JomCare Study - A Harm Reduction Study

NCT06794840 | Not Yet Recruiting DMC

• 2 other identifiers: 24-047-910R01DA061661
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Substance Abuse Disorder

Keywords

HIV; mHealth; JITAI; Chemsex

Outcome Measures

Primary Outcomes (1)

• Number of participants engaged in chemsex risk behavior

  Use of chemsex-associated drugs, engagement in condomless anal sex, CAD overdose since the last EMA

  Up to 6 months

Study Arms (5)

Information-based engagement prompts

EXPERIMENTAL

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).

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

Motivation-based engagement prompts

EXPERIMENTAL

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

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

Behavioral skills-based engagement prompts

EXPERIMENTAL

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

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

Generic engagement prompts

ACTIVE COMPARATOR

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.

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

No engagement prompt

NO INTERVENTION

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.

Interventions

JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction. 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; Generic engagement prompts; Information-based engagement prompts; Motivation-based engagement prompts

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender man
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• University of Texas at Tyler: collaborator
• Ohio State University: collaborator
• University of Connecticut: lead
• University of Malaya: collaborator
• Yale University: collaborator
• University of Michigan: collaborator

Study Sites (1)

University of Malaya

Kuala Lumpur, Malaysia

Location

Related Publications (2)

• 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.

  PMID: 31375976 RESULT

• 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.

  PMID: 30021714 RESULT

MeSH Terms

Conditions

Substance-Related Disorders; Chemsex

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Sexual Behavior; Behavior

Study Officials

• Roman Shrestha, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamal Gautam, MPH

CONTACT

860-486-2834; kamal.gautam@uconn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 27, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): May 30, 2029
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

MY (1)