Promoting Repeated HIV Self-testing Among MSM in Hong Kong | NCT04434950

Studies
Promoting Repeated HIV Self-testing Among MSM in Hong Kong

NCT04434950

Sponsor

Chinese University of Hong Kong

Status

Unknown status

Last Update Posted

Aug 13, 2020Actual

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Behavior, Health

Interventions

Promoting and implementing repeated HIV self-testing and online real-time counseling

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Jul 31, 2021Estimated

Completion Date

Jul 31, 2021Estimated

First Submitted Date

Jun 15, 2020

First Submission Date that Met QC Criteria

Jun 15, 2020

First Posted Date

Jun 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2020

Last Update Posted Date

Aug 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zixin Wang, Assistant Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this longitudinal study, we will firstly construct a cohort of HIV negative MSM, who will be exposed to an online video-based intervention promoting HIV testing in general and real-time HIV self-testing with online counselling service (HIVST-online) in particular. Participants will receive intervention at baseline, Month 6 and Month 12.

Detailed Description

500 MSM will be recruited via venue-based, online outreach, and NGO referrals. At baseline, Month 6 and Month 12, participants received online intervention promoting HIV testing in general and HIV testing with online real-time counseling service. Free HIV self-testing kits will be mailed to participants at baseline, Month 6 and Month 12. Upon appointment, a testing administrator will provide online real-time pre-test and post-test counseling service for HIV self-testing users.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Intervention group	Behavioral: Promoting and implementing repeated HIV self-testing and online real-time counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Promoting and implementing repeated HIV self-testing and online real-time counseling	Behavioral	At baseline, Month 6 and Month 12, participants will view an online video clip promoting the needs for HIV testing in general and HIV self-testing with online real-time counseling. A free HIV self-testing kit will be sent to participants. An HIVST administrator will provide online real-time pre-test and post-test counseling.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HIV testing of any type	Taking up any type of HIV testing during the follow-up period	14 months

Secondary Outcomes

Measure	Description	Time Frame
HIV self-testing	Taking up HIV self-testing during the follow-up period	14 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hong Kong Chinese speaking men
≥18 years old
Anal intercourse with at least one man in the last six months
Access to online face-to-face communication tools (e.g., Line, Skype, WhatsApp)

Exclusion Criteria:

Self-reported to be HIV positive

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zixin Wang	Contact	51669414		wangzx@cuhk.edu.hk

Overall Officials

Name	Affiliation	Role
Zixin Wang	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Health Behaviours Research, the Chinese University of Hong Kong	Recruiting	Hong Kong		666888	Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided