Developing and testing of an interactive internet-based intervention to reduce sexual harm of sexualised drug use (‘chemsex’) among men who have sex with men in Hong Kong
| ISRCTN | ISRCTN20134522 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20134522 |
- Submission date
- 15/03/2021
- Registration date
- 17/03/2021
- Last edited
- 09/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Sexualised drug use, known as 'chemsex' or 'chemfun', is the practice of intentionally using illicit drugs before or during sexual activates to enhance sexual arousal and pleasure. This practice, however, poses harmful risks to sexual health. Chemsex is common among men who have sex with men (MSM). Chemsex has been found to increase the likelihood of engaging in other risky sexual behaviours that might increase the spread of sexually transmitted infections (STIs) and HIV.
We propose this trial because chemsex, which is an emerging issue among MSM, substantially increases the risk of HIV and STIs. In spite of this, there has been very limited research evaluating the effectiveness of interventions or health promotion programmes that specifically aim to reduce the intention to engage in chemsex and the actual chemsex behaviours among MSM.
Who can participate?
Men who have sex with men aged over 18 years.
What does the study involve?
Participants will be allocated to one of two groups, with an equal chance of being in either group (like tossing a coin). Participants and researchers will not have a choice in the treatment given. Participants in the first group will receive a web-based treatment containing interactive content that aims to:
1. Lower the desire to use drugs at sex by enhancing participants’ knowledge of chemsex, including negative health impacts, risks, social stigmas, and legal consequences
2. Foster a positive attitude towards consistent condom use
3. Foster a positive attitude toward regular HIV/STI testing
4. Increase the self-efficacy of refusing chemsex
5. Improve participants’ perceived self-efficacy in making informed decisions on HIV/STI prevention in both sober and drug-influenced sex
6. Set expectations that consistent condom use and regular HIV/STI testing are normative
The second group will receive only web-based information without sexual health components.
Participants in both groups will be evaluated before starting the web-based treatment and three months after starting the web-based treatment.
What are the possible benefits and risks of participating?
One possible benefit is that participants can enhance their sexual health knowledge. There is no significant risk in the study.
Where is the study run from?
School of Nursing, University of Hong Kong (Hong Kong)
When is the study starting and how long is it expected to run for?
From June 2020 to February 2022
Who is funding the study?
Council for the AIDS Trust Fund, Hong Kong (Hong Kong)
Who is the main contact?
Dr Edmond Pui Hang Choi, h0714919@connect.hku.hk
Contact information
Scientific
School of Nursing
The University of Hong Kong
4/F, William M.W. Mong Block
21 Sassoon Road, Pokfulam
Hong Kong
0000
Hong Kong
 ORCID ID |
0000-0001-9062-3540 |
|---|---|
| Phone | +852 3917 6600 |
| h0714919@connect.hku.hk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Developing and testing of an interactive internet-based intervention to reduce sexual harm of sexualised drug use ('chemsex') among men who have sex with men in Hong Kong |
| Study objectives | Participants receiving the internet-based intervention will be more likely to exhibit better self-efficacy in refusing risky sexual behaviours and chemsex, lower intention to engage in chemsex and chemsex behaviours, higher condom use consistency, and more HIV and STI testing, compared to MSM in the control group. |
| Ethics approval(s) | Approved 28/10/2020, Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (Room 901, 9/F, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong; +852 2255 4086; hkwirb@ha.org.hk), ref: HKU/HA HKW IRB: UW 20-650 |
| Health condition(s) or problem(s) studied | Safe sex to prevent sexually transmitted infections (STI) |
| Intervention | Participants will be randomly assigned to either the intervention group or control group via computer-generated block randomisation (with blocks of size 4) on a 1:1 randomisation ratio; no stratification will be applied. Men who have sex with men will be recruited and randomly allocated into either the intervention (n = 125) or control group (n = 125). Subjects in the intervention group will receive the web-based intervention containing interactive content that aims to: 1. Lower the desire to use drugs at sex by enhancing participants’ knowledge of chemsex, including negative health impacts, risks, social stigmas, and legal consequences 2. Foster a positive attitude towards consistent condom use 3. Foster a positive attitude toward regular HIV/STI testing 4. Increase the self-efficacy of refusing chemsex 5. Improve participants’ perceived self-efficacy in making informed decisions on HIV/STI prevention in both sober and drug-influenced sex 6. Set expectations that consistent condom use and regular HIV/STI testing are normative Participants in the control group will receive a web-based intervention without any sexual health information and without any interactive components. The contents for the control group will only include educational materials on general health information. |
| Intervention type | Behavioural |
| Primary outcome measure | Self-efficacy in refusing risky sexual behaviours and chemsex as measured using the Chinese version of Drug Avoidance Self-Efficacy Scale (DASES), the Self-Efficacy for Sexual Safety scale, and the traditional Chinese version of the Condom Self-Efficacy Scale (CSES) at baseline and 3 months |
| Secondary outcome measures | 1. Intention to have chemsex measured using participant interview at baseline and 3 months 2. Actual engagement in chemsex measured using participant interview at baseline and 3 months 3. Practice of condomless sex both sober and drug-influenced measured using participant interview at baseline and 3 months 4. The number of HIV/STI tests in the previous three months measured using participant interview at baseline and 3 months |
| Overall study start date | 29/06/2020 |
| Completion date | 16/02/2022 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 250 |
| Total final enrolment | 316 |
| Key inclusion criteria | 1. Cisgender men who have sex with men 2. Aged ≥18 years 3. Internet access 4. Able to read and understand Chinese |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 15/06/2021 |
| Date of final enrolment | 05/11/2021 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
21 Sassoon Road
Pokfulam
Hong Kong
0000
Hong Kong
Sponsor information
University/education
School of Nursing
4/F, William M.W. Mong Block
21 Sassoon Road
Pokfulam
Hong Kong
0000
Hong Kong
| Phone | +852 3917 6600 |
|---|---|
| nursing@hku.hk | |
| Website | http://www.hku.hk/ |
"ROR" |
https://ror.org/02zhqgq86 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Results will be published in peer-reviewed journals. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 13/04/2021 | 15/04/2021 | Yes | No | |
| Results article | primary and secondary results | 05/01/2023 | 09/01/2023 | Yes | No |
Editorial Notes
09/01/2023: Publication reference added.
01/04/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/10/2021 to 05/11/2021.
2. The overall trial end date has been changed from 31/10/2021 to 16/02/2022 and the plain English summary has been updated to reflect this change.
3. The total final enrolment number has been added.
15/06/2021: The recruitment start date was changed from 01/06/2021 to 15/06/2021.
11/05/2021: The recruitment start date was changed from 01/05/2021 to 01/06/2021.
19/04/2021: The recruitment start date was changed from 01/04/2021 to 01/05/2021.
15/04/2021: Publication reference added.
17/03/2021: Trial’s existence confirmed by Council for the AIDS Trust Fund, Hong Kong.
