Clinical trial NCT06794840: JomCare Study - A Harm Reduction Study
Official title: Optimizing a Just-in-Time Adaptive Intervention to Increase Uptake of Chemsex Harm Reduction Services in MSM: A Micro-randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Substance Abuse Disorder
Keywords: HIV
mHealth
JITAI
Chemsex
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: University of Malaya
name: Yale University
name: National Institute on Drug Abuse (NIDA)
name: University of Michigan
name: University of Texas at Tyler
name: Ohio State University
First posted: 2025-01-27
Enrollment: 482
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of participants engaged in chemsex risk behavior
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
Study officials:
affiliation: University of Connecticut
name: Roman Shrestha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.