txt2protect: Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men
Condition: Human Papillomavirus
Study type: Interventional

Summary: 
      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:

        1. 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.

        2. 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.
    


Intervention name(s): txt2protect; Sexual Health Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.; Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.
Other intervention name(s): t2p
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Human Papillomavirus; Men Who Have Sex with Men