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

Northwestern University

Status: Completed

Conditions: Human Papillomavirus

Treatments: Behavioral: Sexual Health Control; Behavioral: txt2protect

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02994108

1R21CA208329-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Male

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Participants must:

1. Be male (sex at birth and gender identity)
2. Self-identify as gay, bisexual, or queer; ever had sex with a man; or be physically attracted to men
3. Be English speaking
4. Live in the Chicago metro area
5. Be the exclusive owner of a cell phone
6. Have used text messaging for at least 6 months
7. Plan to have the same cell phone number for the next 9 months
8. Be enrolled in an unlimited text messaging plan

Exclusion Criteria

• Participants must not have been previously vaccinated for HPV.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

txt2protect

Experimental group

Description:

Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed 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 largely reinforced Phase 1 content to foster continued engagement with the program. txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.

Treatment:

Behavioral: txt2protect

Sexual Health Control

Active Comparator group

Description:

Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 "booster" messages largely reinforced Phase 1 content to foster continued engagement with the program. Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.

Treatment:

Behavioral: Sexual Health Control