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

Human Papillomavirus Clinical Trial

— t2p  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994108
• Other study ID #: 1R21CA208329-01
• Secondary ID: 1R21CA208329-01
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2020
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

Behavioral:
• txt2protect
Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.
• Sexual Health Control
Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Information: HPV-related Knowledge	Assessed with two questions (e.g., "HPV can cause anal cancer.") interspersed among other true/false questions assessing HIV/STI knowledge. Participants received one point for each correct response and zero points for incorrect and "don't know" responses. Points were summed to create a composite score that ranged from 0 to 2.	3 Weeks
Secondary	Motivation: Attitudes	Assessed with one item: "My attitude toward getting vaccinated for HPV in the next 9 months is..." 1 = very negative to 5 = very positive.	3 Weeks
Secondary	Motivation: Subjective Norms	Assessed with one item: "People who are important to me would want me to get vaccinated for HPV in the next 9 months." 1 = strongly disagree to 5 = strongly agree.	3 Weeks
Secondary	Motivation: Perceived Susceptibility	Assessed with four items (e.g., "If you don't get the HPV vaccine, what do you think are the chances that you will get HPV?" 1 = very unlikely to 5 = very likely).	3 Weeks
Secondary	Motivation: Perceived Severity	Assessed with four items (e.g., "How serious would each of the following be for you: If you developed warts on your penis or scrotum?" 1 = not at all serious to 5 = very serious).	3 Weeks
Secondary	Motivation: Anticipated Regret	Assessed with two items (e.g., "How much regret would you feel if you decided not to get the HPV vaccine and later developed genital or anal warts?" 1 = none to 5 = quite a lot).	3 Weeks
Secondary	Behavioral Skills: Perceived Behavioral Control	Assessed with one item: "To what extent is whether or not you get vaccinated for HPV in the next 9 months under your control?" 1 = not at all to 5 = completely.	3 Weeks
Secondary	Behavioral Skills: Self-efficacy	Assessed with one item: "Assuming you wanted to, how hard or easy would it be for you to get vaccinated for HPV in the next 9 months?" 1 = very hard to 5 = very easy.	3 Weeks
Secondary	Behavioral Intentions	Assessed with one item: "I intend to get vaccinated for HPV in the next 9 months." 1 = strongly disagree to 5 = strongly agree.	3 Weeks