The development of an online intervention to reduce HIV/STI risk and drug use-related harms among stimulant-using men who have sex with men (MSM) in Malaysia

ISRCTN	ISRCTN14406171
DOI	https://doi.org/10.1186/ISRCTN14406171
Secondary identifying numbers	UPUM/2020-MAC.588

Submission date: 22/10/2021
Registration date: 15/12/2021
Last edited: 11/07/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The study aims to develop a community-based, online intervention to address the mental health and sexual health needs among stimulant-using MSM in Malaysia. Recreational drug use in the sexual context (“chemsex”) is driving the HIV epidemic among MSM in Malaysia and yet community-based, harm-reduction services are not available for MSM who wish to reduce their drug use or support their recovery from drug abuse. In this study, participants will be able to receive peer counselling on drug use and sexual risk reduction, access interactive online education materials to support their recovery, at their own privacy and convenient time. This randomized controlled trial will provide feasibility, acceptability, and efficacy of a community-led online intervention to reduce harms associated with stimulant use among MSM in Malaysia. Specifically, this online intervention will address HIV/STI/Hepatitis risk and a range of adverse mental health conditions such as depression, suicidality, and harms related to methamphetamine overdose and methamphetamine-induced psychosis.

Who can participate?
Men aged at least 18 years who eEngaged in chemsex with other men (defined as using crystal methamphetamine, GBL/GHB, or ecstasy/MDMA) in the past 12 months

What does the study involve?
Participants will be randomly allocated to two groups:
Group A will receive the developed intervention tool comprising a Brief Intervention (FRAME Model). An online meeting will be arranged with a trained, peer counsellor to discuss drug use behaviour and to provide support and motivation to change. After the brief counseling, participant will then be directed to the Chemsex Care Plan, a self-directed interactive program that participants can access anytime at their convenience and will provide participants access to online materials (videos, infographics, etc) to educate stimulant-using MSM on reducing risky drug-use behaviour, as well as goal-setting. Participant will be asked to complete a brief survey at 6-week and 12-week follow-up to assess the drug use behavior and motivation to change.

Group B will receive a self-help toolkit from the World Health Organization for cutting down and stopping drug use. Participant is encouraged to use the toolkit to manage their drug use for 12 weeks. Similar to Group A, they will then be asked to complete a follow-up survey after 6 weeks and 12 weeks. After the end of the study, they will be given access to the Chemsex Care Plan.

What are the possible benefits and risks of participating?
Possible benefits
All participants will be provided with the online education and psychosocial support listed within the study, which will provide them assistance in managing/reducing drug use, risky sexual behavior, as well as improving mental health. Participants will also be given referred to HIV prevention services under the Malaysian AIDS Council to reduce their risk for HIV/STI/Hep C infection. They will also be referred to access substance abuse treatment services available in Malaysia as they wish.
Possible risks
Some questions asked might be sensitive in nature, and may cause discomfort or distress while answering. This may also occur during sessions with counselor or caseworker. Participation itself might cause a risk, as the nature of the study can be considered sensitive.

Where is the study run from?
This study is an online intervention by Malaysian Aids Council and Centre of Excellence for Research in AIDS (CERiA), University of Malaya.

When is the study starting and how long is it expected to run for?
December 2020 to June 2022

Who is funding the study?
The Global Fund to Fight AIDS, Tuberculosis and Malaria, the Sustainability of HIV Services for Key Populations in Asia Program (SKPA) and the Malaysian AIDS Council.

Who is the main contact?
1. Dr Lim Sin How, howie.ceria@gmail.com
2. Associate Prof Dr Anne Yee, annyee17@um.edu.my

Study website

Contact information

Miss Jia Ying Yap
Public

Centre of Excellence for Research in AIDS (CERiA)
Level 17, Wisma R&D.
Universiti Malaya
Jalan Pantai Baharu
Kuala Lumpur
59900
Malaysia

Phone	+60163218296
Email	mac.umcss@gmail.com

Dr Sin How Lim
Scientific

Centre of Excellence for Research in AIDS (CERiA)
Level 17, Wisma R&D.
Universiti Malaya
Jalan Pantai Baharu
Kuala Lumpur
59900
Malaysia

ORCID ID	0000-0002-8727-4826
Phone	+60129533220
Email	howie.ceria@gmail.com

Prof Anne Yee
Scientific

Centre of Excellence for Research in AIDS (CERiA)
Level 17, Wisma R&D.
Universiti Malaya
Jalan Pantai Baharu
Kuala Lumpur
59900
Malaysia

