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

NCT06741306 | Recruiting

• 1 other identifier: IHRI025
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

ChemSex Users for YMSM

Keywords

ChemSex Users

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Group1 BEHAVIORAL

Current chemsex users Men who have sex with men, Aged 16-35 years (defined as last chemsex used within 3 months), Able to communicate in Thai fluently.

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: male
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Current chemsex users

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Institute of HIV Research and Innovation Foundation, Thailand: lead
• The US NIH through the International Epidemiology Databases to Evaluate AIDS (IeDEA) IeDEA Asia-Pacific: collaborator
• amfAR, The Foundation for AIDS Research: collaborator

Study Sites (2)

Rainbow Sky Association of Thailand (RSAT)

Bangkok, Bangkapi, 10240, Thailand

RECRUITING

Foundation for Action on Inclusion Rights (FAIR)

Bangkok, Minburi, 10510, Thailand

RECRUITING

Study Officials

• Siriporn Nonenoy, BNH,MPH

  Institute of HIV Research and Inovation

  STUDY CHAIR

Central Study Contacts

Nittaya Phanuphak, MD.,PhD

CONTACT

6681 825 3544; nittaya.p@ihri.org

Jakkrapatara Boonruang, MD

CONTACT

6689 965 7862; jakkrapatara.b@ihri.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 18, 2024
• Study Start: March 14, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

TH (2)