Condition category
Infections and Infestations
Date applied
28/08/2018
Date assigned
27/09/2018
Last edited
27/09/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Human immunodeficiency virus (HIV) is a major public health threat causing heavy social and medical costs. Although the prevalence of HIV in Hong Kong has been fairly stable over the past few years, the proportion of HIV cases attributed to unprotected homosexual and bisexual contacts have increased drastically. Behavioural interventions are needed to address the HIV burden among men who sex with men (MSM). Narrative persuasion (providing information in a story format) is proposed as a promising health communication approach to promote behavioural changes, but few studies have explored its efficacy in addressing HIV prevention.
This study, the HeHe Talks project, aims to investigate how well the narrative messages work in terms of reducing HIV risk behaviors among MSM in Hong Kong.

Who can participate?
Males aged 18 years or older who have engaged in anal sex with another man in the past 6 months, use the internet at least once per week, are able to read Chinese and are either HIV negative or status unknown

What does the study involve?
Participants will be randomly allocated to the intervention condition or the control one. All participants will watch six HIV prevention-themed videos on the study website, which are made available sequentially weekly. For the intervention group, the videos contain both narrative and didactic messages; whereas for the control group, the videos contain the didactic ones only.

What are the possible benefits and risks of participating?
The benefit of taking part is that participants will learn more about HIV prevention and may have a reduction in their HIV risk behaviours as a result. They will receive supermarket coupons as the compensation for their participation. There are no known risks to participants taking part in this study. Completing the intervention videos and evaluation surveys may cause fatigue among some participants.

Where is the study run from?
AIDS Concern Health Service Center, Hong Kong

When is the study starting and how long is it expected to run for?
May 2016 to October 2018

Who is funding the study?
General Research Funds by the Research Grant Council of Hong Kong

Who is the main contact?
Dr. Phoenix Kit-han, MO
phoenix.mo@cuhk.edu.hk

Trial website

https://hehetalks.com

Contact information

Type

Scientific

Primary contact

Dr Phoenix Kit-han Mo

ORCID ID

Contact details

Room 508
School of Public Health
Prince of Wales Hospital
Shatin
N.T.
Hong Kong
Hong Kong
NA
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RGC Ref No.14612615

Study information

Scientific title

Efficacy of the narrative persuasion intervention in changing HIV risk perceptions and behaviours among men who have sex with men in Hong Kong: an online randomised controlled trial

Acronym

HeHe Talks

Study hypothesis

The aim of this study is to test the efficacy of online narratives in changing HIV risk perceptions and behaviors among men who have sex with men (MSM) in Hong Kong using a randomised controlled trial design. The specific objectives are as below:
1. To examine the efficacy of an online intervention involving narrative and didactic information about HIV prevention in reducing unprotected anal intercourse, increasing HIV/STI risk perceptions, improving condom social norms, increasing HIV
testing behaviors, and increasing intentions to use condom and intentions to receive HIV testing among MSM, compared to the control group who will only receive online didactic information about HIV prevention.
2. To examine the information processing mechanisms underlying the potential efficacy of the intervention information.

Ethics approval

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee, 03/06/2014, reference number: 2014.274-T

Study design

Interventional single-centre two-arm single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Prevention

Patient information sheet

https://hehetalks.com/about

Condition

HIV prevention

Intervention

Participants will be randomly allocated to the intervention group or the control group using the web-based tool Research Randomizer.
The multiple-session intervention will last for 6 weeks and both groups will be provided with six HIV-themed videos on the study website, which are made available sequentially weekly. For the intervention group, the videos contain both narrative and didactic messages; whereas for the control group, the videos contain the didactic ones only. Firsthand stories will be elicited from eligible MSM peers with diverse behavioral patterns and experiences of HIV/STI infection to generate collective narrative messages under six themes related to HIV prevention. Theme-equivalent didactic messages will then be developed accordingly. For the intervention group, the information will be related to reducing unprotected anal intercourse, increasing HIV/STI risk perceptions, improving condom social norms, increasing HIV testing behaviors, and increasing intentions to use condom and intentions to receive HIV testing among MSM.
Efficacy outcomes will be measured at baseline (T0), post-intervention (T1) and six-month follow-up (T2).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The following will be measured through an online self-administered survey (The HIV Preventive Behavior Survey) on the study website:
1. Unprotected anal intercourse: the frequency of condom use in both receptive and insertive anal sex with different types of sex partners (regular and non-regular partners) in the past 3 months at T0, during the intervention period at T1, and during the follow-up period at T2; and whether they had used a condom in the last sex encounter with the different types of sex partners.
2. HIV testing: whether they have taken part in HIV testing in the past six months at T0, during the intervention period at T1, and during the follow-up period at T2

Secondary outcome measures

The following will be measured through an online self-administered survey (The HIV Preventive Behavior Survey) on the study website:
1. Cognitive correlates of behavioural outcomes, assessed at the baseline (T0), during the intervention period at T1 and during the follow-up period at T2:
1.1. Intention to use a condom
1.2. Perceived behavioural control over condom use
1.3. Condom social norms
1.4. Attitudes towards condom use
1.5. Risk perceptions about HIV/STIs
1.6. Self-efficacy about condom use
1.7. Intention to be tested for HIV
2. Measures of information processing mechanisms, assessed during the intervention period at T1 and during the follow-up period at T2:
2.1. Argument-based cognitive responses
2.2. Narrative responses

Overall trial start date

01/05/2016

Overall trial end date

31/10/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male
2. Aged 18 years or older
3. Self-reported to have engaged in anal sex with another man in the past 6 months
4. Self-reported as a regular internet use (use the internet at least once per week)
5. Able to read Chinese

Participant type

Other

Age group

Adult

Gender

Male

Target number of participants

118 for the intervention group and 118 for the control group. 236 participants in total

Participant exclusion criteria

Diagnosed as HIV positive prior to enrolment

Recruitment start date

01/09/2017

Recruitment end date

15/03/2018

Locations

Countries of recruitment

Hong Kong

Trial participating centre

AIDS Concern Health Service Center
Flat B, 3/F, Fu Lee Commercial Building, 14 – 20 Pilkem Street, Jordan, Kowloon
Hong Kong
NA
Hong Kong

Sponsor information

Organisation

the Research Grants Council of Hong Kong

Sponsor details

7/F.
Shui On Centre
6-8 Harbour Road
Wanchai
Hong Kong SAR
China.
Hong Kong
NA
Hong Kong

Sponsor type

Research council

Website

https://www.ugc.edu.hk/eng/rgc/index.html

Funders

Funder type

Not defined

Funder name

the Research Grants Council of Hong Kong

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Methods for the intervention development, findings of process evaluation and efficacy evaluation will be published in the peer-reviewed journals and disseminated in the international conferences within 3 years of the end of the project.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to the confidentiality agreement made between the research team and MSM participants to address the ethical concern.

Intention to publish date

31/12/2018

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes