HPV Vaccine Reminders - SEARCH II Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Human Papillomavirus Vaccination

Intervention / Treatment
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* Behavioral: Text Message/automated phone 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 previous HPV vaccine reminder study

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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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text message/automated phone reminders<br>Text message or automated phone reminders | Behavioral: Text Message/automated phone reminder<br>* Receipt of text message or automated phone reminders 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 First HPV Vaccine Dose | Timeliness of vaccination (time to event) will be measured | 12 months | 
| Time to Receipt of Second HPV Vaccine Dose | Timeliness of vaccination (time to event) will be measured | 12 months | 

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