Evaluation of an Interactive Web-based Sexual Health Literacy Program to Safe Sex Practice for Female University Students: A Multicentred Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 781
- 试验地点
- 2
- 主要终点
- Change from consistency in condom use with every partner at 3 months
研究概览
简要总结
The primary objective is to evaluate the efficacy of an Interactive web-based sexual health literacy program to enhance safe sex practice among female university students. Based on Health Belief Model, the intervention comprising: (1) personalized perceived susceptibility and perceived severity of STIs and cervical cancer; (2) perceived benefits and perceived barriers of safe sex practice via knowledge- based information; (3) cue to action via the local resources; and (4) self-efficacy via narrative stories, which are tailored for female university students, to communicate safe sex messages. The investigators hypothesised that the intervention will enhance consistency of condom use, knowledge, attitude, norms, self-efficacy towards condom use, sexual consent, sexual communication and reduce sexual coercion and casual sex among participants in intervention group compared to those in control group.
A multicentered randomized controlled trial will be conducted in 500 female university students in 5 universities with dormitories. Inclusion criteria are unmarried female university Chinese students aged at least 18-year and not received any sexual health intervention in the past 12 months. The main outcome measures will be self-reported consistency of condom use with every partner in 3-month assessments, sexual coercion, sexual consent, casual sex and sexual communication. The study instruments used will be UCLA Multidimensional Condom Attitudes Scale; Sexual Consent Scale-Revised; Conflict Tactic Scale-Revised; and Sexual Communication Self-Efficacy Scale. The data analysis will be a linear mixed effects model with intervention group and baseline consistency of condom use as the covariates. The investigators expected that the intervention will enhance consistency of condom use with Cohen effect size of 0.3.
详细描述
Subject recruitment procedures:
Recruitment of participants will be conducted by using bulk electronic mails, promotional brochures, posters and campus booths. An invitation card with a QR code of the web-based intervention will be used for inviting female university students to enrol the study. Online enrolment will be done for screening participants for eligibility. From the investigators' past experience in recruiting university students, the investigators shall be able to reach over 30,000 female university students in five universities.
Participants will be asked to complete the web-based baseline survey at enrolment. The web-based questionnaire will be set up under an online platform. Participants may use their mobile devices including laptop computers and smartphones to complete the questionnaire. Participation is entirely voluntary. Written informed consent will be obtained via the web-based platform before completing the baseline questionnaire.
After completion of the questionnaire, the recruited students will then be randomized to either intervention group or control group, according to a list prepared by blocked randomization of a size decided by a randomizer. The block size and order of allocation will be kept securely in the randomizer to avoid selection bias. Allocation concealment will be done at the online platform according to the participants' enrolment sequence. The participants will then be guided to a web-page according to their group allocation.
At 3-month and 6-month after the entry of the study, participants will receive a link through their e-mail to complete a follow-up questionnaire (T2). Three months later, another e-mail link will be sent to participants for completing the last follow-up questionnaire (T3). If no response from a participant, a follow-up telephone text-message and/or telephone call will be sent after 1 week as a reminder.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female university students aged at least 18 years
- •Able to read Chinese or understand Cantonese
- •Unmarried
- •Having intimate partners in the past 12 months
- •Did not receive any sexual health information including formal face-to-face or online education/ training courses related to contraceptives and sexually transmitted diseases from university, hospitals, clinics and non-governmental organizations in the past 12 months
排除标准
- •Unwilling to complete the questionnaires at 3 time points
- •Pregnant women and postnatal women
- •With psychiatric illness
结局指标
主要结局
Change from consistency in condom use with every partner at 3 months
时间窗: Baseline, 3-month post intervention and 6-month post intervention
It will be assessed by using percentage of male condom protected sex with every partner according to the recommended guidelines from the systematic review of 56 studies. Other behavioural items will also be asked, for examples, condom use at last sex and description of sexual partners (dating partner vs casual partner) at last sex.
次要结局
- Knowledge, attitude, norms and self-efficacy of sexual coercion and sexual consent(Baseline, 3-month post intervention and 6-month post intervention)
- Knowledge, attitude, norms and self-efficacy of condom use(Baseline, 3-month post intervention and 6-month post intervention)
- Engagement time of the participants(6-month post intervention)
- Incidence of adverse events of the intervention(6-month post intervention)
- Overall satisfaction of the intervention(6-month post intervention)
- Incidence of searching more information about safe sex practice(3-month post intervention and 6-month post intervention)
- Demographics(Baseline, 3-month post intervention and 6-month post intervention)
- Retention of the participant(6-month post intervention)
- Percentage of performance on the interactive tasks(6-month post intervention)
- Total pages of the website each participant visited(6-month post intervention)
- Sexual coercion(Baseline, 3-month post intervention and 6-month post intervention)
- Self-efficacy in sexual communication(Baseline, 3-month post intervention and 6-month post intervention)
研究者
Dr. Janet Wong
Associate Professor
The University of Hong Kong