HIVJomCareNCT06794840
JomCare Study - A Harm Reduction Study
A study testing JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction. in people with HIV and Substance Abuse Disorder, run by University of Connecticut at 1 site in Malaysia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Substance Abuse Disorder
- What is being tested?
- JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Nov 2026to 30 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
University of Malaya
Kuala Lumpur
Iskandar Azwa, MD, 03-2246 3383, iskandar.azwa@um.edu.my
About this study
Official title: Optimizing a Just-in-Time Adaptive Intervention to Increase Uptake of Chemsex Harm Reduction Services in MSM: A Micro-randomized Trial
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.
Read the 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
- Being tested
- JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction.
- Keywords
- HIV, mHealth, JITAI, Chemsex
- Medical subject headings
- Substance-Related Disorders, Chemsex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction.Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants engaged in chemsex risk behavior
Use of chemsex-associated drugs, engagement in condomless anal sex, CAD overdose since the last EMA
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Nov 2026 (estimated)
- Primary completion30 May 2029 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya, Yale University, National Institute on Drug Abuse (NIDA), University of Michigan, University of Texas at Tyler, Ohio State University
- Responsible party
- Principal investigator, Roman Shrestha, University of Connecticut
- Investigators
- Roman Shrestha, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794840
- Sponsor's protocol ID
- 24-047-910
- Other IDs
- R01DA061661
- Acronym
- JomCare
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31375976Rabbi 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.
PubMed 30021714
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Just-in-Time Adaptive Intervention to Increase Uptake of Chemsex Harm Reduction Services in MSM: A Micro-randomized Trial
- ClinicalTrials.gov ID
- NCT06794840
- Acronym / sponsor ID
- JomCare / 24-047-910
- Conditions
- HIV, Substance Abuse Disorder
- Keywords
- HIV, mHealth, JITAI, Chemsex
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 482 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- University of Malaya, Yale University, National Institute on Drug Abuse (NIDA), University of Michigan, University of Texas at Tyler, Ohio State University
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Information-based engagement prompts | Experimental | Behavioral: JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction.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). |
| Motivation-based engagement prompts | Experimental | Behavioral: JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction.Motivation-based engagement prompts are expected to increase the salience of participants' beliefs about the importance of their harm reduction needs. |
| Behavioral skills-based engagement prompts | Experimental | Behavioral: JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction.Behavioral skills-based engagement prompts are expected to improve self-efficacy and the ability to engage in intervention. |
| Generic engagement prompts | Active comparator | Behavioral: JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction.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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Behavioral skills-based engagement prompts, Generic engagement prompts, Information-based engagement prompts, Motivation-based engagement prompts |
Primary outcome
Number of participants engaged in chemsex risk behavior
Time frame: Up to 6 months
Use of chemsex-associated drugs, engagement in condomless anal sex, CAD overdose since the last EMA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Results publication: PubMed 31375976Shrestha 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.
- Results publication: PubMed 30021714Rabbi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roman Shrestha, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction. in people with HIV and Substance Abuse Disorder, run by University of Connecticut at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kamal Gautam, MPH (860-486-2834, kamal.gautam@uconn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants engaged in chemsex risk behavior (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06794840, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.