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

NCT06189729 | Active Not Recruiting DMC

• 1 other identifier: 22-0406
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hiv

Keywords

men who have sex with men; hiv self-test

Outcome Measures

Primary Outcomes (2)

• Proportion of HIV tests performed with result returned

  Number of HIV self-test results returned divided by the total number of HIV self-tests delivered

  Month 3 to Month 12

• Retention rate

  Proportion of participants completed the questionnaire at Month 12

  Month 12

Secondary Outcomes (5)

• HIV incidence

  Month 3 to Month 12

• Linkage to care rate

  Month 3 to Month 12

• Single ease question

  Month 3 to Month 12

• Net promoter score

  Month 3 to Month 12

• System usability scale

  Month 3 to Month 12

Study Arms (3)

Cluster 1

OTHER

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; Behavioral: HIV self-test

Cluster 2

OTHER

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; Behavioral: HIV self-test

Cluster 3

OTHER

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; Behavioral: HIV self-test

Interventions

Text reminder BEHAVIORAL

Participants will receive trimonthly text reminders through instant messaging mobile applications or short message service.

Cluster 1; Cluster 2; Cluster 3

HIV self-test BEHAVIORAL

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.

Cluster 1; Cluster 2; Cluster 3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Stanley Ho Centre for Emerging Infectious Diseases

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Homosexuality

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexuality; Sexual Behavior; Behavior

Study Officials

• Tsz Ho Kwan, PhD

  Jockey Club School of Public Health and Primary Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: This is a stepped wedge trial. 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.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: January 3, 2024
• Study Start: January 15, 2024
• Primary Completion: December 18, 2025
• Study Completion (Estimated): November 29, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

HK (1)