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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA253604-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Makerere University | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text message reminders | Experimental | Text message reminders |
|
| Usual Care | No Intervention | No reminders |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text message reminder | Behavioral | Receipt of text messages notifying when the next HPV vaccine dose is due (either first or second) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months from randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa S. Stockwell, MD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States | ||
| Makerere University/Mulago Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40324213 | Derived | Kitaka SB, Rujumba J, Zalwango SK, Pfeffer B, Kizza L, Nattimba JP, Stephens AB, Nabukeera-Barungi N, Wynn CS, Babirye JN, Mukisa J, Mupere E, Stockwell MS. SEARCH Study: Text Messages and Automated Phone Reminders for HPV Vaccination in Uganda: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 May 5;13:e63527. doi: 10.2196/63527. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Text Message Reminders | Text message reminders Text message reminder: Receipt of text messages notifying when the next HPV vaccine dose is due (either first or second) |
| FG001 | Usual Care | No reminders |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Text Message Reminders | Text message reminders Text message reminder: Receipt of text messages notifying when the next HPV vaccine dose is due (either first or second) |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 6 months from randomization |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Text Message Reminders | Text message reminders Text message reminder: Receipt of text messages notifying when the next HPV vaccine dose is due (either first or second) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Stockwell | Columbia University | 2123425732 | mss2112@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2021 | Jul 3, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2023 | Jan 3, 2024 | SAP_001.pdf |
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| Kampala |
| Uganda |
No reminders
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Language | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 78 |
| 0 |
| 78 |
| 0 |
| 78 |
| EG001 | Usual Care | No reminders | 0 | 76 | 0 | 76 | 0 | 76 |
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