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txt2protect: Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men (t2p)

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ClinicalTrials.gov Identifier: NCT02994108
Recruitment Status : Active, not recruiting
First Posted : December 15, 2016
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mary Gerend, Florida State University

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.


Condition or disease Intervention/treatment Phase
Human Papillomavirus Behavioral: txt2protect Behavioral: Sexual Health Knowledge Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: txt2protect
Content will be delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants will receive 5-10 messages daily. During Phase 2 (weeks 4-36), message frequency will decrease from weekly to monthly messages. Phase 1 content will be presented in 3 modules. Module 1 will address information about HPV infection and HPV vaccine. Module 2 will address motivations to receive HPV vaccine. Module 3 will focus on 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 will largely reinforce previous content to foster continued engagement with the program, although some new content will also be introduced.
Behavioral: txt2protect
Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.
Other Name: t2p

Active Comparator: Sexual Health Knowledge Control
Content will be delivered in 2 phases over 36 weeks. Phase 1 content will be presented in 3 modules; however, unlike the treatment group, content will be topic-based rather than theory-based and will focus on general sexual health. Module 1 will address basic facts about HIV and STIs, including HPV. Module 2 will address HIV/STI prevention (e.g., condom use) and will include basic facts about HPV vaccination that are currently available online. Module 3 will address healthy relationships. Phase 2 messages will reinforce Phase 1 content to maintain engagement.
Behavioral: Sexual Health Knowledge Control
Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.




Primary Outcome Measures :
  1. Retention [ Time Frame: 9 Month ]
    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.

  2. Intervention Acceptability for Phase 1 [ Time Frame: 3 Weeks ]
    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 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. An average score ≥4 will be used to indicate an acceptable intervention.

  3. Intervention Acceptability for Full Intervention [ Time Frame: 9 Month ]
    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 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. An average score ≥4 will be used to indicate an acceptable intervention.

  4. Vaccination Status [ Time Frame: 9 Month ]
    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 where they were received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994108


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mary Gerend, PhD Florida State University
Principal Investigator: Brian Mustanski, PhD Northwestern University

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Responsible Party: Mary Gerend, Associate Professor, Behavioral Sciences and Social Medicine, College of Medicine, Florida State University
ClinicalTrials.gov Identifier: NCT02994108     History of Changes
Other Study ID Numbers: 1R21CA208329-01 ( U.S. NIH Grant/Contract )
1R21CA208329-01 ( U.S. NIH Grant/Contract )
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The PI agrees to develop a de-identified database, codebook, and mechanism by which IPD could be shared with other investigators upon approval of the PI. Data will be available for request approximately 6 months after completion of the project. Interested investigators will be asked to complete a standardized request form stating the specific aims of the analysis, the analytic plans, resources the requestors have to carry out the project, the proposed timeline, and distribution goals (manuscripts and/or grant application). The PI will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to undertake the request, how data will be protected/managed, and whether there are sufficient resources to honor the request. If any of these issues are problematic, the PI will attempt to negotiate a fair resolution with the interested parties and/or with NIH program staff.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mary Gerend, Florida State University:
Human Papillomavirus
Men Who Have Sex with Men

Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs