Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05151367 |
| Other study ID # |
AAAT1572 |
| Secondary ID |
1R21CA253604-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 23, 2022 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Columbia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
