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

NCT02994108 | Completed Results

• 1 other identifier: 1R21CA208329-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Human Papillomavirus

Keywords

Human Papillomavirus; Men Who Have Sex with Men

Outcome Measures

Primary Outcomes (5)

• Retention

  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.

  9 Month

• Intervention Acceptability for Phase 1

  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 12 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 were combined to compute an average score (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.

  3 Weeks

• Intervention Acceptability for Full Intervention

  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 11 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 (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.

  9 Month

• Number of Participants Who Initiated the HPV Vaccine Series

  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 received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine initiation was defined as receipt of one or more doses of HPV vaccine by the end of the 9-month trial.

  9 Month

• Number of Participants Who Completed the HPV Vaccine Series

  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 received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine completion was defined as receipt of three doses of HPV vaccine by the end of the 9-month trial.

  9 Month

Secondary Outcomes (9)

• Information: HPV-related Knowledge

  3 Weeks

• Motivation: Attitudes

  3 Weeks

• Motivation: Subjective Norms

  3 Weeks

• Motivation: Perceived Susceptibility

  3 Weeks

• Motivation: Perceived Severity

  3 Weeks

Study Arms (2)

txt2protect

EXPERIMENTAL

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.

Behavioral: txt2protect

Sexual Health Control

ACTIVE COMPARATOR

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.

Behavioral: Sexual Health Control

Interventions

txt2protect BEHAVIORAL

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

Also known as: t2p

txt2protect

Sexual Health Control BEHAVIORAL

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

Sexual Health Control

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Participants must not have been previously vaccinated for HPV.

Sponsors & Collaborators

• Northwestern University: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 32914838 DERIVED

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Results Point of Contact

• Title: Mary Gerend
• Organization: Florida State University College of Medicine

mary.gerend@med.fsu.edu

8506451541

Study Officials

• Mary Gerend, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

• Brian Mustanski, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Behavioral Sciences and Social Medicine, College of Medicine

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 15, 2016
• Study Start: January 3, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 20, 2020
• Results First Posted: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)