Comprehensive Assessment in a Longitudinal Study on Young Men Who Have Sex With Men Attracting to chemseX-2

CLYMAX is a two-phase observational study that assess multiple aspects of chemsex and young men who have sex with men (YMSM).

Phase I of the study (CLYMAX,IRB No. 0695/65) was a cross-sectional descriptive study using a mixed methods data collection (focusing on qualitative data collection) assessing multiple aspects of chemsex, including the patterns of chemsex use and the perspectives on factors influencing chemsex initiation/discontinuation, effects on physical health, mental health and social outcomes, and the necessary services for a comprehensive chemsex clinic among YMSM; and the acceptability and feasibility of developing a comprehensive chemsex clinic from the perspective of YMSM, their family members or peers, and clinic staff.

This phase II study (CLYMAX-2) will be a prospective cohort study using a quantitative data collection exploring the effectiveness of the implementation strategy of harm reduction models and consist of a larger number of YMSM, important baseline and follow-up information on multiple aspects of physical, psychological, and social harms.

Study Overview

• Status: Recruiting
• Conditions: ChemSex Users for YMSM
• Intervention / Treatment: Behavioral: Group1

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Nittaya Phanuphak, MD.,PhD; Phone Number: 6681 825 3544; Email: nittaya.p@ihri.org
• Study Contact Backup: Name: Jakkrapatara Boonruang, MD; Phone Number: 6689 965 7862; Email: jakkrapatara.b@ihri.org

Study Locations

• Thailand
  • Bangkapi
    • Bangkok, Bangkapi, Thailand, 10240
      • Recruiting
      • Rainbow Sky Association of Thailand (RSAT)
      • Contact: Tanachai Chaisalee; Phone Number: 6683 897 1691; Email: tanachai@rsat.info
  • Minburi
    • Bangkok, Minburi, Thailand, 10510
      • Recruiting
      • Foundation for Action on Inclusion Rights (FAIR)
      • Contact: Jarunee Siriphan; Phone Number: 6684 899 2772; Email: jarunee.siriphan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Current chemsex users

Description

Inclusion Criteria:

1. Men who have sex with men
2. Aged 16-35 years
3. Current chemsex users (defined as last chemsex used within 3 months)
4. Able to read and communicate in Thai
5. Provide informed consent

Exclusion Criteria:

None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The study outcomes of phase II can be broadly categorized into implementation outcomes include the prevalence and incidence of physical, psychological, and social harms which will be evaluated by laboratory or self-reported assessments as follows:	STIs testing including HIV (either HIV self-testing or facility-based HIV testing), HCV, HBV, gonorrhea, chlamydia, and syphilis will be offered at baseline and month 6. It will be optional for participants to decide whether to undergo the testing. Behavioral risk, substance use, mental health, quality of life, and criminality assessments will be conducted at every visit. Categorical data will be summarized as frequencies and percentages, while continuous data will be summarized as means and standard deviations or medians and interquartile ranges, as appropriate. In addition to describing the cohort, mixed-effects regression models will be used to assess temporal changes in each health outcome. Linear models will be applied for continuous outcomes (such as changes in depression, anxiety, and quality of life scores), and logistic models will be used for dichotomous outcomes.	18 months

Collaborators and Investigators

• Sponsor: Institute of HIV Research and Innovation Foundation, Thailand
• Collaborators: amfAR, The Foundation for AIDS Research; The US NIH through the International Epidemiology Databases to Evaluate AIDS (IeDEA) IeDEA Asia-Pacific
• Investigators: Study Chair: Siriporn Nonenoy, BNH,MPH, Institute of HIV Research and Inovation

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ChemSex Users
• Other Study ID Numbers: IHRI025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No