NCT05811611

Brief Summary

A non-blinded parallel group randomized controlled trial is conducted. Adult male full-time employees of factories in Shenzhen who have access to smartphone and WeChat are recruited by staff of the Longhua Center for Disease Control and Prevention (CDC). After completing an online baseline questionnaire, participants will be randomized evenly to either the intervention group or the control group. Participants in the control group will have access to a WeChat Mini Program providing HIV and sexually transmitted prevention information during the project period. In addition to those received by the control group, the Mini Program will proactively ask participants in the intervention group some simple questions to assess presence of sexual risk behaviors at Month 0 and Month 1, and invite them to watch online health promotion video(s) tailored to their current sexual risk behaviors. All participants will complete two online follow-up surveys six and twelve months after completion of the interventions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

April 13, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

March 20, 2023

Last Update Submit

March 31, 2023

Conditions

Behavior, Sex

Outcome Measures

Primary Outcomes (2)

  • Sexual intercourse with non-regular female sex partner

    Proportion of the participants who have sexual intercourse with a non-regular female sex partner in the past six months

    6 months

  • Sexual intercourse with female sex workers

    Proportion of participants who have sexual intercourse with a female sex worker in the past six months

    6 months

Secondary Outcomes (2)

  • Condomless sex with non-regular female sex partners

    6 months

  • Condomless sex with female sex workers

    6 months

Study Arms (2)

WeChat Mini Program plus tailored online promotion videos

EXPERIMENTAL

1. Having access to a WeChat Mini Program providing HIV and STI prevention information during the project period 2. The WeChat Mini Program proactively asks questions assessing sexual risk behaviors at Month 0 and Month 1, and invite participants two watch online health promotion videos tailored to their sexual risk behaviors status.

Behavioral: WeChat Mini Program plus tailored online health promotion videos

WeChat Mini Program Only

ACTIVE COMPARATOR

Having access to a WeChat Mini Program providing HIV and STI prevention information during the project period

Behavioral: WeChat Mini Program Only

Interventions

WeChat Mini Program plus tailored online health promotion videosBEHAVIORAL

Participants have access to a WeChat Mini Program. Participants will also watch online health promotion videos tailored to their current sexual behaviors.

WeChat Mini Program plus tailored online promotion videos
WeChat Mini Program OnlyBEHAVIORAL

Participants only have access to a WeChat Mini Program.

WeChat Mini Program Only

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale at birth
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male at birth
  • Aged 18 years or above
  • Full-time employee of a factory in Shenzhen
  • Having a smartphone with internet access
  • Having installed or willing to install WeChat on the smartphone
  • Willing to complete follow-up surveys at Month 6 and 12

You may not qualify if:

  • Oral or anal sex with a man
  • Blindness ot deafness
  • Not able to communicate effectively with project staff
  • Self-reported as HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Health Behaviours Research, the Chinese University of Hong Kong

Hong Kong, 666888, Hong Kong

RECRUITING

Related Publications (1)

  • Zhang K, Cao B, Fang Y, Liang X, Ye D, Chen YQ, Zhong R, Cao H, Hu T, Li T, Cai Y, Zou H, Wang Z. Comparing the Efficacy of 2 WeChat Mini Programs in Reducing Nonmarital Heterosexual Contact by Male Factory Workers: Randomized Controlled Trial. J Med Internet Res. 2024 Sep 9;26:e49362. doi: 10.2196/49362.

    PMID: 39250213DERIVED

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Zixin Wang, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zixin Wang, PhD

CONTACT

+852 22528740wangzx@cuhk.edu.hk

Study Design

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

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 13, 2023

Study Start

December 1, 2021

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

April 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

The data involve sensitive sexual behaviors of the participants

Locations

HK(1)