Human Papillomavirus
Conditions
Keywords
Human Papillomavirus, Men Who Have Sex with Men
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.
Interventions
BEHAVIORALtxt2protect
Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.
BEHAVIORALSexual Health Control
Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | 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. |
| Intervention Acceptability for Phase 1 | 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 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. |
| Intervention Acceptability for Full Intervention | 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 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. |
| Number of Participants Who Initiated the HPV Vaccine Series | 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 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. |
| Number of Participants Who Completed the HPV Vaccine Series | 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motivation: Anticipated Regret | 3 Weeks | 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). |
| Behavioral Skills: Perceived Behavioral Control | 3 Weeks | 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. |
| Information: HPV-related Knowledge | 3 Weeks | 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. |
| Behavioral Intentions | 3 Weeks | Assessed with one item: I intend to get vaccinated for HPV in the next 9 months. 1 = strongly disagree to 5 = strongly agree. |
| Behavioral Skills: Self-efficacy | 3 Weeks | 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. |
| Motivation: Attitudes | 3 Weeks | Assessed with one item: My attitude toward getting vaccinated for HPV in the next 9 months is... 1 = very negative to 5 = very positive. |
| Motivation: Subjective Norms | 3 Weeks | 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. |
| Motivation: Perceived Susceptibility | 3 Weeks | 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). |
| Motivation: Perceived Severity | 3 Weeks | 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). |
Countries
United States
Participant flow
Recruitment details
Study recruitment took place from January through early September 2018 in the Chicago area.
Pre-assignment details
Although 155 participants completed the baseline survey, only 150 of them were randomized. A double screening protocol was used to ensure participants who had already been vaccinated were not accidentally enrolled. Five participants reported receiving a dose of HPV vaccine on baseline so they were no longer eligible for the RCT.
Participants by arm
| Arm | Count |
|---|---|
| txt2protect 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. | 72 |
| Sexual Health Control 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 Knowledge Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination. | 76 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Intervention Messages | Withdrawal by Subject | 2 | 0 |
| Phase 1 Assessment | Lost to Follow-up | 5 | 3 |
| Phase 2 Assessment | Lost to Follow-up | 8 | 7 |
| Phase 2 Assessment | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | txt2protect | Sexual Health Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 72 Participants | 76 Participants | 148 Participants |
| Age, Continuous | 22.78 years STANDARD_DEVIATION 2.03 | 23.06 years STANDARD_DEVIATION 2.39 | 22.92 years STANDARD_DEVIATION 2.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 20 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 56 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 18 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) White | 42 Participants | 38 Participants | 80 Participants |
| Region of Enrollment United States | 72 Participants | 76 Participants | 148 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 72 Participants | 76 Participants | 148 Participants |
| Sexual Orientation Bisexual | 17 Participants | 15 Participants | 32 Participants |
| Sexual Orientation Gay | 53 Participants | 57 Participants | 110 Participants |
| Sexual Orientation Other (e.g., queer, pansexual) | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 76 |
| other Total, other adverse events | 0 / 72 | 0 / 76 |
| serious Total, serious adverse events | 0 / 72 | 0 / 76 |
Outcome results
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.
Time frame: 9 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| txt2protect | Intervention Acceptability for Full Intervention | 4.22 score on a scale | Standard Deviation 0.51 |
| Sexual Health Control | Intervention Acceptability for Full Intervention | 4.18 score on a scale | Standard Deviation 0.5 |
p-value: 0.675t-test, 2 sided
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.
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| txt2protect | Intervention Acceptability for Phase 1 | 4.25 score on a scale | Standard Deviation 0.44 |
| Sexual Health Control | Intervention Acceptability for Phase 1 | 4.16 score on a scale | Standard Deviation 0.49 |
p-value: 0.249t-test, 2 sided
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.
