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



Status:Active, not recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 25
Updated:3/17/2019
Start Date:January 3, 2018
End Date:June 2019

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

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.


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.
We found this trial at
1
site
303 East Superior Street
Chicago, Illinois 60611
Phone: 312-503-5421
?
mi
from
Chicago, IL
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