txt2protect: Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men (t2p)
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|ClinicalTrials.gov Identifier: NCT02994108|
Recruitment Status : Active, not recruiting
First Posted : December 15, 2016
Last Update Posted : March 15, 2019
Human Papillomavirus (HPV) is a common sexually transmitted infection that can cause cancer (anal, penile, oropharyngeal) and genital warts in men. Due to their sexual practices (e.g., receptive anal intercourse), men who have sex with men (MSM) are at particularly high risk for HPV infection and are disproportionately affected by HPV-related cancers. A safe and effective vaccine is available to prevent HPV infection, yet HPV vaccination rates in the U.S. have been low, particularly among males. To remedy this gap, the goal of this study is to develop and pilot test a text messaging intervention to increase HPV vaccination in young MSM.
The study has two specific aims:
- Develop, iteratively refine, and pre-test messages using a formative research procedure for designing targeted health interventions. The procedure consists of the following steps: 1) conduct online focus groups, an online survey, and in-depth interviews to inform message content, 2) draft initial messages based on focus group findings and pilot data, 3) refine message content and assess acceptability using content advisory teams, 4) conduct internal alpha testing to ensure software functionality, and 5) beta test the protocol.
- Test the feasibility, acceptability, and preliminary efficacy of the txt2protect (t2p) text messaging intervention in a pilot randomized controlled trial (RCT). To achieve this aim, 460 unvaccinated MSM (ages 18-25) who live in the Chicago metro area will be randomly assigned to the treatment (t2p) or control condition. The treatment condition will receive a culturally appropriate text messaging-based HPV vaccination intervention based on the Information, Motivation, and Behavioral Skills model, whereas the control condition will receive a text messaging-based sexual health intervention that includes basic facts about HPV vaccination readily accessible online.
Primary outcome measures include intervention feasibility (e.g., retention in the trial), acceptability (satisfaction with the intervention), and preliminary efficacy as determined by initiation (receipt of the first dose) and completion of the 3-dose HPV vaccine series at the end of the 9-month trial.
The study team hypothesizes that participants in the t2p condition (vs. control) will report greater acceptability of the intervention and will be significantly more likely to initiate and complete the 3-dose HPV vaccine series by the end of the trial.
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus||Behavioral: txt2protect Behavioral: Sexual Health Knowledge Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men|
|Actual Study Start Date :||January 3, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Content will be delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants will receive 5-10 messages daily. During Phase 2 (weeks 4-36), message frequency will decrease from weekly to monthly messages. Phase 1 content will be presented in 3 modules. Module 1 will address information about HPV infection and HPV vaccine. Module 2 will address motivations to receive HPV vaccine. Module 3 will focus on behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 "booster" messages will largely reinforce previous content to foster continued engagement with the program, although some new content will also be introduced.
Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.
Other Name: t2p
Active Comparator: Sexual Health Knowledge Control
Content will be delivered in 2 phases over 36 weeks. Phase 1 content will be presented in 3 modules; however, unlike the treatment group, content will be topic-based rather than theory-based and will focus on general sexual health. Module 1 will address basic facts about HIV and STIs, including HPV. Module 2 will address HIV/STI prevention (e.g., condom use) and will include basic facts about HPV vaccination that are currently available online. Module 3 will address healthy relationships. Phase 2 messages will reinforce Phase 1 content to maintain engagement.
Behavioral: Sexual Health Knowledge Control
Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.
- Retention [ Time Frame: 9 Month ]Intervention feasibility will be evaluated by retention in the RCT. The retention rate will be computed at the end of the 9-month trial by dividing the total number of participants who completed the trial (i.e., completed the 9-month assessment) by the total number of participants who were randomized to the treatment or control condition at the beginning of the trial. An 80% 9-month retention rate will be used to indicate a feasible intervention.
- Intervention Acceptability for Phase 1 [ Time Frame: 3 Weeks ]Intervention acceptability for the first 3 weeks of the intervention (Phase 1) will be assessed at the 3-week assessment. The scale includes both open-ended ("What did you like about the program? What could be improved?") and closed-ended questions (e.g., "I would recommend a program like this to my friends" 1=strongly disagree to 5=strongly agree). Closed-ended items will be combined to compute an average score. An average score ≥4 will be used to indicate an acceptable intervention.
- Intervention Acceptability for Full Intervention [ Time Frame: 9 Month ]Intervention acceptability for the full intervention will be assessed at the end the 9-month trial. The scale includes both open-ended ("What did you like about the program? What could be improved?") and closed-ended questions (e.g., "I would recommend a program like this to my friends" 1=strongly disagree to 5=strongly agree). Closed-ended items will be combined to compute an average score. An average score ≥4 will be used to indicate an acceptable intervention.
- Vaccination Status [ Time Frame: 9 Month ]A final confirmatory assessment of HPV vaccination status will be conducted at the 9-month follow-up. Participants will be asked whether they received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of doses and where they were received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994108
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Mary Gerend, PhD||Florida State University|
|Principal Investigator:||Brian Mustanski, PhD||Northwestern University|