NCT03695679

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
781

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 16, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2019

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

2.2 years

First QC Date

September 16, 2018

Last Update Submit

November 7, 2022

Conditions

Keywords

computer-assisted instruction/methodssafe sexstudentsuniversities

Outcome Measures

Primary Outcomes (1)

  • Change from consistency in condom use with every partner at 3 months

    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.

    Baseline, 3-month post intervention and 6-month post intervention

Secondary Outcomes (12)

  • Knowledge, attitude, norms and self-efficacy of condom use

    Baseline, 3-month post intervention and 6-month post intervention

  • Knowledge, attitude, norms and self-efficacy of sexual coercion and sexual consent

    Baseline, 3-month post intervention and 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

  • Retention of the participant

    6-month post intervention

  • +7 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Interactive computer-based intervention

Behavioral: Interactive computer-based intervention

Control group

NO INTERVENTION

An one-page online information about procedures and tips of condom use with minimal intervention

Interventions

There are 4 components of the Interactive computer-based intervention(ICBI) which will be delivered in 3 phases: 1. Perceived Susceptibility and Perceived Severity 2. Perceived Benefits and Perceived Barriers 3. Cue to Action 4. Self-Efficacy In addition, a discussion forum will be created to handle questions from the participants. Also, there will be an email address for enquiries if the participants need any support or if they want to seek further enquiry/ clarification after reading the web-based information.

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unwilling to complete the questionnaires at 3 time points
  • Pregnant women and postnatal women
  • With psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, LKS Faulty of Medicine, The University of Hong Kong

Hong Kong, 852, Hong Kong

Location

Related Publications (2)

  • Zhang W, Wong CKH, Xin Y, Fong DYT, Wong JYH. A Web-Based Sexual Health Intervention to Prevent Sexually Transmitted Infections in Hong Kong: Model-Based Cost-Effectiveness Analysis. J Med Internet Res. 2023 Aug 10;25:e45054. doi: 10.2196/45054.

  • Wong JY, Zhang W, Wu Y, Choi EPH, Lo HHM, Wong W, Chio JHM, Tam HLC, Ngai FW, Tarrant M, Wang MP, Ngan HY, Fong DY. An Interactive Web-Based Sexual Health Literacy Program for Safe Sex Practice for Female Chinese University Students: Multicenter Randomized Controlled Trial. J Med Internet Res. 2021 Mar 12;23(3):e22564. doi: 10.2196/22564.

MeSH Terms

Conditions

Safe Sex

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Janet Yuen Ha Wong, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 16, 2018

First Posted

October 4, 2018

Study Start

September 1, 2017

Primary Completion

October 29, 2019

Study Completion

October 29, 2019

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations