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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA208329-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| txt2protect | Behavioral | Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Participants must:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mary Gerend, PhD | Florida State University | Principal Investigator |
| Brian Mustanski, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32914838 | Derived | 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. |
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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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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.
Study recruitment took place from January through early September 2018 in the Chicago area.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Messages |
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| Phase 1 Assessment |
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| Phase 2 Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 9 Month |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Gerend | Florida State University College of Medicine | 8506451541 | mary.gerend@med.fsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 27, 2019 | Jul 25, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2018 | Jun 11, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| Sexual Health Control | Behavioral | Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination. |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
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| Age, Continuous | Geometric Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Sexual Orientation | Count of Participants | Participants |
|
| OG001 | 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 Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 Weeks |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 9 Month |
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| 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. | 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. | Posted | Count of Participants | Participants | 9 Month |
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| 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. | 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. | Posted | Count of Participants | Participants | 9 Month |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 Weeks |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 Weeks |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 Weeks |
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| 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). | Posted | Mean | Standard Deviation | score on a scale | 3 Weeks |
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| 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). | Posted | Mean | Standard Deviation | score on a scale | 3 Weeks |
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| 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). | Posted | Mean | Standard Deviation | score on a scale | 3 Weeks |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 Weeks |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 Weeks |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 Weeks |
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|
| 0 |
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | 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. | 0 | 76 | 0 | 76 | 0 | 76 |
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