Recruiting

NCT Number: NCT06741306

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.

Recruiting

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Key information

Conditions

ChemSex Users for YMSM

Age range

16 year–35 year

Sex eligibility

Male

Study type

Observational

Primary location

Rainbow Sky Association of Thailand (RSAT), Bangkok, Bangkapi, Thailand

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

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.

Primary outcomes

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:

Time frame: 18 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jakkrapatara Boonruang, MD

CONTACT

[email protected]

6689 965 7862

Nittaya Phanuphak, MD.,PhD

CONTACT

[email protected]

6681 825 3544

Sponsors and collaborators

Lead sponsor

Institute of HIV Research and Innovation Foundation, Thailand

Other

Collaborators

The US NIH through the International Epidemiology Databases to Evaluate AIDS (IeDEA) IeDEA Asia-Pacific
amfAR, The Foundation for AIDS Research

Registry information

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2029
First posted: Dec 18, 2024
Registry last updated: Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed