Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Retention
研究概览
简要总结
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:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants must:
- •Be male (sex at birth and gender identity)
- •Self-identify as gay, bisexual, or queer; ever had sex with a man; or be physically attracted to men
- •Be English speaking
- •Live in the Chicago metro area
- •Be the exclusive owner of a cell phone
- •Have used text messaging for at least 6 months
- •Plan to have the same cell phone number for the next 9 months
- •Be enrolled in an unlimited text messaging plan
排除标准
- •Participants must not have been previously vaccinated for HPV.
研究组 & 干预措施
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.
干预措施: txt2protect (Behavioral)
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.
干预措施: Sexual Health Control (Behavioral)
结局指标
主要结局
Retention
时间窗: 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 Full Intervention
时间窗: 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 Completed the HPV Vaccine Series
时间窗: 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.
Intervention Acceptability for Phase 1
时间窗: 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.
Number of Participants Who Initiated the HPV Vaccine Series
时间窗: 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.
次要结局
- Behavioral Skills: Self-efficacy(3 Weeks)
- Motivation: Perceived Susceptibility(3 Weeks)
- Information: HPV-related Knowledge(3 Weeks)
- Motivation: Attitudes(3 Weeks)
- Motivation: Subjective Norms(3 Weeks)
- Motivation: Perceived Severity(3 Weeks)
- Motivation: Anticipated Regret(3 Weeks)
- Behavioral Skills: Perceived Behavioral Control(3 Weeks)
- Behavioral Intentions(3 Weeks)
研究者
Mary Gerend
Associate Professor, Behavioral Sciences and Social Medicine, College of Medicine
Florida State University