Clinical trial NCT02994108: txt2protect: Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men
Official title: Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus
Keywords: Human Papillomavirus
Men Who Have Sex with Men
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2016-12-15
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Retention
timeFrame: 9 Month
measure: Intervention Acceptability for Phase 1
timeFrame: 3 Weeks
measure: Intervention Acceptability for Full Intervention
timeFrame: 9 Month
measure: Number of Participants Who Initiated the HPV Vaccine Series
timeFrame: 9 Month
measure: Number of Participants Who Completed the HPV Vaccine Series
timeFrame: 9 Month
Secondary outcomes:
measure: Information: HPV-related Knowledge
timeFrame: 3 Weeks
measure: Motivation: Attitudes
timeFrame: 3 Weeks
measure: Motivation: Subjective Norms
timeFrame: 3 Weeks
measure: Motivation: Perceived Susceptibility
timeFrame: 3 Weeks
measure: Motivation: Perceived Severity
timeFrame: 3 Weeks
measure: Motivation: Anticipated Regret
timeFrame: 3 Weeks
measure: Behavioral Skills: Perceived Behavioral Control
timeFrame: 3 Weeks
measure: Behavioral Skills: Self-efficacy
timeFrame: 3 Weeks
measure: Behavioral Intentions
timeFrame: 3 Weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Florida State University
name: Mary Gerend, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Brian Mustanski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerend MA, Madkins K, Crosby S, Korpak AK, Phillips GL, Bass M, Houlberg M, Mustanski B. Evaluation of a Text Messaging-Based Human Papillomavirus Vaccination Intervention for Young Sexual Minority Men: Results from a Pilot Randomized Controlled Trial. Ann Behav Med. 2021 Apr 7;55(4):321-332. doi: 10.1093/abm/kaaa056.