JomCare Study - A Harm Reduction Study

NCT ID: NCT06794840

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 482 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2029-05-30

Brief Summary

Chemsex, the use of psychoactive drugs before or during sexual activity, is a growing public health concern associated with striking increases in HIV, particularly among men who have sex with men (MSM). This study proposes to optimize an app-based just-in-time adaptive intervention, called JomCare, which aims to reduce chemsex risk by delivering tailored support when a person is most likely to be vulnerable to chemsex risk behaviors and receptive to intervention, with the purpose of reducing risk and averting new HIV infections.

Detailed Description

Chemsex, the use of psychoactive drugs before or during sexual activity, is a growing public health concern due to its association with increased HIV transmission and other harms, particularly among men who have sex with men (MSM). Current estimates suggest that 9-26% of Malaysian MSM participate in chemsex, contributing to recent increases in HIV prevalence. In the absence of evidence-based interventions for chemsex, harm reduction strategies remain the most impactful approach to mitigating chemsex-associated harms. However, getting harm reduction interventions to MSM who engage in chemsex is a major challenge due to the spontaneous and dynamic nature of chemsex risk. Just-in-time adaptive interventions (JITAIs) delivered via smartphones represent a powerful strategy to deliver support by deploying tailored intervention when needed. Specifically, apps that incorporate JITAI can be more effective than traditional app-based interventions by addressing the dynamic nature of chemsex risk and capitalizing on users' changing states of vulnerability (heightened chemsex risk behaviors) and receptivity (willingness to engage in intervention), while also minimizing user burden, disruption, and habituation. Although JITAIs are increasingly being used in domains such as addiction, mental health disorders, physical inactivity, and obesity, research on JITAIs to address chemsex harm reduction is non-existent. In response, a smartphone app-based chemsex harm reduction JITAI called JomCare is developed that uses a machine learning algorithm to determine risk and deliver tailored support as needed. JomCare includes several 'pull' and 'push' intervention components based on the information-motivation-behavioral skills (IMB) model, and has demonstrated high feasibility and utility in our recent pilot work. However, little is known to guide which intervention components should be delivered in specific contexts to achieve maximum benefit, thus indicating the need to optimize JomCare. Framed by the multiphase optimization strategy (MOST) and building on our formative work, this study will optimize JomCare using a micro-randomized trial (MRT) to evaluate: i) which theory-driven intervention components are efficacious in reducing chemsex risk behaviors; and ii) which contexts influence the efficacy of JomCare. Specifically, this study will conduct a 90-day MRT of the JomCare JITAI among 482 chemsex-involved Malaysian MSM. Participants will be randomized twice daily via the app to receive: i) no prompt; ii) a generic engagement prompt; or iii) one of three IMB model-based engagement prompts. The specific aims of this application include: i) Evaluate the effects of any intervention (i.e., theory-driven or generic engagement prompts) versus no intervention on chemsex risk behaviors (proximal outcomes) at subsequent EMAs following randomization; ii) Compare the effects of theory-driven and generic engagement prompts on proximal outcomes; and iii) Examine contextual moderators of intervention on proximal outcomes.

Conditions

HIV; Substance Abuse Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Information-based engagement prompts

Information-based engagement prompts are expected to improve participants' knowledge of harm reduction needs by providing information relevant to HIV (e.g., HIV/STI risk reduction), chemsex (e.g., safer drug use, CAD overdose prevention, drug interactions), and other topics (e.g., mental health).

Group Type: EXPERIMENTAL

JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction.

Intervention Type: BEHAVIORAL

JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) that uses an EMA-based machine learning (ML) algorithm to anticipate chemsex risk and deliver appropriate chemsex-related harm reduction and HIV prevention services when the risk is detected.

Motivation-based engagement prompts

Motivation-based engagement prompts are expected to increase the salience of participants' beliefs about the importance of their harm reduction needs.

Group Type: EXPERIMENTAL

JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction.

Intervention Type: BEHAVIORAL

JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) that uses an EMA-based machine learning (ML) algorithm to anticipate chemsex risk and deliver appropriate chemsex-related harm reduction and HIV prevention services when the risk is detected.

Behavioral skills-based engagement prompts

Behavioral skills-based engagement prompts are expected to improve self-efficacy and the ability to engage in intervention.

Group Type: EXPERIMENTAL

JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction.

Intervention Type: BEHAVIORAL

JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) that uses an EMA-based machine learning (ML) algorithm to anticipate chemsex risk and deliver appropriate chemsex-related harm reduction and HIV prevention services when the risk is detected.

Generic engagement prompts

Generic engagement prompts are included as active comparators to the theory-driven components, as they control for the potential influence of receiving any engagement prompts. Given the aim to optimize JITAI, including generic prompts provides the mechanism for distinguishing the effects of receiving any prompt from the theory-driven prompts.

Group Type: ACTIVE_COMPARATOR

JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction.

Intervention Type: BEHAVIORAL

JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) that uses an EMA-based machine learning (ML) algorithm to anticipate chemsex risk and deliver appropriate chemsex-related harm reduction and HIV prevention services when the risk is detected.

No engagement prompt

No engagement prompt is included as an inactive comparator. Participants will not receive any prompt when randomized to this group. Inclusion of the "no engagement prompt" will control for the potential impact of being notified of heightened risk, which could activate any pre-existing strategies to reduce or prevent risk.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction.

JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) that uses an EMA-based machine learning (ML) algorithm to anticipate chemsex risk and deliver appropriate chemsex-related harm reduction and HIV prevention services when the risk is detected.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years;
• Cisgender man;
• HIV-negative or HIV status unknown;
• Having engaged in "chemsex" in the past 12 months (defined as using CAD, including crystal methamphetamine, mephedrone, GBL/GHB, and/or ecstasy/MDMA)
• Own a smartphone

Exclusion Criteria

• Unable to provide informed consent
• Enrolled in drug rehabilitation, substance use treatment, and narcotics or other behavioral intervention-based treatment
• Unable to read and understand English or Bahasa Malaysia

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Malaya

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

University of Texas at Tyler

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Roman Shrestha

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roman Shrestha, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

University of Malaya

Kuala Lumpur, , Malaysia

Countries

Malaysia

Central Contacts

Kamal Gautam, MPH

Role: CONTACT

kamal.gautam@uconn.edu

860-486-2834

Facility Contacts

Iskandar Azwa, MD

Role: primary

iskandar.azwa@um.edu.my

03-2246 3383

References

Shrestha R, Lim SH, Altice FL, Copenhaver M, Wickersham JA, Saifi R, Ab Halim MA, Naning H, Kamarulzaman A. Use of Smartphone to Seek Sexual Health Information Online Among Malaysian Men Who Have Sex with Men (MSM): Implications for mHealth Intervention to Increase HIV Testing and Reduce HIV Risks. J Community Health. 2020 Feb;45(1):10-19. doi: 10.1007/s10900-019-00713-x.

Reference Type: BACKGROUND

PMID: 31375976 (View on PubMed)

Rabbi M, Philyaw Kotov M, Cunningham R, Bonar EE, Nahum-Shani I, Klasnja P, Walton M, Murphy S. Toward Increasing Engagement in Substance Use Data Collection: Development of the Substance Abuse Research Assistant App and Protocol for a Microrandomized Trial Using Adolescents and Emerging Adults. JMIR Res Protoc. 2018 Jul 18;7(7):e166. doi: 10.2196/resprot.9850.

Reference Type: BACKGROUND

PMID: 30021714 (View on PubMed)

Other Identifiers

R01DA061661

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-047-910

Identifier Type: -

Identifier Source: org_study_id