Time frame: 9 Month
Population: A total of 150 participants were randomized. Three participants, all of whom were in the txt2protect arm, withdrew from the study. One of the three participants who withdrew provided permission to use include his data up until his withdrawal in month 3 and thus this participant was included in the primary analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| txt2protect | Number of Participants Who Completed the HPV Vaccine Series | 2 Participants |
| Sexual Health Control | Number of Participants Who Completed the HPV Vaccine Series | 1 Participants |
p-value: 0.92395% CI: [0.08, 16.95]Regression, Logistic
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.
Time frame: 9 Month
Population: A total of 150 participants were randomized. Three participants, all of whom were in the txt2protect arm, withdrew from the study. One of the three participants who withdrew provided permission to use include his data up until his withdrawal in month 3 and thus this participant was included in the primary analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| txt2protect | Number of Participants Who Initiated the HPV Vaccine Series | 14 Participants |
| Sexual Health Control | Number of Participants Who Initiated the HPV Vaccine Series | 5 Participants |
p-value: 0.02595% CI: [1.17, 10.08]Regression, Logistic
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.
Time frame: 9 Month
Population: A total of 150 participants were randomized. Three participants, all of whom were in the txt2protect arm, withdrew from the study. One of the three participants who withdrew provided permission to use include his data up until his withdrawal in month 3 and thus this participant was included in the primary analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| txt2protect | Retention | 63 Participants |
| Sexual Health Control | Retention | 69 Participants |
p-value: 0.601Chi-squared
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.
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| txt2protect | Behavioral Intentions | 4.16 score on a scale | Standard Deviation 0.86 |
| Sexual Health Control | Behavioral Intentions | 3.75 score on a scale | Standard Deviation 1.06 |
p-value: 0.013t-test, 2 sided
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.
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| txt2protect | Behavioral Skills: Perceived Behavioral Control | 4.42 score on a scale | Standard Deviation 0.68 |
| Sexual Health Control | Behavioral Skills: Perceived Behavioral Control | 4.19 score on a scale | Standard Deviation 1.07 |
p-value: 0.147t-test, 2 sided
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.
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| txt2protect | Behavioral Skills: Self-efficacy | 3.96 score on a scale | Standard Deviation 0.98 |
| Sexual Health Control | Behavioral Skills: Self-efficacy | 3.67 score on a scale | Standard Deviation 1.05 |
p-value: 0.096t-test, 2 sided
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.
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| txt2protect | Information: HPV-related Knowledge | 1.11 score on a scale | Standard Deviation 0.4 |
| Sexual Health Control | Information: HPV-related Knowledge | 1.00 score on a scale | Standard Deviation 0.5 |
p-value: 0.174t-test, 2 sided
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).
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| txt2protect | Motivation: Anticipated Regret | 4.76 score on a scale | Standard Deviation 0.6 |
| Sexual Health Control | Motivation: Anticipated Regret | 4.50 score on a scale | Standard Deviation 0.99 |
p-value: 0.064t-test, 2 sided
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.
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| txt2protect | Motivation: Attitudes | 4.51 score on a scale | Standard Deviation 0.61 |
| Sexual Health Control | Motivation: Attitudes | 4.11 score on a scale | Standard Deviation 0.87 |
p-value: 0.002t-test, 2 sided
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).
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| txt2protect | Motivation: Perceived Severity | 4.56 score on a scale | Standard Deviation 0.49 |
| Sexual Health Control | Motivation: Perceived Severity | 4.66 score on a scale | Standard Deviation 0.44 |
p-value: 0.183t-test, 2 sided
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).
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| txt2protect | Motivation: Perceived Susceptibility | 3.12 score on a scale | Standard Deviation 1 |
| Sexual Health Control | Motivation: Perceived Susceptibility | 2.78 score on a scale | Standard Deviation 1.04 |
p-value: 0.053t-test, 2 sided
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.
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| txt2protect | Motivation: Subjective Norms | 4.10 score on a scale | Standard Deviation 0.78 |
| Sexual Health Control | Motivation: Subjective Norms | 4.11 score on a scale | Standard Deviation 0.94 |
p-value: 0.964t-test, 2 sided