ORCID ID	0000-0002-9835-6798
Phone	+60198891360
Email	annyee17@um.edu.my

Study information

Study design	Interventional randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Internet/virtual
Study type	Prevention
Participant information sheet	https://chemfunsupport.online/consent
Scientific title	Development of an online intervention to reduce HIV/STI risk and drug use-related harms among stimulant-using MSM in Malaysia
Study objectives	The development of the online intervention will address the worsening HIV epidemic in a subpopulation of MSM in Malaysia. This pilot study will collect the feasibility, acceptability, and preliminary efficacy of ASSIST-Brief Intervention and Chemsex Care Plan to reduce harms related to drug use and sexual risk among MSM.
Ethics approval(s)	Approved 07/09/2020, UMMC Medical Research Ethics Committee (2nd floor, Kompleks Pendidikan Sains Kejururawatan, Pusat Perubatan Universiti Malaya 59100 Kuala Lumpur, Malaysia; +60 3 7949 3209, ummc-mrec@ummc.edu.my), ref: 202092-9036
Health condition(s) or problem(s) studied	Online intervention to reduce HIV/STI risk and drug use-related harms among stimulant-using MSM in Malaysia
Intervention	The study aims to develop a community-based, online intervention to address the mental health and sexual health needs among stimulant-using MSM in Malaysia. Participants will be able to receive peer counselling on drug use and sexual risk reduction, access interactive online education materials to support their recovery, at their own privacy and convenient time. The psychosocial interventions selected for the study (ASSIST-Brief Intervention and Chemsex Care Plan) are rooted in motivational interviewing which is client-oriented and aims to enhance participants’ motivation in changing drug use and risky sexual behaviors, and helps participants establish and meet their goals in reducing both behaviors. The study will be a behavioral intervention trial, whereby eligible participants will be recruited and go through a baseline screening for demographic and health status assessment. After that, they will then be randomly assigned into one of the two groups: (i) Group A will receive the developed intervention tool comprising a Brief Intervention (FRAME Model). An online meeting will be arranged with a trained, peer counsellor to discuss drug use behaviour and to provide support and motivation to change. After the brief counseling, participant will then be directed to the Chemsex Care Plan, a self-directed interactive program that participants can access anytime at their convenience and will provide participants access to online materials (videos, infographics, etc) to educate stimulant-using MSM on reducing risky drug-use behaviour, as well as goal-setting. Participant will be asked to complete a brief survey at 6-week and 12-week follow-up to assess the drug use behavior and motivation to change. (ii) Group B will receive a self-help toolkit from the World Health Organization for cutting down and stopping drug use. Participant is encouraged to use the toolkit to manage their drug use for 12 weeks. Similar to Group A, they will then be asked to complete a follow-up survey after 6 weeks and 12 weeks. After the end of the study, they will be given access to the Chemsex Care Plan. Randomization: Computer-generated (www.randomization.com) Participants who agree to the follow-up study are sent a link and a password (unique password for each participant) to log onto the study website. Those logging on are randomized in 1:1 ratio with no stratification to receive their respective materials.
Intervention type	Behavioural
Primary outcome measure	Stimulant use severity is measured using e-ASSIST (eASSIST; measured at baseline and 12-week follow-up)
Secondary outcome measures	Measured at baseline, 6-week, and 12-week follow-up: 1. Number of days stimulants used in the last 30 days 2. Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)
Overall study start date	01/12/2020
Completion date	30/06/2022

Eligibility

Participant type(s)	Other
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	226
Total final enrolment	154
Key inclusion criteria	1. Being biologically male 2. Aged at least 18 years 3. Engaged in chemsex with other men (defined as using crystal methamphetamine, GBL/GHB, or ecstasy/MDMA) in the past 12 months 4. Capable of understanding and reading English or Malay 5. Willing to be contactable by messaging service for follow-up online surveys
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/10/2021
Date of final enrolment	07/03/2022

Locations

Countries of recruitment

Malaysia

Study participating centre

Centre of Excellence For Research in AIDS, University of Malaya

Level 17, Wisma R&D.
Universiti Malaya
Jalan Pantai Baharu
Kuala Lumpur
59900
Malaysia

Sponsor information

Malaysian Aids Council
Other

No 12, Jalan 13/48A
The Boulevard Shop Office
Off Jalan Sentul
Kuala Lumpur
51000
Malaysia

Phone	+60340474222
Email	contactus@mac.org.my
Website	https://www.mac.org.my/

Funders

Funder type

Charity

Global Fund to Fight AIDS, Tuberculosis and Malaria
Private sector organisation / International organizations

Alternative name(s): Global Fund, Fonds mondial, The Global Fund to Fight AIDS, Tuberculosis and Malaria, Fonds mondial de lutte contre le sida, la tuberculose et le paludisme, The Global Fund, Le Fonds mondial, GFATM
Location: Switzerland

Sustainability of HIV Services for Key Populations in Asia Program (SKPA)

No information available

Results and Publications

Intention to publish date	31/12/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version 2.1	08/03/2022	08/03/2022	No	No
Funder report results			11/07/2023	No	No

Additional files

ISRCTN14406171 Protocol v2.1 08Mar2022.pdf
ISRCTN14406171 CS Study Report Final.pdf

Editorial Notes

11/07/2023: Sponsor report and total final enrolment added.
10/07/2023: The intention to publish date was changed from 31/08/2023 to 31/12/2023.
14/03/2023: The intention to publish date was changed from 31/03/2023 to 31/08/2023.
06/12/2022: The intention to publish date was changed from 31/12/2022 to 31/03/2023.
11/08/2022: The intention to publish date was changed from 31/08/2022 to 31/12/2022.
04/04/2022: The intention to publish date was changed from 30/04/2022 to 31/08/2022.
08/03/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2022 to 07/03/2022.
2. Uploaded protocol (not peer-reviewed) as an additional file.
05/01/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2021 to 31/03/2022.
2. The overall trial end date has been changed from 28/03/2022 to 30/06/2022.
3. The target number of participants and the total target enrolment number have been changed from 150 to 226.
4. Two study contacts haves been updated.
5. The plain English summary has been updated to reflect the changes above.
28/10/2021: Trial's existence confirmed by UMMC Medical Research Ethics Committee