vaccination (time to event) will be measured
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Human Papillomavirus Vaccination
Active, not recruitingPhase 4
Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial
Human Papillomavirus-Related Cervical Carcinoma
Active, not recruitingPhase 1/2
A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Human Papillomavirus-Related Carcinoma
Not yet recruiting
Web-based Health Education on Information, Motivation, Behavioral Skills Related to Human Papilloma Virus Vaccination
Web Based Intervention
Enrolling by invitationObservational study
Long-Term Immune Persistence After Bivalent HPV Vaccination in Females From Study 311-HPV-1005
Human Papillomavirus Infection, Cervical Intraepithelial Neoplasia
Active, not recruitingObservational study
Long-term Immune Persistence of a Bivalent HPV Vaccine in Females From Study 311-HPV-1004
Human Papillomavirus Infection
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/automated phone 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to Receipt of First HPV Vaccine Dose (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.