Facilitating Routine HIV Testing Among MSM by a Subscription-based Self-test Distribution Model

March 17, 2026 updated by: Tsz Ho Kwan, Chinese University of Hong Kong

Facilitating Routine HIV Testing Among MSM by a Subscription-based HIV Self-test Distribution Model: a Stepped Wedge Randomised Controlled Trial

The goal of this stepped wedge trial is to assess if a subscription-based HIV self-test distribution model could facilitate routine HIV testing in the men who have sex with men community. The main questions it aims to answer are the effectiveness of the model in enhancing routine HIV testing and its acceptability in the community. The 1-year observation period would be divided into control and intervention period. Participants will be reminded to get HIV tested via instant messaging apps or short message service during the control period. During the intervention period, the researchers will deliver an HIV self-test to the participants. Researchers will compare the testing rate between the two periods to see if the intervention can facilitate HIV testing.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants would be assigned randomly to a sequence group and crossed over from the control to intervention. In this study, the 1-year observation period is divided into four three-month intervals. All sequences would start with a control period. The three sequences would cross over to the intervention at Month 3, 6, and 9, respectively. All participants would therefore eventually receive intervention. The investigators adopt an mHealth approach for both control and intervention. Based on the results of a previous study that text messages through short message service (SMS) and instant messing (IM) apps are acceptable and feasible in promoting HIV self-management, participants during the control period would receive trimonthly text reminders through their designated IM app or SMS. The message would invite them to get HIV tested with free VCT service provider information. After 14 days, a follow-up message with the link to an online survey would be sent to enquire whether the participants had been tested or not. Participants during the intervention period would receive a trimonthly text messages asking them to choose a pickup point run by the delivery company to collect the free HIVST. Upon receiving the delivery instruction, the HIVST with bilingual (Chinese and English) instructions would be delivered to the designated location. Participants would be asked to perform the self-test and return the photographed result within 14 days. Similarly, after 14 days, a follow-up message with the link to an online survey would be sent to ask them to upload the photo of the test result. The uploaded images would be verified by the research team who are experienced in reading HIVST results both online and offline. Follow-up confirmation testing and medical service referral would be offered if the result was indeterminate or suspected to be positive. If the results were not returned after 14 days, an exit survey would be sent to the participants through IM apps or SMS.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Stanley Ho Centre for Emerging Infectious Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • be aged 18 years or above
  • be biologically male
  • have ever had sex with another men
  • have more than 1 male sex partners in the past 6 months
  • normally reside in Hong Kong
  • be able to communicate in written and spoken Chinese or English

Exclusion Criteria:

  • previously HIV diagnosis
  • unable or unwilling to give informed consent, to complete the questionnaires, to receive text messages as scheduled and when necessary, and to provide the mobile phone number to receive text messages for reminders and delivery notices

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cluster 1
Participants will receive text reminders at Month 0 only. They will receive an HIV self-test at Months 3, 6, 9 and 12, upon submission of the self-test result.
Behavioral: Text reminder
Participants will receive trimonthly text reminders through instant messaging mobile applications or short message service.
Behavioral: HIV self-test
Participants will receive trimonthly text messages asking them to choose a pickup point run by the delivery company to collect the free HIV self-test. Upon receiving the delivery instruction, the self-test kit with bilingual (Chinese and English) instructions would be delivered to the designated location.
Other: Cluster 2
Participants will receive text reminders at Months 0 and 3. They will receive an HIV self-test at Months 6, 9 and 12, upon submission of the self-test result.
Behavioral: Text reminder
Participants will receive trimonthly text reminders through instant messaging mobile applications or short message service.
Behavioral: HIV self-test
Participants will receive trimonthly text messages asking them to choose a pickup point run by the delivery company to collect the free HIV self-test. Upon receiving the delivery instruction, the self-test kit with bilingual (Chinese and English) instructions would be delivered to the designated location.
Other: Cluster 3
Participants will receive text reminders at Months 0, 3 and 6. They will receive an HIV self-test at Months 9 and 12, upon submission of the self-test result.
Behavioral: Text reminder
Participants will receive trimonthly text reminders through instant messaging mobile applications or short message service.
Behavioral: HIV self-test
Participants will receive trimonthly text messages asking them to choose a pickup point run by the delivery company to collect the free HIV self-test. Upon receiving the delivery instruction, the self-test kit with bilingual (Chinese and English) instructions would be delivered to the designated location.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of HIV tests performed with result returned
Time Frame: Month 3 to Month 12
Number of HIV self-test results returned divided by the total number of HIV self-tests delivered
Month 3 to Month 12
Retention rate
Time Frame: Month 12
Proportion of participants completed the questionnaire at Month 12
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV incidence
Time Frame: Month 3 to Month 12
Dividing the number of laboratory confirmed HIV-positive results by the total number of person-years
Month 3 to Month 12
Linkage to care rate
Time Frame: Month 3 to Month 12
The proportion of tests requiring further confirmation and medical service referral.
Month 3 to Month 12
Single ease question
Time Frame: Month 3 to Month 12
In a scale of 1-7, how easy or difficult was the task was?
Month 3 to Month 12
Net promoter score
Time Frame: Month 3 to Month 12
In a scale of 0-10, how likely would the participant recommend this model to their peers?
Month 3 to Month 12
System usability scale
Time Frame: Month 3 to Month 12
There are ten 5-point Likert scale questions. The scores would be summed and multiply by a factor of 2.5 according to the formula to come up with the score between 0 to 100.
Month 3 to Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Tsz Ho Kwan, PhD, Jockey Club School of Public Health and Primary Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Actual)

December 18, 2025

Study Completion (Estimated)

November 29, 2026

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0406

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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