SMS HPV Vaccine Reminders

Study Overview
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Brief Summary
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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
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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.

Official Title
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SEARCH: Short Message Service (SMS) Electronic Adolescent Reminders for Completion of HPV Vaccination - Uganda: Pilot

Conditions
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Human Papillomavirus Vaccination

Intervention / Treatment
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* Behavioral: Text message reminder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Parenting adult speaks other language than English or Luganda only Parenting adult already enrolled in the study for another child Participation in pretesting activities

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text message reminders<br>Text message reminders | Behavioral: Text message reminder<br>* Receipt of text messages notifying when the next HPV vaccine dose is due (either first or second)<br>|
| No Intervention: Usual Care<br>No reminders | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Receipt of Next HPV Vaccine Dose | Timeliness of vaccination (time to event) will be measured. | Up to 6 months from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMS, Human papillomavirus, Vaccination, Text message, mHealth, Reminder, Uganda