txt2protect: Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men

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.

Conditions

• Human Papillomavirus

Interventions

BEHAVIORAL

txt2protect

Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.

BEHAVIORAL

Sexual Health Control

Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• Northwestern University

  lead OTHER

Principal Investigators

• Mary Gerend, PhD · Florida State University

• Brian Mustanski, PhD · Northwestern University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

25 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-01-03

Primary Completion

2019-06-30

Completion

2019-06-30

Countries

• United States

Study Locations