An interventional study of Text message reminder in Human Papillomavirus Vaccination, sponsored by Columbia University. Completed at 2 sites in 2 countries. Open to female participants aged 10 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Columbia University · Not applicable, Interventional, and Health services research
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.
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.
Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Text message reminders
Behavioral: Text message reminder
No reminders
Receipt of text messages notifying when the next HPV vaccine dose is due (either first or second)
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.
Time frame: Up to 6 months from randomization
| Milestone | Text Message Reminders | Usual Care |
|---|---|---|
| Started | 78 | 76 |
| Completed | 78 | 76 |
| Not completed | 0 | 0 |
Timeliness of vaccination will be measured by the number of participants who received the next HPV vaccine dose.
| Participants | Text Message Reminders | Usual Care |
|---|---|---|
| Number of Participants Who Received the Next HPV Vaccine Dose | 51 | 27 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Text Message Reminders | 0/78 (0%) | 0/78 (0%) | 0/78 (0%) |
| Usual Care | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
| Age, Customized(Participants) | Text Message Reminders | Usual Care | Total |
|---|---|---|---|
| 10 years | 15 | 17 | 32 |
| 11 years | 20 | 18 | 38 |
| 12 years | 19 | 12 | 31 |
| 13 years | 17 | 23 | 40 |
| 14 years | 7 | 6 | 13 |
| Sex: Female, Male(Participants) | Text Message Reminders | Usual Care | Total |
|---|---|---|---|
| Female | 78 | 76 | 154 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Text Message Reminders | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 78 | 76 | 154 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Text Message Reminders | Usual Care | Total |
|---|---|---|---|
| Uganda | 78 | 76 | 154 |
| Language(Participants) | Text Message Reminders | Usual Care | Total |
|---|---|---|---|
| English | 28 | 27 | 55 |
| Luganda | 50 | 49 | 99 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Columbia University