NCT03660709

Brief Summary

Objective The objectives of the study are to evaluate the relative efficacy of an enhanced version of HIV testing and counselling (EHTC) versus standard-of-care HIV testing and counselling (SHTC) in reducing sexual risk behaviours, increasing retesting rate and risk perception among men who have sex with men (MSM) in Hong Kong. Participants Inclusion criteria are: 1) men of age 18 years or above using HTC services at AIDS Concern, 2) anal intercourse with at least one man in the last six months, 3) able to read and comprehend Cantonese, 4) willingness to provide contact information and to complete a simple follow up evaluation at Month 6, and 5) no intention to leave Hong Kong for one month consecutively within the next six months. Those self-reported or tested to be HIV positive will be excluded from the study. Design A parallel-group and non-blinded randomized controlled trial (RCT) will be conducted. A total of 430 participants will be randomly allocated into the intervention group receiving EHTC (n=215) and the control group receiving SHTC (n=215). Evaluation will be performed six months afterwards. Outcomes Primary outcomes are: 1) Prevalence of unprotected anal intercourse with any and specific types of male partners during the 6-month follow up period; 2) uptake of any type of HIV antibody testing within the 6-month follow-up period, and 3) HIV risk perception.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
430

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

September 4, 2018

Last Update Submit

May 20, 2020

Conditions

Behavior, Sex

Keywords

Unprotected anal intercourseHIV retestingRisk perception

Outcome Measures

Primary Outcomes (1)

  • Take up any type of HIV antibody testing

    Uptake of any type of HIV antibody testing within the follow-up period will be assessed at Month 6 telephone follow-up evaluation

    six months

Secondary Outcomes (2)

  • Unprotected anal intercourse with any and specific types of male partners

    six months

  • Risk perception

    six months

Study Arms (2)

Intervention

EXPERIMENTAL

enhanced version of HIV testing and counseling

Behavioral: Intervention

Control

ACTIVE COMPARATOR

standard-of-care HIV testing and counseling

Behavioral: Control

Interventions

InterventionBEHAVIORAL

1. Standard-of-care HIV testing and counseling 2. Watch a video clip while waiting for the HIV testing result on a tablet. 3. Receive a pamphlet and post-test counselling promoting HIV retesting. 4. Receive the e-health HIV risk calculator through e-mail, SMS or social media means 3 and 5 months afterwards. 5. Receive brief e-health reminder for retesting at Month 3 and 5.

Intervention
ControlBEHAVIORAL

Standard-of-care HIV testing and counseling

Control

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men of age 18 years or above taking up HIV testing and counselling (HTC) at a collaborative non-governmental organization (NGO),
  • anal intercourse with at least one man in the last six months
  • able to read and comprehend Cantonese
  • willingness to provide contact information and to complete a simple follow up evaluation at Month 6
  • no intention to leave Hong Kong for one month consecutively within the next six months.

You may not qualify if:

  • self-reported or tested to be 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

Location

MeSH Terms

Conditions

Sexual Behavior

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Zixin Wang, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

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
Research Assistant Professor

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 6, 2018

Study Start

September 1, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

May 21, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)